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Preamble (Recitals)
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(1)
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, the placing on the market, the putting into service and the use of artificial intelligence systems (AI systems) in the Union, in accordance with Union values, to promote the uptake of human centric and trustworthy artificial intelligence (AI) while ensuring a high level of protection of health, safety, fundamental rights as enshrined in the Charter of Fundamental Rights of the European Union (the ‘Charter’), including democracy, the rule of law and environmental protection, to protect against the harmful effects of AI systems in the Union, and to support innovation. This Regulation ensures the free movement, cross-border, of AI-based goods and services, thus preventing Member States from imposing restrictions on the development, marketing and use of AI systems, unless explicitly authorised by this Regulation.
(2)
This Regulation should be applied in accordance with the values of the Union enshrined as in the Charter, facilitating the protection of natural persons, undertakings, democracy, the rule of law and environmental protection, while boosting innovation and employment and making the Union a leader in the uptake of trustworthy AI.
(3)
AI systems can be easily deployed in a large variety of sectors of the economy and many parts of society, including across borders, and can easily circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that AI is trustworthy and safe and is developed and used in accordance with fundamental rights obligations. Diverging national rules may lead to the fragmentation of the internal market and may decrease legal certainty for operators that develop, import or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured in order to achieve trustworthy AI, while divergences hampering the free circulation, innovation, deployment and the uptake of AI systems and related products and services within the internal market should be prevented by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market on the basis of Article 114 of the Treaty on the Functioning of the European Union (TFEU). To the extent that this Regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of AI systems for remote biometric identification for the purpose of law enforcement, of the use of AI systems for risk assessments of natural persons for the purpose of law enforcement and of the use of AI systems of biometric categorisation for the purpose of law enforcement, it is appropriate to base this Regulation, in so far as those specific rules are concerned, on Article 16 TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection Board.
(4)
AI is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal benefits across the entire spectrum of industries and social activities. By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of AI can provide key competitive advantages to undertakings and support socially and environmentally beneficial outcomes, for example in healthcare, agriculture, food safety, education and training, media, sports, culture, infrastructure management, energy, transport and logistics, public services, security, justice, resource and energy efficiency, environmental monitoring, the conservation and restoration of biodiversity and ecosystems and climate change mitigation and adaptation.
(5)
At the same time, depending on the circumstances regarding its specific application, use, and level of technological development, AI may generate risks and cause harm to public interests and fundamental rights that are protected by Union law. Such harm might be material or immaterial, including physical, psychological, societal or economic harm.
(6)
Given the major impact that AI can have on society and the need to build trust, it is vital for AI and its regulatory framework to be developed in accordance with Union values as enshrined in Article 2 of the Treaty on European Union (TEU), the fundamental rights and freedoms enshrined in the Treaties and, pursuant to Article 6 TEU, the Charter. As a prerequisite, AI should be a human-centric technology. It should serve as a tool for people, with the ultimate aim of increasing human well-being.
(7)
In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common rules for high-risk AI systems should be established. Those rules should be consistent with the Charter, non-discriminatory and in line with the Union’s international trade commitments. They should also take into account the European Declaration on Digital Rights and Principles for the Digital Decade and the Ethics guidelines for trustworthy AI of the High-Level Expert Group on Artificial Intelligence (AI HLEG).
(8)
A Union legal framework laying down harmonised rules on AI is therefore needed to foster the development, use and uptake of AI in the internal market that at the same time meets a high level of protection of public interests, such as health and safety and the protection of fundamental rights, including democracy, the rule of law and environmental protection as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market, the putting into service and the use of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. Those rules should be clear and robust in protecting fundamental rights, supportive of new innovative solutions, enabling a European ecosystem of public and private actors creating AI systems in line with Union values and unlocking the potential of the digital transformation across all regions of the Union. By laying down those rules as well as measures in support of innovation with a particular focus on small and medium enterprises (SMEs), including startups, this Regulation supports the objective of promoting the European human-centric approach to AI and being a global leader in the development of secure, trustworthy and ethical AI as stated by the European Council(), and it ensures the protection of ethical principles, as specifically requested by the European Parliament().
(9)
Harmonised rules applicable to the placing on the market, the putting into service and the use of high-risk AI systems should be laid down consistently with Regulation (EC) No 765/2008 of the European Parliament and of the Council(), Decision No 768/2008/EC of the European Parliament and of the Council()and Regulation (EU) 2019/1020 of the European Parliament and of the Council()(New Legislative Framework). The harmonised rules laid down in this Regulation should apply across sectors and, in line with the New Legislative Framework, should be without prejudice to existing Union law, in particular on data protection, consumer protection, fundamental rights, employment, and protection of workers, and product safety, to which this Regulation is complementary. As a consequence, all rights and remedies provided for by such Union law to consumers, and other persons on whom AI systems may have a negative impact, including as regards the compensation of possible damages pursuant to Council Directive 85/374/EEC()remain unaffected and fully applicable. Furthermore, in the context of employment and protection of workers, this Regulation should therefore not affect Union law on social policy and national labour law, in compliance with Union law, concerning employment and working conditions, including health and safety at work and the relationship between employers and workers. This Regulation should also not affect the exercise of fundamental rights as recognised in the Member States and at Union level, including the right or freedom to strike or to take other action covered by the specific industrial relations systems in Member States as well as the right to negotiate, to conclude and enforce collective agreements or to take collective action in accordance with national law. This Regulation should not affect the provisions aiming to improve working conditions in platform work laid down in a Directive of the European Parliament and of the Council on improving working conditions in platform work. Moreover, this Regulation aims to strengthen the effectiveness of such existing rights and remedies by establishing specific requirements and obligations, including in respect of the transparency, technical documentation and record-keeping of AI systems. Furthermore, the obligations placed on various operators involved in the AI value chain under this Regulation should apply without prejudice to national law, in compliance with Union law, having the effect of limiting the use of certain AI systems where such law falls outside the scope of this Regulation or pursues legitimate public interest objectives other than those pursued by this Regulation. For example, national labour law and law on the protection of minors, namely persons below the age of 18, taking into account the UNCRC General Comment No 25 (2021) on children’s rights in relation to the digital environment, insofar as they are not specific to AI systems and pursue other legitimate public interest objectives, should not be affected by this Regulation.
(10)
The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679()and (EU) 2018/1725()of the European Parliament and of the Council and Directive (EU) 2016/680 of the European Parliament and of the Council(). Directive 2002/58/EC of the European Parliament and of the Council()additionally protects private life and the confidentiality of communications, including by way of providing conditions for any storing of personal and non-personal data in, and access from, terminal equipment. Those Union legal acts provide the basis for sustainable and responsible data processing, including where data sets include a mix of personal and non-personal data. This Regulation does not seek to affect the application of existing Union law governing the processing of personal data, including the tasks and powers of the independent supervisory authorities competent to monitor compliance with those instruments. It also does not affect the obligations of providers and deployers of AI systems in their role as data controllers or processors stemming from Union or national law on the protection of personal data in so far as the design, the development or the use of AI systems involves the processing of personal data. It is also appropriate to clarify that data subjects continue to enjoy all the rights and guarantees awarded to them by such Union law, including the rights related to solely automated individual decision-making, including profiling. Harmonised rules for the placing on the market, the putting into service and the use of AI systems established under this Regulation should facilitate the effective implementation and enable the exercise of the data subjects’ rights and other remedies guaranteed under Union law on the protection of personal data and of other fundamental rights.
(11)
This Regulation should be without prejudice to the provisions regarding the liability of providers of intermediary services as set out in Regulation (EU) 2022/2065 of the European Parliament and of the Council().
(12)
The notion of ‘AI system’ in this Regulation should be clearly defined and should be closely aligned with the work of international organisations working on AI to ensure legal certainty, facilitate international convergence and wide acceptance, while providing the flexibility to accommodate the rapid technological developments in this field. Moreover, the definition should be based on key characteristics of AI systems that distinguish it from simpler traditional software systems or programming approaches and should not cover systems that are based on the rules defined solely by natural persons to automatically execute operations. A key characteristic of AI systems is their capability to infer. This capability to infer refers to the process of obtaining the outputs, such as predictions, content, recommendations, or decisions, which can influence physical and virtual environments, and to a capability of AI systems to derive models or algorithms, or both, from inputs or data. The techniques that enable inference while building an AI system include machine learning approaches that learn from data how to achieve certain objectives, and logic- and knowledge-based approaches that infer from encoded knowledge or symbolic representation of the task to be solved. The capacity of an AI system to infer transcends basic data processing by enabling learning, reasoning or modelling. The term ‘machine-based’ refers to the fact that AI systems run on machines. The reference to explicit or implicit objectives underscores that AI systems can operate according to explicit defined objectives or to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system in a specific context. For the purposes of this Regulation, environments should be understood to be the contexts in which the AI systems operate, whereas outputs generated by the AI system reflect different functions performed by AI systems and include predictions, content, recommendations or decisions. AI systems are designed to operate with varying levels of autonomy, meaning that they have some degree of independence of actions from human involvement and of capabilities to operate without human intervention. The adaptiveness that an AI system could exhibit after deployment, refers to self-learning capabilities, allowing the system to change while in use. AI systems can be used on a stand-alone basis or as a component of a product, irrespective of whether the system is physically integrated into the product (embedded) or serves the functionality of the product without being integrated therein (non-embedded).
(13)
The notion of ‘deployer’ referred to in this Regulation should be interpreted as any natural or legal person, including a public authority, agency or other body, using an AI system under its authority, except where the AI system is used in the course of a personal non-professional activity. Depending on the type of AI system, the use of the system may affect persons other than the deployer.
(14)
The notion of ‘biometric data’ used in this Regulation should be interpreted in light of the notion of biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679, Article 3, point (18) of Regulation (EU) 2018/1725 and Article 3, point (13) of Directive (EU) 2016/680. Biometric data can allow for the authentication, identification or categorisation of natural persons and for the recognition of emotions of natural persons.
(15)
The notion of ‘biometric identification’ referred to in this Regulation should be defined as the automated recognition of physical, physiological and behavioural human features such as the face, eye movement, body shape, voice, prosody, gait, posture, heart rate, blood pressure, odour, keystrokes characteristics, for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a reference database, irrespective of whether the individual has given its consent or not. This excludes AI systems intended to be used for biometric verification, which includes authentication, whose sole purpose is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having security access to premises.
(16)
The notion of ‘biometric categorisation’ referred to in this Regulation should be defined as assigning natural persons to specific categories on the basis of their biometric data. Such specific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos, behavioural or personality traits, language, religion, membership of a national minority, sexual or political orientation. This does not include biometric categorisation systems that are a purely ancillary feature intrinsically linked to another commercial service, meaning that the feature cannot, for objective technical reasons, be used without the principal service, and the integration of that feature or functionality is not a means to circumvent the applicability of the rules of this Regulation. For example, filters categorising facial or body features used on online marketplaces could constitute such an ancillary feature as they can be used only in relation to the principal service which consists in selling a product by allowing the consumer to preview the display of the product on him or herself and help the consumer to make a purchase decision. Filters used on online social network services which categorise facial or body features to allow users to add or modify pictures or videos could also be considered to be ancillary feature as such filter cannot be used without the principal service of the social network services consisting in the sharing of content online.
(17)
The notion of ‘remote biometric identification system’ referred to in this Regulation should be defined functionally, as an AI system intended for the identification of natural persons without their active involvement, typically at a distance, through the comparison of a person’s biometric data with the biometric data contained in a reference database, irrespectively of the particular technology, processes or types of biometric data used. Such remote biometric identification systems are typically used to perceive multiple persons or their behaviour simultaneously in order to facilitate significantly the identification of natural persons without their active involvement. This excludes AI systems intended to be used for biometric verification, which includes authentication, the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having security access to premises. That exclusion is justified by the fact that such systems are likely to have a minor impact on fundamental rights of natural persons compared to the remote biometric identification systems which may be used for the processing of the biometric data of a large number of persons without their active involvement. In the case of ‘real-time’ systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems concerned by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or ‘near-live’ material, such as video footage, generated by a camera or other device with similar functionality. In the case of ‘post’ systems, in contrast, the biometric data has already been captured and the comparison and identification occur only after a significant delay. This involves material, such as pictures or video footage generated by closed circuit television cameras or private devices, which has been generated before the use of the system in respect of the natural persons concerned.
(18)
The notion of ‘emotion recognition system’ referred to in this Regulation should be defined as an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data. The notion refers to emotions or intentions such as happiness, sadness, anger, surprise, disgust, embarrassment, excitement, shame, contempt, satisfaction and amusement. It does not include physical states, such as pain or fatigue, including, for example, systems used in detecting the state of fatigue of professional pilots or drivers for the purpose of preventing accidents. This does also not include the mere detection of readily apparent expressions, gestures or movements, unless they are used for identifying or inferring emotions. Those expressions can be basic facial expressions, such as a frown or a smile, or gestures such as the movement of hands, arms or head, or characteristics of a person’s voice, such as a raised voice or whispering.
(19)
For the purposes of this Regulation the notion of ‘publicly accessible space’ should be understood as referring to any physical space that is accessible to an undetermined number of natural persons, and irrespective of whether the space in question is privately or publicly owned, irrespective of the activity for which the space may be used, such as for commerce, for example, shops, restaurants, cafés; for services, for example, banks, professional activities, hospitality; for sport, for example, swimming pools, gyms, stadiums; for transport, for example, bus, metro and railway stations, airports, means of transport; for entertainment, for example, cinemas, theatres, museums, concert and conference halls; or for leisure or otherwise, for example, public roads and squares, parks, forests, playgrounds. A space should also be classified as being publicly accessible if, regardless of potential capacity or security restrictions, access is subject to certain predetermined conditions which can be fulfilled by an undetermined number of persons, such as the purchase of a ticket or title of transport, prior registration or having a certain age. In contrast, a space should not be considered to be publicly accessible if access is limited to specific and defined natural persons through either Union or national law directly related to public safety or security or through the clear manifestation of will by the person having the relevant authority over the space. The factual possibility of access alone, such as an unlocked door or an open gate in a fence, does not imply that the space is publicly accessible in the presence of indications or circumstances suggesting the contrary, such as. signs prohibiting or restricting access. Company and factory premises, as well as offices and workplaces that are intended to be accessed only by relevant employees and service providers, are spaces that are not publicly accessible. Publicly accessible spaces should not include prisons or border control. Some other spaces may comprise both publicly accessible and non-publicly accessible spaces, such as the hallway of a private residential building necessary to access a doctor’s office or an airport. Online spaces are not covered, as they are not physical spaces. Whether a given space is accessible to the public should however be determined on a case-by-case basis, having regard to the specificities of the individual situation at hand.
(20)
In order to obtain the greatest benefits from AI systems while protecting fundamental rights, health and safety and to enable democratic control, AI literacy should equip providers, deployers and affected persons with the necessary notions to make informed decisions regarding AI systems. Those notions may vary with regard to the relevant context and can include understanding the correct application of technical elements during the AI system’s development phase, the measures to be applied during its use, the suitable ways in which to interpret the AI system’s output, and, in the case of affected persons, the knowledge necessary to understand how decisions taken with the assistance of AI will have an impact on them. In the context of the application this Regulation, AI literacy should provide all relevant actors in the AI value chain with the insights required to ensure the appropriate compliance and its correct enforcement. Furthermore, the wide implementation of AI literacy measures and the introduction of appropriate follow-up actions could contribute to improving working conditions and ultimately sustain the consolidation, and innovation path of trustworthy AI in the Union. The European Artificial Intelligence Board (the ‘Board’) should support the Commission, to promote AI literacy tools, public awareness and understanding of the benefits, risks, safeguards, rights and obligations in relation to the use of AI systems. In cooperation with the relevant stakeholders, the Commission and the Member States should facilitate the drawing up of voluntary codes of conduct to advance AI literacy among persons dealing with the development, operation and use of AI.
(21)
In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory manner, irrespective of whether they are established within the Union or in a third country, and to deployers of AI systems established within the Union.
(22)
In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are not placed on the market, put into service, or used in the Union. This is the case, for example, where an operator established in the Union contracts certain services to an operator established in a third country in relation to an activity to be performed by an AI system that would qualify as high-risk. In those circumstances, the AI system used in a third country by the operator could process data lawfully collected in and transferred from the Union, and provide to the contracting operator in the Union the output of that AI system resulting from that processing, without that AI system being placed on the market, put into service or used in the Union. To prevent the circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this Regulation should also apply to providers and deployers of AI systems that are established in a third country, to the extent the output produced by those systems is intended to be used in the Union. Nonetheless, to take into account existing arrangements and special needs for future cooperation with foreign partners with whom information and evidence is exchanged, this Regulation should not apply to public authorities of a third country and international organisations when acting in the framework of cooperation or international agreements concluded at Union or national level for law enforcement and judicial cooperation with the Union or the Member States, provided that the relevant third country or international organisation provides adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Where relevant, this may cover activities of entities entrusted by the third countries to carry out specific tasks in support of such law enforcement and judicial cooperation. Such framework for cooperation or agreements have been established bilaterally between Member States and third countries or between the European Union, Europol and other Union agencies and third countries and international organisations. The authorities competent for supervision of the law enforcement and judicial authorities under this Regulation should assess whether those frameworks for cooperation or international agreements include adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Recipient national authorities and Union institutions, bodies, offices and agencies making use of such outputs in the Union remain accountable to ensure their use complies with Union law. When those international agreements are revised or new ones are concluded in the future, the contracting parties should make utmost efforts to align those agreements with the requirements of this Regulation.
(23)
This Regulation should also apply to Union institutions, bodies, offices and agencies when acting as a provider or deployer of an AI system.
(24)
If, and insofar as, AI systems are placed on the market, put into service, or used with or without modification of such systems for military, defence or national security purposes, those should be excluded from the scope of this Regulation regardless of which type of entity is carrying out those activities, such as whether it is a public or private entity. As regards military and defence purposes, such exclusion is justified both by Article 4(2) TEU and by the specificities of the Member States’ and the common Union defence policy covered by Chapter 2 of Title V TEU that are subject to public international law, which is therefore the more appropriate legal framework for the regulation of AI systems in the context of the use of lethal force and other AI systems in the context of military and defence activities. As regards national security purposes, the exclusion is justified both by the fact that national security remains the sole responsibility of Member States in accordance with Article 4(2) TEU and by the specific nature and operational needs of national security activities and specific national rules applicable to those activities. Nonetheless, if an AI system developed, placed on the market, put into service or used for military, defence or national security purposes is used outside those temporarily or permanently for other purposes, for example, civilian or humanitarian purposes, law enforcement or public security purposes, such a system would fall within the scope of this Regulation. In that case, the entity using the AI system for other than military, defence or national security purposes should ensure the compliance of the AI system with this Regulation, unless the system is already compliant with this Regulation. AI systems placed on the market or put into service for an excluded purpose, namely military, defence or national security, and one or more non-excluded purposes, such as civilian purposes or law enforcement, fall within the scope of this Regulation and providers of those systems should ensure compliance with this Regulation. In those cases, the fact that an AI system may fall within the scope of this Regulation should not affect the possibility of entities carrying out national security, defence and military activities, regardless of the type of entity carrying out those activities, to use AI systems for national security, military and defence purposes, the use of which is excluded from the scope of this Regulation. An AI system placed on the market for civilian or law enforcement purposes which is used with or without modification for military, defence or national security purposes should not fall within the scope of this Regulation, regardless of the type of entity carrying out those activities.
(25)
This Regulation should support innovation, should respect freedom of science, and should not undermine research and development activity. It is therefore necessary to exclude from its scope AI systems and models specifically developed and put into service for the sole purpose of scientific research and development. Moreover, it is necessary to ensure that this Regulation does not otherwise affect scientific research and development activity on AI systems or models prior to being placed on the market or put into service. As regards product-oriented research, testing and development activity regarding AI systems or models, the provisions of this Regulation should also not apply prior to those systems and models being put into service or placed on the market. That exclusion is without prejudice to the obligation to comply with this Regulation where an AI system falling into the scope of this Regulation is placed on the market or put into service as a result of such research and development activity and to the application of provisions on AI regulatory sandboxes and testing in real world conditions. Furthermore, without prejudice to the exclusion of AI systems specifically developed and put into service for the sole purpose of scientific research and development, any other AI system that may be used for the conduct of any research and development activity should remain subject to the provisions of this Regulation. In any event, any research and development activity should be carried out in accordance with recognised ethical and professional standards for scientific research and should be conducted in accordance with applicable Union law.
(26)
In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain unacceptable AI practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems.
(27)
While the risk-based approach is the basis for a proportionate and effective set of binding rules, it is important to recall the 2019 Ethics guidelines for trustworthy AI developed by the independent AI HLEG appointed by the Commission. In those guidelines, the AI HLEG developed seven non-binding ethical principles for AI which are intended to help ensure that AI is trustworthy and ethically sound. The seven principles include human agency and oversight; technical robustness and safety; privacy and data governance; transparency; diversity, non-discrimination and fairness; societal and environmental well-being and accountability. Without prejudice to the legally binding requirements of this Regulation and any other applicable Union law, those guidelines contribute to the design of coherent, trustworthy and human-centric AI, in line with the Charter and with the values on which the Union is founded. According to the guidelines of the AI HLEG, human agency and oversight means that AI systems are developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans. Technical robustness and safety means that AI systems are developed and used in a way that allows robustness in the case of problems and resilience against attempts to alter the use or performance of the AI system so as to allow unlawful use by third parties, and minimise unintended harm. Privacy and data governance means that AI systems are developed and used in accordance with privacy and data protection rules, while processing data that meets high standards in terms of quality and integrity. Transparency means that AI systems are developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact with an AI system, as well as duly informing deployers of the capabilities and limitations of that AI system and affected persons about their rights. Diversity, non-discrimination and fairness means that AI systems are developed and used in a way that includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding discriminatory impacts and unfair biases that are prohibited by Union or national law. Social and environmental well-being means that AI systems are developed and used in a sustainable and environmentally friendly manner as well as in a way to benefit all human beings, while monitoring and assessing the long-term impacts on the individual, society and democracy. The application of those principles should be translated, when possible, in the design and use of AI models. They should in any case serve as a basis for the drafting of codes of conduct under this Regulation. All stakeholders, including industry, academia, civil society and standardisation organisations, are encouraged to take into account, as appropriate, the ethical principles for the development of voluntary best practices and standards.
(28)
Aside from the many beneficial uses of AI, it can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particularly harmful and abusive and should be prohibited because they contradict Union values of respect for human dignity, freedom, equality, democracy and the rule of law and fundamental rights enshrined in the Charter, including the right to non-discrimination, to data protection and to privacy and the rights of the child.
(29)
AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to deceive them by nudging them into decisions in a way that subverts and impairs their autonomy, decision-making and free choices. The placing on the market, the putting into service or the use of certain AI systems with the objective to or the effect of materially distorting human behaviour, whereby significant harms, in particular having sufficiently important adverse impacts on physical, psychological health or financial interests are likely to occur, are particularly dangerous and should therefore be prohibited. Such AI systems deploy subliminal components such as audio, image, video stimuli that persons cannot perceive, as those stimuli are beyond human perception, or other manipulative or deceptive techniques that subvert or impair person’s autonomy, decision-making or free choice in ways that people are not consciously aware of those techniques or, where they are aware of them, can still be deceived or are not able to control or resist them. This could be facilitated, for example, by machine-brain interfaces or virtual reality as they allow for a higher degree of control of what stimuli are presented to persons, insofar as they may materially distort their behaviour in a significantly harmful manner. In addition, AI systems may also otherwise exploit the vulnerabilities of a person or a specific group of persons due to their age, disability within the meaning of Directive (EU) 2019/882 of the European Parliament and of the Council(), or a specific social or economic situation that is likely to make those persons more vulnerable to exploitation such as persons living in extreme poverty, ethnic or religious minorities. Such AI systems can be placed on the market, put into service or used with the objective to or the effect of materially distorting the behaviour of a person and in a manner that causes or is reasonably likely to cause significant harm to that or another person or groups of persons, including harms that may be accumulated over time and should therefore be prohibited. It may not be possible to assume that there is an intention to distort behaviour where the distortion results from factors external to the AI system which are outside the control of the provider or the deployer, namely factors that may not be reasonably foreseeable and therefore not possible for the provider or the deployer of the AI system to mitigate. In any case, it is not necessary for the provider or the deployer to have the intention to cause significant harm, provided that such harm results from the manipulative or exploitative AI-enabled practices. The prohibitions for such AI practices are complementary to the provisions contained in Directive 2005/29/EC of the European Parliament and of the Council(), in particular unfair commercial practices leading to economic or financial harms to consumers are prohibited under all circumstances, irrespective of whether they are put in place through AI systems or otherwise. The prohibitions of manipulative and exploitative practices in this Regulation should not affect lawful practices in the context of medical treatment such as psychological treatment of a mental disease or physical rehabilitation, when those practices are carried out in accordance with the applicable law and medical standards, for example explicit consent of the individuals or their legal representatives. In addition, common and legitimate commercial practices, for example in the field of advertising, that comply with the applicable law should not, in themselves, be regarded as constituting harmful manipulative AI-enabled practices.
(30)
Biometric categorisation systems that are based on natural persons’ biometric data, such as an individual person’s face or fingerprint, to deduce or infer an individuals’ political opinions, trade union membership, religious or philosophical beliefs, race, sex life or sexual orientation should be prohibited. That prohibition should not cover the lawful labelling, filtering or categorisation of biometric data sets acquired in line with Union or national law according to biometric data, such as the sorting of images according to hair colour or eye colour, which can for example be used in the area of law enforcement.
(31)
AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory outcomes and the exclusion of certain groups. They may violate the right to dignity and non-discrimination and the values of equality and justice. Such AI systems evaluate or classify natural persons or groups thereof on the basis of multiple data points related to their social behaviour in multiple contexts or known, inferred or predicted personal or personality characteristics over certain periods of time. The social score obtained from such AI systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts, which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. AI systems entailing such unacceptable scoring practices and leading to such detrimental or unfavourable outcomes should therefore be prohibited. That prohibition should not affect lawful evaluation practices of natural persons that are carried out for a specific purpose in accordance with Union and national law.
(32)
The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is particularly intrusive to the rights and freedoms of the concerned persons, to the extent that it may affect the private life of a large part of the population, evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. Such possible biased results and discriminatory effects are particularly relevant with regard to age, ethnicity, race, sex or disabilities. In addition, the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in real-time carry heightened risks for the rights and freedoms of the persons concerned in the context of, or impacted by, law enforcement activities.
(33)
The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively listed and narrowly defined situations, where the use is strictly necessary to achieve a substantial public interest, the importance of which outweighs the risks. Those situations involve the search for certain victims of crime including missing persons; certain threats to the life or to the physical safety of natural persons or of a terrorist attack; and the localisation or identification of perpetrators or suspects of the criminal offences listed in an annex to this Regulation, where those criminal offences are punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years and as they are defined in the law of that Member State. Such a threshold for the custodial sentence or detention order in accordance with national law contributes to ensuring that the offence should be serious enough to potentially justify the use of ‘real-time’ remote biometric identification systems. Moreover, the list of criminal offences provided in an annex to this Regulation is based on the 32 criminal offences listed in the Council Framework Decision 2002/584/JHA(), taking into account that some of those offences are, in practice, likely to be more relevant than others, in that the recourse to ‘real-time’ remote biometric identification could, foreseeably, be necessary and proportionate to highly varying degrees for the practical pursuit of the localisation or identification of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness, probability and scale of the harm or possible negative consequences. An imminent threat to life or the physical safety of natural persons could also result from a serious disruption of critical infrastructure, as defined in Article 2, point (4) of Directive (EU) 2022/2557 of the European Parliament and of the Council(), where the disruption or destruction of such critical infrastructure would result in an imminent threat to life or the physical safety of a person, including through serious harm to the provision of basic supplies to the population or to the exercise of the core function of the State. In addition, this Regulation should preserve the ability for law enforcement, border control, immigration or asylum authorities to carry out identity checks in the presence of the person concerned in accordance with the conditions set out in Union and national law for such checks. In particular, law enforcement, border control, immigration or asylum authorities should be able to use information systems, in accordance with Union or national law, to identify persons who, during an identity check, either refuse to be identified or are unable to state or prove their identity, without being required by this Regulation to obtain prior authorisation. This could be, for example, a person involved in a crime, being unwilling, or unable due to an accident or a medical condition, to disclose their identity to law enforcement authorities.
(34)
In order to ensure that those systems are used in a responsible and proportionate manner, it is also important to establish that, in each of those exhaustively listed and narrowly defined situations, certain elements should be taken into account, in particular as regards the nature of the situation giving rise to the request and the consequences of the use for the rights and freedoms of all persons concerned and the safeguards and conditions provided for with the use. In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement should be deployed only to confirm the specifically targeted individual’s identity and should be limited to what is strictly necessary concerning the period of time, as well as the geographic and personal scope, having regard in particular to the evidence or indications regarding the threats, the victims or perpetrator. The use of the real-time remote biometric identification system in publicly accessible spaces should be authorised only if the relevant law enforcement authority has completed a fundamental rights impact assessment and, unless provided otherwise in this Regulation, has registered the system in the database as set out in this Regulation. The reference database of persons should be appropriate for each use case in each of the situations mentioned above.
(35)
Each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent administrative authority of a Member State whose decision is binding. Such authorisation should, in principle, be obtained prior to the use of the AI system with a view to identifying a person or persons. Exceptions to that rule should be allowed in duly justified situations on grounds of urgency, namely in situations where the need to use the systems concerned is such as to make it effectively and objectively impossible to obtain an authorisation before commencing the use of the AI system. In such situations of urgency, the use of the AI system should be restricted to the absolute minimum necessary and should be subject to appropriate safeguards and conditions, as determined in national law and specified in the context of each individual urgent use case by the law enforcement authority itself. In addition, the law enforcement authority should in such situations request such authorisation while providing the reasons for not having been able to request it earlier, without undue delay and at the latest within 24 hours. If such an authorisation is rejected, the use of real-time biometric identification systems linked to that authorisation should cease with immediate effect and all the data related to such use should be discarded and deleted. Such data includes input data directly acquired by an AI system in the course of the use of such system as well as the results and outputs of the use linked to that authorisation. It should not include input that is legally acquired in accordance with another Union or national law. In any case, no decision producing an adverse legal effect on a person should be taken based solely on the output of the remote biometric identification system.
(36)
In order to carry out their tasks in accordance with the requirements set out in this Regulation as well as in national rules, the relevant market surveillance authority and the national data protection authority should be notified of each use of the real-time biometric identification system. Market surveillance authorities and the national data protection authorities that have been notified should submit to the Commission an annual report on the use of real-time biometric identification systems.
(37)
Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a Member State in accordance with this Regulation should only be possible where and in as far as the Member State concerned has decided to expressly provide for the possibility to authorise such use in its detailed rules of national law. Consequently, Member States remain free under this Regulation not to provide for such a possibility at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use identified in this Regulation. Such national rules should be notified to the Commission within 30 days of their adoption.
(38)
The use of AI systems for real-time remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of biometric data. The rules of this Regulation that prohibit, subject to certain exceptions, such use, which are based on Article 16 TFEU, should apply aslex specialisin respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU) 2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner. Therefore, such use and processing should be possible only in as far as it is compatible with the framework set by this Regulation, without there being scope, outside that framework, for the competent authorities, where they act for purpose of law enforcement, to use such systems and process such data in connection thereto on the grounds listed in Article 10 of Directive (EU) 2016/680. In that context, this Regulation is not intended to provide the legal basis for the processing of personal data under Article 8 of Directive (EU) 2016/680. However, the use of real-time remote biometric identification systems in publicly accessible spaces for purposes other than law enforcement, including by competent authorities, should not be covered by the specific framework regarding such use for the purpose of law enforcement set by this Regulation. Such use for purposes other than law enforcement should therefore not be subject to the requirement of an authorisation under this Regulation and the applicable detailed rules of national law that may give effect to that authorisation.
(39)
Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in connection to the use of real-time remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement as regulated by this Regulation, should continue to comply with all requirements resulting from Article 10 of Directive (EU) 2016/680. For purposes other than law enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation (EU) 2018/1725 prohibit the processing of biometric data subject to limited exceptions as provided in those Articles. In the application of Article 9(1) of Regulation (EU) 2016/679, the use of remote biometric identification for purposes other than law enforcement has already been subject to prohibition decisions by national data protection authorities.
(40)
In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), first subparagraph, point (g), to the extent it applies to the use of biometric categorisation systems for activities in the field of police cooperation and judicial cooperation in criminal matters, Article 5(1), first subparagraph, point (d), to the extent it applies to the use of AI systems covered by that provision, Article 5(1), first subparagraph, point (h), Article 5(2) to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16 TFEU which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the rules governing the forms of judicial cooperation in criminal matters or police cooperation which require compliance with the provisions laid down on the basis of Article 16 TFEU.
(41)
In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not bound by rules laid down in Article 5(1), first subparagraph, point (g), to the extent it applies to the use of biometric categorisation systems for activities in the field of police cooperation and judicial cooperation in criminal matters, Article 5(1), first subparagraph, point (d), to the extent it applies to the use of AI systems covered by that provision, Article 5(1), first subparagraph, point (h), (2) to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16 TFEU, or subject to their application, which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU.
(42)
In line with the presumption of innocence, natural persons in the Union should always be judged on their actual behaviour. Natural persons should never be judged on AI-predicted behaviour based solely on their profiling, personality traits or characteristics, such as nationality, place of birth, place of residence, number of children, level of debt or type of car, without a reasonable suspicion of that person being involved in a criminal activity based on objective verifiable facts and without human assessment thereof. Therefore, risk assessments carried out with regard to natural persons in order to assess the likelihood of their offending or to predict the occurrence of an actual or potential criminal offence based solely on profiling them or on assessing their personality traits and characteristics should be prohibited. In any case, that prohibition does not refer to or touch upon risk analytics that are not based on the profiling of individuals or on the personality traits and characteristics of individuals, such as AI systems using risk analytics to assess the likelihood of financial fraud by undertakings on the basis of suspicious transactions or risk analytic tools to predict the likelihood of the localisation of narcotics or illicit goods by customs authorities, for example on the basis of known trafficking routes.
(43)
The placing on the market, the putting into service for that specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage, should be prohibited because that practice adds to the feeling of mass surveillance and can lead to gross violations of fundamental rights, including the right to privacy.
(44)
There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly as expression of emotions vary considerably across cultures and situations, and even within a single individual. Among the key shortcomings of such systems are the limited reliability, the lack of specificity and the limited generalisability. Therefore, AI systems identifying or inferring emotions or intentions of natural persons on the basis of their biometric data may lead to discriminatory outcomes and can be intrusive to the rights and freedoms of the concerned persons. Considering the imbalance of power in the context of work or education, combined with the intrusive nature of these systems, such systems could lead to detrimental or unfavourable treatment of certain natural persons or whole groups thereof. Therefore, the placing on the market, the putting into service, or the use of AI systems intended to be used to detect the emotional state of individuals in situations related to the workplace and education should be prohibited. That prohibition should not cover AI systems placed on the market strictly for medical or safety reasons, such as systems intended for therapeutical use.
(45)
Practices that are prohibited by Union law, including data protection law, non-discrimination law, consumer protection law, and competition law, should not be affected by this Regulation.
(46)
High-risk AI systems should only be placed on the Union market, put into service or used if they comply with certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests as recognised and protected by Union law. On the basis of the New Legislative Framework, as clarified in the Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’(), the general rule is that more than one legal act of Union harmonisation legislation, such as Regulations (EU) 2017/745()and (EU) 2017/746()of the European Parliament and of the Council or Directive 2006/42/EC of the European Parliament and of the Council(), may be applicable to one product, since the making available or putting into service can take place only when the product complies with all applicable Union harmonisation legislation. To ensure consistency and avoid unnecessary administrative burdens or costs, providers of a product that contains one or more high-risk AI systems, to which the requirements of this Regulation and of the Union harmonisation legislation listed in an annex to this Regulation apply, should have flexibility with regard to operational decisions on how to ensure compliance of a product that contains one or more AI systems with all applicable requirements of the Union harmonisation legislation in an optimal manner. AI systems identified as high-risk should be limited to those that have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such limitation should minimise any potential restriction to international trade.
(47)
AI systems could have an adverse impact on the health and safety of persons, in particular when such systems operate as safety components of products. Consistent with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate.
(48)
The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, the right to non-discrimination, the right to education, consumer protection, workers’ rights, the rights of persons with disabilities, gender equality, intellectual property rights, the right to an effective remedy and to a fair trial, the right of defence and the presumption of innocence, and the right to good administration. In addition to those rights, it is important to highlight the fact that children have specific rights as enshrined in Article 24 of the Charter and in the United Nations Convention on the Rights of the Child, further developed in the UNCRC General Comment No 25 as regards the digital environment, both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.
(49)
As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the Council(), Regulation (EU) No 167/2013 of the European Parliament and of the Council(), Regulation (EU) No 168/2013 of the European Parliament and of the Council(), Directive 2014/90/EU of the European Parliament and of the Council(), Directive (EU) 2016/797 of the European Parliament and of the Council(), Regulation (EU) 2018/858 of the European Parliament and of the Council(), Regulation (EU) 2018/1139 of the European Parliament and of the Council(), and Regulation (EU) 2019/2144 of the European Parliament and of the Council(), it is appropriate to amend those acts to ensure that the Commission takes into account, on the basis of the technical and regulatory specificities of each sector, and without interfering with existing governance, conformity assessment and enforcement mechanisms and authorities established therein, the mandatory requirements for high-risk AI systems laid down in this Regulation when adopting any relevant delegated or implementing acts on the basis of those acts.
(50)
As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation legislation listed in an annex to this Regulation, it is appropriate to classify them as high-risk under this Regulation if the product concerned undergoes the conformity assessment procedure with a third-party conformity assessment body pursuant to that relevant Union harmonisation legislation. In particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, medical devices,in vitrodiagnostic medical devices, automotive and aviation.
(51)
The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered to be high-risk under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is, in particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity assessment is provided for medium-risk and high-risk products.
(52)
As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in this Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological development, as well as the potential changes in the use of AI systems.
(53)
It is also important to clarify that there may be specific cases in which AI systems referred to in pre-defined areas specified in this Regulation do not lead to a significant risk of harm to the legal interests protected under those areas because they do not materially influence the decision-making or do not harm those interests substantially. For the purposes of this Regulation, an AI system that does not materially influence the outcome of decision-making should be understood to be an AI system that does not have an impact on the substance, and thereby the outcome, of decision-making, whether human or automated. An AI system that does not materially influence the outcome of decision-making could include situations in which one or more of the following conditions are fulfilled. The first such condition should be that the AI system is intended to perform a narrow procedural task, such as an AI system that transforms unstructured data into structured data, an AI system that classifies incoming documents into categories or an AI system that is used to detect duplicates among a large number of applications. Those tasks are of such narrow and limited nature that they pose only limited risks which are not increased through the use of an AI system in a context that is listed as a high-risk use in an annex to this Regulation. The second condition should be that the task performed by the AI system is intended to improve the result of a previously completed human activity that may be relevant for the purposes of the high-risk uses listed in an annex to this Regulation. Considering those characteristics, the AI system provides only an additional layer to a human activity with consequently lowered risk. That condition would, for example, apply to AI systems that are intended to improve the language used in previously drafted documents, for example in relation to professional tone, academic style of language or by aligning text to a certain brand messaging. The third condition should be that the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns. The risk would be lowered because the use of the AI system follows a previously completed human assessment which it is not meant to replace or influence, without proper human review. Such AI systems include for instance those that, given a certain grading pattern of a teacher, can be used to checkex postwhether the teacher may have deviated from the grading pattern so as to flag potential inconsistencies or anomalies. The fourth condition should be that the AI system is intended to perform a task that is only preparatory to an assessment relevant for the purposes of the AI systems listed in an annex to this Regulation, thus making the possible impact of the output of the system very low in terms of representing a risk for the assessment to follow. That condition covers, inter alia, smart solutions for file handling, which include various functions from indexing, searching, text and speech processing or linking data to other data sources, or AI systems used for translation of initial documents. In any case, AI systems used in high-risk use-cases listed in an annex to this Regulation should be considered to pose significant risks of harm to the health, safety or fundamental rights if the AI system implies profiling within the meaning of Article 4, point (4) of Regulation (EU) 2016/679 or Article 3, point (4) of Directive (EU) 2016/680 or Article 3, point (5) of Regulation (EU) 2018/1725. To ensure traceability and transparency, a provider who considers that an AI system is not high-risk on the basis of the conditions referred to above should draw up documentation of the assessment before that system is placed on the market or put into service and should provide that documentation to national competent authorities upon request. Such a provider should be obliged to register the AI system in the EU database established under this Regulation. With a view to providing further guidance for the practical implementation of the conditions under which the AI systems listed in an annex to this Regulation are, on an exceptional basis, non-high-risk, the Commission should, after consulting the Board, provide guidelines specifying that practical implementation, completed by a comprehensive list of practical examples of use cases of AI systems that are high-risk and use cases that are not.
(54)
As biometric data constitutes a special category of personal data, it is appropriate to classify as high-risk several critical-use cases of biometric systems, insofar as their use is permitted under relevant Union and national law. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. The risk of such biased results and discriminatory effects is particularly relevant with regard to age, ethnicity, race, sex or disabilities. Remote biometric identification systems should therefore be classified as high-risk in view of the risks that they pose. Such a classification excludes AI systems intended to be used for biometric verification, including authentication, the sole purpose of which is to confirm that a specific natural person is who that person claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having secure access to premises. In addition, AI systems intended to be used for biometric categorisation according to sensitive attributes or characteristics protected under Article 9(1) of Regulation (EU) 2016/679 on the basis of biometric data, in so far as these are not prohibited under this Regulation, and emotion recognition systems that are not prohibited under this Regulation, should be classified as high-risk. Biometric systems which are intended to be used solely for the purpose of enabling cybersecurity and personal data protection measures should not be considered to be high-risk AI systems.
(55)
As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of critical digital infrastructure as listed in point (8) of the Annex to Directive (EU) 2022/2557, road traffic and the supply of water, gas, heating and electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. Safety components of critical infrastructure, including critical digital infrastructure, are systems used to directly protect the physical integrity of critical infrastructure or the health and safety of persons and property but which are not necessary in order for the system to function. The failure or malfunctioning of such components might directly lead to risks to the physical integrity of critical infrastructure and thus to risks to health and safety of persons and property. Components intended to be used solely for cybersecurity purposes should not qualify as safety components. Examples of safety components of such critical infrastructure may include systems for monitoring water pressure or fire alarm controlling systems in cloud computing centres.
(56)
The deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners and teachers to acquire and share the necessary digital skills and competences, including media literacy, and critical thinking, to take an active part in the economy, society, and in democratic processes. However, AI systems used in education or vocational training, in particular for determining access or admission, for assigning persons to educational and vocational training institutions or programmes at all levels, for evaluating learning outcomes of persons, for assessing the appropriate level of education for an individual and materially influencing the level of education and training that individuals will receive or will be able to access or for monitoring and detecting prohibited behaviour of students during tests should be classified as high-risk AI systems, since they may determine the educational and professional course of a person’s life and therefore may affect that person’s ability to secure a livelihood. When improperly designed and used, such systems may be particularly intrusive and may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation.
(57)
AI systems used in employment, workers management and access to self-employment, in particular for the recruitment and selection of persons, for making decisions affecting terms of the work-related relationship, promotion and termination of work-related contractual relationships, for allocating tasks on the basis of individual behaviour, personal traits or characteristics and for monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may have an appreciable impact on future career prospects, livelihoods of those persons and workers’ rights. Relevant work-related contractual relationships should, in a meaningful manner, involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of such persons may also undermine their fundamental rights to data protection and privacy.
(58)
Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. In particular, natural persons applying for or receiving essential public assistance benefits and services from public authorities namely healthcare services, social security benefits, social services providing protection in cases such as maternity, illness, industrial accidents, dependency or old age and loss of employment and social and housing assistance, are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services should be granted, denied, reduced, revoked or reclaimed by authorities, including whether beneficiaries are legitimately entitled to such benefits or services, those systems may have a significant impact on persons’ livelihood and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity or an effective remedy and should therefore be classified as high-risk. Nonetheless, this Regulation should not hamper the development and use of innovative approaches in the public administration, which would stand to benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to legal and natural persons. In addition, AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources or essential services such as housing, electricity, and telecommunication services. AI systems used for those purposes may lead to discrimination between persons or groups and may perpetuate historical patterns of discrimination, such as that based on racial or ethnic origins, gender, disabilities, age or sexual orientation, or may create new forms of discriminatory impacts. However, AI systems provided for by Union law for the purpose of detecting fraud in the offering of financial services and for prudential purposes to calculate credit institutions’ and insurance undertakings’ capital requirements should not be considered to be high-risk under this Regulation. Moreover, AI systems intended to be used for risk assessment and pricing in relation to natural persons for health and life insurance can also have a significant impact on persons’ livelihood and if not duly designed, developed and used, can infringe their fundamental rights and can lead to serious consequences for people’s life and health, including financial exclusion and discrimination. Finally, AI systems used to evaluate and classify emergency calls by natural persons or to dispatch or establish priority in the dispatching of emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems, should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.
(59)
Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high-quality data, does not meet adequate requirements in terms of its performance, its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular, where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, a number of AI systems intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the nature of the activities and the risks relating thereto, those high-risk AI systems should include in particular AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices, or agencies in support of law enforcement authorities for assessing the risk of a natural person to become a victim of criminal offences, as polygraphs and similar tools, for the evaluation of the reliability of evidence in in the course of investigation or prosecution of criminal offences, and, insofar as not prohibited under this Regulation, for assessing the risk of a natural person offending or reoffending not solely on the basis of the profiling of natural persons or the assessment of personality traits and characteristics or the past criminal behaviour of natural persons or groups, for profiling in the course of detection, investigation or prosecution of criminal offences. AI systems specifically intended to be used for administrative proceedings by tax and customs authorities as well as by financial intelligence units carrying out administrative tasks analysing information pursuant to Union anti-money laundering law should not be classified as high-risk AI systems used by law enforcement authorities for the purpose of prevention, detection, investigation and prosecution of criminal offences. The use of AI tools by law enforcement and other relevant authorities should not become a factor of inequality, or exclusion. The impact of the use of AI tools on the defence rights of suspects should not be ignored, in particular the difficulty in obtaining meaningful information on the functioning of those systems and the resulting difficulty in challenging their results in court, in particular by natural persons under investigation.
(60)
AI systems used in migration, asylum and border control management affect persons who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore particularly important to guarantee respect for the fundamental rights of the affected persons, in particular their rights to free movement, non-discrimination, protection of private life and personal data, international protection and good administration. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies charged with tasks in the fields of migration, asylum and border control management as polygraphs and similar tools, for assessing certain risks posed by natural persons entering the territory of a Member State or applying for visa or asylum, for assisting competent public authorities for the examination, including related assessment of the reliability of evidence, of applications for asylum, visa and residence permits and associated complaints with regard to the objective to establish the eligibility of the natural persons applying for a status, for the purpose of detecting, recognising or identifying natural persons in the context of migration, asylum and border control management, with the exception of verification of travel documents. AI systems in the area of migration, asylum and border control management covered by this Regulation should comply with the relevant procedural requirements set by the Regulation (EC) No 810/2009 of the European Parliament and of the Council(), the Directive 2013/32/EU of the European Parliament and of the Council(), and other relevant Union law. The use of AI systems in migration, asylum and border control management should, in no circumstances, be used by Member States or Union institutions, bodies, offices or agencies as a means to circumvent their international obligations under the UN Convention relating to the Status of Refugees done at Geneva on 28 July 1951 as amended by the Protocol of 31 January 1967. Nor should they be used to in any way infringe on the principle of non-refoulement, or to deny safe and effective legal avenues into the territory of the Union, including the right to international protection.
(61)
Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, the rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is appropriate to qualify as high-risk AI systems intended to be used by a judicial authority or on its behalf to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. AI systems intended to be used by alternative dispute resolution bodies for those purposes should also be considered to be high-risk when the outcomes of the alternative dispute resolution proceedings produce legal effects for the parties. The use of AI tools can support the decision-making power of judges or judicial independence, but should not replace it: the final decision-making must remain a human-driven activity. The classification of AI systems as high-risk should not, however, extend to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks.
(62)
Without prejudice to the rules provided for in Regulation (EU) 2024/900 of the European Parliament and of the Council(), and in order to address the risks of undue external interference with the right to vote enshrined in Article 39 of the Charter, and of adverse effects on democracy and the rule of law, AI systems intended to be used to influence the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda should be classified as high-risk AI systems with the exception of AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistical point of view.
(63)
The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as indicating that the use of the system is lawful under other acts of Union law or under national law compatible with Union law, such as on the protection of personal data, on the use of polygraphs and similar tools or other systems to detect the emotional state of natural persons. Any such use should continue to occur solely in accordance with the applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and national law. This Regulation should not be understood as providing for the legal ground for processing of personal data, including special categories of personal data, where relevant, unless it is specifically otherwise provided for in this Regulation.
(64)
To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of trustworthiness, certain mandatory requirements should apply to high-risk AI systems, taking into account the intended purpose and the context of use of the AI system and according to the risk-management system to be established by the provider. The measures adopted by the providers to comply with the mandatory requirements of this Regulation should take into account the generally acknowledged state of the art on AI, be proportionate and effective to meet the objectives of this Regulation. Based on the New Legislative Framework, as clarified in Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’, the general rule is that more than one legal act of Union harmonisation legislation may be applicable to one product, since the making available or putting into service can take place only when the product complies with all applicable Union harmonisation legislation. The hazards of AI systems covered by the requirements of this Regulation concern different aspects than the existing Union harmonisation legislation and therefore the requirements of this Regulation would complement the existing body of the Union harmonisation legislation. For example, machinery or medical devices products incorporating an AI system might present risks not addressed by the essential health and safety requirements set out in the relevant Union harmonised legislation, as that sectoral law does not deal with risks specific to AI systems. This calls for a simultaneous and complementary application of the various legislative acts. To ensure consistency and to avoid an unnecessary administrative burden and unnecessary costs, providers of a product that contains one or more high-risk AI system, to which the requirements of this Regulation and of the Union harmonisation legislation based on the New Legislative Framework and listed in an annex to this Regulation apply, should have flexibility with regard to operational decisions on how to ensure compliance of a product that contains one or more AI systems with all the applicable requirements of that Union harmonised legislation in an optimal manner. That flexibility could mean, for example a decision by the provider to integrate a part of the necessary testing and reporting processes, information and documentation required under this Regulation into already existing documentation and procedures required under existing Union harmonisation legislation based on the New Legislative Framework and listed in an annex to this Regulation. This should not, in any way, undermine the obligation of the provider to comply with all the applicable requirements.
(65)
The risk-management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system. That process should be aimed at identifying and mitigating the relevant risks of AI systems on health, safety and fundamental rights. The risk-management system should be regularly reviewed and updated to ensure its continuing effectiveness, as well as justification and documentation of any significant decisions and actions taken subject to this Regulation. This process should ensure that the provider identifies risks or adverse impacts and implements mitigation measures for the known and reasonably foreseeable risks of AI systems to the health, safety and fundamental rights in light of their intended purpose and reasonably foreseeable misuse, including the possible risks arising from the interaction between the AI system and the environment within which it operates. The risk-management system should adopt the most appropriate risk-management measures in light of the state of the art in AI. When identifying the most appropriate risk-management measures, the provider should document and explain the choices made and, when relevant, involve experts and external stakeholders. In identifying the reasonably foreseeable misuse of high-risk AI systems, the provider should cover uses of AI systems which, while not directly covered by the intended purpose and provided for in the instruction for use may nevertheless be reasonably expected to result from readily predictable human behaviour in the context of the specific characteristics and use of a particular AI system. Any known or foreseeable circumstances related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights should be included in the instructions for use that are provided by the provider. This is to ensure that the deployer is aware and takes them into account when using the high-risk AI system. Identifying and implementing risk mitigation measures for foreseeable misuse under this Regulation should not require specific additional training for the high-risk AI system by the provider to address foreseeable misuse. The providers however are encouraged to consider such additional training measures to mitigate reasonable foreseeable misuses as necessary and appropriate.
(66)
Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights. As no other less trade restrictive measures are reasonably available those requirements are not unjustified restrictions to trade.
(67)
High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely and it does not become a source of discrimination prohibited by Union law. High-quality data sets for training, validation and testing require the implementation of appropriate data governance and management practices. Data sets for training, validation and testing, including the labels, should be relevant, sufficiently representative, and to the best extent possible free of errors and complete in view of the intended purpose of the system. In order to facilitate compliance with Union data protection law, such as Regulation (EU) 2016/679, data governance and management practices should include, in the case of personal data, transparency about the original purpose of the data collection. The data sets should also have the appropriate statistical properties, including as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used, with specific attention to the mitigation of possible biases in the data sets, that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations (feedback loops). Biases can for example be inherent in underlying data sets, especially when historical data is being used, or generated when the systems are implemented in real world settings. Results provided by AI systems could be influenced by such inherent biases that are inclined to gradually increase and thereby perpetuate and amplify existing discrimination, in particular for persons belonging to certain vulnerable groups, including racial or ethnic groups. The requirement for the data sets to be to the best extent possible complete and free of errors should not affect the use of privacy-preserving techniques in the context of the development and testing of AI systems. In particular, data sets should take into account, to the extent required by their intended purpose, the features, characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting which the AI system is intended to be used. The requirements related to data governance can be complied with by having recourse to third parties that offer certified compliance services including verification of data governance, data set integrity, and data training, validation and testing practices, as far as compliance with the data requirements of this Regulation are ensured.
(68)
For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as European Digital Innovation Hubs, testing experimentation facilities and researchers, should be able to access and use high-quality data sets within the fields of activities of those actors which are related to this Regulation. European common data spaces established by the Commission and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful, accountable and non-discriminatory access to high-quality data for the training, validation and testing of AI systems. For example, in health, the European health data space will facilitate non-discriminatory access to health data and the training of AI algorithms on those data sets, in a privacy-preserving, secure, timely, transparent and trustworthy manner, and with an appropriate institutional governance. Relevant competent authorities, including sectoral ones, providing or supporting the access to data may also support the provision of high-quality data for the training, validation and testing of AI systems.
(69)
The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system. In this regard, the principles of data minimisation and data protection by design and by default, as set out in Union data protection law, are applicable when personal data are processed. Measures taken by providers to ensure compliance with those principles may include not only anonymisation and encryption, but also the use of technology that permits algorithms to be brought to the data and allows training of AI systems without the transmission between parties or copying of the raw or structured data themselves, without prejudice to the requirements on data governance provided for in this Regulation.
(70)
In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers should, exceptionally, to the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the high-risk AI systems, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons and following the application of all applicable conditions laid down under this Regulation in addition to the conditions laid down in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, be able to process also special categories of personal data, as a matter of substantial public interest within the meaning of Article 9(2), point (g) of Regulation (EU) 2016/679 and Article 10(2), point (g) of Regulation (EU) 2018/1725.
(71)
Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements under this Regulation, as well as monitoring of their operations and post market monitoring. This requires keeping records and the availability of technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements and facilitate post market monitoring. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk-management system and drawn in a clear and comprehensive form. The technical documentation should be kept up to date, appropriately throughout the lifetime of the AI system. Furthermore, high-risk AI systems should technically allow for the automatic recording of events, by means of logs, over the duration of the lifetime of the system.
(72)
To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this Regulation, transparency should be required for high-risk AI systems before they are placed on the market or put it into service. High-risk AI systems should be designed in a manner to enable deployers to understand how the AI system works, evaluate its functionality, and comprehend its strengths and limitations. High-risk AI systems should be accompanied by appropriate information in the form of instructions of use. Such information should include the characteristics, capabilities and limitations of performance of the AI system. Those would cover information on possible known and foreseeable circumstances related to the use of the high-risk AI system, including deployer action that may influence system behaviour and performance, under which the AI system can lead to risks to health, safety, and fundamental rights, on the changes that have been pre-determined and assessed for conformity by the provider and on the relevant human oversight measures, including the measures to facilitate the interpretation of the outputs of the AI system by the deployers. Transparency, including the accompanying instructions for use, should assist deployers in the use of the system and support informed decision making by them. Deployers should, inter alia, be in a better position to make the correct choice of the system that they intend to use in light of the obligations applicable to them, be educated about the intended and precluded uses, and use the AI system correctly and as appropriate. In order to enhance legibility and accessibility of the information included in the instructions of use, where appropriate, illustrative examples, for instance on the limitations and on the intended and precluded uses of the AI system, should be included. Providers should ensure that all documentation, including the instructions for use, contains meaningful, comprehensive, accessible and understandable information, taking into account the needs and foreseeable knowledge of the target deployers. Instructions for use should be made available in a language which can be easily understood by target deployers, as determined by the Member State concerned.
(73)
High-risk AI systems should be designed and developed in such a way that natural persons can oversee their functioning, ensure that they are used as intended and that their impacts are addressed over the system’s lifecycle. To that end, appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. In particular, where appropriate, such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator, and that the natural persons to whom human oversight has been assigned have the necessary competence, training and authority to carry out that role. It is also essential, as appropriate, to ensure that high-risk AI systems include mechanisms to guide and inform a natural person to whom human oversight has been assigned to make informed decisions if, when and how to intervene in order to avoid negative consequences or risks, or stop the system if it does not perform as intended. Considering the significant consequences for persons in the case of an incorrect match by certain biometric identification systems, it is appropriate to provide for an enhanced human oversight requirement for those systems so that no action or decision may be taken by the deployer on the basis of the identification resulting from the system unless this has been separately verified and confirmed by at least two natural persons. Those persons could be from one or more entities and include the person operating or using the system. This requirement should not pose unnecessary burden or delays and it could be sufficient that the separate verifications by the different persons are automatically recorded in the logs generated by the system. Given the specificities of the areas of law enforcement, migration, border control and asylum, this requirement should not apply where Union or national law considers the application of that requirement to be disproportionate.
(74)
High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity, in light of their intended purpose and in accordance with the generally acknowledged state of the art. The Commission and relevant organisations and stakeholders are encouraged to take due consideration of the mitigation of risks and the negative impacts of the AI system. The expected level of performance metrics should be declared in the accompanying instructions of use. Providers are urged to communicate that information to deployers in a clear and easily understandable way, free of misunderstandings or misleading statements. Union law on legal metrology, including Directives 2014/31/EU()and 2014/32/EU()of the European Parliament and of the Council, aims to ensure the accuracy of measurements and to help the transparency and fairness of commercial transactions. In that context, in cooperation with relevant stakeholders and organisation, such as metrology and benchmarking authorities, the Commission should encourage, as appropriate, the development of benchmarks and measurement methodologies for AI systems. In doing so, the Commission should take note and collaborate with international partners working on metrology and relevant measurement indicators relating to AI.
(75)
Technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or otherwise undesirable behaviour that may result from limitations within the systems or the environment in which the systems operate (e.g. errors, faults, inconsistencies, unexpected situations). Therefore, technical and organisational measures should be taken to ensure robustness of high-risk AI systems, for example by designing and developing appropriate technical solutions to prevent or minimise harmful or otherwise undesirable behaviour. Those technical solution may include for instance mechanisms enabling the system to safely interrupt its operation (fail-safe plans) in the presence of certain anomalies or when operation takes place outside certain predetermined boundaries. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system.
(76)
Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks or membership inference), or exploit vulnerabilities in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks, suitable measures, such as security controls, should therefore be taken by the providers of high-risk AI systems, also taking into account as appropriate the underlying ICT infrastructure.
(77)
Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall within the scope of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, in accordance with that regulation may demonstrate compliance with the cybersecurity requirements of this Regulation by fulfilling the essential cybersecurity requirements set out in that regulation. When high-risk AI systems fulfil the essential requirements of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, they should be deemed compliant with the cybersecurity requirements set out in this Regulation in so far as the achievement of those requirements is demonstrated in the EU declaration of conformity or parts thereof issued under that regulation. To that end, the assessment of the cybersecurity risks, associated to a product with digital elements classified as high-risk AI system according to this Regulation, carried out under a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, should consider risks to the cyber resilience of an AI system as regards attempts by unauthorised third parties to alter its use, behaviour or performance, including AI specific vulnerabilities such as data poisoning or adversarial attacks, as well as, as relevant, risks to fundamental rights as required by this Regulation.
(78)
The conformity assessment procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a product with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and classified as a high-risk AI system under this Regulation. However, this rule should not result in reducing the necessary level of assurance for critical products with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements. Therefore, by way of derogation from this rule, high-risk AI systems that fall within the scope of this Regulation and are also qualified as important and critical products with digital elements pursuant to a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and to which the conformity assessment procedure based on internal control set out in an annex to this Regulation applies, are subject to the conformity assessment provisions of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements insofar as the essential cybersecurity requirements of that regulation are concerned. In this case, for all the other aspects covered by this Regulation the respective provisions on conformity assessment based on internal control set out in an annex to this Regulation should apply. Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under the Regulation (EU) 2019/881 of the European Parliament and of the Council(), the Commission should cooperate with ENISA on issues related to cybersecurity of AI systems.
(79)
It is appropriate that a specific natural or legal person, defined as the provider, takes responsibility for the placing on the market or the putting into service of a high-risk AI system, regardless of whether that natural or legal person is the person who designed or developed the system.
(80)
As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the Member States are legally obliged to protect persons with disabilities from discrimination and promote their equality, to ensure that persons with disabilities have access, on an equal basis with others, to information and communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the growing importance and use of AI systems, the application of universal design principles to all new technologies and services should ensure full and equal access for everyone potentially affected by or using AI technologies, including persons with disabilities, in a way that takes full account of their inherent dignity and diversity. It is therefore essential that providers ensure full compliance with accessibility requirements, including Directive (EU) 2016/2102 of the European Parliament and of the Council()and Directive (EU) 2019/882. Providers should ensure compliance with these requirements by design. Therefore, the necessary measures should be integrated as much as possible into the design of the high-risk AI system.
(81)
The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Providers of high-risk AI systems that are subject to obligations regarding quality management systems under relevant sectoral Union law should have the possibility to include the elements of the quality management system provided for in this Regulation as part of the existing quality management system provided for in that other sectoral Union law. The complementarity between this Regulation and existing sectoral Union law should also be taken into account in future standardisation activities or guidance adopted by the Commission. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority concerned.
(82)
To enable enforcement of this Regulation and create a level playing field for operators, and, taking into account the different forms of making available of digital products, it is important to ensure that, under all circumstances, a person established in the Union can provide authorities with all the necessary information on the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, providers established in third countries should, by written mandate, appoint an authorised representative established in the Union. This authorised representative plays a pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or put into service in the Union by those providers who are not established in the Union and in serving as their contact person established in the Union.
(83)
In light of the nature and complexity of the value chain for AI systems and in line with the New Legislative Framework, it is essential to ensure legal certainty and facilitate the compliance with this Regulation. Therefore, it is necessary to clarify the role and the specific obligations of relevant operators along that value chain, such as importers and distributors who may contribute to the development of AI systems. In certain situations those operators could act in more than one role at the same time and should therefore fulfil cumulatively all relevant obligations associated with those roles. For example, an operator could act as a distributor and an importer at the same time.
(84)
To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer, deployer or other third-party should be considered to be a provider of a high-risk AI system and therefore assume all the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are allocated otherwise. This would also be the case if that party makes a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in a way that it remains a high-risk AI system in accordance with this Regulation, or if it modifies the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service, in a way that the AI system becomes a high-risk AI system in accordance with this Regulation. Those provisions should apply without prejudice to more specific provisions established in certain Union harmonisation legislation based on the New Legislative Framework, together with which this Regulation should apply. For example, Article 16(2) of Regulation (EU) 2017/745, establishing that certain changes should not be considered to be modifications of a device that could affect its compliance with the applicable requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that Regulation.
(85)
General-purpose AI systems may be used as high-risk AI systems by themselves or be components of other high-risk AI systems. Therefore, due to their particular nature and in order to ensure a fair sharing of responsibilities along the AI value chain, the providers of such systems should, irrespective of whether they may be used as high-risk AI systems as such by other providers or as components of high-risk AI systems and unless provided otherwise under this Regulation, closely cooperate with the providers of the relevant high-risk AI systems to enable their compliance with the relevant obligations under this Regulation and with the competent authorities established under this Regulation.
(86)
Where, under the conditions laid down in this Regulation, the provider that initially placed the AI system on the market or put it into service should no longer be considered to be the provider for the purposes of this Regulation, and when that provider has not expressly excluded the change of the AI system into a high-risk AI system, the former provider should nonetheless closely cooperate and make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems.
(87)
In addition, where a high-risk AI system that is a safety component of a product which falls within the scope of Union harmonisation legislation based on the New Legislative Framework is not placed on the market or put into service independently from the product, the product manufacturer defined in that legislation should comply with the obligations of the provider established in this Regulation and should, in particular, ensure that the AI system embedded in the final product complies with the requirements of this Regulation.
(88)
Along the AI value chain multiple parties often supply AI systems, tools and services but also components or processes that are incorporated by the provider into the AI system with various objectives, including the model training, model retraining, model testing and evaluation, integration into software, or other aspects of model development. Those parties have an important role to play in the value chain towards the provider of the high-risk AI system into which their AI systems, tools, services, components or processes are integrated, and should provide by written agreement this provider with the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider to fully comply with the obligations set out in this Regulation, without compromising their own intellectual property rights or trade secrets.
(89)
Third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models, should not be mandated to comply with requirements targeting the responsibilities along the AI value chain, in particular towards the provider that has used or integrated them, when those tools, services, processes, or AI components are made accessible under a free and open-source licence. Developers of free and open-source tools, services, processes, or AI components other than general-purpose AI models should be encouraged to implement widely adopted documentation practices, such as model cards and data sheets, as a way to accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the Union.
(90)
The Commission could develop and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used or integrated in high-risk AI systems, to facilitate the cooperation along the value chain. When developing voluntary model contractual terms, the Commission should also take into account possible contractual requirements applicable in specific sectors or business cases.
(91)
Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regards the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it is appropriate to set specific responsibilities for deployers. Deployers should in particular take appropriate technical and organisational measures to ensure they use high-risk AI systems in accordance with the instructions of use and certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and with regard to record-keeping, as appropriate. Furthermore, deployers should ensure that the persons assigned to implement the instructions for use and human oversight as set out in this Regulation have the necessary competence, in particular an adequate level of AI literacy, training and authority to properly fulfil those tasks. Those obligations should be without prejudice to other deployer obligations in relation to high-risk AI systems under Union or national law.
(92)
This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or their representatives under Union or national law and practice, including Directive 2002/14/EC of the European Parliament and of the Council(), on decisions to put into service or use AI systems. It remains necessary to ensure information of workers and their representatives on the planned deployment of high-risk AI systems at the workplace where the conditions for those information or information and consultation obligations in other legal instruments are not fulfilled. Moreover, such information right is ancillary and necessary to the objective of protecting fundamental rights that underlies this Regulation. Therefore, an information requirement to that effect should be laid down in this Regulation, without affecting any existing rights of workers.
(93)
Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that fundamental rights are protected, complementing the obligations of the provider when developing the AI system. Deployers are best placed to understand how the high-risk AI system will be used concretely and can therefore identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge of the context of use, the persons or groups of persons likely to be affected, including vulnerable groups. Deployers of high-risk AI systems listed in an annex to this Regulation also play a critical role in informing natural persons and should, when they make decisions or assist in making decisions related to natural persons, where applicable, inform the natural persons that they are subject to the use of the high-risk AI system. This information should include the intended purpose and the type of decisions it makes. The deployer should also inform the natural persons about their right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law enforcement purposes, that obligation should be implemented in accordance with Article 13 of Directive (EU) 2016/680.
(94)
Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of law enforcement needs to comply with Article 10 of Directive (EU) 2016/680, that allows such processing only where strictly necessary, subject to appropriate safeguards for the rights and freedoms of the data subject, and where authorised by Union or Member State law. Such use, when authorised, also needs to respect the principles laid down in Article 4 (1) of Directive (EU) 2016/680 including lawfulness, fairness and transparency, purpose limitation, accuracy and storage limitation.
(95)
Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and Directive (EU) 2016/680, considering the intrusive nature of post-remote biometric identification systems, the use of post-remote biometric identification systems should be subject to safeguards. Post-remote biometric identification systems should always be used in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in terms of the individuals to be identified, the location, temporal scope and based on a closed data set of legally acquired video footage. In any case, post-remote biometric identification systems should not be used in the framework of law enforcement to lead to indiscriminate surveillance. The conditions for post-remote biometric identification should in any case not provide a basis to circumvent the conditions of the prohibition and strict exceptions for real time remote biometric identification.
(96)
In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public law, or private entities providing public services and deployers of certain high-risk AI systems listed in an annex to this Regulation, such as banking or insurance entities, should carry out a fundamental rights impact assessment prior to putting it into use. Services important for individuals that are of public nature may also be provided by private entities. Private entities providing such public services are linked to tasks in the public interest such as in the areas of education, healthcare, social services, housing, administration of justice. The aim of the fundamental rights impact assessment is for the deployer to identify the specific risks to the rights of individuals or groups of individuals likely to be affected, identify measures to be taken in the case of a materialisation of those risks. The impact assessment should be performed prior to deploying the high-risk AI system, and should be updated when the deployer considers that any of the relevant factors have changed. The impact assessment should identify the deployer’s relevant processes in which the high-risk AI system will be used in line with its intended purpose, and should include a description of the period of time and frequency in which the system is intended to be used as well as of specific categories of natural persons and groups who are likely to be affected in the specific context of use. The assessment should also include the identification of specific risks of harm likely to have an impact on the fundamental rights of those persons or groups. While performing this assessment, the deployer should take into account information relevant to a proper assessment of the impact, including but not limited to the information given by the provider of the high-risk AI system in the instructions for use. In light of the risks identified, deployers should determine measures to be taken in the case of a materialisation of those risks, including for example governance arrangements in that specific context of use, such as arrangements for human oversight according to the instructions of use or, complaint handling and redress procedures, as they could be instrumental in mitigating risks to fundamental rights in concrete use-cases. After performing that impact assessment, the deployer should notify the relevant market surveillance authority. Where appropriate, to collect relevant information necessary to perform the impact assessment, deployers of high-risk AI system, in particular when AI systems are used in the public sector, could involve relevant stakeholders, including the representatives of groups of persons likely to be affected by the AI system, independent experts, and civil society organisations in conducting such impact assessments and designing measures to be taken in the case of materialisation of the risks. The European Artificial Intelligence Office (AI Office) should develop a template for a questionnaire in order to facilitate compliance and reduce the administrative burden for deployers.
(97)
The notion of general-purpose AI models should be clearly defined and set apart from the notion of AI systems to enable legal certainty. The definition should be based on the key functional characteristics of a general-purpose AI model, in particular the generality and the capability to competently perform a wide range of distinct tasks. These models are typically trained on large amounts of data, through various methods, such as self-supervised, unsupervised or reinforcement learning. General-purpose AI models may be placed on the market in various ways, including through libraries, application programming interfaces (APIs), as direct download, or as physical copy. These models may be further modified or fine-tuned into new models. Although AI models are essential components of AI systems, they do not constitute AI systems on their own. AI models require the addition of further components, such as for example a user interface, to become AI systems. AI models are typically integrated into and form part of AI systems. This Regulation provides specific rules for general-purpose AI models and for general-purpose AI models that pose systemic risks, which should apply also when these models are integrated or form part of an AI system. It should be understood that the obligations for the providers of general-purpose AI models should apply once the general-purpose AI models are placed on the market. When the provider of a general-purpose AI model integrates an own model into its own AI system that is made available on the market or put into service, that model should be considered to be placed on the market and, therefore, the obligations in this Regulation for models should continue to apply in addition to those for AI systems. The obligations laid down for models should in any case not apply when an own model is used for purely internal processes that are not essential for providing a product or a service to third parties and the rights of natural persons are not affected. Considering their potential significantly negative effects, the general-purpose AI models with systemic risk should always be subject to the relevant obligations under this Regulation. The definition should not cover AI models used before their placing on the market for the sole purpose of research, development and prototyping activities. This is without prejudice to the obligation to comply with this Regulation when, following such activities, a model is placed on the market.
(98)
Whereas the generality of a model could, inter alia, also be determined by a number of parameters, models with at least a billion of parameters and trained with a large amount of data using self-supervision at scale should be considered to display significant generality and to competently perform a wide range of distinctive tasks.
(99)
Large generative AI models are a typical example for a general-purpose AI model, given that they allow for flexible generation of content, such as in the form of text, audio, images or video, that can readily accommodate a wide range of distinctive tasks.
(100)
When a general-purpose AI model is integrated into or forms part of an AI system, this system should be considered to be general-purpose AI system when, due to this integration, this system has the capability to serve a variety of purposes. A general-purpose AI system can be used directly, or it may be integrated into other AI systems.
(101)
Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the models they provide may form the basis for a range of downstream systems, often provided by downstream providers that necessitate a good understanding of the models and their capabilities, both to enable the integration of such models into their products, and to fulfil their obligations under this or other regulations. Therefore, proportionate transparency measures should be laid down, including the drawing up and keeping up to date of documentation, and the provision of information on the general-purpose AI model for its usage by the downstream providers. Technical documentation should be prepared and kept up to date by the general-purpose AI model provider for the purpose of making it available, upon request, to the AI Office and the national competent authorities. The minimal set of elements to be included in such documentation should be set out in specific annexes to this Regulation. The Commission should be empowered to amend those annexes by means of delegated acts in light of evolving technological developments.
(102)
Software and data, including models, released under a free and open-source licence that allows them to be openly shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can contribute to research and innovation in the market and can provide significant growth opportunities for the Union economy. General-purpose AI models released under free and open-source licences should be considered to ensure high levels of transparency and openness if their parameters, including the weights, the information on the model architecture, and the information on model usage are made publicly available. The licence should be considered to be free and open-source also when it allows users to run, copy, distribute, study, change and improve software and data, including models under the condition that the original provider of the model is credited, the identical or comparable terms of distribution are respected.
(103)
Free and open-source AI components covers the software and data, including models and general-purpose AI models, tools, services or processes of an AI system. Free and open-source AI components can be provided through different channels, including their development on open repositories. For the purposes of this Regulation, AI components that are provided against a price or otherwise monetised, including through the provision of technical support or other services, including through a software platform, related to the AI component, or the use of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software, with the exception of transactions between microenterprises, should not benefit from the exceptions provided to free and open-source AI components. The fact of making AI components available through open repositories should not, in itself, constitute a monetisation.
(104)
The providers of general-purpose AI models that are released under a free and open-source licence, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available should be subject to exceptions as regards the transparency-related requirements imposed on general-purpose AI models, unless they can be considered to present a systemic risk, in which case the circumstance that the model is transparent and accompanied by an open-source license should not be considered to be a sufficient reason to exclude compliance with the obligations under this Regulation. In any case, given that the release of general-purpose AI models under free and open-source licence does not necessarily reveal substantial information on the data set used for the training or fine-tuning of the model and on how compliance of copyright law was thereby ensured, the exception provided for general-purpose AI models from compliance with the transparency-related requirements should not concern the obligation to produce a summary about the content used for model training and the obligation to put in place a policy to comply with Union copyright law, in particular to identify and comply with the reservation of rights pursuant to Article 4(3) of Directive (EU) 2019/790 of the European Parliament and of the Council().
(105)
General-purpose AI models, in particular large generative AI models, capable of generating text, images, and other content, present unique innovation opportunities but also challenges to artists, authors, and other creators and the way their creative content is created, distributed, used and consumed. The development and training of such models require access to vast amounts of text, images, videos and other data. Text and data mining techniques may be used extensively in this context for the retrieval and analysis of such content, which may be protected by copyright and related rights. Any use of copyright protected content requires the authorisation of the rightsholder concerned unless relevant copyright exceptions and limitations apply. Directive (EU) 2019/790 introduced exceptions and limitations allowing reproductions and extractions of works or other subject matter, for the purpose of text and data mining, under certain conditions. Under these rules, rightsholders may choose to reserve their rights over their works or other subject matter to prevent text and data mining, unless this is done for the purposes of scientific research. Where the rights to opt out has been expressly reserved in an appropriate manner, providers of general-purpose AI models need to obtain an authorisation from rightsholders if they want to carry out text and data mining over such works.
(106)
Providers that place general-purpose AI models on the Union market should ensure compliance with the relevant obligations in this Regulation. To that end, providers of general-purpose AI models should put in place a policy to comply with Union law on copyright and related rights, in particular to identify and comply with the reservation of rights expressed by rightsholders pursuant to Article 4(3) of Directive (EU) 2019/790. Any provider placing a general-purpose AI model on the Union market should comply with this obligation, regardless of the jurisdiction in which the copyright-relevant acts underpinning the training of those general-purpose AI models take place. This is necessary to ensure a level playing field among providers of general-purpose AI models where no provider should be able to gain a competitive advantage in the Union market by applying lower copyright standards than those provided in the Union.
(107)
In order to increase transparency on the data that is used in the pre-training and training of general-purpose AI models, including text and data protected by copyright law, it is adequate that providers of such models draw up and make publicly available a sufficiently detailed summary of the content used for training the general-purpose AI model. While taking into due account the need to protect trade secrets and confidential business information, this summary should be generally comprehensive in its scope instead of technically detailed to facilitate parties with legitimate interests, including copyright holders, to exercise and enforce their rights under Union law, for example by listing the main data collections or sets that went into training the model, such as large private or public databases or data archives, and by providing a narrative explanation about other data sources used. It is appropriate for the AI Office to provide a template for the summary, which should be simple, effective, and allow the provider to provide the required summary in narrative form.
(108)
With regard to the obligations imposed on providers of general-purpose AI models to put in place a policy to comply with Union copyright law and make publicly available a summary of the content used for the training, the AI Office should monitor whether the provider has fulfilled those obligations without verifying or proceeding to a work-by-work assessment of the training data in terms of copyright compliance. This Regulation does not affect the enforcement of copyright rules as provided for under Union law.
(109)
Compliance with the obligations applicable to the providers of general-purpose AI models should be commensurate and proportionate to the type of model provider, excluding the need for compliance for persons who develop or use models for non-professional or scientific research purposes, who should nevertheless be encouraged to voluntarily comply with these requirements. Without prejudice to Union copyright law, compliance with those obligations should take due account of the size of the provider and allow simplified ways of compliance for SMEs, including start-ups, that should not represent an excessive cost and not discourage the use of such models. In the case of a modification or fine-tuning of a model, the obligations for providers of general-purpose AI models should be limited to that modification or fine-tuning, for example by complementing the already existing technical documentation with information on the modifications, including new training data sources, as a means to comply with the value chain obligations provided in this Regulation.
(110)
General-purpose AI models could pose systemic risks which include, but are not limited to, any actual or reasonably foreseeable negative effects in relation to major accidents, disruptions of critical sectors and serious consequences to public health and safety; any actual or reasonably foreseeable negative effects on democratic processes, public and economic security; the dissemination of illegal, false, or discriminatory content. Systemic risks should be understood to increase with model capabilities and model reach, can arise along the entire lifecycle of the model, and are influenced by conditions of misuse, model reliability, model fairness and model security, the level of autonomy of the model, its access to tools, novel or combined modalities, release and distribution strategies, the potential to remove guardrails and other factors. In particular, international approaches have so far identified the need to pay attention to risks from potential intentional misuse or unintended issues of control relating to alignment with human intent; chemical, biological, radiological, and nuclear risks, such as the ways in which barriers to entry can be lowered, including for weapons development, design acquisition, or use; offensive cyber capabilities, such as the ways in vulnerability discovery, exploitation, or operational use can be enabled; the effects of interaction and tool use, including for example the capacity to control physical systems and interfere with critical infrastructure; risks from models of making copies of themselves or ‘self-replicating’ or training other models; the ways in which models can give rise to harmful bias and discrimination with risks to individuals, communities or societies; the facilitation of disinformation or harming privacy with threats to democratic values and human rights; risk that a particular event could lead to a chain reaction with considerable negative effects that could affect up to an entire city, an entire domain activity or an entire community.
(111)
It is appropriate to establish a methodology for the classification of general-purpose AI models as general-purpose AI model with systemic risks. Since systemic risks result from particularly high capabilities, a general-purpose AI model should be considered to present systemic risks if it has high-impact capabilities, evaluated on the basis of appropriate technical tools and methodologies, or significant impact on the internal market due to its reach. High-impact capabilities in general-purpose AI models means capabilities that match or exceed the capabilities recorded in the most advanced general-purpose AI models. The full range of capabilities in a model could be better understood after its placing on the market or when deployers interact with the model. According to the state of the art at the time of entry into force of this Regulation, the cumulative amount of computation used for the training of the general-purpose AI model measured in floating point operations is one of the relevant approximations for model capabilities. The cumulative amount of computation used for training includes the computation used across the activities and methods that are intended to enhance the capabilities of the model prior to deployment, such as pre-training, synthetic data generation and fine-tuning. Therefore, an initial threshold of floating point operations should be set, which, if met by a general-purpose AI model, leads to a presumption that the model is a general-purpose AI model with systemic risks. This threshold should be adjusted over time to reflect technological and industrial changes, such as algorithmic improvements or increased hardware efficiency, and should be supplemented with benchmarks and indicators for model capability. To inform this, the AI Office should engage with the scientific community, industry, civil society and other experts. Thresholds, as well as tools and benchmarks for the assessment of high-impact capabilities, should be strong predictors of generality, its capabilities and associated systemic risk of general-purpose AI models, and could take into account the way the model will be placed on the market or the number of users it may affect. To complement this system, there should be a possibility for the Commission to take individual decisions designating a general-purpose AI model as a general-purpose AI model with systemic risk if it is found that such model has capabilities or an impact equivalent to those captured by the set threshold. That decision should be taken on the basis of an overall assessment of the criteria for the designation of a general-purpose AI model with systemic risk set out in an annex to this Regulation, such as quality or size of the training data set, number of business and end users, its input and output modalities, its level of autonomy and scalability, or the tools it has access to. Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic risk, the Commission should take the request into account and may decide to reassess whether the general-purpose AI model can still be considered to present systemic risks.
(112)
It is also necessary to clarify a procedure for the classification of a general-purpose AI model with systemic risks. A general-purpose AI model that meets the applicable threshold for high-impact capabilities should be presumed to be a general-purpose AI models with systemic risk. The provider should notify the AI Office at the latest two weeks after the requirements are met or it becomes known that a general-purpose AI model will meet the requirements that lead to the presumption. This is especially relevant in relation to the threshold of floating point operations because training of general-purpose AI models takes considerable planning which includes the upfront allocation of compute resources and, therefore, providers of general-purpose AI models are able to know if their model would meet the threshold before the training is completed. In the context of that notification, the provider should be able to demonstrate that, because of its specific characteristics, a general-purpose AI model exceptionally does not present systemic risks, and that it thus should not be classified as a general-purpose AI model with systemic risks. That information is valuable for the AI Office to anticipate the placing on the market of general-purpose AI models with systemic risks and the providers can start to engage with the AI Office early on. That information is especially important with regard to general-purpose AI models that are planned to be released as open-source, given that, after the open-source model release, necessary measures to ensure compliance with the obligations under this Regulation may be more difficult to implement.
(113)
If the Commission becomes aware of the fact that a general-purpose AI model meets the requirements to classify as a general-purpose AI model with systemic risk, which previously had either not been known or of which the relevant provider has failed to notify the Commission, the Commission should be empowered to designate it so. A system of qualified alerts should ensure that the AI Office is made aware by the scientific panel of general-purpose AI models that should possibly be classified as general-purpose AI models with systemic risk, in addition to the monitoring activities of the AI Office.
(114)
The providers of general-purpose AI models presenting systemic risks should be subject, in addition to the obligations provided for providers of general-purpose AI models, to obligations aimed at identifying and mitigating those risks and ensuring an adequate level of cybersecurity protection, regardless of whether it is provided as a standalone model or embedded in an AI system or a product. To achieve those objectives, this Regulation should require providers to perform the necessary model evaluations, in particular prior to its first placing on the market, including conducting and documenting adversarial testing of models, also, as appropriate, through internal or independent external testing. In addition, providers of general-purpose AI models with systemic risks should continuously assess and mitigate systemic risks, including for example by putting in place risk-management policies, such as accountability and governance processes, implementing post-market monitoring, taking appropriate measures along the entire model’s lifecycle and cooperating with relevant actors along the AI value chain.
(115)
Providers of general-purpose AI models with systemic risks should assess and mitigate possible systemic risks. If, despite efforts to identify and prevent risks related to a general-purpose AI model that may present systemic risks, the development or use of the model causes a serious incident, the general-purpose AI model provider should without undue delay keep track of the incident and report any relevant information and possible corrective measures to the Commission and national competent authorities. Furthermore, providers should ensure an adequate level of cybersecurity protection for the model and its physical infrastructure, if appropriate, along the entire model lifecycle. Cybersecurity protection related to systemic risks associated with malicious use or attacks should duly consider accidental model leakage, unauthorised releases, circumvention of safety measures, and defence against cyberattacks, unauthorised access or model theft. That protection could be facilitated by securing model weights, algorithms, servers, and data sets, such as through operational security measures for information security, specific cybersecurity policies, adequate technical and established solutions, and cyber and physical access controls, appropriate to the relevant circumstances and the risks involved.
(116)
The AI Office should encourage and facilitate the drawing up, review and adaptation of codes of practice, taking into account international approaches. All providers of general-purpose AI models could be invited to participate. To ensure that the codes of practice reflect the state of the art and duly take into account a diverse set of perspectives, the AI Office should collaborate with relevant national competent authorities, and could, where appropriate, consult with civil society organisations and other relevant stakeholders and experts, including the Scientific Panel, for the drawing up of such codes. Codes of practice should cover obligations for providers of general-purpose AI models and of general-purpose AI models presenting systemic risks. In addition, as regards systemic risks, codes of practice should help to establish a risk taxonomy of the type and nature of the systemic risks at Union level, including their sources. Codes of practice should also be focused on specific risk assessment and mitigation measures.
(117)
The codes of practice should represent a central tool for the proper compliance with the obligations provided for under this Regulation for providers of general-purpose AI models. Providers should be able to rely on codes of practice to demonstrate compliance with the obligations. By means of implementing acts, the Commission may decide to approve a code of practice and give it a general validity within the Union, or, alternatively, to provide common rules for the implementation of the relevant obligations, if, by the time this Regulation becomes applicable, a code of practice cannot be finalised or is not deemed adequate by the AI Office. Once a harmonised standard is published and assessed as suitable to cover the relevant obligations by the AI Office, compliance with a European harmonised standard should grant providers the presumption of conformity. Providers of general-purpose AI models should furthermore be able to demonstrate compliance using alternative adequate means, if codes of practice or harmonised standards are not available, or they choose not to rely on those.
(118)
This Regulation regulates AI systems and AI models by imposing certain requirements and obligations for relevant market actors that are placing them on the market, putting into service or use in the Union, thereby complementing obligations for providers of intermediary services that embed such systems or models into their services regulated by Regulation (EU) 2022/2065. To the extent that such systems or models are embedded into designated very large online platforms or very large online search engines, they are subject to the risk-management framework provided for in Regulation (EU) 2022/2065. Consequently, the corresponding obligations of this Regulation should be presumed to be fulfilled, unless significant systemic risks not covered by Regulation (EU) 2022/2065 emerge and are identified in such models. Within this framework, providers of very large online platforms and very large online search engines are obliged to assess potential systemic risks stemming from the design, functioning and use of their services, including how the design of algorithmic systems used in the service may contribute to such risks, as well as systemic risks stemming from potential misuses. Those providers are also obliged to take appropriate mitigating measures in observance of fundamental rights.
(119)
Considering the quick pace of innovation and the technological evolution of digital services in scope of different instruments of Union law in particular having in mind the usage and the perception of their recipients, the AI systems subject to this Regulation may be provided as intermediary services or parts thereof within the meaning of Regulation (EU) 2022/2065, which should be interpreted in a technology-neutral manner. For example, AI systems may be used to provide online search engines, in particular, to the extent that an AI system such as an online chatbot performs searches of, in principle, all websites, then incorporates the results into its existing knowledge and uses the updated knowledge to generate a single output that combines different sources of information.
(120)
Furthermore, obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially generated or manipulated are particularly relevant to facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards the obligations of providers of very large online platforms or very large online search engines to identify and mitigate systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated, in particular risk of the actual or foreseeable negative effects on democratic processes, civic discourse and electoral processes, including through disinformation.
(121)
Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation, in line with the state of the art, to promote innovation as well as competitiveness and growth in the single market. Compliance with harmonised standards as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012 of the European Parliament and of the Council(), which are normally expected to reflect the state of the art, should be a means for providers to demonstrate conformity with the requirements of this Regulation. A balanced representation of interests involving all relevant stakeholders in the development of standards, in particular SMEs, consumer organisations and environmental and social stakeholders in accordance with Articles 5 and 6 of Regulation (EU) No 1025/2012 should therefore be encouraged. In order to facilitate compliance, the standardisation requests should be issued by the Commission without undue delay. When preparing the standardisation request, the Commission should consult the advisory forum and the Board in order to collect relevant expertise. However, in the absence of relevant references to harmonised standards, the Commission should be able to establish, via implementing acts, and after consultation of the advisory forum, common specifications for certain requirements under this Regulation. The common specification should be an exceptional fall back solution to facilitate the provider’s obligation to comply with the requirements of this Regulation, when the standardisation request has not been accepted by any of the European standardisation organisations, or when the relevant harmonised standards insufficiently address fundamental rights concerns, or when the harmonised standards do not comply with the request, or when there are delays in the adoption of an appropriate harmonised standard. Where such a delay in the adoption of a harmonised standard is due to the technical complexity of that standard, this should be considered by the Commission before contemplating the establishment of common specifications. When developing common specifications, the Commission is encouraged to cooperate with international partners and international standardisation bodies.
(122)
It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of a high-risk AI system that has been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which the AI system is intended to be used, should be presumed to comply with the relevant measure provided for under the requirement on data governance set out in this Regulation. Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, in accordance with Article 54(3) of Regulation (EU) 2019/881, high-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to that Regulation and the references of which have been published in theOfficial Journal of the European Unionshould be presumed to comply with the cybersecurity requirement of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover the cybersecurity requirement of this Regulation. This remains without prejudice to the voluntary nature of that cybersecurity scheme.
(123)
In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into service.
(124)
It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk AI systems related to products which are covered by existing Union harmonisation legislation based on the New Legislative Framework, the compliance of those AI systems with the requirements of this Regulation should be assessed as part of the conformity assessment already provided for in that law. The applicability of the requirements of this Regulation should thus not affect the specific logic, methodology or general structure of conformity assessment under the relevant Union harmonisation legislation.
(125)
Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third party conformity assessment. However, given the current experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for biometrics.
(126)
In order to carry out third-party conformity assessments when so required, notified bodies should be notified under this Regulation by the national competent authorities, provided that they comply with a set of requirements, in particular on independence, competence, absence of conflicts of interests and suitable cybersecurity requirements. Notification of those bodies should be sent by national competent authorities to the Commission and the other Member States by means of the electronic notification tool developed and managed by the Commission pursuant to Article R23 of Annex I to Decision No 768/2008/EC.
(127)
In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is adequate to facilitate the mutual recognition of conformity assessment results produced by competent conformity assessment bodies, independent of the territory in which they are established, provided that those conformity assessment bodies established under the law of a third country meet the applicable requirements of this Regulation and the Union has concluded an agreement to that extent. In this context, the Commission should actively explore possible international instruments for that purpose and in particular pursue the conclusion of mutual recognition agreements with third countries.
(128)
In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is appropriate that whenever a change occurs which may affect the compliance of a high-risk AI system with this Regulation (e.g. change of operating system or software architecture), or when the intended purpose of the system changes, that AI system should be considered to be a new AI system which should undergo a new conformity assessment. However, changes occurring to the algorithm and the performance of AI systems which continue to ‘learn’ after being placed on the market or put into service, namely automatically adapting how functions are carried out, should not constitute a substantial modification, provided that those changes have been pre-determined by the provider and assessed at the moment of the conformity assessment.
(129)
High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE marking should be affixed, and may be complemented by a digital CE marking. For high-risk AI systems only provided digitally, a digital CE marking should be used. Member States should not create unjustified obstacles to the placing on the market or the putting into service of high-risk AI systems that comply with the requirements laid down in this Regulation and bear the CE marking.
(130)
Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons, the protection of the environment and climate change and for society as a whole. It is thus appropriate that under exceptional reasons of public security or protection of life and health of natural persons, environmental protection and the protection of key industrial and infrastructural assets, market surveillance authorities could authorise the placing on the market or the putting into service of AI systems which have not undergone a conformity assessment. In duly justified situations, as provided for in this Regulation, law enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation of the market surveillance authority, provided that such authorisation is requested during or after the use without undue delay.
(131)
In order to facilitate the work of the Commission and the Member States in the AI field as well as to increase the transparency towards the public, providers of high-risk AI systems other than those related to products falling within the scope of relevant existing Union harmonisation legislation, as well as providers who consider that an AI system listed in the high-risk use cases in an annex to this Regulation is not high-risk on the basis of a derogation, should be required to register themselves and information about their AI system in an EU database, to be established and managed by the Commission. Before using an AI system listed in the high-risk use cases in an annex to this Regulation, deployers of high-risk AI systems that are public authorities, agencies or bodies, should register themselves in such database and select the system that they envisage to use. Other deployers should be entitled to do so voluntarily. This section of the EU database should be publicly accessible, free of charge, the information should be easily navigable, understandable and machine-readable. The EU database should also be user-friendly, for example by providing search functionalities, including through keywords, allowing the general public to find relevant information to be submitted upon the registration of high-risk AI systems and on the use case of high-risk AI systems, set out in an annex to this Regulation, to which the high-risk AI systems correspond. Any substantial modification of high-risk AI systems should also be registered in the EU database. For high-risk AI systems in the area of law enforcement, migration, asylum and border control management, the registration obligations should be fulfilled in a secure non-public section of the EU database. Access to the secure non-public section should be strictly limited to the Commission as well as to market surveillance authorities with regard to their national section of that database. High-risk AI systems in the area of critical infrastructure should only be registered at national level. The Commission should be the controller of the EU database, in accordance with Regulation (EU) 2018/1725. In order to ensure the full functionality of the EU database, when deployed, the procedure for setting the database should include the development of functional specifications by the Commission and an independent audit report. The Commission should take into account cybersecurity risks when carrying out its tasks as data controller on the EU database. In order to maximise the availability and use of the EU database by the public, the EU database, including the information made available through it, should comply with requirements under the Directive (EU) 2019/882.
(132)
Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. In certain circumstances, the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk AI systems and subject to targeted exceptions to take into account the special need of law enforcement. In particular, natural persons should be notified that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect taking into account the circumstances and the context of use. When implementing that obligation, the characteristics of natural persons belonging to vulnerable groups due to their age or disability should be taken into account to the extent the AI system is intended to interact with those groups as well. Moreover, natural persons should be notified when they are exposed to AI systems that, by processing their biometric data, can identify or infer the emotions or intentions of those persons or assign them to specific categories. Such specific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos, personal traits, ethnic origin, personal preferences and interests. Such information and notifications should be provided in accessible formats for persons with disabilities.
(133)
A variety of AI systems can generate large quantities of synthetic content that becomes increasingly hard for humans to distinguish from human-generated and authentic content. The wide availability and increasing capabilities of those systems have a significant impact on the integrity and trust in the information ecosystem, raising new risks of misinformation and manipulation at scale, fraud, impersonation and consumer deception. In light of those impacts, the fast technological pace and the need for new methods and techniques to trace origin of information, it is appropriate to require providers of those systems to embed technical solutions that enable marking in a machine readable format and detection that the output has been generated or manipulated by an AI system and not a human. Such techniques and methods should be sufficiently reliable, interoperable, effective and robust as far as this is technically feasible, taking into account available techniques or a combination of such techniques, such as watermarks, metadata identifications, cryptographic methods for proving provenance and authenticity of content, logging methods, fingerprints or other techniques, as may be appropriate. When implementing this obligation, providers should also take into account the specificities and the limitations of the different types of content and the relevant technological and market developments in the field, as reflected in the generally acknowledged state of the art. Such techniques and methods can be implemented at the level of the AI system or at the level of the AI model, including general-purpose AI models generating content, thereby facilitating fulfilment of this obligation by the downstream provider of the AI system. To remain proportionate, it is appropriate to envisage that this marking obligation should not cover AI systems performing primarily an assistive function for standard editing or AI systems not substantially altering the input data provided by the deployer or the semantics thereof.
(134)
Further to the technical solutions employed by the providers of the AI system, deployers who use an AI system to generate or manipulate image, audio or video content that appreciably resembles existing persons, objects, places, entities or events and would falsely appear to a person to be authentic or truthful (deep fakes), should also clearly and distinguishably disclose that the content has been artificially created or manipulated by labelling the AI output accordingly and disclosing its artificial origin. Compliance with this transparency obligation should not be interpreted as indicating that the use of the AI system or its output impedes the right to freedom of expression and the right to freedom of the arts and sciences guaranteed in the Charter, in particular where the content is part of an evidently creative, satirical, artistic, fictional or analogous work or programme, subject to appropriate safeguards for the rights and freedoms of third parties. In those cases, the transparency obligation for deep fakes set out in this Regulation is limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not hamper the display or enjoyment of the work, including its normal exploitation and use, while maintaining the utility and quality of the work. In addition, it is also appropriate to envisage a similar disclosure obligation in relation to AI-generated or manipulated text to the extent it is published with the purpose of informing the public on matters of public interest unless the AI-generated content has undergone a process of human review or editorial control and a natural or legal person holds editorial responsibility for the publication of the content.
(135)
Without prejudice to the mandatory nature and full applicability of the transparency obligations, the Commission may also encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content, including to support practical arrangements for making, as appropriate, the detection mechanisms accessible and facilitating cooperation with other actors along the value chain, disseminating content or checking its authenticity and provenance to enable the public to effectively distinguish AI-generated content.
(136)
The obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially generated or manipulated are particularly relevant to facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards the obligations of providers of very large online platforms or very large online search engines to identify and mitigate systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated, in particular the risk of the actual or foreseeable negative effects on democratic processes, civic discourse and electoral processes, including through disinformation. The requirement to label content generated by AI systems under this Regulation is without prejudice to the obligation in Article 16(6) of Regulation (EU) 2022/2065 for providers of hosting services to process notices on illegal content received pursuant to Article 16(1) of that Regulation and should not influence the assessment and the decision on the illegality of the specific content. That assessment should be performed solely with reference to the rules governing the legality of the content.
(137)
Compliance with the transparency obligations for the AI systems covered by this Regulation should not be interpreted as indicating that the use of the AI system or its output is lawful under this Regulation or other Union and Member State law and should be without prejudice to other transparency obligations for deployers of AI systems laid down in Union or national law.
(138)
AI is a rapidly developing family of technologies that requires regulatory oversight and a safe and controlled space for experimentation, while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. To ensure a legal framework that promotes innovation, is future-proof and resilient to disruption, Member States should ensure that their national competent authorities establish at least one AI regulatory sandbox at national level to facilitate the development and testing of innovative AI systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service. Member States could also fulfil this obligation through participating in already existing regulatory sandboxes or establishing jointly a sandbox with one or more Member States’ competent authorities, insofar as this participation provides equivalent level of national coverage for the participating Member States. AI regulatory sandboxes could be established in physical, digital or hybrid form and may accommodate physical as well as digital products. Establishing authorities should also ensure that the AI regulatory sandboxes have the adequate resources for their functioning, including financial and human resources.
(139)
The objectives of the AI regulatory sandboxes should be to foster AI innovation by establishing a controlled experimentation and testing environment in the development and pre-marketing phase with a view to ensuring compliance of the innovative AI systems with this Regulation and other relevant Union and national law. Moreover, the AI regulatory sandboxes should aim to enhance legal certainty for innovators and the competent authorities’ oversight and understanding of the opportunities, emerging risks and the impacts of AI use, to facilitate regulatory learning for authorities and undertakings, including with a view to future adaptions of the legal framework, to support cooperation and the sharing of best practices with the authorities involved in the AI regulatory sandbox, and to accelerate access to markets, including by removing barriers for SMEs, including start-ups. AI regulatory sandboxes should be widely available throughout the Union, and particular attention should be given to their accessibility for SMEs, including start-ups. The participation in the AI regulatory sandbox should focus on issues that raise legal uncertainty for providers and prospective providers to innovate, experiment with AI in the Union and contribute to evidence-based regulatory learning. The supervision of the AI systems in the AI regulatory sandbox should therefore cover their development, training, testing and validation before the systems are placed on the market or put into service, as well as the notion and occurrence of substantial modification that may require a new conformity assessment procedure. Any significant risks identified during the development and testing of such AI systems should result in adequate mitigation and, failing that, in the suspension of the development and testing process. Where appropriate, national competent authorities establishing AI regulatory sandboxes should cooperate with other relevant authorities, including those supervising the protection of fundamental rights, and could allow for the involvement of other actors within the AI ecosystem such as national or European standardisation organisations, notified bodies, testing and experimentation facilities, research and experimentation labs, European Digital Innovation Hubs and relevant stakeholder and civil society organisations. To ensure uniform implementation across the Union and economies of scale, it is appropriate to establish common rules for the AI regulatory sandboxes’ implementation and a framework for cooperation between the relevant authorities involved in the supervision of the sandboxes. AI regulatory sandboxes established under this Regulation should be without prejudice to other law allowing for the establishment of other sandboxes aiming to ensure compliance with law other than this Regulation. Where appropriate, relevant competent authorities in charge of those other regulatory sandboxes should consider the benefits of using those sandboxes also for the purpose of ensuring compliance of AI systems with this Regulation. Upon agreement between the national competent authorities and the participants in the AI regulatory sandbox, testing in real world conditions may also be operated and supervised in the framework of the AI regulatory sandbox.
(140)
This Regulation should provide the legal basis for the providers and prospective providers in the AI regulatory sandbox to use personal data collected for other purposes for developing certain AI systems in the public interest within the AI regulatory sandbox, only under specified conditions, in accordance with Article 6(4) and Article 9(2), point (g), of Regulation (EU) 2016/679, and Articles 5, 6 and 10 of Regulation (EU) 2018/1725, and without prejudice to Article 4(2) and Article 10 of Directive (EU) 2016/680. All other obligations of data controllers and rights of data subjects under Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 remain applicable. In particular, this Regulation should not provide a legal basis in the meaning of Article 22(2), point (b) of Regulation (EU) 2016/679 and Article 24(2), point (b) of Regulation (EU) 2018/1725. Providers and prospective providers in the AI regulatory sandbox should ensure appropriate safeguards and cooperate with the competent authorities, including by following their guidance and acting expeditiously and in good faith to adequately mitigate any identified significant risks to safety, health, and fundamental rights that may arise during the development, testing and experimentation in that sandbox.
(141)
In order to accelerate the process of development and the placing on the market of the high-risk AI systems listed in an annex to this Regulation, it is important that providers or prospective providers of such systems may also benefit from a specific regime for testing those systems in real world conditions, without participating in an AI regulatory sandbox. However, in such cases, taking into account the possible consequences of such testing on individuals, it should be ensured that appropriate and sufficient guarantees and conditions are introduced by this Regulation for providers or prospective providers. Such guarantees should include, inter alia, requesting informed consent of natural persons to participate in testing in real world conditions, with the exception of law enforcement where the seeking of informed consent would prevent the AI system from being tested. Consent of subjects to participate in such testing under this Regulation is distinct from, and without prejudice to, consent of data subjects for the processing of their personal data under the relevant data protection law. It is also important to minimise the risks and enable oversight by competent authorities and therefore require prospective providers to have a real-world testing plan submitted to competent market surveillance authority, register the testing in dedicated sections in the EU database subject to some limited exceptions, set limitations on the period for which the testing can be done and require additional safeguards for persons belonging to certain vulnerable groups, as well as a written agreement defining the roles and responsibilities of prospective providers and deployers and effective oversight by competent personnel involved in the real world testing. Furthermore, it is appropriate to envisage additional safeguards to ensure that the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded and that personal data is protected and is deleted when the subjects have withdrawn their consent to participate in the testing without prejudice to their rights as data subjects under the Union data protection law. As regards transfer of data, it is also appropriate to envisage that data collected and processed for the purpose of testing in real-world conditions should be transferred to third countries only where appropriate and applicable safeguards under Union law are implemented, in particular in accordance with bases for transfer of personal data under Union law on data protection, while for non-personal data appropriate safeguards are put in place in accordance with Union law, such as Regulations (EU) 2022/868()and (EU) 2023/2854()of the European Parliament and of the Council.
(142)
To ensure that AI leads to socially and environmentally beneficial outcomes, Member States are encouraged to support and promote research and development of AI solutions in support of socially and environmentally beneficial outcomes, such as AI-based solutions to increase accessibility for persons with disabilities, tackle socio-economic inequalities, or meet environmental targets, by allocating sufficient resources, including public and Union funding, and, where appropriate and provided that the eligibility and selection criteria are fulfilled, considering in particular projects which pursue such objectives. Such projects should be based on the principle of interdisciplinary cooperation between AI developers, experts on inequality and non-discrimination, accessibility, consumer, environmental, and digital rights, as well as academics.
(143)
In order to promote and protect innovation, it is important that the interests of SMEs, including start-ups, that are providers or deployers of AI systems are taken into particular account. To that end, Member States should develop initiatives, which are targeted at those operators, including on awareness raising and information communication. Member States should provide SMEs, including start-ups, that have a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes provided that they fulfil the eligibility conditions and selection criteria and without precluding other providers and prospective providers to access the sandboxes provided the same conditions and criteria are fulfilled. Member States should utilise existing channels and where appropriate, establish new dedicated channels for communication with SMEs, including start-ups, deployers, other innovators and, as appropriate, local public authorities, to support SMEs throughout their development path by providing guidance and responding to queries about the implementation of this Regulation. Where appropriate, these channels should work together to create synergies and ensure homogeneity in their guidance to SMEs, including start-ups, and deployers. Additionally, Member States should facilitate the participation of SMEs and other relevant stakeholders in the standardisation development processes. Moreover, the specific interests and needs of providers that are SMEs, including start-ups, should be taken into account when notified bodies set conformity assessment fees. The Commission should regularly assess the certification and compliance costs for SMEs, including start-ups, through transparent consultations and should work with Member States to lower such costs. For example, translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators, in particular those of a smaller scale. Member States should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border deployers. In order to address the specific needs of SMEs, including start-ups, the Commission should provide standardised templates for the areas covered by this Regulation, upon request of the Board. Additionally, the Commission should complement Member States’ efforts by providing a single information platform with easy-to-use information with regards to this Regulation for all providers and deployers, by organising appropriate communication campaigns to raise awareness about the obligations arising from this Regulation, and by evaluating and promoting the convergence of best practices in public procurement procedures in relation to AI systems. Medium-sized enterprises which until recently qualified as small enterprises within the meaning of the Annex to Commission Recommendation 2003/361/EC()should have access to those support measures, as those new medium-sized enterprises may sometimes lack the legal resources and training necessary to ensure proper understanding of, and compliance with, this Regulation.
(144)
In order to promote and protect innovation, the AI-on-demand platform, all relevant Union funding programmes and projects, such as Digital Europe Programme, Horizon Europe, implemented by the Commission and the Member States at Union or national level should, as appropriate, contribute to the achievement of the objectives of this Regulation.
(145)
In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers, in particular SMEs, including start-ups, and notified bodies with their obligations under this Regulation, the AI-on-demand platform, the European Digital Innovation Hubs and the testing and experimentation facilities established by the Commission and the Member States at Union or national level should contribute to the implementation of this Regulation. Within their respective mission and fields of competence, the AI-on-demand platform, the European Digital Innovation Hubs and the testing and experimentation Facilities are able to provide in particular technical and scientific support to providers and notified bodies.
(146)
Moreover, in light of the very small size of some operators and in order to ensure proportionality regarding costs of innovation, it is appropriate to allow microenterprises to fulfil one of the most costly obligations, namely to establish a quality management system, in a simplified manner which would reduce the administrative burden and the costs for those enterprises without affecting the level of protection and the need for compliance with the requirements for high-risk AI systems. The Commission should develop guidelines to specify the elements of the quality management system to be fulfilled in this simplified manner by microenterprises.
(147)
It is appropriate that the Commission facilitates, to the extent possible, access to testing and experimentation facilities to bodies, groups or laboratories established or accredited pursuant to any relevant Union harmonisation legislation and which fulfil tasks in the context of conformity assessment of products or devices covered by that Union harmonisation legislation. This is, in particular, the case as regards expert panels, expert laboratories and reference laboratories in the field of medical devices pursuant to Regulations (EU) 2017/745 and (EU) 2017/746.
(148)
This Regulation should establish a governance framework that both allows to coordinate and support the application of this Regulation at national level, as well as build capabilities at Union level and integrate stakeholders in the field of AI. The effective implementation and enforcement of this Regulation require a governance framework that allows to coordinate and build up central expertise at Union level. The AI Office was established by Commission Decision()and has as its mission to develop Union expertise and capabilities in the field of AI and to contribute to the implementation of Union law on AI. Member States should facilitate the tasks of the AI Office with a view to support the development of Union expertise and capabilities at Union level and to strengthen the functioning of the digital single market. Furthermore, a Board composed of representatives of the Member States, a scientific panel to integrate the scientific community and an advisory forum to contribute stakeholder input to the implementation of this Regulation, at Union and national level, should be established. The development of Union expertise and capabilities should also include making use of existing resources and expertise, in particular through synergies with structures built up in the context of the Union level enforcement of other law and synergies with related initiatives at Union level, such as the EuroHPC Joint Undertaking and the AI testing and experimentation facilities under the Digital Europe Programme.
(149)
In order to facilitate a smooth, effective and harmonised implementation of this Regulation a Board should be established. The Board should reflect the various interests of the AI eco-system and be composed of representatives of the Member States. The Board should be responsible for a number of advisory tasks, including issuing opinions, recommendations, advice or contributing to guidance on matters related to the implementation of this Regulation, including on enforcement matters, technical specifications or existing standards regarding the requirements established in this Regulation and providing advice to the Commission and the Member States and their national competent authorities on specific questions related to AI. In order to give some flexibility to Member States in the designation of their representatives in the Board, such representatives may be any persons belonging to public entities who should have the relevant competences and powers to facilitate coordination at national level and contribute to the achievement of the Board’s tasks. The Board should establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities on issues related, respectively, to market surveillance and notified bodies. The standing subgroup for market surveillance should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020. In accordance with Article 33 of that Regulation, the Commission should support the activities of the standing subgroup for market surveillance by undertaking market evaluations or studies, in particular with a view to identifying aspects of this Regulation requiring specific and urgent coordination among market surveillance authorities. The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. The Board should also cooperate, as appropriate, with relevant Union bodies, experts groups and networks active in the context of relevant Union law, including in particular those active under relevant Union law on data, digital products and services.
(150)
With a view to ensuring the involvement of stakeholders in the implementation and application of this Regulation, an advisory forum should be established to advise and provide technical expertise to the Board and the Commission. To ensure a varied and balanced stakeholder representation between commercial and non-commercial interest and, within the category of commercial interests, with regards to SMEs and other undertakings, the advisory forum should comprise inter alia industry, start-ups, SMEs, academia, civil society, including the social partners, as well as the Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI).
(151)
To support the implementation and enforcement of this Regulation, in particular the monitoring activities of the AI Office as regards general-purpose AI models, a scientific panel of independent experts should be established. The independent experts constituting the scientific panel should be selected on the basis of up-to-date scientific or technical expertise in the field of AI and should perform their tasks with impartiality, objectivity and ensure the confidentiality of information and data obtained in carrying out their tasks and activities. To allow the reinforcement of national capacities necessary for the effective enforcement of this Regulation, Member States should be able to request support from the pool of experts constituting the scientific panel for their enforcement activities.
(152)
In order to support adequate enforcement as regards AI systems and reinforce the capacities of the Member States, Union AI testing support structures should be established and made available to the Member States.
(153)
Member States hold a key role in the application and enforcement of this Regulation. In that respect, each Member State should designate at least one notifying authority and at least one market surveillance authority as national competent authorities for the purpose of supervising the application and implementation of this Regulation. Member States may decide to appoint any kind of public entity to perform the tasks of the national competent authorities within the meaning of this Regulation, in accordance with their specific national organisational characteristics and needs. In order to increase organisation efficiency on the side of Member States and to set a single point of contact vis-à-vis the public and other counterparts at Member State and Union levels, each Member State should designate a market surveillance authority to act as a single point of contact.
(154)
The national competent authorities should exercise their powers independently, impartially and without bias, so as to safeguard the principles of objectivity of their activities and tasks and to ensure the application and implementation of this Regulation. The members of these authorities should refrain from any action incompatible with their duties and should be subject to confidentiality rules under this Regulation.
(155)
In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible corrective action in a timely manner, all providers should have a post-market monitoring system in place. Where relevant, post-market monitoring should include an analysis of the interaction with other AI systems including other devices and software. Post-market monitoring should not cover sensitive operational data of deployers which are law enforcement authorities. This system is also key to ensure that the possible risks emerging from AI systems which continue to ‘learn’ after being placed on the market or put into service can be more efficiently and timely addressed. In this context, providers should also be required to have a system in place to report to the relevant authorities any serious incidents resulting from the use of their AI systems, meaning incident or malfunctioning leading to death or serious damage to health, serious and irreversible disruption of the management and operation of critical infrastructure, infringements of obligations under Union law intended to protect fundamental rights or serious damage to property or the environment.
(156)
In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union harmonisation legislation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply in its entirety. Market surveillance authorities designated pursuant to this Regulation should have all enforcement powers laid down in this Regulation and in Regulation (EU) 2019/1020 and should exercise their powers and carry out their duties independently, impartially and without bias. Although the majority of AI systems are not subject to specific requirements and obligations under this Regulation, market surveillance authorities may take measures in relation to all AI systems when they present a risk in accordance with this Regulation. Due to the specific nature of Union institutions, agencies and bodies falling within the scope of this Regulation, it is appropriate to designate the European Data Protection Supervisor as a competent market surveillance authority for them. This should be without prejudice to the designation of national competent authorities by the Member States. Market surveillance activities should not affect the ability of the supervised entities to carry out their tasks independently, when such independence is required by Union law.
(157)
This Regulation is without prejudice to the competences, tasks, powers and independence of relevant national public authorities or bodies which supervise the application of Union law protecting fundamental rights, including equality bodies and data protection authorities. Where necessary for their mandate, those national public authorities or bodies should also have access to any documentation created under this Regulation. A specific safeguard procedure should be set for ensuring adequate and timely enforcement against AI systems presenting a risk to health, safety and fundamental rights. The procedure for such AI systems presenting a risk should be applied to high-risk AI systems presenting a risk, prohibited systems which have been placed on the market, put into service or used in violation of the prohibited practices laid down in this Regulation and AI systems which have been made available in violation of the transparency requirements laid down in this Regulation and present a risk.
(158)
Union financial services law includes internal governance and risk-management rules and requirements which are applicable to regulated financial institutions in the course of provision of those services, including when they make use of AI systems. In order to ensure coherent application and enforcement of the obligations under this Regulation and relevant rules and requirements of the Union financial services legal acts, the competent authorities for the supervision and enforcement of those legal acts, in particular competent authorities as defined in Regulation (EU) No 575/2013 of the European Parliament and of the Council()and Directives 2008/48/EC(), 2009/138/EC(), 2013/36/EU(), 2014/17/EU()and (EU) 2016/97()of the European Parliament and of the Council, should be designated, within their respective competences, as competent authorities for the purpose of supervising the implementation of this Regulation, including for market surveillance activities, as regards AI systems provided or used by regulated and supervised financial institutions unless Member States decide to designate another authority to fulfil these market surveillance tasks. Those competent authorities should have all powers under this Regulation and Regulation (EU) 2019/1020 to enforce the requirements and obligations of this Regulation, including powers to carry ourex postmarket surveillance activities that can be integrated, as appropriate, into their existing supervisory mechanisms and procedures under the relevant Union financial services law. It is appropriate to envisage that, when acting as market surveillance authorities under this Regulation, the national authorities responsible for the supervision of credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Council Regulation (EU) No 1024/2013(), should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the European Central Bank’s prudential supervisory tasks as specified in that Regulation. To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated under Directive 2013/36/EU, it is also appropriate to integrate some of the providers’ procedural obligations in relation to risk management, post marketing monitoring and documentation into the existing obligations and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged in relation to the quality management system of providers and the monitoring obligation placed on deployers of high-risk AI systems to the extent that these apply to credit institutions regulated by Directive 2013/36/EU. The same regime should apply to insurance and re-insurance undertakings and insurance holding companies under Directive 2009/138/EC and the insurance intermediaries under Directive (EU) 2016/97 and other types of financial institutions subject to requirements regarding internal governance, arrangements or processes established pursuant to the relevant Union financial services law to ensure consistency and equal treatment in the financial sector.
(159)
Each market surveillance authority for high-risk AI systems in the area of biometrics, as listed in an annex to this Regulation insofar as those systems are used for the purposes of law enforcement, migration, asylum and border control management, or the administration of justice and democratic processes, should have effective investigative and corrective powers, including at least the power to obtain access to all personal data that are being processed and to all information necessary for the performance of its tasks. The market surveillance authorities should be able to exercise their powers by acting with complete independence. Any limitations of their access to sensitive operational data under this Regulation should be without prejudice to the powers conferred to them by Directive (EU) 2016/680. No exclusion on disclosing data to national data protection authorities under this Regulation should affect the current or future powers of those authorities beyond the scope of this Regulation.
(160)
The market surveillance authorities and the Commission should be able to propose joint activities, including joint investigations, to be conducted by market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States. Joint activities to promote compliance should be carried out in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office should provide coordination support for joint investigations.
(161)
It is necessary to clarify the responsibilities and competences at Union and national level as regards AI systems that are built on general-purpose AI models. To avoid overlapping competences, where an AI system is based on a general-purpose AI model and the model and system are provided by the same provider, the supervision should take place at Union level through the AI Office, which should have the powers of a market surveillance authority within the meaning of Regulation (EU) 2019/1020 for this purpose. In all other cases, national market surveillance authorities remain responsible for the supervision of AI systems. However, for general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk, market surveillance authorities should cooperate with the AI Office to carry out evaluations of compliance and inform the Board and other market surveillance authorities accordingly. Furthermore, market surveillance authorities should be able to request assistance from the AI Office where the market surveillance authority is unable to conclude an investigation on a high-risk AI system because of its inability to access certain information related to the general-purpose AI model on which the high-risk AI system is built. In such cases, the procedure regarding mutual assistance in cross-border cases in Chapter VI of Regulation (EU) 2019/1020 should applymutatis mutandis.
(162)
To make best use of the centralised Union expertise and synergies at Union level, the powers of supervision and enforcement of the obligations on providers of general-purpose AI models should be a competence of the Commission. The AI Office should be able to carry out all necessary actions to monitor the effective implementation of this Regulation as regards general-purpose AI models. It should be able to investigate possible infringements of the rules on providers of general-purpose AI models both on its own initiative, following the results of its monitoring activities, or upon request from market surveillance authorities in line with the conditions set out in this Regulation. To support effective monitoring of the AI Office, it should provide for the possibility that downstream providers lodge complaints about possible infringements of the rules on providers of general-purpose AI models and systems.
(163)
With a view to complementing the governance systems for general-purpose AI models, the scientific panel should support the monitoring activities of the AI Office and may, in certain cases, provide qualified alerts to the AI Office which trigger follow-ups, such as investigations. This should be the case where the scientific panel has reason to suspect that a general-purpose AI model poses a concrete and identifiable risk at Union level. Furthermore, this should be the case where the scientific panel has reason to suspect that a general-purpose AI model meets the criteria that would lead to a classification as general-purpose AI model with systemic risk. To equip the scientific panel with the information necessary for the performance of those tasks, there should be a mechanism whereby the scientific panel can request the Commission to require documentation or information from a provider.
(164)
The AI Office should be able to take the necessary actions to monitor the effective implementation of and compliance with the obligations for providers of general-purpose AI models laid down in this Regulation. The AI Office should be able to investigate possible infringements in accordance with the powers provided for in this Regulation, including by requesting documentation and information, by conducting evaluations, as well as by requesting measures from providers of general-purpose AI models. When conducting evaluations, in order to make use of independent expertise, the AI Office should be able to involve independent experts to carry out the evaluations on its behalf. Compliance with the obligations should be enforceable, inter alia, through requests to take appropriate measures, including risk mitigation measures in the case of identified systemic risks as well as restricting the making available on the market, withdrawing or recalling the model. As a safeguard, where needed beyond the procedural rights provided for in this Regulation, providers of general-purpose AI models should have the procedural rights provided for in Article 18 of Regulation (EU) 2019/1020, which should applymutatis mutandis, without prejudice to more specific procedural rights provided for by this Regulation.
(165)
The development of AI systems other than high-risk AI systems in accordance with the requirements of this Regulation may lead to a larger uptake of ethical and trustworthy AI in the Union. Providers of AI systems that are not high-risk should be encouraged to create codes of conduct, including related governance mechanisms, intended to foster the voluntary application of some or all of the mandatory requirements applicable to high-risk AI systems, adapted in light of the intended purpose of the systems and the lower risk involved and taking into account the available technical solutions and industry best practices such as model and data cards. Providers and, as appropriate, deployers of all AI systems, high-risk or not, and AI models should also be encouraged to apply on a voluntary basis additional requirements related, for example, to the elements of the Union’s Ethics Guidelines for Trustworthy AI, environmental sustainability, AI literacy measures, inclusive and diverse design and development of AI systems, including attention to vulnerable persons and accessibility to persons with disability, stakeholders’ participation with the involvement, as appropriate, of relevant stakeholders such as business and civil society organisations, academia, research organisations, trade unions and consumer protection organisations in the design and development of AI systems, and diversity of the development teams, including gender balance. To ensure that the voluntary codes of conduct are effective, they should be based on clear objectives and key performance indicators to measure the achievement of those objectives. They should also be developed in an inclusive way, as appropriate, with the involvement of relevant stakeholders such as business and civil society organisations, academia, research organisations, trade unions and consumer protection organisation. The Commission may develop initiatives, including of a sectoral nature, to facilitate the lowering of technical barriers hindering cross-border exchange of data for AI development, including on data access infrastructure, semantic and technical interoperability of different types of data.
(166)
It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus are not required to comply with the requirements set out for high-risk AI systems are nevertheless safe when placed on the market or put into service. To contribute to this objective, Regulation (EU) 2023/988 of the European Parliament and of the Council()would apply as a safety net.
(167)
In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all parties involved in the application of this Regulation should respect the confidentiality of information and data obtained in carrying out their tasks, in accordance with Union or national law. They should carry out their tasks and activities in such a manner as to protect, in particular, intellectual property rights, confidential business information and trade secrets, the effective implementation of this Regulation, public and national security interests, the integrity of criminal and administrative proceedings, and the integrity of classified information.
(168)
Compliance with this Regulation should be enforceable by means of the imposition of penalties and other enforcement measures. Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement, and to respect thene bis in idemprinciple. In order to strengthen and harmonise administrative penalties for infringement of this Regulation, the upper limits for setting the administrative fines for certain specific infringements should be laid down. When assessing the amount of the fines, Member States should, in each individual case, take into account all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and to the size of the provider, in particular if the provider is an SME, including a start-up. The European Data Protection Supervisor should have the power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation.
(169)
Compliance with the obligations on providers of general-purpose AI models imposed under this Regulation should be enforceable, inter alia, by means of fines. To that end, appropriate levels of fines should also be laid down for infringement of those obligations, including the failure to comply with measures requested by the Commission in accordance with this Regulation, subject to appropriate limitation periods in accordance with the principle of proportionality. All decisions taken by the Commission under this Regulation are subject to review by the Court of Justice of the European Union in accordance with the TFEU, including the unlimited jurisdiction of the Court of Justice with regard to penalties pursuant to Article 261 TFEU.
(170)
Union and national law already provide effective remedies to natural and legal persons whose rights and freedoms are adversely affected by the use of AI systems. Without prejudice to those remedies, any natural or legal person that has grounds to consider that there has been an infringement of this Regulation should be entitled to lodge a complaint to the relevant market surveillance authority.
(171)
Affected persons should have the right to obtain an explanation where a deployer’s decision is based mainly upon the output from certain high-risk AI systems that fall within the scope of this Regulation and where that decision produces legal effects or similarly significantly affects those persons in a way that they consider to have an adverse impact on their health, safety or fundamental rights. That explanation should be clear and meaningful and should provide a basis on which the affected persons are able to exercise their rights. The right to obtain an explanation should not apply to the use of AI systems for which exceptions or restrictions follow from Union or national law and should apply only to the extent this right is not already provided for under Union law.
(172)
Persons acting as whistleblowers on the infringements of this Regulation should be protected under the Union law. Directive (EU) 2019/1937 of the European Parliament and of the Council()should therefore apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
(173)
In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the conditions under which an AI system is not to be considered to be high-risk, the list of high-risk AI systems, the provisions regarding technical documentation, the content of the EU declaration of conformity the provisions regarding the conformity assessment procedures, the provisions establishing the high-risk AI systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply, the threshold, benchmarks and indicators, including by supplementing those benchmarks and indicators, in the rules for the classification of general-purpose AI models with systemic risk, the criteria for the designation of general-purpose AI models with systemic risk, the technical documentation for providers of general-purpose AI models and the transparency information for providers of general-purpose AI models. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(174)
Given the rapid technological developments and the technical expertise required to effectively apply this Regulation, the Commission should evaluate and review this Regulation by 2 August 2029 and every four years thereafter and report to the European Parliament and the Council. In addition, taking into account the implications for the scope of this Regulation, the Commission should carry out an assessment of the need to amend the list of high-risk AI systems and the list of prohibited practices once a year. Moreover, by 2 August 2028 and every four years thereafter, the Commission should evaluate and report to the European Parliament and to the Council on the need to amend the list of high-risk areas headings in the annex to this Regulation, the AI systems within the scope of the transparency obligations, the effectiveness of the supervision and governance system and the progress on the development of standardisation deliverables on energy efficient development of general-purpose AI models, including the need for further measures or actions. Finally, by 2 August 2028 and every three years thereafter, the Commission should evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements provided for high-risk AI systems in the case of AI systems other than high-risk AI systems and possibly other additional requirements for such AI systems.
(175)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council().
(176)
Since the objective of this Regulation, namely to improve the functioning of the internal market and to promote the uptake of human centric and trustworthy AI, while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection against harmful effects of AI systems in the Union and supporting innovation, cannot be sufficiently achieved by the Member States and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(177)
In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the market, including by ensuring continuity of the use of AI systems, it is appropriate that this Regulation applies to the high-risk AI systems that have been placed on the market or put into service before the general date of application thereof, only if, from that date, those systems are subject to significant changes in their design or intended purpose. It is appropriate to clarify that, in this respect, the concept of significant change should be understood as equivalent in substance to the notion of substantial modification, which is used with regard only to high-risk AI systems pursuant to this Regulation. On an exceptional basis and in light of public accountability, operators of AI systems which are components of the large-scale IT systems established by the legal acts listed in an annex to this Regulation and operators of high-risk AI systems that are intended to be used by public authorities should, respectively, take the necessary steps to comply with the requirements of this Regulation by end of 2030 and by 2 August 2030.
(178)
Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant obligations of this Regulation already during the transitional period.
(179)
This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions as well as the general provisions of this Regulation should already apply from 2 February 2025. While the full effect of those prohibitions follows with the establishment of the governance and enforcement of this Regulation, anticipating the application of the prohibitions is important to take account of unacceptable risks and to have an effect on other procedures, such as in civil law. Moreover, the infrastructure related to the governance and the conformity assessment system should be operational before 2 August 2026, therefore the provisions on notified bodies and governance structure should apply from 2 August 2025. Given the rapid pace of technological advancements and adoption of general-purpose AI models, obligations for providers of general-purpose AI models should apply from 2 August 2025. Codes of practice should be ready by 2 May 2025 in view of enabling providers to demonstrate compliance on time. The AI Office should ensure that classification rules and procedures are up to date in light of technological developments. In addition, Member States should lay down and notify to the Commission the rules on penalties, including administrative fines, and ensure that they are properly and effectively implemented by the date of application of this Regulation. Therefore the provisions on penalties should apply from 2 August 2025.
(180)
The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) and (2) of Regulation (EU) 2018/1725 and delivered their joint opinion on 18 June 2021,
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purpose regulation improve functioning internal market laying uniform legal framework particular development placing market putting service use artificial intelligence system system union accordance union value promote uptake human centric trustworthy artificial intelligence ensuring high level protection health safety fundamental right enshrined charter fundamental right european union charter including democracy rule law environmental protection protect harmful effect system union support innovation regulation ensures free movement cross border based good service thus preventing member state imposing restriction development marketing use system unless explicitly authorised regulation regulation applied accordance value union enshrined charter facilitating protection natural person undertaking democracy rule law environmental protection boosting innovation employment making union leader uptake trustworthy system easily deployed large variety sector economy many part society including across border easily circulate throughout union certain member state already explored adoption national rule ensure trustworthy safe developed used accordance fundamental right obligation diverging national rule may lead fragmentation internal market may decrease legal certainty operator develop import use system consistent high level protection throughout union therefore ensured order achieve trustworthy divergence hampering free circulation innovation deployment uptake system related product service within internal market prevented laying uniform obligation operator guaranteeing uniform protection overriding reason public interest right person throughout internal market basis article 114 treaty functioning european union tfeu extent regulation contains specific rule protection individual regard processing personal data concerning restriction use system remote biometric identification purpose law enforcement use system risk assessment natural person purpose law enforcement use system biometric categorisation purpose law enforcement appropriate base regulation far specific rule concerned article tfeu light specific rule recourse article tfeu appropriate consult european data protection board fast evolving family technology contributes wide array economic environmental societal benefit across entire spectrum industry social activity improving prediction optimising operation resource allocation personalising digital solution available individual organisation use provide key competitive advantage undertaking support socially environmentally beneficial outcome example healthcare agriculture food safety education training medium sport culture infrastructure management energy transport logistics public service security justice resource energy efficiency environmental monitoring conservation restoration biodiversity ecosystem climate change mitigation adaptation time depending circumstance regarding specific application use level technological development may generate risk cause harm public interest fundamental right protected union law harm might material immaterial including physical psychological societal economic harm given major impact society need build trust vital regulatory framework developed accordance union value enshrined article treaty european union teu fundamental right freedom enshrined treaty pursuant article teu charter prerequisite human centric technology serve tool people ultimate aim increasing human well order ensure consistent high level protection public interest regard health safety fundamental right common rule high risk system established rule consistent charter non discriminatory line union international trade commitment also take account european declaration digital right principle digital decade ethic guideline trustworthy high level expert group artificial intelligence hleg union legal framework laying harmonised rule therefore needed foster development use uptake internal market time meet high level protection public interest health safety protection fundamental right including democracy rule law environmental protection recognised protected union law achieve objective rule regulating placing market putting service use certain system laid thus ensuring smooth functioning internal market allowing system benefit principle free movement good service rule clear robust protecting fundamental right supportive new innovative solution enabling european ecosystem public private actor creating system line union value unlocking potential digital transformation across region union laying rule well measure support innovation particular focus small medium enterprise smes including startup regulation support objective promoting european human centric approach global leader development secure trustworthy ethical stated european council ensures protection ethical principle specifically requested european parliament harmonised rule applicable placing market putting service use high risk system laid consistently regulation 765 2008 european parliament council decision 768 2008 european parliament council regulation 2019 1020 european parliament council new legislative framework harmonised rule laid regulation apply across sector line new legislative framework without prejudice existing union law particular data protection consumer protection fundamental right employment protection worker product safety regulation complementary consequence right remedy provided union law consumer person system may negative impact including regard compensation possible damage pursuant council directive 374 eec remain unaffected fully applicable furthermore context employment protection worker regulation therefore affect union law social policy national labour law compliance union law concerning employment working condition including health safety work relationship employer worker regulation also affect exercise fundamental right recognised member state union level including right freedom strike take action covered specific industrial relation system member state well right negotiate conclude enforce collective agreement take collective action accordance national law regulation affect provision aiming improve working condition platform work laid directive european parliament council improving working condition platform work moreover regulation aim strengthen effectiveness existing right remedy establishing specific requirement obligation including respect transparency technical documentation record keeping system furthermore obligation placed various operator involved value chain regulation apply without prejudice national law compliance union law effect limiting use certain system law fall outside scope regulation pursues legitimate public interest objective pursued regulation example national labour law law protection minor namely person age taking account uncrc general comment 2021 child right relation digital environment insofar specific system pursue legitimate public interest objective affected regulation fundamental right protection personal data safeguarded particular regulation 2016 679 2018 1725 european parliament council directive 2016 680 european parliament council directive 2002 european parliament council additionally protects private life confidentiality communication including way providing condition storing personal non personal data access terminal equipment union legal act provide basis sustainable responsible data processing including data set include mix personal non personal data regulation seek affect application existing union law governing processing personal data including task power independent supervisory authority competent monitor compliance instrument also affect obligation provider deployers system role data controller processor stemming union national law protection personal data far design development use system involves processing personal data also appropriate clarify data subject continue enjoy right guarantee awarded union law including right related solely automated individual decision making including profiling harmonised rule placing market putting service use system established regulation facilitate effective implementation enable exercise data subject right remedy guaranteed union law protection personal data fundamental right regulation without prejudice provision regarding liability provider intermediary service set regulation 2022 2065 european parliament council notion system regulation clearly defined closely aligned work international organisation working ensure legal certainty facilitate international convergence wide acceptance providing flexibility accommodate rapid technological development field moreover definition based key characteristic system distinguish simpler traditional software system programming approach cover system based rule defined solely natural person automatically execute operation key characteristic system capability infer capability infer refers process obtaining output prediction content recommendation decision influence physical virtual environment capability system derive model algorithm input data technique enable inference building system include machine learning approach learn data achieve certain objective logic knowledge based approach infer encoded knowledge symbolic representation task solved capacity system infer transcends basic data processing enabling learning reasoning modelling term machine based refers fact system run machine reference explicit implicit objective underscore system operate according explicit defined objective implicit objective objective system may different intended purpose system specific context purpose regulation environment understood context system operate whereas output generated system reflect different function performed system include prediction content recommendation decision system designed operate varying level autonomy meaning degree independence action human involvement capability operate without human intervention adaptiveness system could exhibit deployment refers self learning capability allowing system change use system used stand alone basis component product irrespective whether system physically integrated product embedded serf functionality product without integrated therein non embedded notion deployer referred regulation interpreted natural legal person including public authority agency body using system authority except system used course personal non professional activity depending type system use system may affect person deployer notion biometric data used regulation interpreted light notion biometric data defined article point regulation 2016 679 article point regulation 2018 1725 article point directive 2016 680 biometric data allow authentication identification categorisation natural person recognition emotion natural person notion biometric identification referred regulation defined automated recognition physical physiological behavioural human feature face eye movement body shape voice prosody gait posture heart rate blood pressure odour keystroke characteristic purpose establishing individual identity comparing biometric data individual stored biometric data individual reference database irrespective whether individual given consent excludes system intended used biometric verification includes authentication whose sole purpose confirm specific natural person person claim confirm identity natural person sole purpose access service unlocking device security access premise notion biometric categorisation referred regulation defined assigning natural person specific category basis biometric data specific category relate aspect sex age hair colour eye colour tattoo behavioural personality trait language religion membership national minority sexual political orientation include biometric categorisation system purely ancillary feature intrinsically linked another commercial service meaning feature objective technical reason used without principal service integration feature functionality mean circumvent applicability rule regulation example filter categorising facial body feature used online marketplace could constitute ancillary feature used relation principal service consists selling product allowing consumer preview display product help consumer make purchase decision filter used online social network service categorise facial body feature allow user add modify picture video could also considered ancillary feature filter used without principal service social network service consisting sharing content online notion remote biometric identification system referred regulation defined functionally system intended identification natural person without active involvement typically distance comparison person biometric data biometric data contained reference database irrespectively particular technology process type biometric data used remote biometric identification system typically used perceive multiple person behaviour simultaneously order facilitate significantly identification natural person without active involvement excludes system intended used biometric verification includes authentication sole purpose confirm specific natural person person claim confirm identity natural person sole purpose access service unlocking device security access premise exclusion justified fact system likely minor impact fundamental right natural person compared remote biometric identification system may used processing biometric data large number person without active involvement case real time system capturing biometric data comparison identification occur instantaneously near instantaneously event without significant delay regard scope circumventing rule regulation real time use system concerned providing minor delay real time system involve use live near live material video footage generated camera device similar functionality case post system contrast biometric data already captured comparison identification occur significant delay involves material picture video footage generated closed circuit television camera private device generated use system respect natural person concerned notion emotion recognition system referred regulation defined system purpose identifying inferring emotion intention natural person basis biometric data notion refers emotion intention happiness sadness anger surprise disgust embarrassment excitement shame contempt satisfaction amusement include physical state pain fatigue including example system used detecting state fatigue professional pilot driver purpose preventing accident also include mere detection readily apparent expression gesture movement unless used identifying inferring emotion expression basic facial expression frown smile gesture movement hand arm head characteristic person voice raised voice whispering purpose regulation notion publicly accessible space understood referring physical space accessible undetermined number natural person irrespective whether space question privately publicly owned irrespective activity space may used commerce example shop restaurant cafés service example bank professional activity hospitality sport example swimming pool gym stadium transport example bus metro railway station airport mean transport entertainment example cinema theatre museum concert conference hall leisure otherwise example public road square park forest playground space also classified publicly accessible regardless potential capacity security restriction access subject certain predetermined condition fulfilled undetermined number person purchase ticket title transport prior registration certain age contrast space considered publicly accessible access limited specific defined natural person either union national law directly related public safety security clear manifestation person relevant authority space factual possibility access alone unlocked door open gate fence imply space publicly accessible presence indication circumstance suggesting contrary sign prohibiting restricting access company factory premise well office workplace intended accessed relevant employee service provider space publicly accessible publicly accessible space include prison border control space may comprise publicly accessible non publicly accessible space hallway private residential building necessary access doctor office airport online space covered physical space whether given space accessible public however determined case case basis regard specificity individual situation hand order obtain greatest benefit system protecting fundamental right health safety enable democratic control literacy equip provider deployers affected person necessary notion make informed decision regarding system notion may vary regard relevant context include understanding correct application technical element system development phase measure applied use suitable way interpret system output case affected person knowledge necessary understand decision taken assistance impact context application regulation literacy provide relevant actor value chain insight required ensure appropriate compliance correct enforcement furthermore wide implementation literacy measure introduction appropriate follow action could contribute improving working condition ultimately sustain consolidation innovation path trustworthy union european artificial intelligence board board support commission promote literacy tool public awareness understanding benefit risk safeguard right obligation relation use system cooperation relevant stakeholder commission member state facilitate drawing voluntary code conduct advance literacy among person dealing development operation use order ensure level playing field effective protection right freedom individual across union rule established regulation apply provider system non discriminatory manner irrespective whether established within union third country deployers system established within union light digital nature certain system fall within scope regulation even placed market put service used union case example operator established union contract certain service operator established third country relation activity performed system would qualify high risk circumstance system used third country operator could process data lawfully collected transferred union provide contracting operator union output system resulting processing without system placed market put service used union prevent circumvention regulation ensure effective protection natural person located union regulation also apply provider deployers system established third country extent output produced system intended used union nonetheless take account existing arrangement special need future cooperation foreign partner information evidence exchanged regulation apply public authority third country international organisation acting framework cooperation international agreement concluded union national level law enforcement judicial cooperation union member state provided relevant third country international organisation provides adequate safeguard respect protection fundamental right freedom individual relevant may cover activity entity entrusted third country carry specific task support law enforcement judicial cooperation framework cooperation agreement established bilaterally member state third country european union europol union agency third country international organisation authority competent supervision law enforcement judicial authority regulation assess whether framework cooperation international agreement include adequate safeguard respect protection fundamental right freedom individual recipient national authority union institution body office agency making use output union remain accountable ensure use complies union law international agreement revised new one concluded future contracting party make utmost effort align agreement requirement regulation regulation also apply union institution body office agency acting provider deployer system insofar system placed market put service used without modification system military defence national security purpose excluded scope regulation regardless type entity carrying activity whether public private entity regard military defence purpose exclusion justified article teu specificity member state common union defence policy covered chapter title teu subject public international law therefore appropriate legal framework regulation system context use lethal force system context military defence activity regard national security purpose exclusion justified fact national security remains sole responsibility member state accordance article teu specific nature operational need national security activity specific national rule applicable activity nonetheless system developed placed market put service used military defence national security purpose used outside temporarily permanently purpose example civilian humanitarian purpose law enforcement public security purpose system would fall within scope regulation case entity using system military defence national security purpose ensure compliance system regulation unless system already compliant regulation system placed market put service excluded purpose namely military defence national security one non excluded purpose civilian purpose law enforcement fall within scope regulation provider system ensure compliance regulation case fact system may fall within scope regulation affect possibility entity carrying national security defence military activity regardless type entity carrying activity use system national security military defence purpose use excluded scope regulation system placed market civilian law enforcement purpose used without modification military defence national security purpose fall within scope regulation regardless type entity carrying activity regulation support innovation respect freedom science undermine research development activity therefore necessary exclude scope system model specifically developed put service sole purpose scientific research development moreover necessary ensure regulation otherwise affect scientific research development activity system model prior placed market put service regard product oriented research testing development activity regarding system model provision regulation also apply prior system model put service placed market exclusion without prejudice obligation comply regulation system falling scope regulation placed market put service result research development activity application provision regulatory sandbox testing real world condition furthermore without prejudice exclusion system specifically developed put service sole purpose scientific research development system may used conduct research development activity remain subject provision regulation event research development activity carried accordance recognised ethical professional standard scientific research conducted accordance applicable union law order introduce proportionate effective set binding rule system clearly defined risk based approach followed approach tailor type content rule intensity scope risk system generate therefore necessary prohibit certain unacceptable practice lay requirement high risk system obligation relevant operator lay transparency obligation certain system risk based approach basis proportionate effective set binding rule important recall 2019 ethic guideline trustworthy developed independent hleg appointed commission guideline hleg developed seven non binding ethical principle intended help ensure trustworthy ethically sound seven principle include human agency oversight technical robustness safety privacy data governance transparency diversity non discrimination fairness societal environmental well accountability without prejudice legally binding requirement regulation applicable union law guideline contribute design coherent trustworthy human centric line charter value union founded according guideline hleg human agency oversight mean system developed used tool serf people respect human dignity personal autonomy functioning way appropriately controlled overseen human technical robustness safety mean system developed used way allows robustness case problem resilience attempt alter use performance system allow unlawful use third party minimise unintended harm privacy data governance mean system developed used accordance privacy data protection rule processing data meet high standard term quality integrity transparency mean system developed used way allows appropriate traceability explainability making human aware communicate interact system well duly informing deployers capability limitation system affected person right diversity non discrimination fairness mean system developed used way includes diverse actor promotes equal access gender equality cultural diversity avoiding discriminatory impact unfair bias prohibited union national law social environmental well mean system developed used sustainable environmentally friendly manner well way benefit human being monitoring assessing long term impact individual society democracy application principle translated possible design use model case serve basis drafting code conduct regulation stakeholder including industry academia civil society standardisation organisation encouraged take account appropriate ethical principle development voluntary best practice standard aside many beneficial us also misused provide novel powerful tool manipulative exploitative social control practice practice particularly harmful abusive prohibited contradict union value respect human dignity freedom equality democracy rule law fundamental right enshrined charter including right non discrimination data protection privacy right child enabled manipulative technique used persuade person engage unwanted behaviour deceive nudging decision way subverts impairs autonomy decision making free choice placing market putting service use certain system objective effect materially distorting human behaviour whereby significant harm particular sufficiently important adverse impact physical psychological health financial interest likely occur particularly dangerous therefore prohibited system deploy subliminal component audio image video stimulus person perceive stimulus beyond human perception manipulative deceptive technique subvert impair person autonomy decision making free choice way people consciously aware technique aware still deceived able control resist could facilitated example machine brain interface virtual reality allow higher degree control stimulus presented person insofar may materially distort behaviour significantly harmful manner addition system may also otherwise exploit vulnerability person specific group person due age disability within meaning directive 2019 882 european parliament council specific social economic situation likely make person vulnerable exploitation person living extreme poverty ethnic religious minority system placed market put service used objective effect materially distorting behaviour person manner cause reasonably likely cause significant harm another person group person including harm may accumulated time therefore prohibited may possible assume intention distort behaviour distortion result factor external system outside control provider deployer namely factor may reasonably foreseeable therefore possible provider deployer system mitigate case necessary provider deployer intention cause significant harm provided harm result manipulative exploitative enabled practice prohibition practice complementary provision contained directive 2005 european parliament council particular unfair commercial practice leading economic financial harm consumer prohibited circumstance irrespective whether put place system otherwise prohibition manipulative exploitative practice regulation affect lawful practice context medical treatment psychological treatment mental disease physical rehabilitation practice carried accordance applicable law medical standard example explicit consent individual legal representative addition common legitimate commercial practice example field advertising comply applicable law regarded constituting harmful manipulative enabled practice biometric categorisation system based natural person biometric data individual person face fingerprint deduce infer individual political opinion trade union membership religious philosophical belief race sex life sexual orientation prohibited prohibition cover lawful labelling filtering categorisation biometric data set acquired line union national law according biometric data sorting image according hair colour eye colour example used area law enforcement system providing social scoring natural person public private actor may lead discriminatory outcome exclusion certain group may violate right dignity non discrimination value equality justice system evaluate classify natural person group thereof basis multiple data point related social behaviour multiple context known inferred predicted personal personality characteristic certain period time social score obtained system may lead detrimental unfavourable treatment natural person whole group thereof social context unrelated context data originally generated collected detrimental treatment disproportionate unjustified gravity social behaviour system entailing unacceptable scoring practice leading detrimental unfavourable outcome therefore prohibited prohibition affect lawful evaluation practice natural person carried specific purpose accordance union national law use system real time remote biometric identification natural person publicly accessible space purpose law enforcement particularly intrusive right freedom concerned person extent may affect private life large part population evoke feeling constant surveillance indirectly dissuade exercise freedom assembly fundamental right technical inaccuracy system intended remote biometric identification natural person lead biased result entail discriminatory effect possible biased result discriminatory effect particularly relevant regard age ethnicity race sex disability addition immediacy impact limited opportunity check correction relation use system operating real time carry heightened risk right freedom person concerned context impacted law enforcement activity use system purpose law enforcement therefore prohibited except exhaustively listed narrowly defined situation use strictly necessary achieve substantial public interest importance outweighs risk situation involve search certain victim crime including missing person certain threat life physical safety natural person terrorist attack localisation identification perpetrator suspect criminal offence listed annex regulation criminal offence punishable member state concerned custodial sentence detention order maximum period least four year defined law member state threshold custodial sentence detention order accordance national law contributes ensuring offence serious enough potentially justify use real time remote biometric identification system moreover list criminal offence provided annex regulation based criminal offence listed council framework decision 2002 584 jha taking account offence practice likely relevant others recourse real time remote biometric identification could foreseeably necessary proportionate highly varying degree practical pursuit localisation identification perpetrator suspect different criminal offence listed regard likely difference seriousness probability scale harm possible negative consequence imminent threat life physical safety natural person could also result serious disruption critical infrastructure defined article point directive 2022 2557 european parliament council disruption destruction critical infrastructure would result imminent threat life physical safety person including serious harm provision basic supply population exercise core function state addition regulation preserve ability law enforcement border control immigration asylum authority carry identity check presence person concerned accordance condition set union national law check particular law enforcement border control immigration asylum authority able use information system accordance union national law identify person identity check either refuse identified unable state prove identity without required regulation obtain prior authorisation could example person involved crime unwilling unable due accident medical condition disclose identity law enforcement authority order ensure system used responsible proportionate manner also important establish exhaustively listed narrowly defined situation certain element taken account particular regard nature situation giving rise request consequence use right freedom person concerned safeguard condition provided use addition use real time remote biometric identification system publicly accessible space purpose law enforcement deployed confirm specifically targeted individual identity limited strictly necessary concerning period time well geographic personal scope regard particular evidence indication regarding threat victim perpetrator use real time remote biometric identification system publicly accessible space authorised relevant law enforcement authority completed fundamental right impact assessment unless provided otherwise regulation registered system database set regulation reference database person appropriate use case situation mentioned use real time remote biometric identification system publicly accessible space purpose law enforcement subject express specific authorisation judicial authority independent administrative authority member state whose decision binding authorisation principle obtained prior use system view identifying person person exception rule allowed duly justified situation ground urgency namely situation need use system concerned make effectively objectively impossible obtain authorisation commencing use system situation urgency use system restricted absolute minimum necessary subject appropriate safeguard condition determined national law specified context individual urgent use case law enforcement authority addition law enforcement authority situation request authorisation providing reason able request earlier without undue delay latest within hour authorisation rejected use real time biometric identification system linked authorisation cease immediate effect data related use discarded deleted data includes input data directly acquired system course use system well result output use linked authorisation include input legally acquired accordance another union national law case decision producing adverse legal effect person taken based solely output remote biometric identification system order carry task accordance requirement set regulation well national rule relevant market surveillance authority national data protection authority notified use real time biometric identification system market surveillance authority national data protection authority notified submit commission annual report use real time biometric identification system furthermore appropriate provide within exhaustive framework set regulation use territory member state accordance regulation possible far member state concerned decided expressly provide possibility authorise use detailed rule national law consequently member state remain free regulation provide possibility provide possibility respect objective capable justifying authorised use identified regulation national rule notified commission within day adoption use system real time remote biometric identification natural person publicly accessible space purpose law enforcement necessarily involves processing biometric data rule regulation prohibit subject certain exception use based article tfeu apply aslex specialisin respect rule processing biometric data contained article directive 2016 680 thus regulating use processing biometric data involved exhaustive manner therefore use processing possible far compatible framework set regulation without scope outside framework competent authority act purpose law enforcement use system process data connection thereto ground listed article directive 2016 680 context regulation intended provide legal basis processing personal data article directive 2016 680 however use real time remote biometric identification system publicly accessible space purpose law enforcement including competent authority covered specific framework regarding use purpose law enforcement set regulation use purpose law enforcement therefore subject requirement authorisation regulation applicable detailed rule national law may give effect authorisation processing biometric data personal data involved use system biometric identification connection use real time remote biometric identification system publicly accessible space purpose law enforcement regulated regulation continue comply requirement resulting article directive 2016 680 purpose law enforcement article regulation 2016 679 article regulation 2018 1725 prohibit processing biometric data subject limited exception provided article application article regulation 2016 679 use remote biometric identification purpose law enforcement already subject prohibition decision national data protection authority accordance article protocol position united kingdom ireland respect area freedom security justice annexed teu tfeu ireland bound rule laid article first subparagraph point extent applies use biometric categorisation system activity field police cooperation judicial cooperation criminal matter article first subparagraph point extent applies use system covered provision article first subparagraph point article article regulation adopted basis article tfeu relate processing personal data member state carrying activity falling within scope chapter chapter title part three tfeu ireland bound rule governing form judicial cooperation criminal matter police cooperation require compliance provision laid basis article tfeu accordance article protocol position denmark annexed teu tfeu denmark bound rule laid article first subparagraph point extent applies use biometric categorisation system activity field police cooperation judicial cooperation criminal matter article first subparagraph point extent applies use system covered provision article first subparagraph point article regulation adopted basis article tfeu subject application relate processing personal data member state carrying activity falling within scope chapter chapter title part three tfeu line presumption innocence natural person union always judged actual behaviour natural person never judged predicted behaviour based solely profiling personality trait characteristic nationality place birth place residence number child level debt type car without reasonable suspicion person involved criminal activity based objective verifiable fact without human assessment thereof therefore risk assessment carried regard natural person order assess likelihood offending predict occurrence actual potential criminal offence based solely profiling assessing personality trait characteristic prohibited case prohibition refer touch upon risk analytics based profiling individual personality trait characteristic individual system using risk analytics assess likelihood financial fraud undertaking basis suspicious transaction risk analytic tool predict likelihood localisation narcotic illicit good custom authority example basis known trafficking route placing market putting service specific purpose use system create expand facial recognition database untargeted scraping facial image internet cctv footage prohibited practice add feeling mass surveillance lead gross violation fundamental right including right privacy serious concern scientific basis system aiming identify infer emotion particularly expression emotion vary considerably across culture situation even within single individual among key shortcoming system limited reliability lack specificity limited generalisability therefore system identifying inferring emotion intention natural person basis biometric data may lead discriminatory outcome intrusive right freedom concerned person considering imbalance power context work education combined intrusive nature system system could lead detrimental unfavourable treatment certain natural person whole group thereof therefore placing market putting service use system intended used detect emotional state individual situation related workplace education prohibited prohibition cover system placed market strictly medical safety reason system intended therapeutical use practice prohibited union law including data protection law non discrimination law consumer protection law competition law affected regulation high risk system placed union market put service used comply certain mandatory requirement requirement ensure high risk system available union whose output otherwise used union pose unacceptable risk important union public interest recognised protected union law basis new legislative framework clarified commission notice blue guide implementation product rule 2022 general rule one legal act union harmonisation legislation regulation 2017 745 2017 746 european parliament council directive 2006 european parliament council may applicable one product since making available putting service take place product complies applicable union harmonisation legislation ensure consistency avoid unnecessary administrative burden cost provider product contains one high risk system requirement regulation union harmonisation legislation listed annex regulation apply flexibility regard operational decision ensure compliance product contains one system applicable requirement union harmonisation legislation optimal manner system identified high risk limited significant harmful impact health safety fundamental right person union limitation minimise potential restriction international trade system could adverse impact health safety person particular system operate safety component product consistent objective union harmonisation legislation facilitate free movement product internal market ensure safe otherwise compliant product find way market important safety risk may generated product whole due digital component including system duly prevented mitigated instance increasingly autonomous robot whether context manufacturing personal assistance care able safely operate performs function complex environment similarly health sector stake life health particularly high increasingly sophisticated diagnostics system system supporting human decision reliable accurate extent adverse impact caused system fundamental right protected charter particular relevance classifying system high risk right include right human dignity respect private family life protection personal data freedom expression information freedom assembly association right non discrimination right education consumer protection worker right right person disability gender equality intellectual property right right effective remedy fair trial right defence presumption innocence right good administration addition right important highlight fact child specific right enshrined article charter united nation convention right child developed uncrc general comment regard digital environment require consideration child vulnerability provision protection care necessary well fundamental right high level environmental protection enshrined charter implemented union policy also considered assessing severity harm system cause including relation health safety person regard high risk system safety component product system product system falling within scope regulation 300 2008 european parliament council regulation 167 2013 european parliament council regulation 168 2013 european parliament council directive 2014 european parliament council directive 2016 797 european parliament council regulation 2018 858 european parliament council regulation 2018 1139 european parliament council regulation 2019 2144 european parliament council appropriate amend act ensure commission take account basis technical regulatory specificity sector without interfering existing governance conformity assessment enforcement mechanism authority established therein mandatory requirement high risk system laid regulation adopting relevant delegated implementing act basis act regard system safety component product product falling within scope certain union harmonisation legislation listed annex regulation appropriate classify high risk regulation product concerned undergoes conformity assessment procedure third party conformity assessment body pursuant relevant union harmonisation legislation particular product machinery toy lift equipment protective system intended use potentially explosive atmosphere radio equipment pressure equipment recreational craft equipment cableway installation appliance burning gaseous fuel medical device vitrodiagnostic medical device automotive aviation classification system high risk pursuant regulation necessarily mean product whose safety component system system product considered high risk criterion established relevant union harmonisation legislation applies product particular case regulation 2017 745 2017 746 third party conformity assessment provided medium risk high risk product regard stand alone system namely high risk system safety component product product appropriate classify high risk light intended purpose pose high risk harm health safety fundamental right person taking account severity possible harm probability occurrence used number specifically pre defined area specified regulation identification system based methodology criterion envisaged also future amendment list high risk system commission empowered adopt via delegated act take account rapid pace technological development well potential change use system also important clarify may specific case system referred pre defined area specified regulation lead significant risk harm legal interest protected area materially influence decision making harm interest substantially purpose regulation system materially influence outcome decision making understood system impact substance thereby outcome decision making whether human automated system materially influence outcome decision making could include situation one following condition fulfilled first condition system intended perform narrow procedural task system transforms unstructured data structured data system classifies incoming document category system used detect duplicate among large number application task narrow limited nature pose limited risk increased use system context listed high risk use annex regulation second condition task performed system intended improve result previously completed human activity may relevant purpose high risk us listed annex regulation considering characteristic system provides additional layer human activity consequently lowered risk condition would example apply system intended improve language used previously drafted document example relation professional tone academic style language aligning text certain brand messaging third condition system intended detect decision making pattern deviation prior decision making pattern risk would lowered use system follows previously completed human assessment meant replace influence without proper human review system include instance given certain grading pattern teacher used checkex postwhether teacher may deviated grading pattern flag potential inconsistency anomaly fourth condition system intended perform task preparatory assessment relevant purpose system listed annex regulation thus making possible impact output system low term representing risk assessment follow condition cover inter alia smart solution file handling include various function indexing searching text speech processing linking data data source system used translation initial document case system used high risk use case listed annex regulation considered pose significant risk harm health safety fundamental right system implies profiling within meaning article point regulation 2016 679 article point directive 2016 680 article point regulation 2018 1725 ensure traceability transparency provider considers system high risk basis condition referred draw documentation assessment system placed market put service provide documentation national competent authority upon request provider obliged register system database established regulation view providing guidance practical implementation condition system listed annex regulation exceptional basis non high risk commission consulting board provide guideline specifying practical implementation completed comprehensive list practical example use case system high risk use case biometric data constitutes special category personal data appropriate classify high risk several critical use case biometric system insofar use permitted relevant union national law technical inaccuracy system intended remote biometric identification natural person lead biased result entail discriminatory effect risk biased result discriminatory effect particularly relevant regard age ethnicity race sex disability remote biometric identification system therefore classified high risk view risk pose classification excludes system intended used biometric verification including authentication sole purpose confirm specific natural person person claim confirm identity natural person sole purpose access service unlocking device secure access premise addition system intended used biometric categorisation according sensitive attribute characteristic protected article regulation 2016 679 basis biometric data far prohibited regulation emotion recognition system prohibited regulation classified high risk biometric system intended used solely purpose enabling cybersecurity personal data protection measure considered high risk system regard management operation critical infrastructure appropriate classify high risk system intended used safety component management operation critical digital infrastructure listed point annex directive 2022 2557 road traffic supply water gas heating electricity since failure malfunctioning may put risk life health person large scale lead appreciable disruption ordinary conduct social economic activity safety component critical infrastructure including critical digital infrastructure system used directly protect physical integrity critical infrastructure health safety person property necessary order system function failure malfunctioning component might directly lead risk physical integrity critical infrastructure thus risk health safety person property component intended used solely cybersecurity purpose qualify safety component example safety component critical infrastructure may include system monitoring water pressure fire alarm controlling system cloud computing centre deployment system education important promote high quality digital education training allow learner teacher acquire share necessary digital skill competence including medium literacy critical thinking take active part economy society democratic process however system used education vocational training particular determining access admission assigning person educational vocational training institution programme level evaluating learning outcome person assessing appropriate level education individual materially influencing level education training individual receive able access monitoring detecting prohibited behaviour student test classified high risk system since may determine educational professional course person life therefore may affect person ability secure livelihood improperly designed used system may particularly intrusive may violate right education training well right discriminated perpetuate historical pattern discrimination example woman certain age group person disability person certain racial ethnic origin sexual orientation system used employment worker management access self employment particular recruitment selection person making decision affecting term work related relationship promotion termination work related contractual relationship allocating task basis individual behaviour personal trait characteristic monitoring evaluation person work related contractual relationship also classified high risk since system may appreciable impact future career prospect livelihood person worker right relevant work related contractual relationship meaningful manner involve employee person providing service platform referred commission work programme 2021 throughout recruitment process evaluation promotion retention person work related contractual relationship system may perpetuate historical pattern discrimination example woman certain age group person disability person certain racial ethnic origin sexual orientation system used monitor performance behaviour person may also undermine fundamental right data protection privacy another area use system deserves special consideration access enjoyment certain essential private public service benefit necessary people fully participate society improve one standard living particular natural person applying receiving essential public assistance benefit service public authority namely healthcare service social security benefit social service providing protection case maternity illness industrial accident dependency old age loss employment social housing assistance typically dependent benefit service vulnerable position relation responsible authority system used determining whether benefit service granted denied reduced revoked reclaimed authority including whether beneficiary legitimately entitled benefit service system may significant impact person livelihood may infringe fundamental right right social protection non discrimination human dignity effective remedy therefore classified high risk nonetheless regulation hamper development use innovative approach public administration would stand benefit wider use compliant safe system provided system entail high risk legal natural person addition system used evaluate credit score creditworthiness natural person classified high risk system since determine person access financial resource essential service housing electricity telecommunication service system used purpose may lead discrimination person group may perpetuate historical pattern discrimination based racial ethnic origin gender disability age sexual orientation may create new form discriminatory impact however system provided union law purpose detecting fraud offering financial service prudential purpose calculate credit institution insurance undertaking capital requirement considered high risk regulation moreover system intended used risk assessment pricing relation natural person health life insurance also significant impact person livelihood duly designed developed used infringe fundamental right lead serious consequence people life health including financial exclusion discrimination finally system used evaluate classify emergency call natural person dispatch establish priority dispatching emergency first response service including police firefighter medical aid well emergency healthcare patient triage system also classified high risk since make decision critical situation life health person property given role responsibility action law enforcement authority involving certain us system characterised significant degree power imbalance may lead surveillance arrest deprivation natural person liberty well adverse impact fundamental right guaranteed charter particular system trained high quality data meet adequate requirement term performance accuracy robustness properly designed tested put market otherwise put service may single people discriminatory otherwise incorrect unjust manner furthermore exercise important procedural fundamental right right effective remedy fair trial well right defence presumption innocence could hampered particular system sufficiently transparent explainable documented therefore appropriate classify high risk insofar use permitted relevant union national law number system intended used law enforcement context accuracy reliability transparency particularly important avoid adverse impact retain public trust ensure accountability effective redress view nature activity risk relating thereto high risk system include particular system intended used behalf law enforcement authority union institution body office agency support law enforcement authority assessing risk natural person become victim criminal offence polygraph similar tool evaluation reliability evidence course investigation prosecution criminal offence insofar prohibited regulation assessing risk natural person offending reoffending solely basis profiling natural person assessment personality trait characteristic past criminal behaviour natural person group profiling course detection investigation prosecution criminal offence system specifically intended used administrative proceeding tax custom authority well financial intelligence unit carrying administrative task analysing information pursuant union anti money laundering law classified high risk system used law enforcement authority purpose prevention detection investigation prosecution criminal offence use tool law enforcement relevant authority become factor inequality exclusion impact use tool defence right suspect ignored particular difficulty obtaining meaningful information functioning system resulting difficulty challenging result court particular natural person investigation system used migration asylum border control management affect person often particularly vulnerable position dependent outcome action competent public authority accuracy non discriminatory nature transparency system used context therefore particularly important guarantee respect fundamental right affected person particular right free movement non discrimination protection private life personal data international protection good administration therefore appropriate classify high risk insofar use permitted relevant union national law system intended used behalf competent public authority union institution body office agency charged task field migration asylum border control management polygraph similar tool assessing certain risk posed natural person entering territory member state applying visa asylum assisting competent public authority examination including related assessment reliability evidence application asylum visa residence permit associated complaint regard objective establish eligibility natural person applying status purpose detecting recognising identifying natural person context migration asylum border control management exception verification travel document system area migration asylum border control management covered regulation comply relevant procedural requirement set regulation 810 2009 european parliament council directive 2013 european parliament council relevant union law use system migration asylum border control management circumstance used member state union institution body office agency mean circumvent international obligation convention relating status refugee done geneva july 1951 amended protocol january 1967 used way infringe principle non refoulement deny safe effective legal avenue territory union including right international protection certain system intended administration justice democratic process classified high risk considering potentially significant impact democracy rule law individual freedom well right effective remedy fair trial particular address risk potential bias error opacity appropriate qualify high risk system intended used judicial authority behalf assist judicial authority researching interpreting fact law applying law concrete set fact system intended used alternative dispute resolution body purpose also considered high risk outcome alternative dispute resolution proceeding produce legal effect party use tool support decision making power judge judicial independence replace final decision making must remain human driven activity classification system high risk however extend system intended purely ancillary administrative activity affect actual administration justice individual case anonymisation pseudonymisation judicial decision document data communication personnel administrative task without prejudice rule provided regulation 2024 900 european parliament council order address risk undue external interference right vote enshrined article charter adverse effect democracy rule law system intended used influence outcome election referendum voting behaviour natural person exercise vote election referendum classified high risk system exception system whose output natural person directly exposed tool used organise optimise structure political campaign administrative logistical point view fact system classified high risk system regulation interpreted indicating use system lawful act union law national law compatible union law protection personal data use polygraph similar tool system detect emotional state natural person use continue occur solely accordance applicable requirement resulting charter applicable act secondary union law national law regulation understood providing legal ground processing personal data including special category personal data relevant unless specifically otherwise provided regulation mitigate risk high risk system placed market put service ensure high level trustworthiness certain mandatory requirement apply high risk system taking account intended purpose context use system according risk management system established provider measure adopted provider comply mandatory requirement regulation take account generally acknowledged state art proportionate effective meet objective regulation based new legislative framework clarified commission notice blue guide implementation product rule 2022 general rule one legal act union harmonisation legislation may applicable one product since making available putting service take place product complies applicable union harmonisation legislation hazard system covered requirement regulation concern different aspect existing union harmonisation legislation therefore requirement regulation would complement existing body union harmonisation legislation example machinery medical device product incorporating system might present risk addressed essential health safety requirement set relevant union harmonised legislation sectoral law deal risk specific system call simultaneous complementary application various legislative act ensure consistency avoid unnecessary administrative burden unnecessary cost provider product contains one high risk system requirement regulation union harmonisation legislation based new legislative framework listed annex regulation apply flexibility regard operational decision ensure compliance product contains one system applicable requirement union harmonised legislation optimal manner flexibility could mean example decision provider integrate part necessary testing reporting process information documentation required regulation already existing documentation procedure required existing union harmonisation legislation based new legislative framework listed annex regulation way undermine obligation provider comply applicable requirement risk management system consist continuous iterative process planned run throughout entire lifecycle high risk system process aimed identifying mitigating relevant risk system health safety fundamental right risk management system regularly reviewed updated ensure continuing effectiveness well justification documentation significant decision action taken subject regulation process ensure provider identifies risk adverse impact implement mitigation measure known reasonably foreseeable risk system health safety fundamental right light intended purpose reasonably foreseeable misuse including possible risk arising interaction system environment within operates risk management system adopt appropriate risk management measure light state art identifying appropriate risk management measure provider document explain choice made relevant involve expert external stakeholder identifying reasonably foreseeable misuse high risk system provider cover us system directly covered intended purpose provided instruction use may nevertheless reasonably expected result readily predictable human behaviour context specific characteristic use particular system known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right included instruction use provided provider ensure deployer aware take account using high risk system identifying implementing risk mitigation measure foreseeable misuse regulation require specific additional training high risk system provider address foreseeable misuse provider however encouraged consider additional training measure mitigate reasonable foreseeable misuse necessary appropriate requirement apply high risk system regard risk management quality relevance data set used technical documentation record keeping transparency provision information deployers human oversight robustness accuracy cybersecurity requirement necessary effectively mitigate risk health safety fundamental right less trade restrictive measure reasonably available requirement unjustified restriction trade high quality data access high quality data play vital role providing structure ensuring performance many system especially technique involving training model used view ensure high risk system performs intended safely become source discrimination prohibited union law high quality data set training validation testing require implementation appropriate data governance management practice data set training validation testing including label relevant sufficiently representative best extent possible free error complete view intended purpose system order facilitate compliance union data protection law regulation 2016 679 data governance management practice include case personal data transparency original purpose data collection data set also appropriate statistical property including regard person group person relation high risk system intended used specific attention mitigation possible bias data set likely affect health safety person negative impact fundamental right lead discrimination prohibited union law especially data output influence input future operation feedback loop bias example inherent underlying data set especially historical data used generated system implemented real world setting result provided system could influenced inherent bias inclined gradually increase thereby perpetuate amplify existing discrimination particular person belonging certain vulnerable group including racial ethnic group requirement data set best extent possible complete free error affect use privacy preserving technique context development testing system particular data set take account extent required intended purpose feature characteristic element particular specific geographical contextual behavioural functional setting system intended used requirement related data governance complied recourse third party offer certified compliance service including verification data governance data set integrity data training validation testing practice far compliance data requirement regulation ensured development assessment high risk system certain actor provider notified body relevant entity european digital innovation hub testing experimentation facility researcher able access use high quality data set within field activity actor related regulation european common data space established commission facilitation data sharing business government public interest instrumental provide trustful accountable non discriminatory access high quality data training validation testing system example health european health data space facilitate non discriminatory access health data training algorithm data set privacy preserving secure timely transparent trustworthy manner appropriate institutional governance relevant competent authority including sectoral one providing supporting access data may also support provision high quality data training validation testing system right privacy protection personal data must guaranteed throughout entire lifecycle system regard principle data minimisation data protection design default set union data protection law applicable personal data processed measure taken provider ensure compliance principle may include anonymisation encryption also use technology permit algorithm brought data allows training system without transmission party copying raw structured data without prejudice requirement data governance provided regulation order protect right others discrimination might result bias system provider exceptionally extent strictly necessary purpose ensuring bias detection correction relation high risk system subject appropriate safeguard fundamental right freedom natural person following application applicable condition laid regulation addition condition laid regulation 2016 679 2018 1725 directive 2016 680 able process also special category personal data matter substantial public interest within meaning article point regulation 2016 679 article point regulation 2018 1725 comprehensible information high risk system developed perform throughout lifetime essential enable traceability system verify compliance requirement regulation well monitoring operation post market monitoring requires keeping record availability technical documentation containing information necessary assess compliance system relevant requirement facilitate post market monitoring information include general characteristic capability limitation system algorithm data training testing validation process used well documentation relevant risk management system drawn clear comprehensive form technical documentation kept date appropriately throughout lifetime system furthermore high risk system technically allow automatic recording event mean log duration lifetime system address concern related opacity complexity certain system help deployers fulfil obligation regulation transparency required high risk system placed market put service high risk system designed manner enable deployers understand system work evaluate functionality comprehend strength limitation high risk system accompanied appropriate information form instruction use information include characteristic capability limitation performance system would cover information possible known foreseeable circumstance related use high risk system including deployer action may influence system behaviour performance system lead risk health safety fundamental right change pre determined assessed conformity provider relevant human oversight measure including measure facilitate interpretation output system deployers transparency including accompanying instruction use assist deployers use system support informed decision making deployers inter alia better position make correct choice system intend use light obligation applicable educated intended precluded us use system correctly appropriate order enhance legibility accessibility information included instruction use appropriate illustrative example instance limitation intended precluded us system included provider ensure documentation including instruction use contains meaningful comprehensive accessible understandable information taking account need foreseeable knowledge target deployers instruction use made available language easily understood target deployers determined member state concerned high risk system designed developed way natural person oversee functioning ensure used intended impact addressed system lifecycle end appropriate human oversight measure identified provider system placing market putting service particular appropriate measure guarantee system subject built operational constraint overridden system responsive human operator natural person human oversight assigned necessary competence training authority carry role also essential appropriate ensure high risk system include mechanism guide inform natural person human oversight assigned make informed decision intervene order avoid negative consequence risk stop system perform intended considering significant consequence person case incorrect match certain biometric identification system appropriate provide enhanced human oversight requirement system action decision may taken deployer basis identification resulting system unless separately verified confirmed least two natural person person could one entity include person operating using system requirement pose unnecessary burden delay could sufficient separate verification different person automatically recorded log generated system given specificity area law enforcement migration border control asylum requirement apply union national law considers application requirement disproportionate high risk system perform consistently throughout lifecycle meet appropriate level accuracy robustness cybersecurity light intended purpose accordance generally acknowledged state art commission relevant organisation stakeholder encouraged take due consideration mitigation risk negative impact system expected level performance metric declared accompanying instruction use provider urged communicate information deployers clear easily understandable way free misunderstanding misleading statement union law legal metrology including directive 2014 2014 european parliament council aim ensure accuracy measurement help transparency fairness commercial transaction context cooperation relevant stakeholder organisation metrology benchmarking authority commission encourage appropriate development benchmark measurement methodology system commission take note collaborate international partner working metrology relevant measurement indicator relating technical robustness key requirement high risk system resilient relation harmful otherwise undesirable behaviour may result limitation within system environment system operate error fault inconsistency unexpected situation therefore technical organisational measure taken ensure robustness high risk system example designing developing appropriate technical solution prevent minimise harmful otherwise undesirable behaviour technical solution may include instance mechanism enabling system safely interrupt operation fail safe plan presence certain anomaly operation take place outside certain predetermined boundary failure protect risk could lead safety impact negatively affect fundamental right example due erroneous decision wrong biased output generated system cybersecurity play crucial role ensuring system resilient attempt alter use behaviour performance compromise security property malicious third party exploiting system vulnerability cyberattacks system leverage specific asset training data set data poisoning trained model adversarial attack membership inference exploit vulnerability system digital asset underlying ict infrastructure ensure level cybersecurity appropriate risk suitable measure security control therefore taken provider high risk system also taking account appropriate underlying ict infrastructure without prejudice requirement related robustness accuracy set regulation high risk system fall within scope regulation european parliament council horizontal cybersecurity requirement product digital element accordance regulation may demonstrate compliance cybersecurity requirement regulation fulfilling essential cybersecurity requirement set regulation high risk system fulfil essential requirement regulation european parliament council horizontal cybersecurity requirement product digital element deemed compliant cybersecurity requirement set regulation far achievement requirement demonstrated declaration conformity part thereof issued regulation end assessment cybersecurity risk associated product digital element classified high risk system according regulation carried regulation european parliament council horizontal cybersecurity requirement product digital element consider risk cyber resilience system regard attempt unauthorised third party alter use behaviour performance including specific vulnerability data poisoning adversarial attack well relevant risk fundamental right required regulation conformity assessment procedure provided regulation apply relation essential cybersecurity requirement product digital element covered regulation european parliament council horizontal cybersecurity requirement product digital element classified high risk system regulation however rule result reducing necessary level assurance critical product digital element covered regulation european parliament council horizontal cybersecurity requirement product digital element therefore way derogation rule high risk system fall within scope regulation also qualified important critical product digital element pursuant regulation european parliament council horizontal cybersecurity requirement product digital element conformity assessment procedure based internal control set annex regulation applies subject conformity assessment provision regulation european parliament council horizontal cybersecurity requirement product digital element insofar essential cybersecurity requirement regulation concerned case aspect covered regulation respective provision conformity assessment based internal control set annex regulation apply building knowledge expertise enisa cybersecurity policy task assigned enisa regulation 2019 881 european parliament council commission cooperate enisa issue related cybersecurity system appropriate specific natural legal person defined provider take responsibility placing market putting service high risk system regardless whether natural legal person person designed developed system signatory united nation convention right person disability union member state legally obliged protect person disability discrimination promote equality ensure person disability access equal basis others information communication technology system ensure respect privacy person disability given growing importance use system application universal design principle new technology service ensure full equal access everyone potentially affected using technology including person disability way take full account inherent dignity diversity therefore essential provider ensure full compliance accessibility requirement including directive 2016 2102 european parliament council directive 2019 882 provider ensure compliance requirement design therefore necessary measure integrated much possible design high risk system provider establish sound quality management system ensure accomplishment required conformity assessment procedure draw relevant documentation establish robust post market monitoring system provider high risk system subject obligation regarding quality management system relevant sectoral union law possibility include element quality management system provided regulation part existing quality management system provided sectoral union law complementarity regulation existing sectoral union law also taken account future standardisation activity guidance adopted commission public authority put service high risk system use may adopt implement rule quality management system part quality management system adopted national regional level appropriate taking account specificity sector competence organisation public authority concerned enable enforcement regulation create level playing field operator taking account different form making available digital product important ensure circumstance person established union provide authority necessary information compliance system therefore prior making system available union provider established third country written mandate appoint authorised representative established union authorised representative play pivotal role ensuring compliance high risk system placed market put service union provider established union serving contact person established union light nature complexity value chain system line new legislative framework essential ensure legal certainty facilitate compliance regulation therefore necessary clarify role specific obligation relevant operator along value chain importer distributor may contribute development system certain situation operator could act one role time therefore fulfil cumulatively relevant obligation associated role example operator could act distributor importer time ensure legal certainty necessary clarify certain specific condition distributor importer deployer third party considered provider high risk system therefore assume relevant obligation would case party put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation allocated otherwise would also case party make substantial modification high risk system already placed market already put service way remains high risk system accordance regulation modifies intended purpose system including general purpose system classified high risk already placed market put service way system becomes high risk system accordance regulation provision apply without prejudice specific provision established certain union harmonisation legislation based new legislative framework together regulation apply example article regulation 2017 745 establishing certain change considered modification device could affect compliance applicable requirement continue apply high risk system medical device within meaning regulation general purpose system may used high risk system component high risk system therefore due particular nature order ensure fair sharing responsibility along value chain provider system irrespective whether may used high risk system provider component high risk system unless provided otherwise regulation closely cooperate provider relevant high risk system enable compliance relevant obligation regulation competent authority established regulation condition laid regulation provider initially placed system market put service longer considered provider purpose regulation provider expressly excluded change system high risk system former provider nonetheless closely cooperate make available necessary information provide reasonably expected technical access assistance required fulfilment obligation set regulation particular regarding compliance conformity assessment high risk system addition high risk system safety component product fall within scope union harmonisation legislation based new legislative framework placed market put service independently product product manufacturer defined legislation comply obligation provider established regulation particular ensure system embedded final product complies requirement regulation along value chain multiple party often supply system tool service also component process incorporated provider system various objective including model training model retraining model testing evaluation integration software aspect model development party important role play value chain towards provider high risk system system tool service component process integrated provide written agreement provider necessary information capability technical access assistance based generally acknowledged state art order enable provider fully comply obligation set regulation without compromising intellectual property right trade secret third party making accessible public tool service process component general purpose model mandated comply requirement targeting responsibility along value chain particular towards provider used integrated tool service process component made accessible free open source licence developer free open source tool service process component general purpose model encouraged implement widely adopted documentation practice model card data sheet way accelerate information sharing along value chain allowing promotion trustworthy system union commission could develop recommend voluntary model contractual term provider high risk system third party supply tool service component process used integrated high risk system facilitate cooperation along value chain developing voluntary model contractual term commission also take account possible contractual requirement applicable specific sector business case given nature system risk safety fundamental right possibly associated use including regard need ensure proper monitoring performance system real life setting appropriate set specific responsibility deployers deployers particular take appropriate technical organisational measure ensure use high risk system accordance instruction use certain obligation provided regard monitoring functioning system regard record keeping appropriate furthermore deployers ensure person assigned implement instruction use human oversight set regulation necessary competence particular adequate level literacy training authority properly fulfil task obligation without prejudice deployer obligation relation high risk system union national law regulation without prejudice obligation employer inform inform consult worker representative union national law practice including directive 2002 european parliament council decision put service use system remains necessary ensure information worker representative planned deployment high risk system workplace condition information information consultation obligation legal instrument fulfilled moreover information right ancillary necessary objective protecting fundamental right underlies regulation therefore information requirement effect laid regulation without affecting existing right worker whilst risk related system result way system designed risk well stem system used deployers high risk system therefore play critical role ensuring fundamental right protected complementing obligation provider developing system deployers best placed understand high risk system used concretely therefore identify potential significant risk foreseen development phase due precise knowledge context use person group person likely affected including vulnerable group deployers high risk system listed annex regulation also play critical role informing natural person make decision assist making decision related natural person applicable inform natural person subject use high risk system information include intended purpose type decision make deployer also inform natural person right explanation provided regulation regard high risk system used law enforcement purpose obligation implemented accordance article directive 2016 680 processing biometric data involved use system biometric identification purpose law enforcement need comply article directive 2016 680 allows processing strictly necessary subject appropriate safeguard right freedom data subject authorised union member state law use authorised also need respect principle laid article directive 2016 680 including lawfulness fairness transparency purpose limitation accuracy storage limitation without prejudice applicable union law particular regulation 2016 679 directive 2016 680 considering intrusive nature post remote biometric identification system use post remote biometric identification system subject safeguard post remote biometric identification system always used way proportionate legitimate strictly necessary thus targeted term individual identified location temporal scope based closed data set legally acquired video footage case post remote biometric identification system used framework law enforcement lead indiscriminate surveillance condition post remote biometric identification case provide basis circumvent condition prohibition strict exception real time remote biometric identification order efficiently ensure fundamental right protected deployers high risk system body governed public law private entity providing public service deployers certain high risk system listed annex regulation banking insurance entity carry fundamental right impact assessment prior putting use service important individual public nature may also provided private entity private entity providing public service linked task public interest area education healthcare social service housing administration justice aim fundamental right impact assessment deployer identify specific risk right individual group individual likely affected identify measure taken case materialisation risk impact assessment performed prior deploying high risk system updated deployer considers relevant factor changed impact assessment identify deployer relevant process high risk system used line intended purpose include description period time frequency system intended used well specific category natural person group likely affected specific context use assessment also include identification specific risk harm likely impact fundamental right person group performing assessment deployer take account information relevant proper assessment impact including limited information given provider high risk system instruction use light risk identified deployers determine measure taken case materialisation risk including example governance arrangement specific context use arrangement human oversight according instruction use complaint handling redress procedure could instrumental mitigating risk fundamental right concrete use case performing impact assessment deployer notify relevant market surveillance authority appropriate collect relevant information necessary perform impact assessment deployers high risk system particular system used public sector could involve relevant stakeholder including representative group person likely affected system independent expert civil society organisation conducting impact assessment designing measure taken case materialisation risk european artificial intelligence office office develop template questionnaire order facilitate compliance reduce administrative burden deployers notion general purpose model clearly defined set apart notion system enable legal certainty definition based key functional characteristic general purpose model particular generality capability competently perform wide range distinct task model typically trained large amount data various method self supervised unsupervised reinforcement learning general purpose model may placed market various way including library application programming interface apis direct download physical copy model may modified fine tuned new model although model essential component system constitute system model require addition component example user interface become system model typically integrated form part system regulation provides specific rule general purpose model general purpose model pose systemic risk apply also model integrated form part system understood obligation provider general purpose model apply general purpose model placed market provider general purpose model integrates model system made available market put service model considered placed market therefore obligation regulation model continue apply addition system obligation laid model case apply model used purely internal process essential providing product service third party right natural person affected considering potential significantly negative effect general purpose model systemic risk always subject relevant obligation regulation definition cover model used placing market sole purpose research development prototyping activity without prejudice obligation comply regulation following activity model placed market whereas generality model could inter alia also determined number parameter model least billion parameter trained large amount data using self supervision scale considered display significant generality competently perform wide range distinctive task large generative model typical example general purpose model given allow flexible generation content form text audio image video readily accommodate wide range distinctive task 100 general purpose model integrated form part system system considered general purpose system due integration system capability serve variety purpose general purpose system used directly may integrated system 101 provider general purpose model particular role responsibility along value chain model provide may form basis range downstream system often provided downstream provider necessitate good understanding model capability enable integration model product fulfil obligation regulation therefore proportionate transparency measure laid including drawing keeping date documentation provision information general purpose model usage downstream provider technical documentation prepared kept date general purpose model provider purpose making available upon request office national competent authority minimal set element included documentation set specific annex regulation commission empowered amend annex mean delegated act light evolving technological development 102 software data including model released free open source licence allows openly shared user freely access use modify redistribute modified version thereof contribute research innovation market provide significant growth opportunity union economy general purpose model released free open source licence considered ensure high level transparency openness parameter including weight information model architecture information model usage made publicly available licence considered free open source also allows user run copy distribute study change improve software data including model condition original provider model credited identical comparable term distribution respected 103 free open source component cover software data including model general purpose model tool service process system free open source component provided different channel including development open repository purpose regulation component provided price otherwise monetised including provision technical support service including software platform related component use personal data reason exclusively improving security compatibility interoperability software exception transaction microenterprises benefit exception provided free open source component fact making component available open repository constitute monetisation 104 provider general purpose model released free open source licence whose parameter including weight information model architecture information model usage made publicly available subject exception regard transparency related requirement imposed general purpose model unless considered present systemic risk case circumstance model transparent accompanied open source license considered sufficient reason exclude compliance obligation regulation case given release general purpose model free open source licence necessarily reveal substantial information data set used training fine tuning model compliance copyright law thereby ensured exception provided general purpose model compliance transparency related requirement concern obligation produce summary content used model training obligation put place policy comply union copyright law particular identify comply reservation right pursuant article directive 2019 790 european parliament council 105 general purpose model particular large generative model capable generating text image content present unique innovation opportunity also challenge artist author creator way creative content created distributed used consumed development training model require access vast amount text image video data text data mining technique may used extensively context retrieval analysis content may protected copyright related right use copyright protected content requires authorisation rightsholder concerned unless relevant copyright exception limitation apply directive 2019 790 introduced exception limitation allowing reproduction extraction work subject matter purpose text data mining certain condition rule rightsholders may choose reserve right work subject matter prevent text data mining unless done purpose scientific research right opt expressly reserved appropriate manner provider general purpose model need obtain authorisation rightsholders want carry text data mining work 106 provider place general purpose model union market ensure compliance relevant obligation regulation end provider general purpose model put place policy comply union law copyright related right particular identify comply reservation right expressed rightsholders pursuant article directive 2019 790 provider placing general purpose model union market comply obligation regardless jurisdiction copyright relevant act underpinning training general purpose model take place necessary ensure level playing field among provider general purpose model provider able gain competitive advantage union market applying lower copyright standard provided union 107 order increase transparency data used pre training training general purpose model including text data protected copyright law adequate provider model draw make publicly available sufficiently detailed summary content used training general purpose model taking due account need protect trade secret confidential business information summary generally comprehensive scope instead technically detailed facilitate party legitimate interest including copyright holder exercise enforce right union law example listing main data collection set went training model large private public database data archive providing narrative explanation data source used appropriate office provide template summary simple effective allow provider provide required summary narrative form 108 regard obligation imposed provider general purpose model put place policy comply union copyright law make publicly available summary content used training office monitor whether provider fulfilled obligation without verifying proceeding work work assessment training data term copyright compliance regulation affect enforcement copyright rule provided union law 109 compliance obligation applicable provider general purpose model commensurate proportionate type model provider excluding need compliance person develop use model non professional scientific research purpose nevertheless encouraged voluntarily comply requirement without prejudice union copyright law compliance obligation take due account size provider allow simplified way compliance smes including start ups represent excessive cost discourage use model case modification fine tuning model obligation provider general purpose model limited modification fine tuning example complementing already existing technical documentation information modification including new training data source mean comply value chain obligation provided regulation 110 general purpose model could pose systemic risk include limited actual reasonably foreseeable negative effect relation major accident disruption critical sector serious consequence public health safety actual reasonably foreseeable negative effect democratic process public economic security dissemination illegal false discriminatory content systemic risk understood increase model capability model reach arise along entire lifecycle model influenced condition misuse model reliability model fairness model security level autonomy model access tool novel combined modality release distribution strategy potential remove guardrail factor particular international approach far identified need pay attention risk potential intentional misuse unintended issue control relating alignment human intent chemical biological radiological nuclear risk way barrier entry lowered including weapon development design acquisition use offensive cyber capability way vulnerability discovery exploitation operational use enabled effect interaction tool use including example capacity control physical system interfere critical infrastructure risk model making copy self replicating training model way model give rise harmful bias discrimination risk individual community society facilitation disinformation harming privacy threat democratic value human right risk particular event could lead chain reaction considerable negative effect could affect entire city entire domain activity entire community 111 appropriate establish methodology classification general purpose model general purpose model systemic risk since systemic risk result particularly high capability general purpose model considered present systemic risk high impact capability evaluated basis appropriate technical tool methodology significant impact internal market due reach high impact capability general purpose model mean capability match exceed capability recorded advanced general purpose model full range capability model could better understood placing market deployers interact model according state art time entry force regulation cumulative amount computation used training general purpose model measured floating point operation one relevant approximation model capability cumulative amount computation used training includes computation used across activity method intended enhance capability model prior deployment pre training synthetic data generation fine tuning therefore initial threshold floating point operation set met general purpose model lead presumption model general purpose model systemic risk threshold adjusted time reflect technological industrial change algorithmic improvement increased hardware efficiency supplemented benchmark indicator model capability inform office engage scientific community industry civil society expert threshold well tool benchmark assessment high impact capability strong predictor generality capability associated systemic risk general purpose model could take account way model placed market number user may affect complement system possibility commission take individual decision designating general purpose model general purpose model systemic risk found model capability impact equivalent captured set threshold decision taken basis overall assessment criterion designation general purpose model systemic risk set annex regulation quality size training data set number business end user input output modality level autonomy scalability tool access upon reasoned request provider whose model designated general purpose model systemic risk commission take request account may decide reassess whether general purpose model still considered present systemic risk 112 also necessary clarify procedure classification general purpose model systemic risk general purpose model meet applicable threshold high impact capability presumed general purpose model systemic risk provider notify office latest two week requirement met becomes known general purpose model meet requirement lead presumption especially relevant relation threshold floating point operation training general purpose model take considerable planning includes upfront allocation compute resource therefore provider general purpose model able know model would meet threshold training completed context notification provider able demonstrate specific characteristic general purpose model exceptionally present systemic risk thus classified general purpose model systemic risk information valuable office anticipate placing market general purpose model systemic risk provider start engage office early information especially important regard general purpose model planned released open source given open source model release necessary measure ensure compliance obligation regulation may difficult implement 113 commission becomes aware fact general purpose model meet requirement classify general purpose model systemic risk previously either known relevant provider failed notify commission commission empowered designate system qualified alert ensure office made aware scientific panel general purpose model possibly classified general purpose model systemic risk addition monitoring activity office 114 provider general purpose model presenting systemic risk subject addition obligation provided provider general purpose model obligation aimed identifying mitigating risk ensuring adequate level cybersecurity protection regardless whether provided standalone model embedded system product achieve objective regulation require provider perform necessary model evaluation particular prior first placing market including conducting documenting adversarial testing model also appropriate internal independent external testing addition provider general purpose model systemic risk continuously assess mitigate systemic risk including example putting place risk management policy accountability governance process implementing post market monitoring taking appropriate measure along entire model lifecycle cooperating relevant actor along value chain 115 provider general purpose model systemic risk assess mitigate possible systemic risk despite effort identify prevent risk related general purpose model may present systemic risk development use model cause serious incident general purpose model provider without undue delay keep track incident report relevant information possible corrective measure commission national competent authority furthermore provider ensure adequate level cybersecurity protection model physical infrastructure appropriate along entire model lifecycle cybersecurity protection related systemic risk associated malicious use attack duly consider accidental model leakage unauthorised release circumvention safety measure defence cyberattacks unauthorised access model theft protection could facilitated securing model weight algorithm server data set operational security measure information security specific cybersecurity policy adequate technical established solution cyber physical access control appropriate relevant circumstance risk involved 116 office encourage facilitate drawing review adaptation code practice taking account international approach provider general purpose model could invited participate ensure code practice reflect state art duly take account diverse set perspective office collaborate relevant national competent authority could appropriate consult civil society organisation relevant stakeholder expert including scientific panel drawing code code practice cover obligation provider general purpose model general purpose model presenting systemic risk addition regard systemic risk code practice help establish risk taxonomy type nature systemic risk union level including source code practice also focused specific risk assessment mitigation measure 117 code practice represent central tool proper compliance obligation provided regulation provider general purpose model provider able rely code practice demonstrate compliance obligation mean implementing act commission may decide approve code practice give general validity within union alternatively provide common rule implementation relevant obligation time regulation becomes applicable code practice finalised deemed adequate office harmonised standard published assessed suitable cover relevant obligation office compliance european harmonised standard grant provider presumption conformity provider general purpose model furthermore able demonstrate compliance using alternative adequate mean code practice harmonised standard available choose rely 118 regulation regulates system model imposing certain requirement obligation relevant market actor placing market putting service use union thereby complementing obligation provider intermediary service embed system model service regulated regulation 2022 2065 extent system model embedded designated large online platform large online search engine subject risk management framework provided regulation 2022 2065 consequently corresponding obligation regulation presumed fulfilled unless significant systemic risk covered regulation 2022 2065 emerge identified model within framework provider large online platform large online search engine obliged assess potential systemic risk stemming design functioning use service including design algorithmic system used service may contribute risk well systemic risk stemming potential misuse provider also obliged take appropriate mitigating measure observance fundamental right 119 considering quick pace innovation technological evolution digital service scope different instrument union law particular mind usage perception recipient system subject regulation may provided intermediary service part thereof within meaning regulation 2022 2065 interpreted technology neutral manner example system may used provide online search engine particular extent system online chatbot performs search principle website incorporates result existing knowledge us updated knowledge generate single output combine different source information 120 furthermore obligation placed provider deployers certain system regulation enable detection disclosure output system artificially generated manipulated particularly relevant facilitate effective implementation regulation 2022 2065 applies particular regard obligation provider large online platform large online search engine identify mitigate systemic risk may arise dissemination content artificially generated manipulated particular risk actual foreseeable negative effect democratic process civic discourse electoral process including disinformation 121 standardisation play key role provide technical solution provider ensure compliance regulation line state art promote innovation well competitiveness growth single market compliance harmonised standard defined article point regulation 1025 2012 european parliament council normally expected reflect state art mean provider demonstrate conformity requirement regulation balanced representation interest involving relevant stakeholder development standard particular smes consumer organisation environmental social stakeholder accordance article regulation 1025 2012 therefore encouraged order facilitate compliance standardisation request issued commission without undue delay preparing standardisation request commission consult advisory forum board order collect relevant expertise however absence relevant reference harmonised standard commission able establish via implementing act consultation advisory forum common specification certain requirement regulation common specification exceptional fall back solution facilitate provider obligation comply requirement regulation standardisation request accepted european standardisation organisation relevant harmonised standard insufficiently address fundamental right concern harmonised standard comply request delay adoption appropriate harmonised standard delay adoption harmonised standard due technical complexity standard considered commission contemplating establishment common specification developing common specification commission encouraged cooperate international partner international standardisation body 122 appropriate without prejudice use harmonised standard common specification provider high risk system trained tested data reflecting specific geographical behavioural contextual functional setting within system intended used presumed comply relevant measure provided requirement data governance set regulation without prejudice requirement related robustness accuracy set regulation accordance article regulation 2019 881 high risk system certified statement conformity issued cybersecurity scheme pursuant regulation reference published theofficial journal european unionshould presumed comply cybersecurity requirement regulation far cybersecurity certificate statement conformity part thereof cover cybersecurity requirement regulation remains without prejudice voluntary nature cybersecurity scheme 123 order ensure high level trustworthiness high risk system system subject conformity assessment prior placing market putting service 124 appropriate order minimise burden operator avoid possible duplication high risk system related product covered existing union harmonisation legislation based new legislative framework compliance system requirement regulation assessed part conformity assessment already provided law applicability requirement regulation thus affect specific logic methodology general structure conformity assessment relevant union harmonisation legislation 125 given complexity high risk system risk associated important develop adequate conformity assessment procedure high risk system involving notified body called third party conformity assessment however given current experience professional pre market certifiers field product safety different nature risk involved appropriate limit least initial phase application regulation scope application third party conformity assessment high risk system related product therefore conformity assessment system carried general rule provider responsibility exception system intended used biometrics 126 order carry third party conformity assessment required notified body notified regulation national competent authority provided comply set requirement particular independence competence absence conflict interest suitable cybersecurity requirement notification body sent national competent authority commission member state mean electronic notification tool developed managed commission pursuant article r23 annex decision 768 2008 127 line union commitment world trade organization agreement technical barrier trade adequate facilitate mutual recognition conformity assessment result produced competent conformity assessment body independent territory established provided conformity assessment body established law third country meet applicable requirement regulation union concluded agreement extent context commission actively explore possible international instrument purpose particular pursue conclusion mutual recognition agreement third country 128 line commonly established notion substantial modification product regulated union harmonisation legislation appropriate whenever change occurs may affect compliance high risk system regulation change operating system software architecture intended purpose system change system considered new system undergo new conformity assessment however change occurring algorithm performance system continue learn placed market put service namely automatically adapting function carried constitute substantial modification provided change pre determined provider assessed moment conformity assessment 129 high risk system bear marking indicate conformity regulation move freely within internal market high risk system embedded product physical marking affixed may complemented digital marking high risk system provided digitally digital marking used member state create unjustified obstacle placing market putting service high risk system comply requirement laid regulation bear marking 130 certain condition rapid availability innovative technology may crucial health safety person protection environment climate change society whole thus appropriate exceptional reason public security protection life health natural person environmental protection protection key industrial infrastructural asset market surveillance authority could authorise placing market putting service system undergone conformity assessment duly justified situation provided regulation law enforcement authority civil protection authority may put specific high risk system service without authorisation market surveillance authority provided authorisation requested use without undue delay 131 order facilitate work commission member state field well increase transparency towards public provider high risk system related product falling within scope relevant existing union harmonisation legislation well provider consider system listed high risk use case annex regulation high risk basis derogation required register information system database established managed commission using system listed high risk use case annex regulation deployers high risk system public authority agency body register database select system envisage use deployers entitled voluntarily section database publicly accessible free charge information easily navigable understandable machine readable database also user friendly example providing search functionality including keywords allowing general public find relevant information submitted upon registration high risk system use case high risk system set annex regulation high risk system correspond substantial modification high risk system also registered database high risk system area law enforcement migration asylum border control management registration obligation fulfilled secure non public section database access secure non public section strictly limited commission well market surveillance authority regard national section database high risk system area critical infrastructure registered national level commission controller database accordance regulation 2018 1725 order ensure full functionality database deployed procedure setting database include development functional specification commission independent audit report commission take account cybersecurity risk carrying task data controller database order maximise availability use database public database including information made available comply requirement directive 2019 882 132 certain system intended interact natural person generate content may pose specific risk impersonation deception irrespective whether qualify high risk certain circumstance use system therefore subject specific transparency obligation without prejudice requirement obligation high risk system subject targeted exception take account special need law enforcement particular natural person notified interacting system unless obvious point view natural person reasonably well informed observant circumspect taking account circumstance context use implementing obligation characteristic natural person belonging vulnerable group due age disability taken account extent system intended interact group well moreover natural person notified exposed system processing biometric data identify infer emotion intention person assign specific category specific category relate aspect sex age hair colour eye colour tattoo personal trait ethnic origin personal preference interest information notification provided accessible format person disability 133 variety system generate large quantity synthetic content becomes increasingly hard human distinguish human generated authentic content wide availability increasing capability system significant impact integrity trust information ecosystem raising new risk misinformation manipulation scale fraud impersonation consumer deception light impact fast technological pace need new method technique trace origin information appropriate require provider system embed technical solution enable marking machine readable format detection output generated manipulated system human technique method sufficiently reliable interoperable effective robust far technically feasible taking account available technique combination technique watermark metadata identification cryptographic method proving provenance authenticity content logging method fingerprint technique may appropriate implementing obligation provider also take account specificity limitation different type content relevant technological market development field reflected generally acknowledged state art technique method implemented level system level model including general purpose model generating content thereby facilitating fulfilment obligation downstream provider system remain proportionate appropriate envisage marking obligation cover system performing primarily assistive function standard editing system substantially altering input data provided deployer semantics thereof 134 technical solution employed provider system deployers use system generate manipulate image audio video content appreciably resembles existing person object place entity event would falsely appear person authentic truthful deep fake also clearly distinguishably disclose content artificially created manipulated labelling output accordingly disclosing artificial origin compliance transparency obligation interpreted indicating use system output impedes right freedom expression right freedom art science guaranteed charter particular content part evidently creative satirical artistic fictional analogous work programme subject appropriate safeguard right freedom third party case transparency obligation deep fake set regulation limited disclosure existence generated manipulated content appropriate manner hamper display enjoyment work including normal exploitation use maintaining utility quality work addition also appropriate envisage similar disclosure obligation relation generated manipulated text extent published purpose informing public matter public interest unless generated content undergone process human review editorial control natural legal person hold editorial responsibility publication content 135 without prejudice mandatory nature full applicability transparency obligation commission may also encourage facilitate drawing code practice union level facilitate effective implementation obligation regarding detection labelling artificially generated manipulated content including support practical arrangement making appropriate detection mechanism accessible facilitating cooperation actor along value chain disseminating content checking authenticity provenance enable public effectively distinguish generated content 136 obligation placed provider deployers certain system regulation enable detection disclosure output system artificially generated manipulated particularly relevant facilitate effective implementation regulation 2022 2065 applies particular regard obligation provider large online platform large online search engine identify mitigate systemic risk may arise dissemination content artificially generated manipulated particular risk actual foreseeable negative effect democratic process civic discourse electoral process including disinformation requirement label content generated system regulation without prejudice obligation article regulation 2022 2065 provider hosting service process notice illegal content received pursuant article regulation influence assessment decision illegality specific content assessment performed solely reference rule governing legality content 137 compliance transparency obligation system covered regulation interpreted indicating use system output lawful regulation union member state law without prejudice transparency obligation deployers system laid union national law 138 rapidly developing family technology requires regulatory oversight safe controlled space experimentation ensuring responsible innovation integration appropriate safeguard risk mitigation measure ensure legal framework promotes innovation future proof resilient disruption member state ensure national competent authority establish least one regulatory sandbox national level facilitate development testing innovative system strict regulatory oversight system placed market otherwise put service member state could also fulfil obligation participating already existing regulatory sandbox establishing jointly sandbox one member state competent authority insofar participation provides equivalent level national coverage participating member state regulatory sandbox could established physical digital hybrid form may accommodate physical well digital product establishing authority also ensure regulatory sandbox adequate resource functioning including financial human resource 139 objective regulatory sandbox foster innovation establishing controlled experimentation testing environment development pre marketing phase view ensuring compliance innovative system regulation relevant union national law moreover regulatory sandbox aim enhance legal certainty innovator competent authority oversight understanding opportunity emerging risk impact use facilitate regulatory learning authority undertaking including view future adaption legal framework support cooperation sharing best practice authority involved regulatory sandbox accelerate access market including removing barrier smes including start ups regulatory sandbox widely available throughout union particular attention given accessibility smes including start ups participation regulatory sandbox focus issue raise legal uncertainty provider prospective provider innovate experiment union contribute evidence based regulatory learning supervision system regulatory sandbox therefore cover development training testing validation system placed market put service well notion occurrence substantial modification may require new conformity assessment procedure significant risk identified development testing system result adequate mitigation failing suspension development testing process appropriate national competent authority establishing regulatory sandbox cooperate relevant authority including supervising protection fundamental right could allow involvement actor within ecosystem national european standardisation organisation notified body testing experimentation facility research experimentation lab european digital innovation hub relevant stakeholder civil society organisation ensure uniform implementation across union economy scale appropriate establish common rule regulatory sandbox implementation framework cooperation relevant authority involved supervision sandbox regulatory sandbox established regulation without prejudice law allowing establishment sandbox aiming ensure compliance law regulation appropriate relevant competent authority charge regulatory sandbox consider benefit using sandbox also purpose ensuring compliance system regulation upon agreement national competent authority participant regulatory sandbox testing real world condition may also operated supervised framework regulatory sandbox 140 regulation provide legal basis provider prospective provider regulatory sandbox use personal data collected purpose developing certain system public interest within regulatory sandbox specified condition accordance article article point regulation 2016 679 article regulation 2018 1725 without prejudice article article directive 2016 680 obligation data controller right data subject regulation 2016 679 2018 1725 directive 2016 680 remain applicable particular regulation provide legal basis meaning article point regulation 2016 679 article point regulation 2018 1725 provider prospective provider regulatory sandbox ensure appropriate safeguard cooperate competent authority including following guidance acting expeditiously good faith adequately mitigate identified significant risk safety health fundamental right may arise development testing experimentation sandbox 141 order accelerate process development placing market high risk system listed annex regulation important provider prospective provider system may also benefit specific regime testing system real world condition without participating regulatory sandbox however case taking account possible consequence testing individual ensured appropriate sufficient guarantee condition introduced regulation provider prospective provider guarantee include inter alia requesting informed consent natural person participate testing real world condition exception law enforcement seeking informed consent would prevent system tested consent subject participate testing regulation distinct without prejudice consent data subject processing personal data relevant data protection law also important minimise risk enable oversight competent authority therefore require prospective provider real world testing plan submitted competent market surveillance authority register testing dedicated section database subject limited exception set limitation period testing done require additional safeguard person belonging certain vulnerable group well written agreement defining role responsibility prospective provider deployers effective oversight competent personnel involved real world testing furthermore appropriate envisage additional safeguard ensure prediction recommendation decision system effectively reversed disregarded personal data protected deleted subject withdrawn consent participate testing without prejudice right data subject union data protection law regard transfer data also appropriate envisage data collected processed purpose testing real world condition transferred third country appropriate applicable safeguard union law implemented particular accordance base transfer personal data union law data protection non personal data appropriate safeguard put place accordance union law regulation 2022 868 2023 2854 european parliament council 142 ensure lead socially environmentally beneficial outcome member state encouraged support promote research development solution support socially environmentally beneficial outcome based solution increase accessibility person disability tackle socio economic inequality meet environmental target allocating sufficient resource including public union funding appropriate provided eligibility selection criterion fulfilled considering particular project pursue objective project based principle interdisciplinary cooperation developer expert inequality non discrimination accessibility consumer environmental digital right well academic 143 order promote protect innovation important interest smes including start ups provider deployers system taken particular account end member state develop initiative targeted operator including awareness raising information communication member state provide smes including start ups registered office branch union priority access regulatory sandbox provided fulfil eligibility condition selection criterion without precluding provider prospective provider access sandbox provided condition criterion fulfilled member state utilise existing channel appropriate establish new dedicated channel communication smes including start ups deployers innovator appropriate local public authority support smes throughout development path providing guidance responding query implementation regulation appropriate channel work together create synergy ensure homogeneity guidance smes including start ups deployers additionally member state facilitate participation smes relevant stakeholder standardisation development process moreover specific interest need provider smes including start ups taken account notified body set conformity assessment fee commission regularly assess certification compliance cost smes including start ups transparent consultation work member state lower cost example translation cost related mandatory documentation communication authority may constitute significant cost provider operator particular smaller scale member state possibly ensure one language determined accepted relevant provider documentation communication operator one broadly understood largest possible number cross border deployers order address specific need smes including start ups commission provide standardised template area covered regulation upon request board additionally commission complement member state effort providing single information platform easy use information regard regulation provider deployers organising appropriate communication campaign raise awareness obligation arising regulation evaluating promoting convergence best practice public procurement procedure relation system medium sized enterprise recently qualified small enterprise within meaning annex commission recommendation 2003 361 access support measure new medium sized enterprise may sometimes lack legal resource training necessary ensure proper understanding compliance regulation 144 order promote protect innovation demand platform relevant union funding programme project digital europe programme horizon europe implemented commission member state union national level appropriate contribute achievement objective regulation 145 order minimise risk implementation resulting lack knowledge expertise market well facilitate compliance provider particular smes including start ups notified body obligation regulation demand platform european digital innovation hub testing experimentation facility established commission member state union national level contribute implementation regulation within respective mission field competence demand platform european digital innovation hub testing experimentation facility able provide particular technical scientific support provider notified body 146 moreover light small size operator order ensure proportionality regarding cost innovation appropriate allow microenterprises fulfil one costly obligation namely establish quality management system simplified manner would reduce administrative burden cost enterprise without affecting level protection need compliance requirement high risk system commission develop guideline specify element quality management system fulfilled simplified manner microenterprises 147 appropriate commission facilitates extent possible access testing experimentation facility body group laboratory established accredited pursuant relevant union harmonisation legislation fulfil task context conformity assessment product device covered union harmonisation legislation particular case regard expert panel expert laboratory reference laboratory field medical device pursuant regulation 2017 745 2017 746 148 regulation establish governance framework allows coordinate support application regulation national level well build capability union level integrate stakeholder field effective implementation enforcement regulation require governance framework allows coordinate build central expertise union level office established commission decision mission develop union expertise capability field contribute implementation union law member state facilitate task office view support development union expertise capability union level strengthen functioning digital single market furthermore board composed representative member state scientific panel integrate scientific community advisory forum contribute stakeholder input implementation regulation union national level established development union expertise capability also include making use existing resource expertise particular synergy structure built context union level enforcement law synergy related initiative union level eurohpc joint undertaking testing experimentation facility digital europe programme 149 order facilitate smooth effective harmonised implementation regulation board established board reflect various interest eco system composed representative member state board responsible number advisory task including issuing opinion recommendation advice contributing guidance matter related implementation regulation including enforcement matter technical specification existing standard regarding requirement established regulation providing advice commission member state national competent authority specific question related order give flexibility member state designation representative board representative may person belonging public entity relevant competence power facilitate coordination national level contribute achievement board task board establish two standing sub group provide platform cooperation exchange among market surveillance authority notifying authority issue related respectively market surveillance notified body standing subgroup market surveillance act administrative cooperation group adco regulation within meaning article regulation 2019 1020 accordance article regulation commission support activity standing subgroup market surveillance undertaking market evaluation study particular view identifying aspect regulation requiring specific urgent coordination among market surveillance authority board may establish standing temporary sub group appropriate purpose examining specific issue board also cooperate appropriate relevant union body expert group network active context relevant union law including particular active relevant union law data digital product service 150 view ensuring involvement stakeholder implementation application regulation advisory forum established advise provide technical expertise board commission ensure varied balanced stakeholder representation commercial non commercial interest within category commercial interest regard smes undertaking advisory forum comprise inter alia industry start ups smes academia civil society including social partner well fundamental right agency enisa european committee standardization cen european committee electrotechnical standardization cenelec european telecommunication standard institute etsi 151 support implementation enforcement regulation particular monitoring activity office regard general purpose model scientific panel independent expert established independent expert constituting scientific panel selected basis date scientific technical expertise field perform task impartiality objectivity ensure confidentiality information data obtained carrying task activity allow reinforcement national capacity necessary effective enforcement regulation member state able request support pool expert constituting scientific panel enforcement activity 152 order support adequate enforcement regard system reinforce capacity member state union testing support structure established made available member state 153 member state hold key role application enforcement regulation respect member state designate least one notifying authority least one market surveillance authority national competent authority purpose supervising application implementation regulation member state may decide appoint kind public entity perform task national competent authority within meaning regulation accordance specific national organisational characteristic need order increase organisation efficiency side member state set single point contact vi vi public counterpart member state union level member state designate market surveillance authority act single point contact 154 national competent authority exercise power independently impartially without bias safeguard principle objectivity activity task ensure application implementation regulation member authority refrain action incompatible duty subject confidentiality rule regulation 155 order ensure provider high risk system take account experience use high risk system improving system design development process take possible corrective action timely manner provider post market monitoring system place relevant post market monitoring include analysis interaction system including device software post market monitoring cover sensitive operational data deployers law enforcement authority system also key ensure possible risk emerging system continue learn placed market put service efficiently timely addressed context provider also required system place report relevant authority serious incident resulting use system meaning incident malfunctioning leading death serious damage health serious irreversible disruption management operation critical infrastructure infringement obligation union law intended protect fundamental right serious damage property environment 156 order ensure appropriate effective enforcement requirement obligation set regulation union harmonisation legislation system market surveillance compliance product established regulation 2019 1020 apply entirety market surveillance authority designated pursuant regulation enforcement power laid regulation regulation 2019 1020 exercise power carry duty independently impartially without bias although majority system subject specific requirement obligation regulation market surveillance authority may take measure relation system present risk accordance regulation due specific nature union institution agency body falling within scope regulation appropriate designate european data protection supervisor competent market surveillance authority without prejudice designation national competent authority member state market surveillance activity affect ability supervised entity carry task independently independence required union law 157 regulation without prejudice competence task power independence relevant national public authority body supervise application union law protecting fundamental right including equality body data protection authority necessary mandate national public authority body also access documentation created regulation specific safeguard procedure set ensuring adequate timely enforcement system presenting risk health safety fundamental right procedure system presenting risk applied high risk system presenting risk prohibited system placed market put service used violation prohibited practice laid regulation system made available violation transparency requirement laid regulation present risk 158 union financial service law includes internal governance risk management rule requirement applicable regulated financial institution course provision service including make use system order ensure coherent application enforcement obligation regulation relevant rule requirement union financial service legal act competent authority supervision enforcement legal act particular competent authority defined regulation 575 2013 european parliament council directive 2008 2009 138 2013 2014 2016 european parliament council designated within respective competence competent authority purpose supervising implementation regulation including market surveillance activity regard system provided used regulated supervised financial institution unless member state decide designate another authority fulfil market surveillance task competent authority power regulation regulation 2019 1020 enforce requirement obligation regulation including power carry ourex postmarket surveillance activity integrated appropriate existing supervisory mechanism procedure relevant union financial service law appropriate envisage acting market surveillance authority regulation national authority responsible supervision credit institution regulated directive 2013 participating single supervisory mechanism established council regulation 1024 2013 report without delay european central bank information identified course market surveillance activity may potential interest european central bank prudential supervisory task specified regulation enhance consistency regulation rule applicable credit institution regulated directive 2013 also appropriate integrate provider procedural obligation relation risk management post marketing monitoring documentation existing obligation procedure directive 2013 order avoid overlap limited derogation also envisaged relation quality management system provider monitoring obligation placed deployers high risk system extent apply credit institution regulated directive 2013 regime apply insurance insurance undertaking insurance holding company directive 2009 138 insurance intermediary directive 2016 type financial institution subject requirement regarding internal governance arrangement process established pursuant relevant union financial service law ensure consistency equal treatment financial sector 159 market surveillance authority high risk system area biometrics listed annex regulation insofar system used purpose law enforcement migration asylum border control management administration justice democratic process effective investigative corrective power including least power obtain access personal data processed information necessary performance task market surveillance authority able exercise power acting complete independence limitation access sensitive operational data regulation without prejudice power conferred directive 2016 680 exclusion disclosing data national data protection authority regulation affect current future power authority beyond scope regulation 160 market surveillance authority commission able propose joint activity including joint investigation conducted market surveillance authority market surveillance authority jointly commission aim promoting compliance identifying non compliance raising awareness providing guidance relation regulation respect specific category high risk system found present serious risk across two member state joint activity promote compliance carried accordance article regulation 2019 1020 office provide coordination support joint investigation 161 necessary clarify responsibility competence union national level regard system built general purpose model avoid overlapping competence system based general purpose model model system provided provider supervision take place union level office power market surveillance authority within meaning regulation 2019 1020 purpose case national market surveillance authority remain responsible supervision system however general purpose system used directly deployers least one purpose classified high risk market surveillance authority cooperate office carry evaluation compliance inform board market surveillance authority accordingly furthermore market surveillance authority able request assistance office market surveillance authority unable conclude investigation high risk system inability access certain information related general purpose model high risk system built case procedure regarding mutual assistance cross border case chapter regulation 2019 1020 applymutatis mutandis 162 make best use centralised union expertise synergy union level power supervision enforcement obligation provider general purpose model competence commission office able carry necessary action monitor effective implementation regulation regard general purpose model able investigate possible infringement rule provider general purpose model initiative following result monitoring activity upon request market surveillance authority line condition set regulation support effective monitoring office provide possibility downstream provider lodge complaint possible infringement rule provider general purpose model system 163 view complementing governance system general purpose model scientific panel support monitoring activity office may certain case provide qualified alert office trigger follow ups investigation case scientific panel reason suspect general purpose model pose concrete identifiable risk union level furthermore case scientific panel reason suspect general purpose model meet criterion would lead classification general purpose model systemic risk equip scientific panel information necessary performance task mechanism whereby scientific panel request commission require documentation information provider 164 office able take necessary action monitor effective implementation compliance obligation provider general purpose model laid regulation office able investigate possible infringement accordance power provided regulation including requesting documentation information conducting evaluation well requesting measure provider general purpose model conducting evaluation order make use independent expertise office able involve independent expert carry evaluation behalf compliance obligation enforceable inter alia request take appropriate measure including risk mitigation measure case identified systemic risk well restricting making available market withdrawing recalling model safeguard needed beyond procedural right provided regulation provider general purpose model procedural right provided article regulation 2019 1020 applymutatis mutandis without prejudice specific procedural right provided regulation 165 development system high risk system accordance requirement regulation may lead larger uptake ethical trustworthy union provider system high risk encouraged create code conduct including related governance mechanism intended foster voluntary application mandatory requirement applicable high risk system adapted light intended purpose system lower risk involved taking account available technical solution industry best practice model data card provider appropriate deployers system high risk model also encouraged apply voluntary basis additional requirement related example element union ethic guideline trustworthy environmental sustainability literacy measure inclusive diverse design development system including attention vulnerable person accessibility person disability stakeholder participation involvement appropriate relevant stakeholder business civil society organisation academia research organisation trade union consumer protection organisation design development system diversity development team including gender balance ensure voluntary code conduct effective based clear objective key performance indicator measure achievement objective also developed inclusive way appropriate involvement relevant stakeholder business civil society organisation academia research organisation trade union consumer protection organisation commission may develop initiative including sectoral nature facilitate lowering technical barrier hindering cross border exchange data development including data access infrastructure semantic technical interoperability different type data 166 important system related product high risk accordance regulation thus required comply requirement set high risk system nevertheless safe placed market put service contribute objective regulation 2023 988 european parliament council would apply safety net 167 order ensure trustful constructive cooperation competent authority union national level party involved application regulation respect confidentiality information data obtained carrying task accordance union national law carry task activity manner protect particular intellectual property right confidential business information trade secret effective implementation regulation public national security interest integrity criminal administrative proceeding integrity classified information 168 compliance regulation enforceable mean imposition penalty enforcement measure member state take necessary measure ensure provision regulation implemented including laying effective proportionate dissuasive penalty infringement respect thene bi idemprinciple order strengthen harmonise administrative penalty infringement regulation upper limit setting administrative fine certain specific infringement laid assessing amount fine member state individual case take account relevant circumstance specific situation due regard particular nature gravity duration infringement consequence size provider particular provider sme including start european data protection supervisor power impose fine union institution agency body falling within scope regulation 169 compliance obligation provider general purpose model imposed regulation enforceable inter alia mean fine end appropriate level fine also laid infringement obligation including failure comply measure requested commission accordance regulation subject appropriate limitation period accordance principle proportionality decision taken commission regulation subject review court justice european union accordance tfeu including unlimited jurisdiction court justice regard penalty pursuant article 261 tfeu 170 union national law already provide effective remedy natural legal person whose right freedom adversely affected use system without prejudice remedy natural legal person ground consider infringement regulation entitled lodge complaint relevant market surveillance authority 171 affected person right obtain explanation deployer decision based mainly upon output certain high risk system fall within scope regulation decision produce legal effect similarly significantly affect person way consider adverse impact health safety fundamental right explanation clear meaningful provide basis affected person able exercise right right obtain explanation apply use system exception restriction follow union national law apply extent right already provided union law 172 person acting whistleblower infringement regulation protected union law directive 2019 1937 european parliament council therefore apply reporting infringement regulation protection person reporting infringement 173 order ensure regulatory framework adapted necessary power adopt act accordance article 290 tfeu delegated commission amend condition system considered high risk list high risk system provision regarding technical documentation content declaration conformity provision regarding conformity assessment procedure provision establishing high risk system conformity assessment procedure based assessment quality management system assessment technical documentation apply threshold benchmark indicator including supplementing benchmark indicator rule classification general purpose model systemic risk criterion designation general purpose model systemic risk technical documentation provider general purpose model transparency information provider general purpose model particular importance commission carry appropriate consultation preparatory work including expert level consultation conducted accordance principle laid interinstitutional agreement april 2016 better law making particular ensure equal participation preparation delegated act european parliament council receive document time member state expert expert systematically access meeting commission expert group dealing preparation delegated act 174 given rapid technological development technical expertise required effectively apply regulation commission evaluate review regulation august 2029 every four year thereafter report european parliament council addition taking account implication scope regulation commission carry assessment need amend list high risk system list prohibited practice year moreover august 2028 every four year thereafter commission evaluate report european parliament council need amend list high risk area heading annex regulation system within scope transparency obligation effectiveness supervision governance system progress development standardisation deliverable energy efficient development general purpose model including need measure action finally august 2028 every three year thereafter commission evaluate impact effectiveness voluntary code conduct foster application requirement provided high risk system case system high risk system possibly additional requirement system 175 order ensure uniform condition implementation regulation implementing power conferred commission power exercised accordance regulation 182 2011 european parliament council 176 since objective regulation namely improve functioning internal market promote uptake human centric trustworthy ensuring high level protection health safety fundamental right enshrined charter including democracy rule law environmental protection harmful effect system union supporting innovation sufficiently achieved member state rather reason scale effect action better achieved union level union may adopt measure accordance principle subsidiarity set article teu accordance principle proportionality set article regulation beyond necessary order achieve objective 177 order ensure legal certainty ensure appropriate adaptation period operator avoid disruption market including ensuring continuity use system appropriate regulation applies high risk system placed market put service general date application thereof date system subject significant change design intended purpose appropriate clarify respect concept significant change understood equivalent substance notion substantial modification used regard high risk system pursuant regulation exceptional basis light public accountability operator system component large scale system established legal act listed annex regulation operator high risk system intended used public authority respectively take necessary step comply requirement regulation end 2030 august 2030 178 provider high risk system encouraged start comply voluntary basis relevant obligation regulation already transitional period 179 regulation apply august 2026 however taking account unacceptable risk associated use certain way prohibition well general provision regulation already apply february 2025 full effect prohibition follows establishment governance enforcement regulation anticipating application prohibition important take account unacceptable risk effect procedure civil law moreover infrastructure related governance conformity assessment system operational august 2026 therefore provision notified body governance structure apply august 2025 given rapid pace technological advancement adoption general purpose model obligation provider general purpose model apply august 2025 code practice ready may 2025 view enabling provider demonstrate compliance time office ensure classification rule procedure date light technological development addition member state lay notify commission rule penalty including administrative fine ensure properly effectively implemented date application regulation therefore provision penalty apply august 2025 180 european data protection supervisor european data protection board consulted accordance article regulation 2018 1725 delivered joint opinion june 2021
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] |
all-MiniLM-L6-v2
| 384 |
Article 1
|
1. The purpose of this Regulation is to improve the functioning of the internal market and promote the uptake of human-centric and trustworthy artificial intelligence (AI), while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection, against the harmful effects of AI systems in the Union and supporting innovation.
2. This Regulation lays down:
(a) harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;
(a)
harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;
(b) prohibitions of certain AI practices;
(b)
prohibitions of certain AI practices;
(c) specific requirements for high-risk AI systems and obligations for operators of such systems;
(c)
specific requirements for high-risk AI systems and obligations for operators of such systems;
(d) harmonised transparency rules for certain AI systems;
(d)
harmonised transparency rules for certain AI systems;
(e) harmonised rules for the placing on the market of general-purpose AI models;
(e)
harmonised rules for the placing on the market of general-purpose AI models;
(f) rules on market monitoring, market surveillance, governance and enforcement;
(f)
rules on market monitoring, market surveillance, governance and enforcement;
(g) measures to support innovation, with a particular focus on SMEs, including start-ups.
(g)
measures to support innovation, with a particular focus on SMEs, including start-ups.
|
purpose regulation improve functioning internal market promote uptake human centric trustworthy artificial intelligence ensuring high level protection health safety fundamental right enshrined charter including democracy rule law environmental protection harmful effect system union supporting innovation regulation lay harmonised rule placing market putting service use system union harmonised rule placing market putting service use system union prohibition certain practice prohibition certain practice specific requirement high risk system obligation operator system specific requirement high risk system obligation operator system harmonised transparency rule certain system harmonised transparency rule certain system harmonised rule placing market general purpose model harmonised rule placing market general purpose model rule market monitoring market surveillance governance enforcement rule market monitoring market surveillance governance enforcement measure support innovation particular focus smes including start ups measure support innovation particular focus smes including start ups
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 2
|
1. This Regulation applies to:
(a) providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
(a)
providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
(b) deployers of AI systems that have their place of establishment or are located within the Union;
(b)
deployers of AI systems that have their place of establishment or are located within the Union;
(c) providers and deployers of AI systems that have their place of establishment or are located in a third country, where the output produced by the AI system is used in the Union;
(c)
providers and deployers of AI systems that have their place of establishment or are located in a third country, where the output produced by the AI system is used in the Union;
(d) importers and distributors of AI systems;
(d)
importers and distributors of AI systems;
(e) product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;
(e)
product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;
(f) authorised representatives of providers, which are not established in the Union;
(f)
authorised representatives of providers, which are not established in the Union;
(g) affected persons that are located in the Union.
(g)
affected persons that are located in the Union.
2. For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 apply. Article 57 applies only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.
3. This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member States with carrying out tasks in relation to those competences.
This Regulation does not apply to AI systems where and in so far they are placed on the market, put into service, or used with or without modification exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities.
This Regulation does not apply to AI systems which are not placed on the market or put into service in the Union, where the output is used in the Union exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities.
4. This Regulation applies neither to public authorities in a third country nor to international organisations falling within the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the framework of international cooperation or agreements for law enforcement and judicial cooperation with the Union or with one or more Member States, provided that such a third country or international organisation provides adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals.
5. This Regulation shall not affect the application of the provisions on the liability of providers of intermediary services as set out in Chapter II of Regulation (EU) 2022/2065.
6. This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into service for the sole purpose of scientific research and development.
7. Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processed in connection with the rights and obligations laid down in this Regulation. This Regulation shall not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680, without prejudice to Article 10(5) and Article 59 of this Regulation.
8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law. Testing in real world conditions shall not be covered by that exclusion.
9. This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety.
10. This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of a purely personal non-professional activity.
11. This Regulation does not preclude the Union or Member States from maintaining or introducing laws, regulations or administrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of AI systems by employers, or from encouraging or allowing the application of collective agreements which are more favourable to workers.
12. This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on the market or put into service as high-risk AI systems or as an AI system that falls under Article 5 or 50.
|
regulation applies provider placing market putting service system placing market general purpose model union irrespective whether provider established located within union third country provider placing market putting service system placing market general purpose model union irrespective whether provider established located within union third country deployers system place establishment located within union deployers system place establishment located within union provider deployers system place establishment located third country output produced system used union provider deployers system place establishment located third country output produced system used union importer distributor system importer distributor system product manufacturer placing market putting service system together product name trademark product manufacturer placing market putting service system together product name trademark authorised representative provider established union authorised representative provider established union affected person located union affected person located union system classified high risk system accordance article related product covered union harmonisation legislation listed section annex article article 102 109 article 112 apply article applies far requirement high risk system regulation integrated union harmonisation legislation regulation apply area outside scope union law shall event affect competence member state concerning national security regardless type entity entrusted member state carrying task relation competence regulation apply system far placed market put service used without modification exclusively military defence national security purpose regardless type entity carrying activity regulation apply system placed market put service union output used union exclusively military defence national security purpose regardless type entity carrying activity regulation applies neither public authority third country international organisation falling within scope regulation pursuant paragraph authority organisation use system framework international cooperation agreement law enforcement judicial cooperation union one member state provided third country international organisation provides adequate safeguard respect protection fundamental right freedom individual regulation shall affect application provision liability provider intermediary service set chapter regulation 2022 2065 regulation apply system model including output specifically developed put service sole purpose scientific research development union law protection personal data privacy confidentiality communication applies personal data processed connection right obligation laid regulation regulation shall affect regulation 2016 679 2018 1725 directive 2002 2016 680 without prejudice article article regulation regulation apply research testing development activity regarding system model prior placed market put service activity shall conducted accordance applicable union law testing real world condition shall covered exclusion regulation without prejudice rule laid union legal act related consumer protection product safety regulation apply obligation deployers natural person using system course purely personal non professional activity regulation preclude union member state maintaining introducing law regulation administrative provision favourable worker term protecting right respect use system employer encouraging allowing application collective agreement favourable worker regulation apply system released free open source licence unless placed market put service high risk system system fall article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 3
|
For the purposes of this Regulation, the following definitions apply:
(1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;
(1)
‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;
(2) ‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;
(2)
‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;
(3) ‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;
(3)
‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;
(4) ‘deployer’ means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;
(4)
‘deployer’ means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;
(5) ‘authorised representative’ means a natural or legal person located or established in the Union who has received and accepted a written mandate from a provider of an AI system or a general-purpose AI model to, respectively, perform and carry out on its behalf the obligations and procedures established by this Regulation;
(5)
‘authorised representative’ means a natural or legal person located or established in the Union who has received and accepted a written mandate from a provider of an AI system or a general-purpose AI model to, respectively, perform and carry out on its behalf the obligations and procedures established by this Regulation;
(6) ‘importer’ means a natural or legal person located or established in the Union that places on the market an AI system that bears the name or trademark of a natural or legal person established in a third country;
(6)
‘importer’ means a natural or legal person located or established in the Union that places on the market an AI system that bears the name or trademark of a natural or legal person established in a third country;
(7) ‘distributor’ means a natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market;
(7)
‘distributor’ means a natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market;
(8) ‘operator’ means a provider, product manufacturer, deployer, authorised representative, importer or distributor;
(8)
‘operator’ means a provider, product manufacturer, deployer, authorised representative, importer or distributor;
(9) ‘placing on the market’ means the first making available of an AI system or a general-purpose AI model on the Union market;
(9)
‘placing on the market’ means the first making available of an AI system or a general-purpose AI model on the Union market;
(10) ‘making available on the market’ means the supply of an AI system or a general-purpose AI model for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(10)
‘making available on the market’ means the supply of an AI system or a general-purpose AI model for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(11) ‘putting into service’ means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose;
(11)
‘putting into service’ means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose;
(12) ‘intended purpose’ means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;
(12)
‘intended purpose’ means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;
(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems, including other AI systems;
(13)
‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems, including other AI systems;
(14) ‘safety component’ means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property;
(14)
‘safety component’ means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property;
(15) ‘instructions for use’ means the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use;
(15)
‘instructions for use’ means the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use;
(16) ‘recall of an AI system’ means any measure aiming to achieve the return to the provider or taking out of service or disabling the use of an AI system made available to deployers;
(16)
‘recall of an AI system’ means any measure aiming to achieve the return to the provider or taking out of service or disabling the use of an AI system made available to deployers;
(17) ‘withdrawal of an AI system’ means any measure aiming to prevent an AI system in the supply chain being made available on the market;
(17)
‘withdrawal of an AI system’ means any measure aiming to prevent an AI system in the supply chain being made available on the market;
(18) ‘performance of an AI system’ means the ability of an AI system to achieve its intended purpose;
(18)
‘performance of an AI system’ means the ability of an AI system to achieve its intended purpose;
(19) ‘notifying authority’ means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring;
(19)
‘notifying authority’ means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring;
(20) ‘conformity assessment’ means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled;
(20)
‘conformity assessment’ means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled;
(21) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities, including testing, certification and inspection;
(21)
‘conformity assessment body’ means a body that performs third-party conformity assessment activities, including testing, certification and inspection;
(22) ‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;
(22)
‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;
(23) ‘substantial modification’ means a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed;
(23)
‘substantial modification’ means a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed;
(24) ‘CE marking’ means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Chapter III, Section 2 and other applicable Union harmonisation legislation providing for its affixing;
(24)
‘CE marking’ means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Chapter III, Section 2 and other applicable Union harmonisation legislation providing for its affixing;
(25) ‘post-market monitoring system’ means all activities carried out by providers of AI systems to collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
(25)
‘post-market monitoring system’ means all activities carried out by providers of AI systems to collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
(26) ‘market surveillance authority’ means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;
(26)
‘market surveillance authority’ means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;
(27) ‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;
(27)
‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;
(28) ‘common specification’ means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation;
(28)
‘common specification’ means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation;
(29) ‘training data’ means data used for training an AI system through fitting its learnable parameters;
(29)
‘training data’ means data used for training an AI system through fitting its learnable parameters;
(30) ‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process in order, inter alia, to prevent underfitting or overfitting;
(30)
‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process in order, inter alia, to prevent underfitting or overfitting;
(31) ‘validation data set’ means a separate data set or part of the training data set, either as a fixed or variable split;
(31)
‘validation data set’ means a separate data set or part of the training data set, either as a fixed or variable split;
(32) ‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;
(32)
‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;
(33) ‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an output;
(33)
‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an output;
(34) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, such as facial images or dactyloscopic data;
(34)
‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, such as facial images or dactyloscopic data;
(35) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, or psychological human features for the purpose of establishing the identity of a natural person by comparing biometric data of that individual to biometric data of individuals stored in a database;
(35)
‘biometric identification’ means the automated recognition of physical, physiological, behavioural, or psychological human features for the purpose of establishing the identity of a natural person by comparing biometric data of that individual to biometric data of individuals stored in a database;
(36) ‘biometric verification’ means the automated, one-to-one verification, including authentication, of the identity of natural persons by comparing their biometric data to previously provided biometric data;
(36)
‘biometric verification’ means the automated, one-to-one verification, including authentication, of the identity of natural persons by comparing their biometric data to previously provided biometric data;
(37) ‘special categories of personal data’ means the categories of personal data referred to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725;
(37)
‘special categories of personal data’ means the categories of personal data referred to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725;
(38) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation or prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings;
(38)
‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation or prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings;
(39) ‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data;
(39)
‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data;
(40) ‘biometric categorisation system’ means an AI system for the purpose of assigning natural persons to specific categories on the basis of their biometric data, unless it is ancillary to another commercial service and strictly necessary for objective technical reasons;
(40)
‘biometric categorisation system’ means an AI system for the purpose of assigning natural persons to specific categories on the basis of their biometric data, unless it is ancillary to another commercial service and strictly necessary for objective technical reasons;
(41) ‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons, without their active involvement, typically at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database;
(41)
‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons, without their active involvement, typically at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database;
(42) ‘real-time remote biometric identification system’ means a remote biometric identification system, whereby the capturing of biometric data, the comparison and the identification all occur without a significant delay, comprising not only instant identification, but also limited short delays in order to avoid circumvention;
(42)
‘real-time remote biometric identification system’ means a remote biometric identification system, whereby the capturing of biometric data, the comparison and the identification all occur without a significant delay, comprising not only instant identification, but also limited short delays in order to avoid circumvention;
(43) ‘post-remote biometric identification system’ means a remote biometric identification system other than a real-time remote biometric identification system;
(43)
‘post-remote biometric identification system’ means a remote biometric identification system other than a real-time remote biometric identification system;
(44) ‘publicly accessible space’ means any publicly or privately owned physical place accessible to an undetermined number of natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential capacity restrictions;
(44)
‘publicly accessible space’ means any publicly or privately owned physical place accessible to an undetermined number of natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential capacity restrictions;
(45) ‘law enforcement authority’ means: (a) any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or (b) any other body or entity entrusted by Member State law to exercise public authority and public powers for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;
(45)
‘law enforcement authority’ means:
(a) any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or
(a)
any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or
(b) any other body or entity entrusted by Member State law to exercise public authority and public powers for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;
(b)
any other body or entity entrusted by Member State law to exercise public authority and public powers for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;
(46) ‘law enforcement’ means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;
(46)
‘law enforcement’ means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;
(47) ‘AI Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission;
(47)
‘AI Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission;
(48) ‘national competent authority’ means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;
(48)
‘national competent authority’ means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;
(49) ‘serious incident’ means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: (a) the death of a person, or serious harm to a person’s health; (b) a serious and irreversible disruption of the management or operation of critical infrastructure; (c) the infringement of obligations under Union law intended to protect fundamental rights; (d) serious harm to property or the environment;
(49)
‘serious incident’ means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following:
(a) the death of a person, or serious harm to a person’s health;
(a)
the death of a person, or serious harm to a person’s health;
(b) a serious and irreversible disruption of the management or operation of critical infrastructure;
(b)
a serious and irreversible disruption of the management or operation of critical infrastructure;
(c) the infringement of obligations under Union law intended to protect fundamental rights;
(c)
the infringement of obligations under Union law intended to protect fundamental rights;
(d) serious harm to property or the environment;
(d)
serious harm to property or the environment;
(50) ‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
(50)
‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
(51) ‘non-personal data’ means data other than personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
(51)
‘non-personal data’ means data other than personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
(52) ‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;
(52)
‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;
(53) ‘real-world testing plan’ means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions;
(53)
‘real-world testing plan’ means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions;
(54) ‘sandbox plan’ means a document agreed between the participating provider and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox;
(54)
‘sandbox plan’ means a document agreed between the participating provider and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox;
(55) ‘AI regulatory sandbox’ means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;
(55)
‘AI regulatory sandbox’ means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;
(56) ‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;
(56)
‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;
(57) ‘testing in real-world conditions’ means the temporary testing of an AI system for its intended purpose in real-world conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all the conditions laid down in Article 57 or 60 are fulfilled;
(57)
‘testing in real-world conditions’ means the temporary testing of an AI system for its intended purpose in real-world conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all the conditions laid down in Article 57 or 60 are fulfilled;
(58) ‘subject’, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions;
(58)
‘subject’, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions;
(59) ‘informed consent’ means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate;
(59)
‘informed consent’ means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate;
(60) ‘deep fake’ means AI-generated or manipulated image, audio or video content that resembles existing persons, objects, places, entities or events and would falsely appear to a person to be authentic or truthful;
(60)
‘deep fake’ means AI-generated or manipulated image, audio or video content that resembles existing persons, objects, places, entities or events and would falsely appear to a person to be authentic or truthful;
(61) ‘widespread infringement’ means any act or omission contrary to Union law protecting the interest of individuals, which: (a) has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State in which: (i) the act or omission originated or took place; (ii) the provider concerned, or, where applicable, its authorised representative is located or established; or (iii) the deployer is established, when the infringement is committed by the deployer; (b) has caused, causes or is likely to cause harm to the collective interests of individuals and has common features, including the same unlawful practice or the same interest being infringed, and is occurring concurrently, committed by the same operator, in at least three Member States;
(61)
‘widespread infringement’ means any act or omission contrary to Union law protecting the interest of individuals, which:
(a) has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State in which: (i) the act or omission originated or took place; (ii) the provider concerned, or, where applicable, its authorised representative is located or established; or (iii) the deployer is established, when the infringement is committed by the deployer;
(a)
has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State in which:
(i) the act or omission originated or took place;
(i)
the act or omission originated or took place;
(ii) the provider concerned, or, where applicable, its authorised representative is located or established; or
(ii)
the provider concerned, or, where applicable, its authorised representative is located or established; or
(iii) the deployer is established, when the infringement is committed by the deployer;
(iii)
the deployer is established, when the infringement is committed by the deployer;
(b) has caused, causes or is likely to cause harm to the collective interests of individuals and has common features, including the same unlawful practice or the same interest being infringed, and is occurring concurrently, committed by the same operator, in at least three Member States;
(b)
has caused, causes or is likely to cause harm to the collective interests of individuals and has common features, including the same unlawful practice or the same interest being infringed, and is occurring concurrently, committed by the same operator, in at least three Member States;
(62) ‘critical infrastructure’ means critical infrastructure as defined in Article 2, point (4), of Directive (EU) 2022/2557;
(62)
‘critical infrastructure’ means critical infrastructure as defined in Article 2, point (4), of Directive (EU) 2022/2557;
(63) ‘general-purpose AI model’ means an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the market;
(63)
‘general-purpose AI model’ means an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the market;
(64) ‘high-impact capabilities’ means capabilities that match or exceed the capabilities recorded in the most advanced general-purpose AI models;
(64)
‘high-impact capabilities’ means capabilities that match or exceed the capabilities recorded in the most advanced general-purpose AI models;
(65) ‘systemic risk’ means a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chain;
(65)
‘systemic risk’ means a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chain;
(66) ‘general-purpose AI system’ means an AI system which is based on a general-purpose AI model and which has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;
(66)
‘general-purpose AI system’ means an AI system which is based on a general-purpose AI model and which has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;
(67) ‘floating-point operation’ means any mathematical operation or assignment involving floating-point numbers, which are a subset of the real numbers typically represented on computers by an integer of fixed precision scaled by an integer exponent of a fixed base;
(67)
‘floating-point operation’ means any mathematical operation or assignment involving floating-point numbers, which are a subset of the real numbers typically represented on computers by an integer of fixed precision scaled by an integer exponent of a fixed base;
(68) ‘downstream provider’ means a provider of an AI system, including a general-purpose AI system, which integrates an AI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by another entity based on contractual relations.
(68)
‘downstream provider’ means a provider of an AI system, including a general-purpose AI system, which integrates an AI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by another entity based on contractual relations.
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purpose regulation following definition apply system mean machine based system designed operate varying level autonomy may exhibit adaptiveness deployment explicit implicit objective infers input receives generate output prediction content recommendation decision influence physical virtual environment system mean machine based system designed operate varying level autonomy may exhibit adaptiveness deployment explicit implicit objective infers input receives generate output prediction content recommendation decision influence physical virtual environment risk mean combination probability occurrence harm severity harm risk mean combination probability occurrence harm severity harm provider mean natural legal person public authority agency body develops system general purpose model system general purpose model developed place market put system service name trademark whether payment free charge provider mean natural legal person public authority agency body develops system general purpose model system general purpose model developed place market put system service name trademark whether payment free charge deployer mean natural legal person public authority agency body using system authority except system used course personal non professional activity deployer mean natural legal person public authority agency body using system authority except system used course personal non professional activity authorised representative mean natural legal person located established union received accepted written mandate provider system general purpose model respectively perform carry behalf obligation procedure established regulation authorised representative mean natural legal person located established union received accepted written mandate provider system general purpose model respectively perform carry behalf obligation procedure established regulation importer mean natural legal person located established union place market system bear name trademark natural legal person established third country importer mean natural legal person located established union place market system bear name trademark natural legal person established third country distributor mean natural legal person supply chain provider importer make system available union market distributor mean natural legal person supply chain provider importer make system available union market operator mean provider product manufacturer deployer authorised representative importer distributor operator mean provider product manufacturer deployer authorised representative importer distributor placing market mean first making available system general purpose model union market placing market mean first making available system general purpose model union market making available market mean supply system general purpose model distribution use union market course commercial activity whether return payment free charge making available market mean supply system general purpose model distribution use union market course commercial activity whether return payment free charge putting service mean supply system first use directly deployer use union intended purpose putting service mean supply system first use directly deployer use union intended purpose intended purpose mean use system intended provider including specific context condition use specified information supplied provider instruction use promotional sale material statement well technical documentation intended purpose mean use system intended provider including specific context condition use specified information supplied provider instruction use promotional sale material statement well technical documentation reasonably foreseeable misuse mean use system way accordance intended purpose may result reasonably foreseeable human behaviour interaction system including system reasonably foreseeable misuse mean use system way accordance intended purpose may result reasonably foreseeable human behaviour interaction system including system safety component mean component product system fulfils safety function product system failure malfunctioning endangers health safety person property safety component mean component product system fulfils safety function product system failure malfunctioning endangers health safety person property instruction use mean information provided provider inform deployer particular system intended purpose proper use instruction use mean information provided provider inform deployer particular system intended purpose proper use recall system mean measure aiming achieve return provider taking service disabling use system made available deployers recall system mean measure aiming achieve return provider taking service disabling use system made available deployers withdrawal system mean measure aiming prevent system supply chain made available market withdrawal system mean measure aiming prevent system supply chain made available market performance system mean ability system achieve intended purpose performance system mean ability system achieve intended purpose notifying authority mean national authority responsible setting carrying necessary procedure assessment designation notification conformity assessment body monitoring notifying authority mean national authority responsible setting carrying necessary procedure assessment designation notification conformity assessment body monitoring conformity assessment mean process demonstrating whether requirement set chapter iii section relating high risk system fulfilled conformity assessment mean process demonstrating whether requirement set chapter iii section relating high risk system fulfilled conformity assessment body mean body performs third party conformity assessment activity including testing certification inspection conformity assessment body mean body performs third party conformity assessment activity including testing certification inspection notified body mean conformity assessment body notified accordance regulation relevant union harmonisation legislation notified body mean conformity assessment body notified accordance regulation relevant union harmonisation legislation substantial modification mean change system placing market putting service foreseen planned initial conformity assessment carried provider result compliance system requirement set chapter iii section affected result modification intended purpose system assessed substantial modification mean change system placing market putting service foreseen planned initial conformity assessment carried provider result compliance system requirement set chapter iii section affected result modification intended purpose system assessed marking mean marking provider indicates system conformity requirement set chapter iii section applicable union harmonisation legislation providing affixing marking mean marking provider indicates system conformity requirement set chapter iii section applicable union harmonisation legislation providing affixing post market monitoring system mean activity carried provider system collect review experience gained use system place market put service purpose identifying need immediately apply necessary corrective preventive action post market monitoring system mean activity carried provider system collect review experience gained use system place market put service purpose identifying need immediately apply necessary corrective preventive action market surveillance authority mean national authority carrying activity taking measure pursuant regulation 2019 1020 market surveillance authority mean national authority carrying activity taking measure pursuant regulation 2019 1020 harmonised standard mean harmonised standard defined article point regulation 1025 2012 harmonised standard mean harmonised standard defined article point regulation 1025 2012 common specification mean set technical specification defined article point regulation 1025 2012 providing mean comply certain requirement established regulation common specification mean set technical specification defined article point regulation 1025 2012 providing mean comply certain requirement established regulation training data mean data used training system fitting learnable parameter training data mean data used training system fitting learnable parameter validation data mean data used providing evaluation trained system tuning non learnable parameter learning process order inter alia prevent underfitting overfitting validation data mean data used providing evaluation trained system tuning non learnable parameter learning process order inter alia prevent underfitting overfitting validation data set mean separate data set part training data set either fixed variable split validation data set mean separate data set part training data set either fixed variable split testing data mean data used providing independent evaluation system order confirm expected performance system placing market putting service testing data mean data used providing independent evaluation system order confirm expected performance system placing market putting service input data mean data provided directly acquired system basis system produce output input data mean data provided directly acquired system basis system produce output biometric data mean personal data resulting specific technical processing relating physical physiological behavioural characteristic natural person facial image dactyloscopic data biometric data mean personal data resulting specific technical processing relating physical physiological behavioural characteristic natural person facial image dactyloscopic data biometric identification mean automated recognition physical physiological behavioural psychological human feature purpose establishing identity natural person comparing biometric data individual biometric data individual stored database biometric identification mean automated recognition physical physiological behavioural psychological human feature purpose establishing identity natural person comparing biometric data individual biometric data individual stored database biometric verification mean automated one one verification including authentication identity natural person comparing biometric data previously provided biometric data biometric verification mean automated one one verification including authentication identity natural person comparing biometric data previously provided biometric data special category personal data mean category personal data referred article regulation 2016 679 article directive 2016 680 article regulation 2018 1725 special category personal data mean category personal data referred article regulation 2016 679 article directive 2016 680 article regulation 2018 1725 sensitive operational data mean operational data related activity prevention detection investigation prosecution criminal offence disclosure could jeopardise integrity criminal proceeding sensitive operational data mean operational data related activity prevention detection investigation prosecution criminal offence disclosure could jeopardise integrity criminal proceeding emotion recognition system mean system purpose identifying inferring emotion intention natural person basis biometric data emotion recognition system mean system purpose identifying inferring emotion intention natural person basis biometric data biometric categorisation system mean system purpose assigning natural person specific category basis biometric data unless ancillary another commercial service strictly necessary objective technical reason biometric categorisation system mean system purpose assigning natural person specific category basis biometric data unless ancillary another commercial service strictly necessary objective technical reason remote biometric identification system mean system purpose identifying natural person without active involvement typically distance comparison person biometric data biometric data contained reference database remote biometric identification system mean system purpose identifying natural person without active involvement typically distance comparison person biometric data biometric data contained reference database real time remote biometric identification system mean remote biometric identification system whereby capturing biometric data comparison identification occur without significant delay comprising instant identification also limited short delay order avoid circumvention real time remote biometric identification system mean remote biometric identification system whereby capturing biometric data comparison identification occur without significant delay comprising instant identification also limited short delay order avoid circumvention post remote biometric identification system mean remote biometric identification system real time remote biometric identification system post remote biometric identification system mean remote biometric identification system real time remote biometric identification system publicly accessible space mean publicly privately owned physical place accessible undetermined number natural person regardless whether certain condition access may apply regardless potential capacity restriction publicly accessible space mean publicly privately owned physical place accessible undetermined number natural person regardless whether certain condition access may apply regardless potential capacity restriction law enforcement authority mean public authority competent prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding prevention threat public security body entity entrusted member state law exercise public authority public power purpose prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding prevention threat public security law enforcement authority mean public authority competent prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding prevention threat public security public authority competent prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding prevention threat public security body entity entrusted member state law exercise public authority public power purpose prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding prevention threat public security body entity entrusted member state law exercise public authority public power purpose prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding prevention threat public security law enforcement mean activity carried law enforcement authority behalf prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding preventing threat public security law enforcement mean activity carried law enforcement authority behalf prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding preventing threat public security office mean commission function contributing implementation monitoring supervision system general purpose model governance provided commission decision january 2024 reference regulation office shall construed reference commission office mean commission function contributing implementation monitoring supervision system general purpose model governance provided commission decision january 2024 reference regulation office shall construed reference commission national competent authority mean notifying authority market surveillance authority regard system put service used union institution agency office body reference national competent authority market surveillance authority regulation shall construed reference european data protection supervisor national competent authority mean notifying authority market surveillance authority regard system put service used union institution agency office body reference national competent authority market surveillance authority regulation shall construed reference european data protection supervisor serious incident mean incident malfunctioning system directly indirectly lead following death person serious harm person health serious irreversible disruption management operation critical infrastructure infringement obligation union law intended protect fundamental right serious harm property environment serious incident mean incident malfunctioning system directly indirectly lead following death person serious harm person health death person serious harm person health serious irreversible disruption management operation critical infrastructure serious irreversible disruption management operation critical infrastructure infringement obligation union law intended protect fundamental right infringement obligation union law intended protect fundamental right serious harm property environment serious harm property environment personal data mean personal data defined article point regulation 2016 679 personal data mean personal data defined article point regulation 2016 679 non personal data mean data personal data defined article point regulation 2016 679 non personal data mean data personal data defined article point regulation 2016 679 profiling mean profiling defined article point regulation 2016 679 profiling mean profiling defined article point regulation 2016 679 real world testing plan mean document describes objective methodology geographical population temporal scope monitoring organisation conduct testing real world condition real world testing plan mean document describes objective methodology geographical population temporal scope monitoring organisation conduct testing real world condition sandbox plan mean document agreed participating provider competent authority describing objective condition timeframe methodology requirement activity carried within sandbox sandbox plan mean document agreed participating provider competent authority describing objective condition timeframe methodology requirement activity carried within sandbox regulatory sandbox mean controlled framework set competent authority offer provider prospective provider system possibility develop train validate test appropriate real world condition innovative system pursuant sandbox plan limited time regulatory supervision regulatory sandbox mean controlled framework set competent authority offer provider prospective provider system possibility develop train validate test appropriate real world condition innovative system pursuant sandbox plan limited time regulatory supervision literacy mean skill knowledge understanding allow provider deployers affected person taking account respective right obligation context regulation make informed deployment system well gain awareness opportunity risk possible harm cause literacy mean skill knowledge understanding allow provider deployers affected person taking account respective right obligation context regulation make informed deployment system well gain awareness opportunity risk possible harm cause testing real world condition mean temporary testing system intended purpose real world condition outside laboratory otherwise simulated environment view gathering reliable robust data assessing verifying conformity system requirement regulation qualify placing system market putting service within meaning regulation provided condition laid article fulfilled testing real world condition mean temporary testing system intended purpose real world condition outside laboratory otherwise simulated environment view gathering reliable robust data assessing verifying conformity system requirement regulation qualify placing system market putting service within meaning regulation provided condition laid article fulfilled subject purpose real world testing mean natural person participates testing real world condition subject purpose real world testing mean natural person participates testing real world condition informed consent mean subject freely given specific unambiguous voluntary expression willingness participate particular testing real world condition informed aspect testing relevant subject decision participate informed consent mean subject freely given specific unambiguous voluntary expression willingness participate particular testing real world condition informed aspect testing relevant subject decision participate deep fake mean generated manipulated image audio video content resembles existing person object place entity event would falsely appear person authentic truthful deep fake mean generated manipulated image audio video content resembles existing person object place entity event would falsely appear person authentic truthful widespread infringement mean act omission contrary union law protecting interest individual harmed likely harm collective interest individual residing least two member state member state act omission originated took place provider concerned applicable authorised representative located established iii deployer established infringement committed deployer caused cause likely cause harm collective interest individual common feature including unlawful practice interest infringed occurring concurrently committed operator least three member state widespread infringement mean act omission contrary union law protecting interest individual harmed likely harm collective interest individual residing least two member state member state act omission originated took place provider concerned applicable authorised representative located established iii deployer established infringement committed deployer harmed likely harm collective interest individual residing least two member state member state act omission originated took place act omission originated took place provider concerned applicable authorised representative located established provider concerned applicable authorised representative located established iii deployer established infringement committed deployer iii deployer established infringement committed deployer caused cause likely cause harm collective interest individual common feature including unlawful practice interest infringed occurring concurrently committed operator least three member state caused cause likely cause harm collective interest individual common feature including unlawful practice interest infringed occurring concurrently committed operator least three member state critical infrastructure mean critical infrastructure defined article point directive 2022 2557 critical infrastructure mean critical infrastructure defined article point directive 2022 2557 general purpose model mean model including model trained large amount data using self supervision scale display significant generality capable competently performing wide range distinct task regardless way model placed market integrated variety downstream system application except model used research development prototyping activity placed market general purpose model mean model including model trained large amount data using self supervision scale display significant generality capable competently performing wide range distinct task regardless way model placed market integrated variety downstream system application except model used research development prototyping activity placed market high impact capability mean capability match exceed capability recorded advanced general purpose model high impact capability mean capability match exceed capability recorded advanced general purpose model systemic risk mean risk specific high impact capability general purpose model significant impact union market due reach due actual reasonably foreseeable negative effect public health safety public security fundamental right society whole propagated scale across value chain systemic risk mean risk specific high impact capability general purpose model significant impact union market due reach due actual reasonably foreseeable negative effect public health safety public security fundamental right society whole propagated scale across value chain general purpose system mean system based general purpose model capability serve variety purpose direct use well integration system general purpose system mean system based general purpose model capability serve variety purpose direct use well integration system floating point operation mean mathematical operation assignment involving floating point number subset real number typically represented computer integer fixed precision scaled integer exponent fixed base floating point operation mean mathematical operation assignment involving floating point number subset real number typically represented computer integer fixed precision scaled integer exponent fixed base downstream provider mean provider system including general purpose system integrates model regardless whether model provided vertically integrated provided another entity based contractual relation downstream provider mean provider system including general purpose system integrates model regardless whether model provided vertically integrated provided another entity based contractual relation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 4
|
Providers and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used.
|
provider deployers system shall take measure ensure best extent sufficient level literacy staff person dealing operation use system behalf taking account technical knowledge experience education training context system used considering person group person system used
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 5
|
1. The following AI practices shall be prohibited:
(a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an informed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that causes or is reasonably likely to cause that person, another person or group of persons significant harm;
(a)
the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an informed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that causes or is reasonably likely to cause that person, another person or group of persons significant harm;
(b) the placing on the market, the putting into service or the use of an AI system that exploits any of the vulnerabilities of a natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm;
(b)
the placing on the market, the putting into service or the use of an AI system that exploits any of the vulnerabilities of a natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm;
(c) the placing on the market, the putting into service or the use of AI systems for the evaluation or classification of natural persons or groups of persons over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both of the following: (i) detrimental or unfavourable treatment of certain natural persons or groups of persons in social contexts that are unrelated to the contexts in which the data was originally generated or collected; (ii) detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or disproportionate to their social behaviour or its gravity;
(c)
the placing on the market, the putting into service or the use of AI systems for the evaluation or classification of natural persons or groups of persons over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both of the following:
(i) detrimental or unfavourable treatment of certain natural persons or groups of persons in social contexts that are unrelated to the contexts in which the data was originally generated or collected;
(i)
detrimental or unfavourable treatment of certain natural persons or groups of persons in social contexts that are unrelated to the contexts in which the data was originally generated or collected;
(ii) detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or disproportionate to their social behaviour or its gravity;
(ii)
detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or disproportionate to their social behaviour or its gravity;
(d) the placing on the market, the putting into service for this specific purpose, or the use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence, based solely on the profiling of a natural person or on assessing their personality traits and characteristics; this prohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in a criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;
(d)
the placing on the market, the putting into service for this specific purpose, or the use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence, based solely on the profiling of a natural person or on assessing their personality traits and characteristics; this prohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in a criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;
(e) the placing on the market, the putting into service for this specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;
(e)
the placing on the market, the putting into service for this specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;
(f) the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer emotions of a natural person in the areas of workplace and education institutions, except where the use of the AI system is intended to be put in place or into the market for medical or safety reasons;
(f)
the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer emotions of a natural person in the areas of workplace and education institutions, except where the use of the AI system is intended to be put in place or into the market for medical or safety reasons;
(g) the placing on the market, the putting into service for this specific purpose, or the use of biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or categorizing of biometric data in the area of law enforcement;
(g)
the placing on the market, the putting into service for this specific purpose, or the use of biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or categorizing of biometric data in the area of law enforcement;
(h) the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement, unless and in so far as such use is strictly necessary for one of the following objectives: (i) the targeted search for specific victims of abduction, trafficking in human beings or sexual exploitation of human beings, as well as the search for missing persons; (ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or a genuine and present or genuine and foreseeable threat of a terrorist attack; (iii) the localisation or identification of a person suspected of having committed a criminal offence, for the purpose of conducting a criminal investigation or prosecution or executing a criminal penalty for offences referred to in Annex II and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years.
(h)
the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement, unless and in so far as such use is strictly necessary for one of the following objectives:
(i) the targeted search for specific victims of abduction, trafficking in human beings or sexual exploitation of human beings, as well as the search for missing persons;
(i)
the targeted search for specific victims of abduction, trafficking in human beings or sexual exploitation of human beings, as well as the search for missing persons;
(ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or a genuine and present or genuine and foreseeable threat of a terrorist attack;
(ii)
the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or a genuine and present or genuine and foreseeable threat of a terrorist attack;
(iii) the localisation or identification of a person suspected of having committed a criminal offence, for the purpose of conducting a criminal investigation or prosecution or executing a criminal penalty for offences referred to in Annex II and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years.
(iii)
the localisation or identification of a person suspected of having committed a criminal offence, for the purpose of conducting a criminal investigation or prosecution or executing a criminal penalty for offences referred to in Annex II and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years.
Point (h) of the first subparagraph is without prejudice to Article 9 of Regulation (EU) 2016/679 for the processing of biometric data for purposes other than law enforcement.
2. The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), shall be deployed for the purposes set out in that point only to confirm the identity of the specifically targeted individual, and it shall take into account the following elements:
(a) the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm that would be caused if the system were not used;
(a)
the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm that would be caused if the system were not used;
(b) the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the seriousness, probability and scale of those consequences.
(b)
the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the seriousness, probability and scale of those consequences.
In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), of this Article shall comply with necessary and proportionate safeguards and conditions in relation to the use in accordance with the national law authorising the use thereof, in particular as regards the temporal, geographic and personal limitations. The use of the ‘real-time’ remote biometric identification system in publicly accessible spaces shall be authorised only if the law enforcement authority has completed a fundamental rights impact assessment as provided for in Article 27 and has registered the system in the EU database according to Article 49. However, in duly justified cases of urgency, the use of such systems may be commenced without the registration in the EU database, provided that such registration is completed without undue delay.
3. For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use for the purposes of law enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or an independent administrative authority whose decision is binding of the Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 5. However, in a duly justified situation of urgency, the use of such system may be commenced without an authorisation provided that such authorisation is requested without undue delay, at the latest within 24 hours. If such authorisation is rejected, the use shall be stopped with immediate effect and all the data, as well as the results and outputs of that use shall be immediately discarded and deleted.
The competent judicial authority or an independent administrative authority whose decision is binding shall grant the authorisation only where it is satisfied, on the basis of objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote biometric identification system concerned is necessary for, and proportionate to, achieving one of the objectives specified in paragraph 1, first subparagraph, point (h), as identified in the request and, in particular, remains limited to what is strictly necessary concerning the period of time as well as the geographic and personal scope. In deciding on the request, that authority shall take into account the elements referred to in paragraph 2. No decision that produces an adverse legal effect on a person may be taken based solely on the output of the ‘real-time’ remote biometric identification system.
4. Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the national data protection authority in accordance with the national rules referred to in paragraph 5. The notification shall, as a minimum, contain the information specified under paragraph 6 and shall not include sensitive operational data.
5. A Member State may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement within the limits and under the conditions listed in paragraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Member States concerned shall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as supervision and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect of which of the objectives listed in paragraph 1, first subparagraph, point (h), including which of the criminal offences referred to in point (h)(iii) thereof, the competent authorities may be authorised to use those systems for the purposes of law enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption thereof. Member States may introduce, in accordance with Union law, more restrictive laws on the use of remote biometric identification systems.
6. National market surveillance authorities and the national data protection authorities of Member States that have been notified of the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement purposes pursuant to paragraph 4 shall submit to the Commission annual reports on such use. For that purpose, the Commission shall provide Member States and national market surveillance and data protection authorities with a template, including information on the number of the decisions taken by competent judicial authorities or an independent administrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and their result.
7. The Commission shall publish annual reports on the use of real-time remote biometric identification systems in publicly accessible spaces for law enforcement purposes, based on aggregated data in Member States on the basis of the annual reports referred to in paragraph 6. Those annual reports shall not include sensitive operational data of the related law enforcement activities.
8. This Article shall not affect the prohibitions that apply where an AI practice infringes other Union law.
|
following practice shall prohibited placing market putting service use system deploys subliminal technique beyond person consciousness purposefully manipulative deceptive technique objective effect materially distorting behaviour person group person appreciably impairing ability make informed decision thereby causing take decision would otherwise taken manner cause reasonably likely cause person another person group person significant harm placing market putting service use system deploys subliminal technique beyond person consciousness purposefully manipulative deceptive technique objective effect materially distorting behaviour person group person appreciably impairing ability make informed decision thereby causing take decision would otherwise taken manner cause reasonably likely cause person another person group person significant harm placing market putting service use system exploit vulnerability natural person specific group person due age disability specific social economic situation objective effect materially distorting behaviour person person belonging group manner cause reasonably likely cause person another person significant harm placing market putting service use system exploit vulnerability natural person specific group person due age disability specific social economic situation objective effect materially distorting behaviour person person belonging group manner cause reasonably likely cause person another person significant harm placing market putting service use system evaluation classification natural person group person certain period time based social behaviour known inferred predicted personal personality characteristic social score leading either following detrimental unfavourable treatment certain natural person group person social context unrelated context data originally generated collected detrimental unfavourable treatment certain natural person group person unjustified disproportionate social behaviour gravity placing market putting service use system evaluation classification natural person group person certain period time based social behaviour known inferred predicted personal personality characteristic social score leading either following detrimental unfavourable treatment certain natural person group person social context unrelated context data originally generated collected detrimental unfavourable treatment certain natural person group person social context unrelated context data originally generated collected detrimental unfavourable treatment certain natural person group person unjustified disproportionate social behaviour gravity detrimental unfavourable treatment certain natural person group person unjustified disproportionate social behaviour gravity placing market putting service specific purpose use system making risk assessment natural person order assess predict risk natural person committing criminal offence based solely profiling natural person assessing personality trait characteristic prohibition shall apply system used support human assessment involvement person criminal activity already based objective verifiable fact directly linked criminal activity placing market putting service specific purpose use system making risk assessment natural person order assess predict risk natural person committing criminal offence based solely profiling natural person assessing personality trait characteristic prohibition shall apply system used support human assessment involvement person criminal activity already based objective verifiable fact directly linked criminal activity placing market putting service specific purpose use system create expand facial recognition database untargeted scraping facial image internet cctv footage placing market putting service specific purpose use system create expand facial recognition database untargeted scraping facial image internet cctv footage placing market putting service specific purpose use system infer emotion natural person area workplace education institution except use system intended put place market medical safety reason placing market putting service specific purpose use system infer emotion natural person area workplace education institution except use system intended put place market medical safety reason placing market putting service specific purpose use biometric categorisation system categorise individually natural person based biometric data deduce infer race political opinion trade union membership religious philosophical belief sex life sexual orientation prohibition cover labelling filtering lawfully acquired biometric datasets image based biometric data categorizing biometric data area law enforcement placing market putting service specific purpose use biometric categorisation system categorise individually natural person based biometric data deduce infer race political opinion trade union membership religious philosophical belief sex life sexual orientation prohibition cover labelling filtering lawfully acquired biometric datasets image based biometric data categorizing biometric data area law enforcement use real time remote biometric identification system publicly accessible space purpose law enforcement unless far use strictly necessary one following objective targeted search specific victim abduction trafficking human being sexual exploitation human being well search missing person prevention specific substantial imminent threat life physical safety natural person genuine present genuine foreseeable threat terrorist attack iii localisation identification person suspected committed criminal offence purpose conducting criminal investigation prosecution executing criminal penalty offence referred annex punishable member state concerned custodial sentence detention order maximum period least four year use real time remote biometric identification system publicly accessible space purpose law enforcement unless far use strictly necessary one following objective targeted search specific victim abduction trafficking human being sexual exploitation human being well search missing person targeted search specific victim abduction trafficking human being sexual exploitation human being well search missing person prevention specific substantial imminent threat life physical safety natural person genuine present genuine foreseeable threat terrorist attack prevention specific substantial imminent threat life physical safety natural person genuine present genuine foreseeable threat terrorist attack iii localisation identification person suspected committed criminal offence purpose conducting criminal investigation prosecution executing criminal penalty offence referred annex punishable member state concerned custodial sentence detention order maximum period least four year iii localisation identification person suspected committed criminal offence purpose conducting criminal investigation prosecution executing criminal penalty offence referred annex punishable member state concerned custodial sentence detention order maximum period least four year point first subparagraph without prejudice article regulation 2016 679 processing biometric data purpose law enforcement use real time remote biometric identification system publicly accessible space purpose law enforcement objective referred paragraph first subparagraph point shall deployed purpose set point confirm identity specifically targeted individual shall take account following element nature situation giving rise possible use particular seriousness probability scale harm would caused system used nature situation giving rise possible use particular seriousness probability scale harm would caused system used consequence use system right freedom person concerned particular seriousness probability scale consequence consequence use system right freedom person concerned particular seriousness probability scale consequence addition use real time remote biometric identification system publicly accessible space purpose law enforcement objective referred paragraph first subparagraph point article shall comply necessary proportionate safeguard condition relation use accordance national law authorising use thereof particular regard temporal geographic personal limitation use real time remote biometric identification system publicly accessible space shall authorised law enforcement authority completed fundamental right impact assessment provided article registered system database according article however duly justified case urgency use system may commenced without registration database provided registration completed without undue delay purpose paragraph first subparagraph point paragraph use purpose law enforcement real time remote biometric identification system publicly accessible space shall subject prior authorisation granted judicial authority independent administrative authority whose decision binding member state use take place issued upon reasoned request accordance detailed rule national law referred paragraph however duly justified situation urgency use system may commenced without authorisation provided authorisation requested without undue delay latest within hour authorisation rejected use shall stopped immediate effect data well result output use shall immediately discarded deleted competent judicial authority independent administrative authority whose decision binding shall grant authorisation satisfied basis objective evidence clear indication presented use real time remote biometric identification system concerned necessary proportionate achieving one objective specified paragraph first subparagraph point identified request particular remains limited strictly necessary concerning period time well geographic personal scope deciding request authority shall take account element referred paragraph decision produce adverse legal effect person may taken based solely output real time remote biometric identification system without prejudice paragraph use real time remote biometric identification system publicly accessible space law enforcement purpose shall notified relevant market surveillance authority national data protection authority accordance national rule referred paragraph notification shall minimum contain information specified paragraph shall include sensitive operational data member state may decide provide possibility fully partially authorise use real time remote biometric identification system publicly accessible space purpose law enforcement within limit condition listed paragraph first subparagraph point paragraph member state concerned shall lay national law necessary detailed rule request issuance exercise well supervision reporting relating authorisation referred paragraph rule shall also specify respect objective listed paragraph first subparagraph point including criminal offence referred point iii thereof competent authority may authorised use system purpose law enforcement member state shall notify rule commission latest day following adoption thereof member state may introduce accordance union law restrictive law use remote biometric identification system national market surveillance authority national data protection authority member state notified use real time remote biometric identification system publicly accessible space law enforcement purpose pursuant paragraph shall submit commission annual report use purpose commission shall provide member state national market surveillance data protection authority template including information number decision taken competent judicial authority independent administrative authority whose decision binding upon request authorisation accordance paragraph result commission shall publish annual report use real time remote biometric identification system publicly accessible space law enforcement purpose based aggregated data member state basis annual report referred paragraph annual report shall include sensitive operational data related law enforcement activity article shall affect prohibition apply practice infringes union law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 6
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1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;
(a)
the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;
(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
(b)
the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.
3. By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making.
The first subparagraph shall apply where any of the following conditions is fulfilled:
(a) the AI system is intended to perform a narrow procedural task;
(a)
the AI system is intended to perform a narrow procedural task;
(b) the AI system is intended to improve the result of a previously completed human activity;
(b)
the AI system is intended to improve the result of a previously completed human activity;
(c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
(c)
the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.
(d)
the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.
Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons.
4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.
5. The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose a significant risk of harm to the health, safety or fundamental rights of natural persons.
7. The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by this Regulation.
8. Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.
|
irrespective whether system placed market put service independently product referred point system shall considered high risk following condition fulfilled system intended used safety component product system product covered union harmonisation legislation listed annex system intended used safety component product system product covered union harmonisation legislation listed annex product whose safety component pursuant point system system product required undergo third party conformity assessment view placing market putting service product pursuant union harmonisation legislation listed annex product whose safety component pursuant point system system product required undergo third party conformity assessment view placing market putting service product pursuant union harmonisation legislation listed annex addition high risk system referred paragraph system referred annex iii shall considered high risk derogation paragraph system referred annex iii shall considered high risk pose significant risk harm health safety fundamental right natural person including materially influencing outcome decision making first subparagraph shall apply following condition fulfilled system intended perform narrow procedural task system intended perform narrow procedural task system intended improve result previously completed human activity system intended improve result previously completed human activity system intended detect decision making pattern deviation prior decision making pattern meant replace influence previously completed human assessment without proper human review system intended detect decision making pattern deviation prior decision making pattern meant replace influence previously completed human assessment without proper human review system intended perform preparatory task assessment relevant purpose use case listed annex iii system intended perform preparatory task assessment relevant purpose use case listed annex iii notwithstanding first subparagraph system referred annex iii shall always considered high risk system performs profiling natural person provider considers system referred annex iii high risk shall document assessment system placed market put service provider shall subject registration obligation set article upon request national competent authority provider shall provide documentation assessment commission shall consulting european artificial intelligence board board later february 2026 provide guideline specifying practical implementation article line article together comprehensive list practical example use case system high risk high risk commission empowered adopt delegated act accordance article order amend paragraph second subparagraph article adding new condition laid therein modifying concrete reliable evidence existence system fall scope annex iii pose significant risk harm health safety fundamental right natural person commission shall adopt delegated act accordance article order amend paragraph second subparagraph article deleting condition laid therein concrete reliable evidence necessary maintain level protection health safety fundamental right provided regulation amendment condition laid paragraph second subparagraph adopted accordance paragraph article shall decrease overall level protection health safety fundamental right provided regulation shall ensure consistency delegated act adopted pursuant article take account market technological development
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 7
|
1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in Annex III;
(a)
the AI systems are intended to be used in any of the areas listed in Annex III;
(b) the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
(b)
the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
2. When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:
(a) the intended purpose of the AI system;
(a)
the intended purpose of the AI system;
(b) the extent to which an AI system has been used or is likely to be used;
(b)
the extent to which an AI system has been used or is likely to be used;
(c) the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
(c)
the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
(d) the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
(d)
the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
(e) the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
(e)
the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
(f) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
(f)
the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
(g) the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
(g)
the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
(h) the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
(h)
the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
(i) the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
(i)
the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
(j) the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
(j)
the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
(k) the extent to which existing Union law provides for: (i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages; (ii) effective measures to prevent or substantially minimise those risks.
(k)
the extent to which existing Union law provides for:
(i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;
(i)
effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;
(ii) effective measures to prevent or substantially minimise those risks.
(ii)
effective measures to prevent or substantially minimise those risks.
3. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:
(a) the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
(a)
the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
(b) the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
(b)
the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
|
commission empowered adopt delegated act accordance article amend annex iii adding modifying use case high risk system following condition fulfilled system intended used area listed annex iii system intended used area listed annex iii system pose risk harm health safety adverse impact fundamental right risk equivalent greater risk harm adverse impact posed high risk system already referred annex iii system pose risk harm health safety adverse impact fundamental right risk equivalent greater risk harm adverse impact posed high risk system already referred annex iii assessing condition paragraph point commission shall take account following criterion intended purpose system intended purpose system extent system used likely used extent system used likely used nature amount data processed used system particular whether special category personal data processed nature amount data processed used system particular whether special category personal data processed extent system act autonomously possibility human override decision recommendation may lead potential harm extent system act autonomously possibility human override decision recommendation may lead potential harm extent use system already caused harm health safety adverse impact fundamental right given rise significant concern relation likelihood harm adverse impact demonstrated example report documented allegation submitted national competent authority report appropriate extent use system already caused harm health safety adverse impact fundamental right given rise significant concern relation likelihood harm adverse impact demonstrated example report documented allegation submitted national competent authority report appropriate potential extent harm adverse impact particular term intensity ability affect multiple person disproportionately affect particular group person potential extent harm adverse impact particular term intensity ability affect multiple person disproportionately affect particular group person extent person potentially harmed suffer adverse impact dependent outcome produced system particular practical legal reason reasonably possible opt outcome extent person potentially harmed suffer adverse impact dependent outcome produced system particular practical legal reason reasonably possible opt outcome extent imbalance power person potentially harmed suffer adverse impact vulnerable position relation deployer system particular due status authority knowledge economic social circumstance age extent imbalance power person potentially harmed suffer adverse impact vulnerable position relation deployer system particular due status authority knowledge economic social circumstance age extent outcome produced involving system easily corrigible reversible taking account technical solution available correct reverse whereby outcome adverse impact health safety fundamental right shall considered easily corrigible reversible extent outcome produced involving system easily corrigible reversible taking account technical solution available correct reverse whereby outcome adverse impact health safety fundamental right shall considered easily corrigible reversible magnitude likelihood benefit deployment system individual group society large including possible improvement product safety magnitude likelihood benefit deployment system individual group society large including possible improvement product safety extent existing union law provides effective measure redress relation risk posed system exclusion claim damage effective measure prevent substantially minimise risk extent existing union law provides effective measure redress relation risk posed system exclusion claim damage effective measure redress relation risk posed system exclusion claim damage effective measure prevent substantially minimise risk effective measure prevent substantially minimise risk commission empowered adopt delegated act accordance article amend list annex iii removing high risk system following condition fulfilled high risk system concerned longer pose significant risk fundamental right health safety taking account criterion listed paragraph high risk system concerned longer pose significant risk fundamental right health safety taking account criterion listed paragraph deletion decrease overall level protection health safety fundamental right union law deletion decrease overall level protection health safety fundamental right union law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 8
|
1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.
2. Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.
|
high risk system shall comply requirement laid section taking account intended purpose well generally acknowledged state art related technology risk management system referred article shall taken account ensuring compliance requirement product contains system requirement regulation well requirement union harmonisation legislation listed section annex apply provider shall responsible ensuring product fully compliant applicable requirement applicable union harmonisation legislation ensuring compliance high risk system referred paragraph requirement set section order ensure consistency avoid duplication minimise additional burden provider shall choice integrating appropriate necessary testing reporting process information documentation provide regard product documentation procedure already exist required union harmonisation legislation listed section annex
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 9
|
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:
(a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
(a)
the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
(b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
(b)
the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
(c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
(c)
the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
(d)
the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
3. The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.
4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.
5. The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.
In identifying the most appropriate risk management measures, the following shall be ensured:
(a) elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
(a)
elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
(b) where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
(b)
where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
(c) provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
(c)
provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context in which the system is intended to be used.
6. High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.
7. Testing procedures may include testing in real-world conditions in accordance with Article 60.
8. The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.
9. When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.
10. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law.
|
risk management system shall established implemented documented maintained relation high risk system risk management system shall understood continuous iterative process planned run throughout entire lifecycle high risk system requiring regular systematic review updating shall comprise following step identification analysis known reasonably foreseeable risk high risk system pose health safety fundamental right high risk system used accordance intended purpose identification analysis known reasonably foreseeable risk high risk system pose health safety fundamental right high risk system used accordance intended purpose estimation evaluation risk may emerge high risk system used accordance intended purpose condition reasonably foreseeable misuse estimation evaluation risk may emerge high risk system used accordance intended purpose condition reasonably foreseeable misuse evaluation risk possibly arising based analysis data gathered post market monitoring system referred article evaluation risk possibly arising based analysis data gathered post market monitoring system referred article adoption appropriate targeted risk management measure designed address risk identified pursuant point adoption appropriate targeted risk management measure designed address risk identified pursuant point risk referred article shall concern may reasonably mitigated eliminated development design high risk system provision adequate technical information risk management measure referred paragraph point shall give due consideration effect possible interaction resulting combined application requirement set section view minimising risk effectively achieving appropriate balance implementing measure fulfil requirement risk management measure referred paragraph point shall relevant residual risk associated hazard well overall residual risk high risk system judged acceptable identifying appropriate risk management measure following shall ensured elimination reduction risk identified evaluated pursuant paragraph far technically feasible adequate design development high risk system elimination reduction risk identified evaluated pursuant paragraph far technically feasible adequate design development high risk system appropriate implementation adequate mitigation control measure addressing risk eliminated appropriate implementation adequate mitigation control measure addressing risk eliminated provision information required pursuant article appropriate training deployers provision information required pursuant article appropriate training deployers view eliminating reducing risk related use high risk system due consideration shall given technical knowledge experience education training expected deployer presumable context system intended used high risk system shall tested purpose identifying appropriate targeted risk management measure testing shall ensure high risk system perform consistently intended purpose compliance requirement set section testing procedure may include testing real world condition accordance article testing high risk system shall performed appropriate time throughout development process event prior placed market put service testing shall carried prior defined metric probabilistic threshold appropriate intended purpose high risk system implementing risk management system provided paragraph provider shall give consideration whether view intended purpose high risk system likely adverse impact person age appropriate vulnerable group provider high risk system subject requirement regarding internal risk management process relevant provision union law aspect provided paragraph may part combined risk management procedure established pursuant law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 10
|
1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.
2. Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:
(a) the relevant design choices;
(a)
the relevant design choices;
(b) data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;
(b)
data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;
(c) relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;
(c)
relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;
(d) the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;
(d)
the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;
(e) an assessment of the availability, quantity and suitability of the data sets that are needed;
(e)
an assessment of the availability, quantity and suitability of the data sets that are needed;
(f) examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;
(f)
examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;
(g) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);
(g)
appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);
(h) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.
(h)
the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.
3. Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination thereof.
4. Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used.
5. To the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with paragraph (2), points (f) and (g) of this Article, the providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, all the following conditions must be met in order for such processing to occur:
(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;
(a)
the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;
(b) the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;
(b)
the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;
(c) the special categories of personal data are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
(c)
the special categories of personal data are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
(d) the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;
(d)
the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;
(e) the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first;
(e)
the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first;
(f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.
(f)
the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.
6. For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2 to 5 apply only to the testing data sets.
|
high risk system make use technique involving training model data shall developed basis training validation testing data set meet quality criterion referred paragraph whenever data set used training validation testing data set shall subject data governance management practice appropriate intended purpose high risk system practice shall concern particular relevant design choice relevant design choice data collection process origin data case personal data original purpose data collection data collection process origin data case personal data original purpose data collection relevant data preparation processing operation annotation labelling cleaning updating enrichment aggregation relevant data preparation processing operation annotation labelling cleaning updating enrichment aggregation formulation assumption particular respect information data supposed measure represent formulation assumption particular respect information data supposed measure represent assessment availability quantity suitability data set needed assessment availability quantity suitability data set needed examination view possible bias likely affect health safety person negative impact fundamental right lead discrimination prohibited union law especially data output influence input future operation examination view possible bias likely affect health safety person negative impact fundamental right lead discrimination prohibited union law especially data output influence input future operation appropriate measure detect prevent mitigate possible bias identified according point appropriate measure detect prevent mitigate possible bias identified according point identification relevant data gap shortcoming prevent compliance regulation gap shortcoming addressed identification relevant data gap shortcoming prevent compliance regulation gap shortcoming addressed training validation testing data set shall relevant sufficiently representative best extent possible free error complete view intended purpose shall appropriate statistical property including applicable regard person group person relation high risk system intended used characteristic data set may met level individual data set level combination thereof data set shall take account extent required intended purpose characteristic element particular specific geographical contextual behavioural functional setting within high risk system intended used extent strictly necessary purpose ensuring bias detection correction relation high risk system accordance paragraph point article provider system may exceptionally process special category personal data subject appropriate safeguard fundamental right freedom natural person addition provision set regulation 2016 679 2018 1725 directive 2016 680 following condition must met order processing occur bias detection correction effectively fulfilled processing data including synthetic anonymised data bias detection correction effectively fulfilled processing data including synthetic anonymised data special category personal data subject technical limitation use personal data state art security privacy preserving measure including pseudonymisation special category personal data subject technical limitation use personal data state art security privacy preserving measure including pseudonymisation special category personal data subject measure ensure personal data processed secured protected subject suitable safeguard including strict control documentation access avoid misuse ensure authorised person access personal data appropriate confidentiality obligation special category personal data subject measure ensure personal data processed secured protected subject suitable safeguard including strict control documentation access avoid misuse ensure authorised person access personal data appropriate confidentiality obligation special category personal data transmitted transferred otherwise accessed party special category personal data transmitted transferred otherwise accessed party special category personal data deleted bias corrected personal data reached end retention period whichever come first special category personal data deleted bias corrected personal data reached end retention period whichever come first record processing activity pursuant regulation 2016 679 2018 1725 directive 2016 680 include reason processing special category personal data strictly necessary detect correct bias objective could achieved processing data record processing activity pursuant regulation 2016 679 2018 1725 directive 2016 680 include reason processing special category personal data strictly necessary detect correct bias objective could achieved processing data development high risk system using technique involving training model paragraph apply testing data set
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 11
|
1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.
3. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.
|
technical documentation high risk system shall drawn system placed market put service shall kept date technical documentation shall drawn way demonstrate high risk system complies requirement set section provide national competent authority notified body necessary information clear comprehensive form assess compliance system requirement shall contain minimum element set annex smes including start ups may provide element technical documentation specified annex simplified manner end commission shall establish simplified technical documentation form targeted need small microenterprises sme including start opts provide information required annex simplified manner shall use form referred paragraph notified body shall accept form purpose conformity assessment high risk system related product covered union harmonisation legislation listed section annex placed market put service single set technical documentation shall drawn containing information set paragraph well information required legal act commission empowered adopt delegated act accordance article order amend annex necessary ensure light technical progress technical documentation provides information necessary assess compliance system requirement set section
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 12
|
1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:
(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
(a)
identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
(b) facilitating the post-market monitoring referred to in Article 72; and
(b)
facilitating the post-market monitoring referred to in Article 72; and
(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).
(c)
monitoring the operation of high-risk AI systems referred to in Article 26(5).
3. For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
(a) recording of the period of each use of the system (start date and time and end date and time of each use);
(a)
recording of the period of each use of the system (start date and time and end date and time of each use);
(b) the reference database against which input data has been checked by the system;
(b)
the reference database against which input data has been checked by the system;
(c) the input data for which the search has led to a match;
(c)
the input data for which the search has led to a match;
(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
(d)
the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
|
high risk system shall technically allow automatic recording event log lifetime system order ensure level traceability functioning high risk system appropriate intended purpose system logging capability shall enable recording event relevant identifying situation may result high risk system presenting risk within meaning article substantial modification identifying situation may result high risk system presenting risk within meaning article substantial modification facilitating post market monitoring referred article facilitating post market monitoring referred article monitoring operation high risk system referred article monitoring operation high risk system referred article high risk system referred point annex iii logging capability shall provide minimum recording period use system start date time end date time use recording period use system start date time end date time use reference database input data checked system reference database input data checked system input data search led match input data search led match identification natural person involved verification result referred article identification natural person involved verification result referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 13
|
1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and deployer set out in Section 3.
2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.
3. The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;
(a)
the identity and the contact details of the provider and, where applicable, of its authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including: (i) its intended purpose; (ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity; (iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2); (iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output; (v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used; (vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system; (vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(b)
the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(i) its intended purpose;
(i)
its intended purpose;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;
(ii)
the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2);
(iii)
any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2);
(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output;
(iv)
where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output;
(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;
(v)
when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;
(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vi)
when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(vii)
where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any;
(c)
the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any;
(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;
(d)
the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;
(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;
(e)
the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;
(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.
(f)
where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.
|
high risk system shall designed developed way ensure operation sufficiently transparent enable deployers interpret system output use appropriately appropriate type degree transparency shall ensured view achieving compliance relevant obligation provider deployer set section high risk system shall accompanied instruction use appropriate digital format otherwise include concise complete correct clear information relevant accessible comprehensible deployers instruction use shall contain least following information identity contact detail provider applicable authorised representative identity contact detail provider applicable authorised representative characteristic capability limitation performance high risk system including intended purpose level accuracy including metric robustness cybersecurity referred article high risk system tested validated expected known foreseeable circumstance may impact expected level accuracy robustness cybersecurity iii known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right referred article applicable technical capability characteristic high risk system provide information relevant explain output appropriate performance regarding specific person group person system intended used appropriate specification input data relevant information term training validation testing data set used taking account intended purpose high risk system vii applicable information enable deployers interpret output high risk system use appropriately characteristic capability limitation performance high risk system including intended purpose intended purpose level accuracy including metric robustness cybersecurity referred article high risk system tested validated expected known foreseeable circumstance may impact expected level accuracy robustness cybersecurity level accuracy including metric robustness cybersecurity referred article high risk system tested validated expected known foreseeable circumstance may impact expected level accuracy robustness cybersecurity iii known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right referred article iii known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right referred article applicable technical capability characteristic high risk system provide information relevant explain output applicable technical capability characteristic high risk system provide information relevant explain output appropriate performance regarding specific person group person system intended used appropriate performance regarding specific person group person system intended used appropriate specification input data relevant information term training validation testing data set used taking account intended purpose high risk system appropriate specification input data relevant information term training validation testing data set used taking account intended purpose high risk system vii applicable information enable deployers interpret output high risk system use appropriately vii applicable information enable deployers interpret output high risk system use appropriately change high risk system performance pre determined provider moment initial conformity assessment change high risk system performance pre determined provider moment initial conformity assessment human oversight measure referred article including technical measure put place facilitate interpretation output high risk system deployers human oversight measure referred article including technical measure put place facilitate interpretation output high risk system deployers computational hardware resource needed expected lifetime high risk system necessary maintenance care measure including frequency ensure proper functioning system including regard software update computational hardware resource needed expected lifetime high risk system necessary maintenance care measure including frequency ensure proper functioning system including regard software update relevant description mechanism included within high risk system allows deployers properly collect store interpret log accordance article relevant description mechanism included within high risk system allows deployers properly collect store interpret log accordance article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 14
|
1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2. Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, in particular where such risks persist despite the application of other requirements set out in this Section.
3. The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk AI system, and shall be ensured through either one or both of the following types of measures:
(a) measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed on the market or put into service;
(a)
measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed on the market or put into service;
(b) measures identified by the provider before placing the high-risk AI system on the market or putting it into service and that are appropriate to be implemented by the deployer.
(b)
measures identified by the provider before placing the high-risk AI system on the market or putting it into service and that are appropriate to be implemented by the deployer.
4. For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:
(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
(a)
to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
(b) to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
(b)
to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
(c) to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;
(c)
to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;
(d) to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;
(d)
to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;
(e) to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state.
(e)
to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state.
5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article shall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification resulting from the system unless that identification has been separately verified and confirmed by at least two natural persons with the necessary competence, training and authority.
The requirement for a separate verification by at least two natural persons shall not apply to high-risk AI systems used for the purposes of law enforcement, migration, border control or asylum, where Union or national law considers the application of this requirement to be disproportionate.
|
high risk system shall designed developed way including appropriate human machine interface tool effectively overseen natural person period use human oversight shall aim prevent minimise risk health safety fundamental right may emerge high risk system used accordance intended purpose condition reasonably foreseeable misuse particular risk persist despite application requirement set section oversight measure shall commensurate risk level autonomy context use high risk system shall ensured either one following type measure measure identified built technically feasible high risk system provider placed market put service measure identified built technically feasible high risk system provider placed market put service measure identified provider placing high risk system market putting service appropriate implemented deployer measure identified provider placing high risk system market putting service appropriate implemented deployer purpose implementing paragraph high risk system shall provided deployer way natural person human oversight assigned enabled appropriate proportionate properly understand relevant capacity limitation high risk system able duly monitor operation including view detecting addressing anomaly dysfunction unexpected performance properly understand relevant capacity limitation high risk system able duly monitor operation including view detecting addressing anomaly dysfunction unexpected performance remain aware possible tendency automatically relying relying output produced high risk system automation bias particular high risk system used provide information recommendation decision taken natural person remain aware possible tendency automatically relying relying output produced high risk system automation bias particular high risk system used provide information recommendation decision taken natural person correctly interpret high risk system output taking account example interpretation tool method available correctly interpret high risk system output taking account example interpretation tool method available decide particular situation use high risk system otherwise disregard override reverse output high risk system decide particular situation use high risk system otherwise disregard override reverse output high risk system intervene operation high risk system interrupt system stop button similar procedure allows system come halt safe state intervene operation high risk system interrupt system stop button similar procedure allows system come halt safe state high risk system referred point annex iii measure referred paragraph article shall ensure addition action decision taken deployer basis identification resulting system unless identification separately verified confirmed least two natural person necessary competence training authority requirement separate verification least two natural person shall apply high risk system used purpose law enforcement migration border control asylum union national law considers application requirement disproportionate
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 15
|
1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2. To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders and organisations such as metrology and benchmarking authorities, encourage, as appropriate, the development of benchmarks and measurement methodologies.
3. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.
4. High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems. Technical and organisational measures shall be taken in this regard.
The robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include backup or fail-safe plans.
High-risk AI systems that continue to learn after being placed on the market or put into service shall be developed in such a way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations (feedback loops), and as to ensure that any such feedback loops are duly addressed with appropriate mitigation measures.
5. High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or performance by exploiting system vulnerabilities.
The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent, detect, respond to, resolve and control for attacks trying to manipulate the training data set (data poisoning), or pre-trained components used in training (model poisoning), inputs designed to cause the AI model to make a mistake (adversarial examples or model evasion), confidentiality attacks or model flaws.
|
high risk system shall designed developed way achieve appropriate level accuracy robustness cybersecurity perform consistently respect throughout lifecycle address technical aspect measure appropriate level accuracy robustness set paragraph relevant performance metric commission shall cooperation relevant stakeholder organisation metrology benchmarking authority encourage appropriate development benchmark measurement methodology level accuracy relevant accuracy metric high risk system shall declared accompanying instruction use high risk system shall resilient possible regarding error fault inconsistency may occur within system environment system operates particular due interaction natural person system technical organisational measure shall taken regard robustness high risk system may achieved technical redundancy solution may include backup fail safe plan high risk system continue learn placed market put service shall developed way eliminate reduce far possible risk possibly biased output influencing input future operation feedback loop ensure feedback loop duly addressed appropriate mitigation measure high risk system shall resilient attempt unauthorised third party alter use output performance exploiting system vulnerability technical solution aiming ensure cybersecurity high risk system shall appropriate relevant circumstance risk technical solution address specific vulnerability shall include appropriate measure prevent detect respond resolve control attack trying manipulate training data set data poisoning pre trained component used training model poisoning input designed cause model make mistake adversarial example model evasion confidentiality attack model flaw
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 16
|
Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(a)
ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(b)
indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(c) have a quality management system in place which complies with Article 17;
(c)
have a quality management system in place which complies with Article 17;
(d) keep the documentation referred to in Article 18;
(d)
keep the documentation referred to in Article 18;
(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(e)
when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
(f)
ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
(g) draw up an EU declaration of conformity in accordance with Article 47;
(g)
draw up an EU declaration of conformity in accordance with Article 47;
(h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(h)
affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(i) comply with the registration obligations referred to in Article 49(1);
(i)
comply with the registration obligations referred to in Article 49(1);
(j) take the necessary corrective actions and provide information as required in Article 20;
(j)
take the necessary corrective actions and provide information as required in Article 20;
(k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(k)
upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
(l)
ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
|
provider high risk system shall ensure high risk system compliant requirement set section ensure high risk system compliant requirement set section indicate high risk system possible packaging accompanying documentation applicable name registered trade name registered trade mark address contacted indicate high risk system possible packaging accompanying documentation applicable name registered trade name registered trade mark address contacted quality management system place complies article quality management system place complies article keep documentation referred article keep documentation referred article control keep log automatically generated high risk system referred article control keep log automatically generated high risk system referred article ensure high risk system undergoes relevant conformity assessment procedure referred article prior placed market put service ensure high risk system undergoes relevant conformity assessment procedure referred article prior placed market put service draw declaration conformity accordance article draw declaration conformity accordance article affix marking high risk system possible packaging accompanying documentation indicate conformity regulation accordance article affix marking high risk system possible packaging accompanying documentation indicate conformity regulation accordance article comply registration obligation referred article comply registration obligation referred article take necessary corrective action provide information required article take necessary corrective action provide information required article upon reasoned request national competent authority demonstrate conformity high risk system requirement set section upon reasoned request national competent authority demonstrate conformity high risk system requirement set section ensure high risk system complies accessibility requirement accordance directive 2016 2102 2019 882 ensure high risk system complies accessibility requirement accordance directive 2016 2102 2019 882
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 17
|
1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:
(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
(a)
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
(b)
techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
(c)
techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;
(d)
examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;
(e) technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;
(e)
technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;
(f) systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;
(f)
systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;
(g) the risk management system referred to in Article 9;
(g)
the risk management system referred to in Article 9;
(h) the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
(h)
the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
(i) procedures related to the reporting of a serious incident in accordance with Article 73;
(i)
procedures related to the reporting of a serious incident in accordance with Article 73;
(j) the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
(j)
the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
(k) systems and procedures for record-keeping of all relevant documentation and information;
(k)
systems and procedures for record-keeping of all relevant documentation and information;
(l) resource management, including security-of-supply related measures;
(l)
resource management, including security-of-supply related measures;
(m) an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.
(m)
an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.
2. The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation.
3. Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law.
4. For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any harmonised standards referred to in Article 40 shall be taken into account.
|
provider high risk system shall put quality management system place ensures compliance regulation system shall documented systematic orderly manner form written policy procedure instruction shall include least following aspect strategy regulatory compliance including compliance conformity assessment procedure procedure management modification high risk system strategy regulatory compliance including compliance conformity assessment procedure procedure management modification high risk system technique procedure systematic action used design design control design verification high risk system technique procedure systematic action used design design control design verification high risk system technique procedure systematic action used development quality control quality assurance high risk system technique procedure systematic action used development quality control quality assurance high risk system examination test validation procedure carried development high risk system frequency carried examination test validation procedure carried development high risk system frequency carried technical specification including standard applied relevant harmonised standard applied full cover relevant requirement set section mean used ensure high risk system complies requirement technical specification including standard applied relevant harmonised standard applied full cover relevant requirement set section mean used ensure high risk system complies requirement system procedure data management including data acquisition data collection data analysis data labelling data storage data filtration data mining data aggregation data retention operation regarding data performed purpose placing market putting service high risk system system procedure data management including data acquisition data collection data analysis data labelling data storage data filtration data mining data aggregation data retention operation regarding data performed purpose placing market putting service high risk system risk management system referred article risk management system referred article setting implementation maintenance post market monitoring system accordance article setting implementation maintenance post market monitoring system accordance article procedure related reporting serious incident accordance article procedure related reporting serious incident accordance article handling communication national competent authority relevant authority including providing supporting access data notified body operator customer interested party handling communication national competent authority relevant authority including providing supporting access data notified body operator customer interested party system procedure record keeping relevant documentation information system procedure record keeping relevant documentation information resource management including security supply related measure resource management including security supply related measure accountability framework setting responsibility management staff regard aspect listed paragraph accountability framework setting responsibility management staff regard aspect listed paragraph implementation aspect referred paragraph shall proportionate size provider organisation provider shall event respect degree rigour level protection required ensure compliance high risk system regulation provider high risk system subject obligation regarding quality management system equivalent function relevant sectoral union law may include aspect listed paragraph part quality management system pursuant law provider financial institution subject requirement regarding internal governance arrangement process union financial service law obligation put place quality management system exception paragraph point article shall deemed fulfilled complying rule internal governance arrangement process pursuant relevant union financial service law end harmonised standard referred article shall taken account
|
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0.02992561273276806,
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] |
all-MiniLM-L6-v2
| 384 |
Article 18
|
1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(a)
the technical documentation referred to in Article 11;
(b) the documentation concerning the quality management system referred to in Article 17;
(b)
the documentation concerning the quality management system referred to in Article 17;
(c) the documentation concerning the changes approved by notified bodies, where applicable;
(c)
the documentation concerning the changes approved by notified bodies, where applicable;
(d) the decisions and other documents issued by the notified bodies, where applicable;
(d)
the decisions and other documents issued by the notified bodies, where applicable;
(e) the EU declaration of conformity referred to in Article 47.
(e)
the EU declaration of conformity referred to in Article 47.
2. Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period.
3. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.
|
provider shall period ending year high risk system placed market put service keep disposal national competent authority technical documentation referred article technical documentation referred article documentation concerning quality management system referred article documentation concerning quality management system referred article documentation concerning change approved notified body applicable documentation concerning change approved notified body applicable decision document issued notified body applicable decision document issued notified body applicable declaration conformity referred article declaration conformity referred article member state shall determine condition documentation referred paragraph remains disposal national competent authority period indicated paragraph case provider authorised representative established territory go bankrupt cease activity prior end period provider financial institution subject requirement regarding internal governance arrangement process union financial service law shall maintain technical documentation part documentation kept relevant union financial service law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 19
|
1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in the applicable Union or national law, in particular in Union law on the protection of personal data.
2. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation kept under the relevant financial services law.
|
provider high risk system shall keep log referred article automatically generated high risk system extent log control without prejudice applicable union national law log shall kept period appropriate intended purpose high risk system least six month unless provided otherwise applicable union national law particular union law protection personal data provider financial institution subject requirement regarding internal governance arrangement process union financial service law shall maintain log automatically generated high risk system part documentation kept relevant financial service law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 20
|
1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to disable it, or to recall it, as appropriate. They shall inform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised representative and importers accordingly.
2. Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the notified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature of the non-compliance and of any relevant corrective action taken.
|
provider high risk system consider reason consider high risk system placed market put service conformity regulation shall immediately take necessary corrective action bring system conformity withdraw disable recall appropriate shall inform distributor high risk system concerned applicable deployers authorised representative importer accordingly high risk system present risk within meaning article provider becomes aware risk shall immediately investigate cause collaboration reporting deployer applicable inform market surveillance authority competent high risk system concerned applicable notified body issued certificate high risk system accordance article particular nature non compliance relevant corrective action taken
|
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-0.04176262766122818
] |
all-MiniLM-L6-v2
| 384 |
Article 21
|
1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, in a language which can be easily understood by the authority in one of the official languages of the institutions of the Union as indicated by the Member State concerned.
2. Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as applicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent such logs are under their control.
3. Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
provider high risk system shall upon reasoned request competent authority provide authority information documentation necessary demonstrate conformity high risk system requirement set section language easily understood authority one official language institution union indicated member state concerned upon reasoned request competent authority provider shall also give requesting competent authority applicable access automatically generated log high risk system referred article extent log control information obtained competent authority pursuant article shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 22
|
1. Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
2. The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider.
3. The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the institutions of the Union, as indicated by the competent authority. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:
(a) verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in Article 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;
(a)
verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in Article 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;
(b) keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for a period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in Article 47, the technical documentation and, if applicable, the certificate issued by the notified body;
(b)
keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for a period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in Article 47, the technical documentation and, if applicable, the certificate issued by the notified body;
(c) provide a competent authority, upon a reasoned request, with all the information and documentation, including that referred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent such logs are under the control of the provider;
(c)
provide a competent authority, upon a reasoned request, with all the information and documentation, including that referred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent such logs are under the control of the provider;
(d) cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;
(d)
cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;
(e) where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.
(e)
where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.
The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the competent authorities, on all issues related to ensuring compliance with this Regulation.
4. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall immediately inform the relevant market surveillance authority, as well as, where applicable, the relevant notified body, about the termination of the mandate and the reasons therefor.
|
prior making high risk system available union market provider established third country shall written mandate appoint authorised representative established union provider shall enable authorised representative perform task specified mandate received provider authorised representative shall perform task specified mandate received provider shall provide copy mandate market surveillance authority upon request one official language institution union indicated competent authority purpose regulation mandate shall empower authorised representative carry following task verify declaration conformity referred article technical documentation referred article drawn appropriate conformity assessment procedure carried provider verify declaration conformity referred article technical documentation referred article drawn appropriate conformity assessment procedure carried provider keep disposal competent authority national authority body referred article period year high risk system placed market put service contact detail provider appointed authorised representative copy declaration conformity referred article technical documentation applicable certificate issued notified body keep disposal competent authority national authority body referred article period year high risk system placed market put service contact detail provider appointed authorised representative copy declaration conformity referred article technical documentation applicable certificate issued notified body provide competent authority upon reasoned request information documentation including referred point subparagraph necessary demonstrate conformity high risk system requirement set section including access log referred article automatically generated high risk system extent log control provider provide competent authority upon reasoned request information documentation including referred point subparagraph necessary demonstrate conformity high risk system requirement set section including access log referred article automatically generated high risk system extent log control provider cooperate competent authority upon reasoned request action latter take relation high risk system particular reduce mitigate risk posed high risk system cooperate competent authority upon reasoned request action latter take relation high risk system particular reduce mitigate risk posed high risk system applicable comply registration obligation referred article registration carried provider ensure information referred point section annex viii correct applicable comply registration obligation referred article registration carried provider ensure information referred point section annex viii correct mandate shall empower authorised representative addressed addition instead provider competent authority issue related ensuring compliance regulation authorised representative shall terminate mandate considers reason consider provider acting contrary obligation pursuant regulation case shall immediately inform relevant market surveillance authority well applicable relevant notified body termination mandate reason therefor
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 23
|
1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(a)
the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(b)
the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(c) the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
(c)
the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
(d) the provider has appointed an authorised representative in accordance with Article 22(1).
(d)
the provider has appointed an authorised representative in accordance with Article 22(1).
2. Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.
3. Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.
4. Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.
5. Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47.
6. Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.
7. Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.
|
placing high risk system market importer shall ensure system conformity regulation verifying relevant conformity assessment procedure referred article carried provider high risk system relevant conformity assessment procedure referred article carried provider high risk system provider drawn technical documentation accordance article annex provider drawn technical documentation accordance article annex system bear required marking accompanied declaration conformity referred article instruction use system bear required marking accompanied declaration conformity referred article instruction use provider appointed authorised representative accordance article provider appointed authorised representative accordance article importer sufficient reason consider high risk system conformity regulation falsified accompanied falsified documentation shall place system market brought conformity high risk system present risk within meaning article importer shall inform provider system authorised representative market surveillance authority effect importer shall indicate name registered trade name registered trade mark address contacted high risk system packaging accompanying documentation applicable importer shall ensure high risk system responsibility storage transport condition applicable jeopardise compliance requirement set section importer shall keep period year high risk system placed market put service copy certificate issued notified body applicable instruction use declaration conformity referred article importer shall provide relevant competent authority upon reasoned request necessary information documentation including referred paragraph demonstrate conformity high risk system requirement set section language easily understood purpose shall also ensure technical documentation made available authority importer shall cooperate relevant competent authority action authority take relation high risk system placed market importer particular reduce mitigate risk posed
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 24
|
1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as laid down in Article 16, points (b) and (c) and Article 23(3).
2. Where a distributor considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI system available on the market until the system has been brought into conformity with those requirements. Furthermore, where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.
3. Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.
4. A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.
5. Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of that system with the requirements set out in Section 2.
6. Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by it.
|
making high risk system available market distributor shall verify bear required marking accompanied copy declaration conformity referred article instruction use provider importer system applicable complied respective obligation laid article point article distributor considers reason consider basis information possession high risk system conformity requirement set section shall make high risk system available market system brought conformity requirement furthermore high risk system present risk within meaning article distributor shall inform provider importer system applicable effect distributor shall ensure high risk system responsibility storage transport condition applicable jeopardise compliance system requirement set section distributor considers reason consider basis information possession high risk system made available market conformity requirement set section shall take corrective action necessary bring system conformity requirement withdraw recall shall ensure provider importer relevant operator appropriate take corrective action high risk system present risk within meaning article distributor shall immediately inform provider importer system authority competent high risk system concerned giving detail particular non compliance corrective action taken upon reasoned request relevant competent authority distributor high risk system shall provide authority information documentation regarding action pursuant paragraph necessary demonstrate conformity system requirement set section distributor shall cooperate relevant competent authority action authority take relation high risk system made available market distributor particular reduce mitigate risk posed
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 25
|
1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated;
(a)
they put their name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated;
(b) they make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in such a way that it remains a high-risk AI system pursuant to Article 6;
(b)
they make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in such a way that it remains a high-risk AI system pursuant to Article 6;
(c) they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such a way that the AI system concerned becomes a high-risk AI system in accordance with Article 6.
(c)
they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such a way that the AI system concerned becomes a high-risk AI system in accordance with Article 6.
2. Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of this Regulation. That initial provider shall closely cooperate with new providers and shall make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems. This paragraph shall not apply in cases where the initial provider has clearly specified that its AI system is not to be changed into a high-risk AI system and therefore does not fall under the obligation to hand over the documentation.
3. In the case of high-risk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk AI system, and shall be subject to the obligations under Article 16 under either of the following circumstances:
(a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;
(a)
the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;
(b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market.
(b)
the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market.
4. The provider of a high-risk AI system and the third party that supplies an AI system, tools, services, components, or processes that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider of the high-risk AI system to fully comply with the obligations set out in this Regulation. This paragraph shall not apply to third parties making accessible to the public tools, services, processes, or components, other than general-purpose AI models, under a free and open-source licence.
The AI Office may develop and recommend voluntary model terms for contracts between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used for or integrated into high-risk AI systems. When developing those voluntary model terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The voluntary model terms shall be published and be available free of charge in an easily usable electronic format.
5. Paragraphs 2 and 3 are without prejudice to the need to observe and protect intellectual property rights, confidential business information and trade secrets in accordance with Union and national law.
|
distributor importer deployer third party shall considered provider high risk system purpose regulation shall subject obligation provider article following circumstance put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation otherwise allocated put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation otherwise allocated make substantial modification high risk system already placed market already put service way remains high risk system pursuant article make substantial modification high risk system already placed market already put service way remains high risk system pursuant article modify intended purpose system including general purpose system classified high risk already placed market put service way system concerned becomes high risk system accordance article modify intended purpose system including general purpose system classified high risk already placed market put service way system concerned becomes high risk system accordance article circumstance referred paragraph occur provider initially placed system market put service shall longer considered provider specific system purpose regulation initial provider shall closely cooperate new provider shall make available necessary information provide reasonably expected technical access assistance required fulfilment obligation set regulation particular regarding compliance conformity assessment high risk system paragraph shall apply case initial provider clearly specified system changed high risk system therefore fall obligation hand documentation case high risk system safety component product covered union harmonisation legislation listed section annex product manufacturer shall considered provider high risk system shall subject obligation article either following circumstance high risk system placed market together product name trademark product manufacturer high risk system placed market together product name trademark product manufacturer high risk system put service name trademark product manufacturer product placed market high risk system put service name trademark product manufacturer product placed market provider high risk system third party supply system tool service component process used integrated high risk system shall written agreement specify necessary information capability technical access assistance based generally acknowledged state art order enable provider high risk system fully comply obligation set regulation paragraph shall apply third party making accessible public tool service process component general purpose model free open source licence office may develop recommend voluntary model term contract provider high risk system third party supply tool service component process used integrated high risk system developing voluntary model term office shall take account possible contractual requirement applicable specific sector business case voluntary model term shall published available free charge easily usable electronic format paragraph without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 26
|
1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
2. Deployers shall assign human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support.
3. The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer obligations under Union or national law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.
4. Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system.
5. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where relevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the high-risk AI system in accordance with the instructions may result in that AI system presenting a risk within the meaning of Article 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance authority, and shall suspend the use of that system. Where deployers have identified a serious incident, they shall also immediately inform first the provider, and then the importer or distributor and the relevant market surveillance authorities of that incident. If the deployer is not able to reach the provider, Article 73 shall applymutatis mutandis. This obligation shall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities.
For deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the relevant financial service law.
6. Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent such logs are under their control, for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of personal data.
Deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service law.
7. Before putting into service or using a high-risk AI system at the workplace, deployers who are employers shall inform workers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This information shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and national law and practice on information of workers and their representatives.
8. Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies, offices or agencies shall comply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system that they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system and shall inform the provider or the distributor.
9. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this Regulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680.
10. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person suspected or convicted of having committed a criminal offence, the deployer of a high-risk AI system for post-remote biometric identification shall request an authorisation,ex ante, or without undue delay and no later than 48 hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the use of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable facts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific criminal offence.
If the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric identification system linked to that requested authorisation shall be stopped with immediate effect and the personal data linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted.
In no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in an untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal offence, or the search for a specific missing person. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the law enforcement authorities based solely on the output of such post-remote biometric identification systems.
This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680 for the processing of biometric data.
Regardless of the purpose or deployer, each use of such high-risk AI systems shall be documented in the relevant police file and shall be made available to the relevant market surveillance authority and the national data protection authority upon request, excluding the disclosure of sensitive operational data related to law enforcement. This subparagraph shall be without prejudice to the powers conferred by Directive (EU) 2016/680 on supervisory authorities.
Deployers shall submit annual reports to the relevant market surveillance and national data protection authorities on their use of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law enforcement. The reports may be aggregated to cover more than one deployment.
Member States may introduce, in accordance with Union law, more restrictive laws on the use of post-remote biometric identification systems.
11. Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that make decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 shall apply.
12. Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to the high-risk AI system in order to implement this Regulation.
|
deployers high risk system shall take appropriate technical organisational measure ensure use system accordance instruction use accompanying system pursuant paragraph deployers shall assign human oversight natural person necessary competence training authority well necessary support obligation set paragraph without prejudice deployer obligation union national law deployer freedom organise resource activity purpose implementing human oversight measure indicated provider without prejudice paragraph extent deployer exercise control input data deployer shall ensure input data relevant sufficiently representative view intended purpose high risk system deployers shall monitor operation high risk system basis instruction use relevant inform provider accordance article deployers reason consider use high risk system accordance instruction may result system presenting risk within meaning article shall without undue delay inform provider distributor relevant market surveillance authority shall suspend use system deployers identified serious incident shall also immediately inform first provider importer distributor relevant market surveillance authority incident deployer able reach provider article shall applymutatis mutandis obligation shall cover sensitive operational data deployers system law enforcement authority deployers financial institution subject requirement regarding internal governance arrangement process union financial service law monitoring obligation set first subparagraph shall deemed fulfilled complying rule internal governance arrangement process mechanism pursuant relevant financial service law deployers high risk system shall keep log automatically generated high risk system extent log control period appropriate intended purpose high risk system least six month unless provided otherwise applicable union national law particular union law protection personal data deployers financial institution subject requirement regarding internal governance arrangement process union financial service law shall maintain log part documentation kept pursuant relevant union financial service law putting service using high risk system workplace deployers employer shall inform worker representative affected worker subject use high risk system information shall provided applicable accordance rule procedure laid union national law practice information worker representative deployers high risk system public authority union institution body office agency shall comply registration obligation referred article deployers find high risk system envisage using registered database referred article shall use system shall inform provider distributor applicable deployers high risk system shall use information provided article regulation comply obligation carry data protection impact assessment article regulation 2016 679 article directive 2016 680 without prejudice directive 2016 680 framework investigation targeted search person suspected convicted committed criminal offence deployer high risk system post remote biometric identification shall request authorisation ante without undue delay later hour judicial authority administrative authority whose decision binding subject judicial review use system except used initial identification potential suspect based objective verifiable fact directly linked offence use shall limited strictly necessary investigation specific criminal offence authorisation requested pursuant first subparagraph rejected use post remote biometric identification system linked requested authorisation shall stopped immediate effect personal data linked use high risk system authorisation requested shall deleted case shall high risk system post remote biometric identification used law enforcement purpose untargeted way without link criminal offence criminal proceeding genuine present genuine foreseeable threat criminal offence search specific missing person shall ensured decision produce adverse legal effect person may taken law enforcement authority based solely output post remote biometric identification system paragraph without prejudice article regulation 2016 679 article directive 2016 680 processing biometric data regardless purpose deployer use high risk system shall documented relevant police file shall made available relevant market surveillance authority national data protection authority upon request excluding disclosure sensitive operational data related law enforcement subparagraph shall without prejudice power conferred directive 2016 680 supervisory authority deployers shall submit annual report relevant market surveillance national data protection authority use post remote biometric identification system excluding disclosure sensitive operational data related law enforcement report may aggregated cover one deployment member state may introduce accordance union law restrictive law use post remote biometric identification system without prejudice article regulation deployers high risk system referred annex iii make decision assist making decision related natural person shall inform natural person subject use high risk system high risk system used law enforcement purpose article directive 2016 680 shall apply deployers shall cooperate relevant competent authority action authority take relation high risk system order implement regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 27
|
1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose, deployers shall perform an assessment consisting of:
(a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
(a)
a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
(b) a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
(b)
a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
(c) the categories of natural persons and groups likely to be affected by its use in the specific context;
(c)
the categories of natural persons and groups likely to be affected by its use in the specific context;
(d) the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;
(d)
the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;
(e) a description of the implementation of human oversight measures, according to the instructions for use;
(e)
a description of the implementation of human oversight measures, according to the instructions for use;
(f) the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
(f)
the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.
3. Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the market surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.
4. If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact assessment.
5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner.
|
prior deploying high risk system referred article exception high risk system intended used area listed point annex iii deployers body governed public law private entity providing public service deployers high risk system referred point annex iii shall perform assessment impact fundamental right use system may produce purpose deployers shall perform assessment consisting description deployer process high risk system used line intended purpose description deployer process high risk system used line intended purpose description period time within frequency high risk system intended used description period time within frequency high risk system intended used category natural person group likely affected use specific context category natural person group likely affected use specific context specific risk harm likely impact category natural person group person identified pursuant point paragraph taking account information given provider pursuant article specific risk harm likely impact category natural person group person identified pursuant point paragraph taking account information given provider pursuant article description implementation human oversight measure according instruction use description implementation human oversight measure according instruction use measure taken case materialisation risk including arrangement internal governance complaint mechanism measure taken case materialisation risk including arrangement internal governance complaint mechanism obligation laid paragraph applies first use high risk system deployer may similar case rely previously conducted fundamental right impact assessment existing impact assessment carried provider use high risk system deployer considers element listed paragraph changed longer date deployer shall take necessary step update information assessment referred paragraph article performed deployer shall notify market surveillance authority result submitting filled template referred paragraph article part notification case referred article deployers may exempt obligation notify obligation laid article already met data protection impact assessment conducted pursuant article regulation 2016 679 article directive 2016 680 fundamental right impact assessment referred paragraph article shall complement data protection impact assessment office shall develop template questionnaire including automated tool facilitate deployers complying obligation article simplified manner
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 28
|
1. Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.
3. Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.
4. Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.
5. Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis.
6. Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
7. Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in fields such as information technologies, AI and law, including the supervision of fundamental rights.
|
member state shall designate establish least one notifying authority responsible setting carrying necessary procedure assessment designation notification conformity assessment body monitoring procedure shall developed cooperation notifying authority member state member state may decide assessment monitoring referred paragraph carried national accreditation body within meaning accordance regulation 765 2008 notifying authority shall established organised operated way conflict interest arises conformity assessment body objectivity impartiality activity safeguarded notifying authority shall organised way decision relating notification conformity assessment body taken competent person different carried assessment body notifying authority shall offer provide neither activity conformity assessment body perform consultancy service commercial competitive basis notifying authority shall safeguard confidentiality information obtain accordance article notifying authority shall adequate number competent personnel disposal proper performance task competent personnel shall necessary expertise applicable function field information technology law including supervision fundamental right
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 29
|
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 31.
Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added.
3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 31.
4. For notified bodies which are designated under any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support their designation procedure under this Regulation, as appropriate. The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements laid down in Article 31.
|
conformity assessment body shall submit application notification notifying authority member state established application notification shall accompanied description conformity assessment activity conformity assessment module module type system conformity assessment body claim competent well accreditation certificate one exists issued national accreditation body attesting conformity assessment body fulfils requirement laid article valid document related existing designation applicant notified body union harmonisation legislation shall added conformity assessment body concerned provide accreditation certificate shall provide notifying authority documentary evidence necessary verification recognition regular monitoring compliance requirement laid article notified body designated union harmonisation legislation document certificate linked designation may used support designation procedure regulation appropriate notified body shall update documentation referred paragraph article whenever relevant change occur order enable authority responsible notified body monitor verify continuous compliance requirement laid article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 30
|
1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31.
2. Notifying authorities shall notify the Commission and the other Member States, using the electronic notification tool developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1.
3. The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment activities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of competence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the competence of the conformity assessment body and to the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 31.
4. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3).
5. Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity assessment body.
|
notifying authority may notify conformity assessment body satisfied requirement laid article notifying authority shall notify commission member state using electronic notification tool developed managed commission conformity assessment body referred paragraph notification referred paragraph article shall include full detail conformity assessment activity conformity assessment module module type system concerned relevant attestation competence notification based accreditation certificate referred article notifying authority shall provide commission member state documentary evidence attests competence conformity assessment body arrangement place ensure body monitored regularly continue satisfy requirement laid article conformity assessment body concerned may perform activity notified body objection raised commission member state within two week notification notifying authority includes accreditation certificate referred article within two month notification notifying authority includes documentary evidence referred article objection raised commission shall without delay enter consultation relevant member state conformity assessment body view thereof commission shall decide whether authorisation justified commission shall address decision member state concerned relevant conformity assessment body
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 31
|
1. A notified body shall be established under the national law of a Member State and shall have legal personality.
2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
3. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall ensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies conduct.
4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such high-risk AI systems for personal purposes.
5. Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services.
6. Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.
7. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out.
8. Notified bodies shall have procedures for the performance of activities which take due account of the size of a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.
9. Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability is assumed by the Member State in which they are established in accordance with national law or that Member State is itself directly responsible for the conformity assessment.
10. Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
11. Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and data computing, and relating to the requirements set out in Section 2.
12. Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in respect of relevant standards.
|
notified body shall established national law member state shall legal personality notified body shall satisfy organisational quality management resource process requirement necessary fulfil task well suitable cybersecurity requirement organisational structure allocation responsibility reporting line operation notified body shall ensure confidence performance result conformity assessment activity notified body conduct notified body shall independent provider high risk system relation perform conformity assessment activity notified body shall also independent operator economic interest high risk system assessed well competitor provider shall preclude use assessed high risk system necessary operation conformity assessment body use high risk system personal purpose neither conformity assessment body top level management personnel responsible carrying conformity assessment task shall directly involved design development marketing use high risk system shall represent party engaged activity shall engage activity might conflict independence judgement integrity relation conformity assessment activity notified shall particular apply consultancy service notified body shall organised operated safeguard independence objectivity impartiality activity notified body shall document implement structure procedure safeguard impartiality promote apply principle impartiality throughout organisation personnel assessment activity notified body shall documented procedure place ensuring personnel committee subsidiary subcontractor associated body personnel external body maintain accordance article confidentiality information come possession performance conformity assessment activity except disclosure required law staff notified body shall bound observe professional secrecy regard information obtained carrying task regulation except relation notifying authority member state activity carried notified body shall procedure performance activity take due account size provider sector operates structure degree complexity system concerned notified body shall take appropriate liability insurance conformity assessment activity unless liability assumed member state established accordance national law member state directly responsible conformity assessment notified body shall capable carrying task regulation highest degree professional integrity requisite competence specific field whether task carried notified body behalf responsibility notified body shall sufficient internal competence able effectively evaluate task conducted external party behalf notified body shall permanent availability sufficient administrative technical legal scientific personnel possess experience knowledge relating relevant type system data data computing relating requirement set section notified body shall participate coordination activity referred article shall also take part directly represented european standardisation organisation ensure aware date respect relevant standard
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 32
|
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in theOfficial Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover those requirements.
|
conformity assessment body demonstrates conformity criterion laid relevant harmonised standard part thereof reference published theofficial journal european union shall presumed comply requirement set article far applicable harmonised standard cover requirement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 33
|
1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and shall inform the notifying authority accordingly.
2. Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available.
4. The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of five years from the termination date of the subcontracting.
|
notified body subcontract specific task connected conformity assessment recourse subsidiary shall ensure subcontractor subsidiary meet requirement laid article shall inform notifying authority accordingly notified body shall take full responsibility task performed subcontractor subsidiary activity may subcontracted carried subsidiary agreement provider notified body shall make list subsidiary publicly available relevant document concerning assessment qualification subcontractor subsidiary work carried regulation shall kept disposal notifying authority period five year termination date subcontracting
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 34
|
1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation.
3. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.
|
notified body shall verify conformity high risk system accordance conformity assessment procedure set article notified body shall avoid unnecessary burden provider performing activity take due account size provider sector operates structure degree complexity high risk system concerned particular view minimising administrative burden compliance cost micro small enterprise within meaning recommendation 2003 361 notified body shall nevertheless respect degree rigour level protection required compliance high risk system requirement regulation notified body shall make available submit upon request relevant documentation including provider documentation notifying authority referred article allow authority conduct assessment designation notification monitoring activity facilitate assessment outlined section
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 35
|
1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act.
2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
|
commission shall assign single identification number notified body even body notified one union act commission shall make publicly available list body notified regulation including identification number activity notified commission shall ensure list kept date
|
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all-MiniLM-L6-v2
| 384 |
Article 36
|
1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.
For changes to the notification other than extensions of its scope, the procedures laid down in paragraphs (3) to (9) shall apply.
3. Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its activities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified body’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.
4. Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body no longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw the designation as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned within 10 days.
6. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying authorities in other Member States and to market surveillance authorities at their request.
7. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:
(a) assess the impact on the certificates issued by the notified body;
(a)
assess the impact on the certificates issued by the notified body;
(b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(b)
submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the market;
(c)
require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the market;
(d) inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
(d)
inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
(e) provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal; that authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
(e)
provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal; that authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in one of the following circumstances:
(a) the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline for actions to remedy the suspension or restriction; or
(a)
the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline for actions to remedy the suspension or restriction; or
(b) the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the event that the notifying authority determines that the notified body does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
(b)
the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the event that the notifying authority determines that the notified body does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months under the following circumstances:
(a) the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and
(a)
the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and
(b) another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.
(b)
another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.
In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which the provider of the system covered by the certificate has its place of business may extend the provisional validity of the certificates for additional periods of three months, which shall not exceed 12 months in total.
The national competent authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
|
notifying authority shall notify commission member state relevant change notification notified body via electronic notification tool referred article procedure laid article shall apply extension scope notification change notification extension scope procedure laid paragraph shall apply notified body decides cease conformity assessment activity shall inform notifying authority provider concerned soon possible case planned cessation least one year ceasing activity certificate notified body may remain valid period nine month cessation notified body activity condition another notified body confirmed writing assume responsibility high risk system covered certificate latter notified body shall complete full assessment high risk system affected end nine month period issuing new certificate system notified body ceased activity notifying authority shall withdraw designation notifying authority sufficient reason consider notified body longer meet requirement laid article failing fulfil obligation notifying authority shall without delay investigate matter utmost diligence context shall inform notified body concerned objection raised give possibility make view known notifying authority come conclusion notified body longer meet requirement laid article failing fulfil obligation shall restrict suspend withdraw designation appropriate depending seriousness failure meet requirement fulfil obligation shall immediately inform commission member state accordingly designation suspended restricted fully partially withdrawn notified body shall inform provider concerned within day event restriction suspension withdrawal designation notifying authority shall take appropriate step ensure file notified body concerned kept make available notifying authority member state market surveillance authority request event restriction suspension withdrawal designation notifying authority shall assess impact certificate issued notified body assess impact certificate issued notified body submit report finding commission member state within three month notified change designation submit report finding commission member state within three month notified change designation require notified body suspend withdraw within reasonable period time determined authority certificate unduly issued order ensure continuing conformity high risk system market require notified body suspend withdraw within reasonable period time determined authority certificate unduly issued order ensure continuing conformity high risk system market inform commission member state certificate suspension withdrawal required inform commission member state certificate suspension withdrawal required provide national competent authority member state provider registered place business relevant information certificate required suspension withdrawal authority shall take appropriate measure necessary avoid potential risk health safety fundamental right provide national competent authority member state provider registered place business relevant information certificate required suspension withdrawal authority shall take appropriate measure necessary avoid potential risk health safety fundamental right exception certificate unduly issued designation suspended restricted certificate shall remain valid one following circumstance notifying authority confirmed within one month suspension restriction risk health safety fundamental right relation certificate affected suspension restriction notifying authority outlined timeline action remedy suspension restriction notifying authority confirmed within one month suspension restriction risk health safety fundamental right relation certificate affected suspension restriction notifying authority outlined timeline action remedy suspension restriction notifying authority confirmed certificate relevant suspension issued amended issued course suspension restriction state whether notified body capability continuing monitor remain responsible existing certificate issued period suspension restriction event notifying authority determines notified body capability support existing certificate issued provider system covered certificate shall confirm writing national competent authority member state registered place business within three month suspension restriction another qualified notified body temporarily assuming function notified body monitor remain responsible certificate period suspension restriction notifying authority confirmed certificate relevant suspension issued amended issued course suspension restriction state whether notified body capability continuing monitor remain responsible existing certificate issued period suspension restriction event notifying authority determines notified body capability support existing certificate issued provider system covered certificate shall confirm writing national competent authority member state registered place business within three month suspension restriction another qualified notified body temporarily assuming function notified body monitor remain responsible certificate period suspension restriction exception certificate unduly issued designation withdrawn certificate shall remain valid period nine month following circumstance national competent authority member state provider high risk system covered certificate registered place business confirmed risk health safety fundamental right associated high risk system concerned national competent authority member state provider high risk system covered certificate registered place business confirmed risk health safety fundamental right associated high risk system concerned another notified body confirmed writing assume immediate responsibility system completes assessment within month withdrawal designation another notified body confirmed writing assume immediate responsibility system completes assessment within month withdrawal designation circumstance referred first subparagraph national competent authority member state provider system covered certificate place business may extend provisional validity certificate additional period three month shall exceed month total national competent authority notified body assuming function notified body affected change designation shall immediately inform commission member state notified body thereof
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 37
|
1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.
2. The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78.
4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
|
commission shall necessary investigate case reason doubt competence notified body continued fulfilment notified body requirement laid article applicable responsibility notifying authority shall provide commission request relevant information relating notification maintenance competence notified body concerned commission shall ensure sensitive information obtained course investigation pursuant article treated confidentially accordance article commission ascertains notified body meet longer meet requirement notification shall inform notifying member state accordingly request take necessary corrective measure including suspension withdrawal notification necessary member state fails take necessary corrective measure commission may mean implementing act suspend restrict withdraw designation implementing act shall adopted accordance examination procedure referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 38
|
1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
2. Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in paragraph 1, directly or through designated representatives.
3. The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
|
commission shall ensure regard high risk system appropriate coordination cooperation notified body active conformity assessment procedure pursuant regulation put place properly operated form sectoral group notified body notifying authority shall ensure body notified participate work group referred paragraph directly designated representative commission shall provide exchange knowledge best practice notifying authority
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 39
|
Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of compliance.
|
conformity assessment body established law third country union concluded agreement may authorised carry activity notified body regulation provided meet requirement laid article ensure equivalent level compliance
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 40
|
1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations.
2. In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of Regulation (EU) No 1025/2012.
3. The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
|
high risk system general purpose model conformity harmonised standard part thereof reference published theofficial journal european unionin accordance regulation 1025 2012 shall presumed conformity requirement set section chapter applicable obligation set chapter section regulation extent standard cover requirement obligation accordance article regulation 1025 2012 commission shall issue without undue delay standardisation request covering requirement set section chapter applicable standardisation request covering obligation set chapter section regulation standardisation request shall also ask deliverable reporting documentation process improve system resource performance reducing high risk system consumption energy resource lifecycle energy efficient development general purpose model preparing standardisation request commission shall consult board relevant stakeholder including advisory forum issuing standardisation request european standardisation organisation commission shall specify standard clear consistent including standard developed various sector product covered existing union harmonisation legislation listed annex aiming ensure high risk system general purpose model placed market put service union meet relevant requirement obligation laid regulation commission shall request european standardisation organisation provide evidence best effort fulfil objective referred first second subparagraph paragraph accordance article regulation 1025 2012 participant standardisation process shall seek promote investment innovation including increasing legal certainty well competitiveness growth union market contribute strengthening global cooperation standardisation taking account existing international standard field consistent union value fundamental right interest enhance multi stakeholder governance ensuring balanced representation interest effective participation relevant stakeholder accordance article regulation 1025 2012
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 41
|
1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:
(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and: (i) the request has not been accepted by any of the European standardisation organisations; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or (iv) the harmonised standards do not comply with the request; and
(a)
the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:
(i) the request has not been accepted by any of the European standardisation organisations; or
(i)
the request has not been accepted by any of the European standardisation organisations; or
(ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
(ii)
the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
(iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
(iii)
the relevant harmonised standards insufficiently address fundamental rights concerns; or
(iv) the harmonised standards do not comply with the request; and
(iv)
the harmonised standards do not comply with the request; and
(b) no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.
(b)
no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.
When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.
3. High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.
4. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in theOfficial Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in theOfficial Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V.
5. Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto.
6. Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.
|
commission may adopt implementing act establishing common specification requirement set section chapter applicable obligation set section chapter following condition fulfilled commission requested pursuant article regulation 1025 2012 one european standardisation organisation draft harmonised standard requirement set section chapter applicable obligation set section chapter request accepted european standardisation organisation harmonised standard addressing request delivered within deadline set accordance article regulation 1025 2012 iii relevant harmonised standard insufficiently address fundamental right concern harmonised standard comply request commission requested pursuant article regulation 1025 2012 one european standardisation organisation draft harmonised standard requirement set section chapter applicable obligation set section chapter request accepted european standardisation organisation request accepted european standardisation organisation harmonised standard addressing request delivered within deadline set accordance article regulation 1025 2012 harmonised standard addressing request delivered within deadline set accordance article regulation 1025 2012 iii relevant harmonised standard insufficiently address fundamental right concern iii relevant harmonised standard insufficiently address fundamental right concern harmonised standard comply request harmonised standard comply request reference harmonised standard covering requirement referred section chapter applicable obligation referred section chapter published theofficial journal european unionin accordance regulation 1025 2012 reference expected published within reasonable period reference harmonised standard covering requirement referred section chapter applicable obligation referred section chapter published theofficial journal european unionin accordance regulation 1025 2012 reference expected published within reasonable period drafting common specification commission shall consult advisory forum referred article implementing act referred first subparagraph paragraph shall adopted accordance examination procedure referred article preparing draft implementing act commission shall inform committee referred article regulation 1025 2012 considers condition laid paragraph article fulfilled high risk system general purpose model conformity common specification referred paragraph part specification shall presumed conformity requirement set section chapter applicable comply obligation referred section chapter extent common specification cover requirement obligation harmonised standard adopted european standardisation organisation proposed commission publication reference theofficial journal european union commission shall assess harmonised standard accordance regulation 1025 2012 reference harmonised standard published theofficial journal european union commission shall repeal implementing act referred paragraph part thereof cover requirement set section chapter applicable obligation set section chapter provider high risk system general purpose model comply common specification referred paragraph shall duly justify adopted technical solution meet requirement referred section chapter applicable comply obligation set section chapter level least equivalent thereto member state considers common specification entirely meet requirement set section applicable comply obligation set section chapter shall inform commission thereof detailed explanation commission shall assess information appropriate amend implementing act establishing common specification concerned
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 42
|
1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4).
2. High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in theOfficial Journal of the European Unionshall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.
|
high risk system trained tested data reflecting specific geographical behavioural contextual functional setting within intended used shall presumed comply relevant requirement laid article high risk system certified statement conformity issued cybersecurity scheme pursuant regulation 2019 881 reference published theofficial journal european unionshall presumed comply cybersecurity requirement set article regulation far cybersecurity certificate statement conformity part thereof cover requirement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 43
|
1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on:
(a) the internal control referred to in Annex VI; or
(a)
the internal control referred to in Annex VI; or
(b) the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.
(b)
the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.
In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where:
(a) harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;
(a)
harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;
(b) the provider has not applied, or has applied only part of, the harmonised standard;
(b)
the provider has not applied, or has applied only part of, the harmonised standard;
(c) the common specifications referred to in point (a) exist, but the provider has not applied them;
(c)
the common specifications referred to in point (a) exist, but the provider has not applied them;
(d) one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.
(d)
one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.
For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in Article 74(8) or (9), as applicable, shall act as a notified body.
2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body.
3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.
For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.
Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.
4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer.
For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.
5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies.
|
high risk system listed point annex iii demonstrating compliance high risk system requirement set section provider applied harmonised standard referred article applicable common specification referred article provider shall opt one following conformity assessment procedure based internal control referred annex internal control referred annex assessment quality management system assessment technical documentation involvement notified body referred annex vii assessment quality management system assessment technical documentation involvement notified body referred annex vii demonstrating compliance high risk system requirement set section provider shall follow conformity assessment procedure set annex vii harmonised standard referred article exist common specification referred article available harmonised standard referred article exist common specification referred article available provider applied applied part harmonised standard provider applied applied part harmonised standard common specification referred point exist provider applied common specification referred point exist provider applied one harmonised standard referred point published restriction part standard restricted one harmonised standard referred point published restriction part standard restricted purpose conformity assessment procedure referred annex vii provider may choose notified body however high risk system intended put service law enforcement immigration asylum authority union institution body office agency market surveillance authority referred article applicable shall act notified body high risk system referred point annex iii provider shall follow conformity assessment procedure based internal control referred annex provide involvement notified body high risk system covered union harmonisation legislation listed section annex provider shall follow relevant conformity assessment procedure required legal act requirement set section chapter shall apply high risk system shall part assessment point fifth paragraph point annex vii shall also apply purpose assessment notified body notified legal act shall entitled control conformity high risk system requirement set section provided compliance notified body requirement laid article assessed context notification procedure legal act legal act listed section annex enables product manufacturer opt third party conformity assessment provided manufacturer applied harmonised standard covering relevant requirement manufacturer may use option also applied harmonised standard applicable common specification referred article covering requirement set section chapter high risk system already subject conformity assessment procedure shall undergo new conformity assessment procedure event substantial modification regardless whether modified system intended distributed continues used current deployer high risk system continue learn placed market put service change high risk system performance pre determined provider moment initial conformity assessment part information contained technical documentation referred point annex shall constitute substantial modification commission empowered adopt delegated act accordance article order amend annex vii updating light technical progress commission empowered adopt delegated act accordance article order amend paragraph article order subject high risk system referred point annex iii conformity assessment procedure referred annex vii part thereof commission shall adopt delegated act taking account effectiveness conformity assessment procedure based internal control referred annex preventing minimising risk health safety protection fundamental right posed system well availability adequate capacity resource among notified body
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 44
|
1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established.
2. Certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may be extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.
3. Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.
An appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.
|
certificate issued notified body accordance annex vii shall drawn language easily understood relevant authority member state notified body established certificate shall valid period indicate shall exceed five year system covered annex four year system covered annex iii request provider validity certificate may extended period exceeding five year system covered annex four year system covered annex iii based assessment accordance applicable conformity assessment procedure supplement certificate shall remain valid provided certificate supplement valid notified body find system longer meet requirement set section shall taking account principle proportionality suspend withdraw certificate issued impose restriction unless compliance requirement ensured appropriate corrective action taken provider system within appropriate deadline set notified body notified body shall give reason decision appeal procedure decision notified body including conformity certificate issued shall available
|
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-0.019796045497059822,
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] |
all-MiniLM-L6-v2
| 384 |
Article 45
|
1. Notified bodies shall inform the notifying authority of the following:
(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(a)
any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(b) any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
(b)
any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
(c) any circumstances affecting the scope of or conditions for notification;
(c)
any circumstances affecting the scope of or conditions for notification;
(d) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d)
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(e) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
(e)
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2. Each notified body shall inform the other notified bodies of:
(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.
4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
|
notified body shall inform notifying authority following union technical documentation assessment certificate supplement certificate quality management system approval issued accordance requirement annex vii union technical documentation assessment certificate supplement certificate quality management system approval issued accordance requirement annex vii refusal restriction suspension withdrawal union technical documentation assessment certificate quality management system approval issued accordance requirement annex vii refusal restriction suspension withdrawal union technical documentation assessment certificate quality management system approval issued accordance requirement annex vii circumstance affecting scope condition notification circumstance affecting scope condition notification request information received market surveillance authority regarding conformity assessment activity request information received market surveillance authority regarding conformity assessment activity request conformity assessment activity performed within scope notification activity performed including cross border activity subcontracting request conformity assessment activity performed within scope notification activity performed including cross border activity subcontracting notified body shall inform notified body quality management system approval refused suspended withdrawn upon request quality system approval issued quality management system approval refused suspended withdrawn upon request quality system approval issued union technical documentation assessment certificate supplement thereto refused withdrawn suspended otherwise restricted upon request certificate supplement thereto issued union technical documentation assessment certificate supplement thereto refused withdrawn suspended otherwise restricted upon request certificate supplement thereto issued notified body shall provide notified body carrying similar conformity assessment activity covering type system relevant information issue relating negative request positive conformity assessment result notified body shall safeguard confidentiality information obtain accordance article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 46
|
1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, taking into account the exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.
2. In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.
3. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities.
4. Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.
5. Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators.
6. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned.
7. For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply.
|
way derogation article upon duly justified request market surveillance authority may authorise placing market putting service specific high risk system within territory member state concerned exceptional reason public security protection life health person environmental protection protection key industrial infrastructural asset authorisation shall limited period necessary conformity assessment procedure carried taking account exceptional reason justifying derogation completion procedure shall undertaken without undue delay duly justified situation urgency exceptional reason public security case specific substantial imminent threat life physical safety natural person law enforcement authority civil protection authority may put specific high risk system service without authorisation referred paragraph provided authorisation requested use without undue delay authorisation referred paragraph refused use high risk system shall stopped immediate effect result output use shall immediately discarded authorisation referred paragraph shall issued market surveillance authority concludes high risk system complies requirement section market surveillance authority shall inform commission member state authorisation issued pursuant paragraph obligation shall cover sensitive operational data relation activity law enforcement authority within calendar day receipt information referred paragraph objection raised either member state commission respect authorisation issued market surveillance authority member state accordance paragraph authorisation shall deemed justified within calendar day receipt notification referred paragraph objection raised member state authorisation issued market surveillance authority another member state commission considers authorisation contrary union law conclusion member state regarding compliance system referred paragraph unfounded commission shall without delay enter consultation relevant member state operator concerned shall consulted possibility present view regard thereto commission shall decide whether authorisation justified commission shall address decision member state concerned relevant operator commission considers authorisation unjustified shall withdrawn market surveillance authority member state concerned high risk system related product covered union harmonisation legislation listed section annex derogation conformity assessment established union harmonisation legislation shall apply
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 47
|
1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request.
2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.
3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.
4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.
|
provider shall draw written machine readable physical electronically signed declaration conformity high risk system keep disposal national competent authority year high risk system placed market put service declaration conformity shall identify high risk system drawn copy declaration conformity shall submitted relevant national competent authority upon request declaration conformity shall state high risk system concerned meet requirement set section declaration conformity shall contain information set annex shall translated language easily understood national competent authority member state high risk system placed market made available high risk system subject union harmonisation legislation also requires declaration conformity single declaration conformity shall drawn respect union law applicable high risk system declaration shall contain information required identify union harmonisation legislation declaration relates drawing declaration conformity provider shall assume responsibility compliance requirement set section provider shall keep declaration conformity date appropriate commission empowered adopt delegated act accordance article order amend annex updating content declaration conformity set annex order introduce element become necessary light technical progress
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 48
|
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.
3. The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate.
4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.
5. Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
|
marking shall subject general principle set article regulation 765 2008 high risk system provided digitally digital marking shall used easily accessed via interface system accessed via easily accessible machine readable code electronic mean marking shall affixed visibly legibly indelibly high risk system possible warranted account nature high risk system shall affixed packaging accompanying documentation appropriate applicable marking shall followed identification number notified body responsible conformity assessment procedure set article identification number notified body shall affixed body instruction provider provider authorised representative identification number shall also indicated promotional material mention high risk system fulfils requirement marking high risk system subject union law also provides affixing marking marking shall indicate high risk system also fulfil requirement law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 49
|
1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71.
2. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.
3. Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.
4. For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in:
(a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(a)
Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(b)
Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(c) Section C, points 1 to 3, of Annex VIII;
(c)
Section C, points 1 to 3, of Annex VIII;
(d) points 1, 2, 3 and 5, of Annex IX.
(d)
points 1, 2, 3 and 5, of Annex IX.
Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph.
5. High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.
|
placing market putting service high risk system listed annex iii exception high risk system referred point annex iii provider applicable authorised representative shall register system database referred article placing market putting service system provider concluded high risk according article provider applicable authorised representative shall register system database referred article putting service using high risk system listed annex iii exception high risk system listed point annex iii deployers public authority union institution body office agency person acting behalf shall register select system register use database referred article high risk system referred point annex iii area law enforcement migration asylum border control management registration referred paragraph article shall secure non public section database referred article shall include following information applicable referred section point annex viii exception point section point annex viii exception point section point point annex viii section point point annex viii section point annex viii section point annex viii point annex point annex commission national authority referred article shall access respective restricted section database listed first subparagraph paragraph high risk system referred point annex iii shall registered national level
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 6
|
1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;
(a)
the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;
(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
(b)
the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.
3. By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making.
The first subparagraph shall apply where any of the following conditions is fulfilled:
(a) the AI system is intended to perform a narrow procedural task;
(a)
the AI system is intended to perform a narrow procedural task;
(b) the AI system is intended to improve the result of a previously completed human activity;
(b)
the AI system is intended to improve the result of a previously completed human activity;
(c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
(c)
the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.
(d)
the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.
Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons.
4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.
5. The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose a significant risk of harm to the health, safety or fundamental rights of natural persons.
7. The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by this Regulation.
8. Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.
|
irrespective whether system placed market put service independently product referred point system shall considered high risk following condition fulfilled system intended used safety component product system product covered union harmonisation legislation listed annex system intended used safety component product system product covered union harmonisation legislation listed annex product whose safety component pursuant point system system product required undergo third party conformity assessment view placing market putting service product pursuant union harmonisation legislation listed annex product whose safety component pursuant point system system product required undergo third party conformity assessment view placing market putting service product pursuant union harmonisation legislation listed annex addition high risk system referred paragraph system referred annex iii shall considered high risk derogation paragraph system referred annex iii shall considered high risk pose significant risk harm health safety fundamental right natural person including materially influencing outcome decision making first subparagraph shall apply following condition fulfilled system intended perform narrow procedural task system intended perform narrow procedural task system intended improve result previously completed human activity system intended improve result previously completed human activity system intended detect decision making pattern deviation prior decision making pattern meant replace influence previously completed human assessment without proper human review system intended detect decision making pattern deviation prior decision making pattern meant replace influence previously completed human assessment without proper human review system intended perform preparatory task assessment relevant purpose use case listed annex iii system intended perform preparatory task assessment relevant purpose use case listed annex iii notwithstanding first subparagraph system referred annex iii shall always considered high risk system performs profiling natural person provider considers system referred annex iii high risk shall document assessment system placed market put service provider shall subject registration obligation set article upon request national competent authority provider shall provide documentation assessment commission shall consulting european artificial intelligence board board later february 2026 provide guideline specifying practical implementation article line article together comprehensive list practical example use case system high risk high risk commission empowered adopt delegated act accordance article order amend paragraph second subparagraph article adding new condition laid therein modifying concrete reliable evidence existence system fall scope annex iii pose significant risk harm health safety fundamental right natural person commission shall adopt delegated act accordance article order amend paragraph second subparagraph article deleting condition laid therein concrete reliable evidence necessary maintain level protection health safety fundamental right provided regulation amendment condition laid paragraph second subparagraph adopted accordance paragraph article shall decrease overall level protection health safety fundamental right provided regulation shall ensure consistency delegated act adopted pursuant article take account market technological development
|
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all-MiniLM-L6-v2
| 384 |
Article 7
|
1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in Annex III;
(a)
the AI systems are intended to be used in any of the areas listed in Annex III;
(b) the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
(b)
the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
2. When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:
(a) the intended purpose of the AI system;
(a)
the intended purpose of the AI system;
(b) the extent to which an AI system has been used or is likely to be used;
(b)
the extent to which an AI system has been used or is likely to be used;
(c) the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
(c)
the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
(d) the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
(d)
the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
(e) the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
(e)
the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
(f) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
(f)
the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
(g) the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
(g)
the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
(h) the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
(h)
the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
(i) the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
(i)
the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
(j) the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
(j)
the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
(k) the extent to which existing Union law provides for: (i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages; (ii) effective measures to prevent or substantially minimise those risks.
(k)
the extent to which existing Union law provides for:
(i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;
(i)
effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;
(ii) effective measures to prevent or substantially minimise those risks.
(ii)
effective measures to prevent or substantially minimise those risks.
3. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:
(a) the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
(a)
the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
(b) the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
(b)
the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
|
commission empowered adopt delegated act accordance article amend annex iii adding modifying use case high risk system following condition fulfilled system intended used area listed annex iii system intended used area listed annex iii system pose risk harm health safety adverse impact fundamental right risk equivalent greater risk harm adverse impact posed high risk system already referred annex iii system pose risk harm health safety adverse impact fundamental right risk equivalent greater risk harm adverse impact posed high risk system already referred annex iii assessing condition paragraph point commission shall take account following criterion intended purpose system intended purpose system extent system used likely used extent system used likely used nature amount data processed used system particular whether special category personal data processed nature amount data processed used system particular whether special category personal data processed extent system act autonomously possibility human override decision recommendation may lead potential harm extent system act autonomously possibility human override decision recommendation may lead potential harm extent use system already caused harm health safety adverse impact fundamental right given rise significant concern relation likelihood harm adverse impact demonstrated example report documented allegation submitted national competent authority report appropriate extent use system already caused harm health safety adverse impact fundamental right given rise significant concern relation likelihood harm adverse impact demonstrated example report documented allegation submitted national competent authority report appropriate potential extent harm adverse impact particular term intensity ability affect multiple person disproportionately affect particular group person potential extent harm adverse impact particular term intensity ability affect multiple person disproportionately affect particular group person extent person potentially harmed suffer adverse impact dependent outcome produced system particular practical legal reason reasonably possible opt outcome extent person potentially harmed suffer adverse impact dependent outcome produced system particular practical legal reason reasonably possible opt outcome extent imbalance power person potentially harmed suffer adverse impact vulnerable position relation deployer system particular due status authority knowledge economic social circumstance age extent imbalance power person potentially harmed suffer adverse impact vulnerable position relation deployer system particular due status authority knowledge economic social circumstance age extent outcome produced involving system easily corrigible reversible taking account technical solution available correct reverse whereby outcome adverse impact health safety fundamental right shall considered easily corrigible reversible extent outcome produced involving system easily corrigible reversible taking account technical solution available correct reverse whereby outcome adverse impact health safety fundamental right shall considered easily corrigible reversible magnitude likelihood benefit deployment system individual group society large including possible improvement product safety magnitude likelihood benefit deployment system individual group society large including possible improvement product safety extent existing union law provides effective measure redress relation risk posed system exclusion claim damage effective measure prevent substantially minimise risk extent existing union law provides effective measure redress relation risk posed system exclusion claim damage effective measure redress relation risk posed system exclusion claim damage effective measure prevent substantially minimise risk effective measure prevent substantially minimise risk commission empowered adopt delegated act accordance article amend list annex iii removing high risk system following condition fulfilled high risk system concerned longer pose significant risk fundamental right health safety taking account criterion listed paragraph high risk system concerned longer pose significant risk fundamental right health safety taking account criterion listed paragraph deletion decrease overall level protection health safety fundamental right union law deletion decrease overall level protection health safety fundamental right union law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 8
|
1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.
2. Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.
|
high risk system shall comply requirement laid section taking account intended purpose well generally acknowledged state art related technology risk management system referred article shall taken account ensuring compliance requirement product contains system requirement regulation well requirement union harmonisation legislation listed section annex apply provider shall responsible ensuring product fully compliant applicable requirement applicable union harmonisation legislation ensuring compliance high risk system referred paragraph requirement set section order ensure consistency avoid duplication minimise additional burden provider shall choice integrating appropriate necessary testing reporting process information documentation provide regard product documentation procedure already exist required union harmonisation legislation listed section annex
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 9
|
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:
(a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
(a)
the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
(b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
(b)
the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
(c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
(c)
the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
(d)
the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
3. The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.
4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.
5. The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.
In identifying the most appropriate risk management measures, the following shall be ensured:
(a) elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
(a)
elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
(b) where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
(b)
where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
(c) provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
(c)
provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context in which the system is intended to be used.
6. High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.
7. Testing procedures may include testing in real-world conditions in accordance with Article 60.
8. The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.
9. When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.
10. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law.
|
risk management system shall established implemented documented maintained relation high risk system risk management system shall understood continuous iterative process planned run throughout entire lifecycle high risk system requiring regular systematic review updating shall comprise following step identification analysis known reasonably foreseeable risk high risk system pose health safety fundamental right high risk system used accordance intended purpose identification analysis known reasonably foreseeable risk high risk system pose health safety fundamental right high risk system used accordance intended purpose estimation evaluation risk may emerge high risk system used accordance intended purpose condition reasonably foreseeable misuse estimation evaluation risk may emerge high risk system used accordance intended purpose condition reasonably foreseeable misuse evaluation risk possibly arising based analysis data gathered post market monitoring system referred article evaluation risk possibly arising based analysis data gathered post market monitoring system referred article adoption appropriate targeted risk management measure designed address risk identified pursuant point adoption appropriate targeted risk management measure designed address risk identified pursuant point risk referred article shall concern may reasonably mitigated eliminated development design high risk system provision adequate technical information risk management measure referred paragraph point shall give due consideration effect possible interaction resulting combined application requirement set section view minimising risk effectively achieving appropriate balance implementing measure fulfil requirement risk management measure referred paragraph point shall relevant residual risk associated hazard well overall residual risk high risk system judged acceptable identifying appropriate risk management measure following shall ensured elimination reduction risk identified evaluated pursuant paragraph far technically feasible adequate design development high risk system elimination reduction risk identified evaluated pursuant paragraph far technically feasible adequate design development high risk system appropriate implementation adequate mitigation control measure addressing risk eliminated appropriate implementation adequate mitigation control measure addressing risk eliminated provision information required pursuant article appropriate training deployers provision information required pursuant article appropriate training deployers view eliminating reducing risk related use high risk system due consideration shall given technical knowledge experience education training expected deployer presumable context system intended used high risk system shall tested purpose identifying appropriate targeted risk management measure testing shall ensure high risk system perform consistently intended purpose compliance requirement set section testing procedure may include testing real world condition accordance article testing high risk system shall performed appropriate time throughout development process event prior placed market put service testing shall carried prior defined metric probabilistic threshold appropriate intended purpose high risk system implementing risk management system provided paragraph provider shall give consideration whether view intended purpose high risk system likely adverse impact person age appropriate vulnerable group provider high risk system subject requirement regarding internal risk management process relevant provision union law aspect provided paragraph may part combined risk management procedure established pursuant law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 10
|
1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.
2. Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:
(a) the relevant design choices;
(a)
the relevant design choices;
(b) data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;
(b)
data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;
(c) relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;
(c)
relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;
(d) the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;
(d)
the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;
(e) an assessment of the availability, quantity and suitability of the data sets that are needed;
(e)
an assessment of the availability, quantity and suitability of the data sets that are needed;
(f) examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;
(f)
examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;
(g) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);
(g)
appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);
(h) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.
(h)
the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.
3. Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination thereof.
4. Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used.
5. To the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with paragraph (2), points (f) and (g) of this Article, the providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, all the following conditions must be met in order for such processing to occur:
(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;
(a)
the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;
(b) the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;
(b)
the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;
(c) the special categories of personal data are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
(c)
the special categories of personal data are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
(d) the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;
(d)
the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;
(e) the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first;
(e)
the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first;
(f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.
(f)
the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.
6. For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2 to 5 apply only to the testing data sets.
|
high risk system make use technique involving training model data shall developed basis training validation testing data set meet quality criterion referred paragraph whenever data set used training validation testing data set shall subject data governance management practice appropriate intended purpose high risk system practice shall concern particular relevant design choice relevant design choice data collection process origin data case personal data original purpose data collection data collection process origin data case personal data original purpose data collection relevant data preparation processing operation annotation labelling cleaning updating enrichment aggregation relevant data preparation processing operation annotation labelling cleaning updating enrichment aggregation formulation assumption particular respect information data supposed measure represent formulation assumption particular respect information data supposed measure represent assessment availability quantity suitability data set needed assessment availability quantity suitability data set needed examination view possible bias likely affect health safety person negative impact fundamental right lead discrimination prohibited union law especially data output influence input future operation examination view possible bias likely affect health safety person negative impact fundamental right lead discrimination prohibited union law especially data output influence input future operation appropriate measure detect prevent mitigate possible bias identified according point appropriate measure detect prevent mitigate possible bias identified according point identification relevant data gap shortcoming prevent compliance regulation gap shortcoming addressed identification relevant data gap shortcoming prevent compliance regulation gap shortcoming addressed training validation testing data set shall relevant sufficiently representative best extent possible free error complete view intended purpose shall appropriate statistical property including applicable regard person group person relation high risk system intended used characteristic data set may met level individual data set level combination thereof data set shall take account extent required intended purpose characteristic element particular specific geographical contextual behavioural functional setting within high risk system intended used extent strictly necessary purpose ensuring bias detection correction relation high risk system accordance paragraph point article provider system may exceptionally process special category personal data subject appropriate safeguard fundamental right freedom natural person addition provision set regulation 2016 679 2018 1725 directive 2016 680 following condition must met order processing occur bias detection correction effectively fulfilled processing data including synthetic anonymised data bias detection correction effectively fulfilled processing data including synthetic anonymised data special category personal data subject technical limitation use personal data state art security privacy preserving measure including pseudonymisation special category personal data subject technical limitation use personal data state art security privacy preserving measure including pseudonymisation special category personal data subject measure ensure personal data processed secured protected subject suitable safeguard including strict control documentation access avoid misuse ensure authorised person access personal data appropriate confidentiality obligation special category personal data subject measure ensure personal data processed secured protected subject suitable safeguard including strict control documentation access avoid misuse ensure authorised person access personal data appropriate confidentiality obligation special category personal data transmitted transferred otherwise accessed party special category personal data transmitted transferred otherwise accessed party special category personal data deleted bias corrected personal data reached end retention period whichever come first special category personal data deleted bias corrected personal data reached end retention period whichever come first record processing activity pursuant regulation 2016 679 2018 1725 directive 2016 680 include reason processing special category personal data strictly necessary detect correct bias objective could achieved processing data record processing activity pursuant regulation 2016 679 2018 1725 directive 2016 680 include reason processing special category personal data strictly necessary detect correct bias objective could achieved processing data development high risk system using technique involving training model paragraph apply testing data set
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 11
|
1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.
3. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.
|
technical documentation high risk system shall drawn system placed market put service shall kept date technical documentation shall drawn way demonstrate high risk system complies requirement set section provide national competent authority notified body necessary information clear comprehensive form assess compliance system requirement shall contain minimum element set annex smes including start ups may provide element technical documentation specified annex simplified manner end commission shall establish simplified technical documentation form targeted need small microenterprises sme including start opts provide information required annex simplified manner shall use form referred paragraph notified body shall accept form purpose conformity assessment high risk system related product covered union harmonisation legislation listed section annex placed market put service single set technical documentation shall drawn containing information set paragraph well information required legal act commission empowered adopt delegated act accordance article order amend annex necessary ensure light technical progress technical documentation provides information necessary assess compliance system requirement set section
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 12
|
1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:
(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
(a)
identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
(b) facilitating the post-market monitoring referred to in Article 72; and
(b)
facilitating the post-market monitoring referred to in Article 72; and
(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).
(c)
monitoring the operation of high-risk AI systems referred to in Article 26(5).
3. For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
(a) recording of the period of each use of the system (start date and time and end date and time of each use);
(a)
recording of the period of each use of the system (start date and time and end date and time of each use);
(b) the reference database against which input data has been checked by the system;
(b)
the reference database against which input data has been checked by the system;
(c) the input data for which the search has led to a match;
(c)
the input data for which the search has led to a match;
(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
(d)
the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
|
high risk system shall technically allow automatic recording event log lifetime system order ensure level traceability functioning high risk system appropriate intended purpose system logging capability shall enable recording event relevant identifying situation may result high risk system presenting risk within meaning article substantial modification identifying situation may result high risk system presenting risk within meaning article substantial modification facilitating post market monitoring referred article facilitating post market monitoring referred article monitoring operation high risk system referred article monitoring operation high risk system referred article high risk system referred point annex iii logging capability shall provide minimum recording period use system start date time end date time use recording period use system start date time end date time use reference database input data checked system reference database input data checked system input data search led match input data search led match identification natural person involved verification result referred article identification natural person involved verification result referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 13
|
1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and deployer set out in Section 3.
2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.
3. The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;
(a)
the identity and the contact details of the provider and, where applicable, of its authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including: (i) its intended purpose; (ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity; (iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2); (iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output; (v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used; (vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system; (vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(b)
the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(i) its intended purpose;
(i)
its intended purpose;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;
(ii)
the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2);
(iii)
any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2);
(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output;
(iv)
where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output;
(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;
(v)
when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;
(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vi)
when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(vii)
where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any;
(c)
the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any;
(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;
(d)
the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;
(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;
(e)
the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;
(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.
(f)
where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.
|
high risk system shall designed developed way ensure operation sufficiently transparent enable deployers interpret system output use appropriately appropriate type degree transparency shall ensured view achieving compliance relevant obligation provider deployer set section high risk system shall accompanied instruction use appropriate digital format otherwise include concise complete correct clear information relevant accessible comprehensible deployers instruction use shall contain least following information identity contact detail provider applicable authorised representative identity contact detail provider applicable authorised representative characteristic capability limitation performance high risk system including intended purpose level accuracy including metric robustness cybersecurity referred article high risk system tested validated expected known foreseeable circumstance may impact expected level accuracy robustness cybersecurity iii known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right referred article applicable technical capability characteristic high risk system provide information relevant explain output appropriate performance regarding specific person group person system intended used appropriate specification input data relevant information term training validation testing data set used taking account intended purpose high risk system vii applicable information enable deployers interpret output high risk system use appropriately characteristic capability limitation performance high risk system including intended purpose intended purpose level accuracy including metric robustness cybersecurity referred article high risk system tested validated expected known foreseeable circumstance may impact expected level accuracy robustness cybersecurity level accuracy including metric robustness cybersecurity referred article high risk system tested validated expected known foreseeable circumstance may impact expected level accuracy robustness cybersecurity iii known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right referred article iii known foreseeable circumstance related use high risk system accordance intended purpose condition reasonably foreseeable misuse may lead risk health safety fundamental right referred article applicable technical capability characteristic high risk system provide information relevant explain output applicable technical capability characteristic high risk system provide information relevant explain output appropriate performance regarding specific person group person system intended used appropriate performance regarding specific person group person system intended used appropriate specification input data relevant information term training validation testing data set used taking account intended purpose high risk system appropriate specification input data relevant information term training validation testing data set used taking account intended purpose high risk system vii applicable information enable deployers interpret output high risk system use appropriately vii applicable information enable deployers interpret output high risk system use appropriately change high risk system performance pre determined provider moment initial conformity assessment change high risk system performance pre determined provider moment initial conformity assessment human oversight measure referred article including technical measure put place facilitate interpretation output high risk system deployers human oversight measure referred article including technical measure put place facilitate interpretation output high risk system deployers computational hardware resource needed expected lifetime high risk system necessary maintenance care measure including frequency ensure proper functioning system including regard software update computational hardware resource needed expected lifetime high risk system necessary maintenance care measure including frequency ensure proper functioning system including regard software update relevant description mechanism included within high risk system allows deployers properly collect store interpret log accordance article relevant description mechanism included within high risk system allows deployers properly collect store interpret log accordance article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 14
|
1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2. Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, in particular where such risks persist despite the application of other requirements set out in this Section.
3. The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk AI system, and shall be ensured through either one or both of the following types of measures:
(a) measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed on the market or put into service;
(a)
measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed on the market or put into service;
(b) measures identified by the provider before placing the high-risk AI system on the market or putting it into service and that are appropriate to be implemented by the deployer.
(b)
measures identified by the provider before placing the high-risk AI system on the market or putting it into service and that are appropriate to be implemented by the deployer.
4. For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:
(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
(a)
to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
(b) to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
(b)
to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
(c) to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;
(c)
to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;
(d) to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;
(d)
to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;
(e) to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state.
(e)
to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state.
5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article shall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification resulting from the system unless that identification has been separately verified and confirmed by at least two natural persons with the necessary competence, training and authority.
The requirement for a separate verification by at least two natural persons shall not apply to high-risk AI systems used for the purposes of law enforcement, migration, border control or asylum, where Union or national law considers the application of this requirement to be disproportionate.
|
high risk system shall designed developed way including appropriate human machine interface tool effectively overseen natural person period use human oversight shall aim prevent minimise risk health safety fundamental right may emerge high risk system used accordance intended purpose condition reasonably foreseeable misuse particular risk persist despite application requirement set section oversight measure shall commensurate risk level autonomy context use high risk system shall ensured either one following type measure measure identified built technically feasible high risk system provider placed market put service measure identified built technically feasible high risk system provider placed market put service measure identified provider placing high risk system market putting service appropriate implemented deployer measure identified provider placing high risk system market putting service appropriate implemented deployer purpose implementing paragraph high risk system shall provided deployer way natural person human oversight assigned enabled appropriate proportionate properly understand relevant capacity limitation high risk system able duly monitor operation including view detecting addressing anomaly dysfunction unexpected performance properly understand relevant capacity limitation high risk system able duly monitor operation including view detecting addressing anomaly dysfunction unexpected performance remain aware possible tendency automatically relying relying output produced high risk system automation bias particular high risk system used provide information recommendation decision taken natural person remain aware possible tendency automatically relying relying output produced high risk system automation bias particular high risk system used provide information recommendation decision taken natural person correctly interpret high risk system output taking account example interpretation tool method available correctly interpret high risk system output taking account example interpretation tool method available decide particular situation use high risk system otherwise disregard override reverse output high risk system decide particular situation use high risk system otherwise disregard override reverse output high risk system intervene operation high risk system interrupt system stop button similar procedure allows system come halt safe state intervene operation high risk system interrupt system stop button similar procedure allows system come halt safe state high risk system referred point annex iii measure referred paragraph article shall ensure addition action decision taken deployer basis identification resulting system unless identification separately verified confirmed least two natural person necessary competence training authority requirement separate verification least two natural person shall apply high risk system used purpose law enforcement migration border control asylum union national law considers application requirement disproportionate
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 15
|
1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2. To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders and organisations such as metrology and benchmarking authorities, encourage, as appropriate, the development of benchmarks and measurement methodologies.
3. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.
4. High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems. Technical and organisational measures shall be taken in this regard.
The robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include backup or fail-safe plans.
High-risk AI systems that continue to learn after being placed on the market or put into service shall be developed in such a way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations (feedback loops), and as to ensure that any such feedback loops are duly addressed with appropriate mitigation measures.
5. High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or performance by exploiting system vulnerabilities.
The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent, detect, respond to, resolve and control for attacks trying to manipulate the training data set (data poisoning), or pre-trained components used in training (model poisoning), inputs designed to cause the AI model to make a mistake (adversarial examples or model evasion), confidentiality attacks or model flaws.
|
high risk system shall designed developed way achieve appropriate level accuracy robustness cybersecurity perform consistently respect throughout lifecycle address technical aspect measure appropriate level accuracy robustness set paragraph relevant performance metric commission shall cooperation relevant stakeholder organisation metrology benchmarking authority encourage appropriate development benchmark measurement methodology level accuracy relevant accuracy metric high risk system shall declared accompanying instruction use high risk system shall resilient possible regarding error fault inconsistency may occur within system environment system operates particular due interaction natural person system technical organisational measure shall taken regard robustness high risk system may achieved technical redundancy solution may include backup fail safe plan high risk system continue learn placed market put service shall developed way eliminate reduce far possible risk possibly biased output influencing input future operation feedback loop ensure feedback loop duly addressed appropriate mitigation measure high risk system shall resilient attempt unauthorised third party alter use output performance exploiting system vulnerability technical solution aiming ensure cybersecurity high risk system shall appropriate relevant circumstance risk technical solution address specific vulnerability shall include appropriate measure prevent detect respond resolve control attack trying manipulate training data set data poisoning pre trained component used training model poisoning input designed cause model make mistake adversarial example model evasion confidentiality attack model flaw
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 16
|
Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(a)
ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(b)
indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(c) have a quality management system in place which complies with Article 17;
(c)
have a quality management system in place which complies with Article 17;
(d) keep the documentation referred to in Article 18;
(d)
keep the documentation referred to in Article 18;
(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(e)
when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
(f)
ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
(g) draw up an EU declaration of conformity in accordance with Article 47;
(g)
draw up an EU declaration of conformity in accordance with Article 47;
(h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(h)
affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(i) comply with the registration obligations referred to in Article 49(1);
(i)
comply with the registration obligations referred to in Article 49(1);
(j) take the necessary corrective actions and provide information as required in Article 20;
(j)
take the necessary corrective actions and provide information as required in Article 20;
(k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(k)
upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
(l)
ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
|
provider high risk system shall ensure high risk system compliant requirement set section ensure high risk system compliant requirement set section indicate high risk system possible packaging accompanying documentation applicable name registered trade name registered trade mark address contacted indicate high risk system possible packaging accompanying documentation applicable name registered trade name registered trade mark address contacted quality management system place complies article quality management system place complies article keep documentation referred article keep documentation referred article control keep log automatically generated high risk system referred article control keep log automatically generated high risk system referred article ensure high risk system undergoes relevant conformity assessment procedure referred article prior placed market put service ensure high risk system undergoes relevant conformity assessment procedure referred article prior placed market put service draw declaration conformity accordance article draw declaration conformity accordance article affix marking high risk system possible packaging accompanying documentation indicate conformity regulation accordance article affix marking high risk system possible packaging accompanying documentation indicate conformity regulation accordance article comply registration obligation referred article comply registration obligation referred article take necessary corrective action provide information required article take necessary corrective action provide information required article upon reasoned request national competent authority demonstrate conformity high risk system requirement set section upon reasoned request national competent authority demonstrate conformity high risk system requirement set section ensure high risk system complies accessibility requirement accordance directive 2016 2102 2019 882 ensure high risk system complies accessibility requirement accordance directive 2016 2102 2019 882
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 17
|
1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:
(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
(a)
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
(b)
techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
(c)
techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;
(d)
examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;
(e) technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;
(e)
technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;
(f) systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;
(f)
systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;
(g) the risk management system referred to in Article 9;
(g)
the risk management system referred to in Article 9;
(h) the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
(h)
the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
(i) procedures related to the reporting of a serious incident in accordance with Article 73;
(i)
procedures related to the reporting of a serious incident in accordance with Article 73;
(j) the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
(j)
the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
(k) systems and procedures for record-keeping of all relevant documentation and information;
(k)
systems and procedures for record-keeping of all relevant documentation and information;
(l) resource management, including security-of-supply related measures;
(l)
resource management, including security-of-supply related measures;
(m) an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.
(m)
an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.
2. The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation.
3. Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law.
4. For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any harmonised standards referred to in Article 40 shall be taken into account.
|
provider high risk system shall put quality management system place ensures compliance regulation system shall documented systematic orderly manner form written policy procedure instruction shall include least following aspect strategy regulatory compliance including compliance conformity assessment procedure procedure management modification high risk system strategy regulatory compliance including compliance conformity assessment procedure procedure management modification high risk system technique procedure systematic action used design design control design verification high risk system technique procedure systematic action used design design control design verification high risk system technique procedure systematic action used development quality control quality assurance high risk system technique procedure systematic action used development quality control quality assurance high risk system examination test validation procedure carried development high risk system frequency carried examination test validation procedure carried development high risk system frequency carried technical specification including standard applied relevant harmonised standard applied full cover relevant requirement set section mean used ensure high risk system complies requirement technical specification including standard applied relevant harmonised standard applied full cover relevant requirement set section mean used ensure high risk system complies requirement system procedure data management including data acquisition data collection data analysis data labelling data storage data filtration data mining data aggregation data retention operation regarding data performed purpose placing market putting service high risk system system procedure data management including data acquisition data collection data analysis data labelling data storage data filtration data mining data aggregation data retention operation regarding data performed purpose placing market putting service high risk system risk management system referred article risk management system referred article setting implementation maintenance post market monitoring system accordance article setting implementation maintenance post market monitoring system accordance article procedure related reporting serious incident accordance article procedure related reporting serious incident accordance article handling communication national competent authority relevant authority including providing supporting access data notified body operator customer interested party handling communication national competent authority relevant authority including providing supporting access data notified body operator customer interested party system procedure record keeping relevant documentation information system procedure record keeping relevant documentation information resource management including security supply related measure resource management including security supply related measure accountability framework setting responsibility management staff regard aspect listed paragraph accountability framework setting responsibility management staff regard aspect listed paragraph implementation aspect referred paragraph shall proportionate size provider organisation provider shall event respect degree rigour level protection required ensure compliance high risk system regulation provider high risk system subject obligation regarding quality management system equivalent function relevant sectoral union law may include aspect listed paragraph part quality management system pursuant law provider financial institution subject requirement regarding internal governance arrangement process union financial service law obligation put place quality management system exception paragraph point article shall deemed fulfilled complying rule internal governance arrangement process pursuant relevant union financial service law end harmonised standard referred article shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 18
|
1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(a)
the technical documentation referred to in Article 11;
(b) the documentation concerning the quality management system referred to in Article 17;
(b)
the documentation concerning the quality management system referred to in Article 17;
(c) the documentation concerning the changes approved by notified bodies, where applicable;
(c)
the documentation concerning the changes approved by notified bodies, where applicable;
(d) the decisions and other documents issued by the notified bodies, where applicable;
(d)
the decisions and other documents issued by the notified bodies, where applicable;
(e) the EU declaration of conformity referred to in Article 47.
(e)
the EU declaration of conformity referred to in Article 47.
2. Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period.
3. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.
|
provider shall period ending year high risk system placed market put service keep disposal national competent authority technical documentation referred article technical documentation referred article documentation concerning quality management system referred article documentation concerning quality management system referred article documentation concerning change approved notified body applicable documentation concerning change approved notified body applicable decision document issued notified body applicable decision document issued notified body applicable declaration conformity referred article declaration conformity referred article member state shall determine condition documentation referred paragraph remains disposal national competent authority period indicated paragraph case provider authorised representative established territory go bankrupt cease activity prior end period provider financial institution subject requirement regarding internal governance arrangement process union financial service law shall maintain technical documentation part documentation kept relevant union financial service law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 19
|
1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in the applicable Union or national law, in particular in Union law on the protection of personal data.
2. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation kept under the relevant financial services law.
|
provider high risk system shall keep log referred article automatically generated high risk system extent log control without prejudice applicable union national law log shall kept period appropriate intended purpose high risk system least six month unless provided otherwise applicable union national law particular union law protection personal data provider financial institution subject requirement regarding internal governance arrangement process union financial service law shall maintain log automatically generated high risk system part documentation kept relevant financial service law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 20
|
1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to disable it, or to recall it, as appropriate. They shall inform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised representative and importers accordingly.
2. Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the notified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature of the non-compliance and of any relevant corrective action taken.
|
provider high risk system consider reason consider high risk system placed market put service conformity regulation shall immediately take necessary corrective action bring system conformity withdraw disable recall appropriate shall inform distributor high risk system concerned applicable deployers authorised representative importer accordingly high risk system present risk within meaning article provider becomes aware risk shall immediately investigate cause collaboration reporting deployer applicable inform market surveillance authority competent high risk system concerned applicable notified body issued certificate high risk system accordance article particular nature non compliance relevant corrective action taken
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 21
|
1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, in a language which can be easily understood by the authority in one of the official languages of the institutions of the Union as indicated by the Member State concerned.
2. Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as applicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent such logs are under their control.
3. Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
provider high risk system shall upon reasoned request competent authority provide authority information documentation necessary demonstrate conformity high risk system requirement set section language easily understood authority one official language institution union indicated member state concerned upon reasoned request competent authority provider shall also give requesting competent authority applicable access automatically generated log high risk system referred article extent log control information obtained competent authority pursuant article shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 22
|
1. Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
2. The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider.
3. The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the institutions of the Union, as indicated by the competent authority. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:
(a) verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in Article 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;
(a)
verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in Article 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;
(b) keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for a period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in Article 47, the technical documentation and, if applicable, the certificate issued by the notified body;
(b)
keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for a period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in Article 47, the technical documentation and, if applicable, the certificate issued by the notified body;
(c) provide a competent authority, upon a reasoned request, with all the information and documentation, including that referred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent such logs are under the control of the provider;
(c)
provide a competent authority, upon a reasoned request, with all the information and documentation, including that referred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent such logs are under the control of the provider;
(d) cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;
(d)
cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;
(e) where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.
(e)
where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.
The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the competent authorities, on all issues related to ensuring compliance with this Regulation.
4. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall immediately inform the relevant market surveillance authority, as well as, where applicable, the relevant notified body, about the termination of the mandate and the reasons therefor.
|
prior making high risk system available union market provider established third country shall written mandate appoint authorised representative established union provider shall enable authorised representative perform task specified mandate received provider authorised representative shall perform task specified mandate received provider shall provide copy mandate market surveillance authority upon request one official language institution union indicated competent authority purpose regulation mandate shall empower authorised representative carry following task verify declaration conformity referred article technical documentation referred article drawn appropriate conformity assessment procedure carried provider verify declaration conformity referred article technical documentation referred article drawn appropriate conformity assessment procedure carried provider keep disposal competent authority national authority body referred article period year high risk system placed market put service contact detail provider appointed authorised representative copy declaration conformity referred article technical documentation applicable certificate issued notified body keep disposal competent authority national authority body referred article period year high risk system placed market put service contact detail provider appointed authorised representative copy declaration conformity referred article technical documentation applicable certificate issued notified body provide competent authority upon reasoned request information documentation including referred point subparagraph necessary demonstrate conformity high risk system requirement set section including access log referred article automatically generated high risk system extent log control provider provide competent authority upon reasoned request information documentation including referred point subparagraph necessary demonstrate conformity high risk system requirement set section including access log referred article automatically generated high risk system extent log control provider cooperate competent authority upon reasoned request action latter take relation high risk system particular reduce mitigate risk posed high risk system cooperate competent authority upon reasoned request action latter take relation high risk system particular reduce mitigate risk posed high risk system applicable comply registration obligation referred article registration carried provider ensure information referred point section annex viii correct applicable comply registration obligation referred article registration carried provider ensure information referred point section annex viii correct mandate shall empower authorised representative addressed addition instead provider competent authority issue related ensuring compliance regulation authorised representative shall terminate mandate considers reason consider provider acting contrary obligation pursuant regulation case shall immediately inform relevant market surveillance authority well applicable relevant notified body termination mandate reason therefor
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 23
|
1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(a)
the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(b)
the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(c) the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
(c)
the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
(d) the provider has appointed an authorised representative in accordance with Article 22(1).
(d)
the provider has appointed an authorised representative in accordance with Article 22(1).
2. Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.
3. Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.
4. Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.
5. Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47.
6. Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.
7. Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.
|
placing high risk system market importer shall ensure system conformity regulation verifying relevant conformity assessment procedure referred article carried provider high risk system relevant conformity assessment procedure referred article carried provider high risk system provider drawn technical documentation accordance article annex provider drawn technical documentation accordance article annex system bear required marking accompanied declaration conformity referred article instruction use system bear required marking accompanied declaration conformity referred article instruction use provider appointed authorised representative accordance article provider appointed authorised representative accordance article importer sufficient reason consider high risk system conformity regulation falsified accompanied falsified documentation shall place system market brought conformity high risk system present risk within meaning article importer shall inform provider system authorised representative market surveillance authority effect importer shall indicate name registered trade name registered trade mark address contacted high risk system packaging accompanying documentation applicable importer shall ensure high risk system responsibility storage transport condition applicable jeopardise compliance requirement set section importer shall keep period year high risk system placed market put service copy certificate issued notified body applicable instruction use declaration conformity referred article importer shall provide relevant competent authority upon reasoned request necessary information documentation including referred paragraph demonstrate conformity high risk system requirement set section language easily understood purpose shall also ensure technical documentation made available authority importer shall cooperate relevant competent authority action authority take relation high risk system placed market importer particular reduce mitigate risk posed
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 24
|
1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as laid down in Article 16, points (b) and (c) and Article 23(3).
2. Where a distributor considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI system available on the market until the system has been brought into conformity with those requirements. Furthermore, where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.
3. Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.
4. A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.
5. Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of that system with the requirements set out in Section 2.
6. Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by it.
|
making high risk system available market distributor shall verify bear required marking accompanied copy declaration conformity referred article instruction use provider importer system applicable complied respective obligation laid article point article distributor considers reason consider basis information possession high risk system conformity requirement set section shall make high risk system available market system brought conformity requirement furthermore high risk system present risk within meaning article distributor shall inform provider importer system applicable effect distributor shall ensure high risk system responsibility storage transport condition applicable jeopardise compliance system requirement set section distributor considers reason consider basis information possession high risk system made available market conformity requirement set section shall take corrective action necessary bring system conformity requirement withdraw recall shall ensure provider importer relevant operator appropriate take corrective action high risk system present risk within meaning article distributor shall immediately inform provider importer system authority competent high risk system concerned giving detail particular non compliance corrective action taken upon reasoned request relevant competent authority distributor high risk system shall provide authority information documentation regarding action pursuant paragraph necessary demonstrate conformity system requirement set section distributor shall cooperate relevant competent authority action authority take relation high risk system made available market distributor particular reduce mitigate risk posed
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 25
|
1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated;
(a)
they put their name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated;
(b) they make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in such a way that it remains a high-risk AI system pursuant to Article 6;
(b)
they make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in such a way that it remains a high-risk AI system pursuant to Article 6;
(c) they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such a way that the AI system concerned becomes a high-risk AI system in accordance with Article 6.
(c)
they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such a way that the AI system concerned becomes a high-risk AI system in accordance with Article 6.
2. Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of this Regulation. That initial provider shall closely cooperate with new providers and shall make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems. This paragraph shall not apply in cases where the initial provider has clearly specified that its AI system is not to be changed into a high-risk AI system and therefore does not fall under the obligation to hand over the documentation.
3. In the case of high-risk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk AI system, and shall be subject to the obligations under Article 16 under either of the following circumstances:
(a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;
(a)
the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;
(b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market.
(b)
the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market.
4. The provider of a high-risk AI system and the third party that supplies an AI system, tools, services, components, or processes that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider of the high-risk AI system to fully comply with the obligations set out in this Regulation. This paragraph shall not apply to third parties making accessible to the public tools, services, processes, or components, other than general-purpose AI models, under a free and open-source licence.
The AI Office may develop and recommend voluntary model terms for contracts between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used for or integrated into high-risk AI systems. When developing those voluntary model terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The voluntary model terms shall be published and be available free of charge in an easily usable electronic format.
5. Paragraphs 2 and 3 are without prejudice to the need to observe and protect intellectual property rights, confidential business information and trade secrets in accordance with Union and national law.
|
distributor importer deployer third party shall considered provider high risk system purpose regulation shall subject obligation provider article following circumstance put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation otherwise allocated put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation otherwise allocated make substantial modification high risk system already placed market already put service way remains high risk system pursuant article make substantial modification high risk system already placed market already put service way remains high risk system pursuant article modify intended purpose system including general purpose system classified high risk already placed market put service way system concerned becomes high risk system accordance article modify intended purpose system including general purpose system classified high risk already placed market put service way system concerned becomes high risk system accordance article circumstance referred paragraph occur provider initially placed system market put service shall longer considered provider specific system purpose regulation initial provider shall closely cooperate new provider shall make available necessary information provide reasonably expected technical access assistance required fulfilment obligation set regulation particular regarding compliance conformity assessment high risk system paragraph shall apply case initial provider clearly specified system changed high risk system therefore fall obligation hand documentation case high risk system safety component product covered union harmonisation legislation listed section annex product manufacturer shall considered provider high risk system shall subject obligation article either following circumstance high risk system placed market together product name trademark product manufacturer high risk system placed market together product name trademark product manufacturer high risk system put service name trademark product manufacturer product placed market high risk system put service name trademark product manufacturer product placed market provider high risk system third party supply system tool service component process used integrated high risk system shall written agreement specify necessary information capability technical access assistance based generally acknowledged state art order enable provider high risk system fully comply obligation set regulation paragraph shall apply third party making accessible public tool service process component general purpose model free open source licence office may develop recommend voluntary model term contract provider high risk system third party supply tool service component process used integrated high risk system developing voluntary model term office shall take account possible contractual requirement applicable specific sector business case voluntary model term shall published available free charge easily usable electronic format paragraph without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law
|
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all-MiniLM-L6-v2
| 384 |
Article 26
|
1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
2. Deployers shall assign human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support.
3. The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer obligations under Union or national law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.
4. Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system.
5. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where relevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the high-risk AI system in accordance with the instructions may result in that AI system presenting a risk within the meaning of Article 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance authority, and shall suspend the use of that system. Where deployers have identified a serious incident, they shall also immediately inform first the provider, and then the importer or distributor and the relevant market surveillance authorities of that incident. If the deployer is not able to reach the provider, Article 73 shall applymutatis mutandis. This obligation shall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities.
For deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the relevant financial service law.
6. Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent such logs are under their control, for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of personal data.
Deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service law.
7. Before putting into service or using a high-risk AI system at the workplace, deployers who are employers shall inform workers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This information shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and national law and practice on information of workers and their representatives.
8. Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies, offices or agencies shall comply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system that they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system and shall inform the provider or the distributor.
9. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this Regulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680.
10. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person suspected or convicted of having committed a criminal offence, the deployer of a high-risk AI system for post-remote biometric identification shall request an authorisation,ex ante, or without undue delay and no later than 48 hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the use of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable facts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific criminal offence.
If the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric identification system linked to that requested authorisation shall be stopped with immediate effect and the personal data linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted.
In no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in an untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal offence, or the search for a specific missing person. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the law enforcement authorities based solely on the output of such post-remote biometric identification systems.
This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680 for the processing of biometric data.
Regardless of the purpose or deployer, each use of such high-risk AI systems shall be documented in the relevant police file and shall be made available to the relevant market surveillance authority and the national data protection authority upon request, excluding the disclosure of sensitive operational data related to law enforcement. This subparagraph shall be without prejudice to the powers conferred by Directive (EU) 2016/680 on supervisory authorities.
Deployers shall submit annual reports to the relevant market surveillance and national data protection authorities on their use of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law enforcement. The reports may be aggregated to cover more than one deployment.
Member States may introduce, in accordance with Union law, more restrictive laws on the use of post-remote biometric identification systems.
11. Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that make decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 shall apply.
12. Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to the high-risk AI system in order to implement this Regulation.
|
deployers high risk system shall take appropriate technical organisational measure ensure use system accordance instruction use accompanying system pursuant paragraph deployers shall assign human oversight natural person necessary competence training authority well necessary support obligation set paragraph without prejudice deployer obligation union national law deployer freedom organise resource activity purpose implementing human oversight measure indicated provider without prejudice paragraph extent deployer exercise control input data deployer shall ensure input data relevant sufficiently representative view intended purpose high risk system deployers shall monitor operation high risk system basis instruction use relevant inform provider accordance article deployers reason consider use high risk system accordance instruction may result system presenting risk within meaning article shall without undue delay inform provider distributor relevant market surveillance authority shall suspend use system deployers identified serious incident shall also immediately inform first provider importer distributor relevant market surveillance authority incident deployer able reach provider article shall applymutatis mutandis obligation shall cover sensitive operational data deployers system law enforcement authority deployers financial institution subject requirement regarding internal governance arrangement process union financial service law monitoring obligation set first subparagraph shall deemed fulfilled complying rule internal governance arrangement process mechanism pursuant relevant financial service law deployers high risk system shall keep log automatically generated high risk system extent log control period appropriate intended purpose high risk system least six month unless provided otherwise applicable union national law particular union law protection personal data deployers financial institution subject requirement regarding internal governance arrangement process union financial service law shall maintain log part documentation kept pursuant relevant union financial service law putting service using high risk system workplace deployers employer shall inform worker representative affected worker subject use high risk system information shall provided applicable accordance rule procedure laid union national law practice information worker representative deployers high risk system public authority union institution body office agency shall comply registration obligation referred article deployers find high risk system envisage using registered database referred article shall use system shall inform provider distributor applicable deployers high risk system shall use information provided article regulation comply obligation carry data protection impact assessment article regulation 2016 679 article directive 2016 680 without prejudice directive 2016 680 framework investigation targeted search person suspected convicted committed criminal offence deployer high risk system post remote biometric identification shall request authorisation ante without undue delay later hour judicial authority administrative authority whose decision binding subject judicial review use system except used initial identification potential suspect based objective verifiable fact directly linked offence use shall limited strictly necessary investigation specific criminal offence authorisation requested pursuant first subparagraph rejected use post remote biometric identification system linked requested authorisation shall stopped immediate effect personal data linked use high risk system authorisation requested shall deleted case shall high risk system post remote biometric identification used law enforcement purpose untargeted way without link criminal offence criminal proceeding genuine present genuine foreseeable threat criminal offence search specific missing person shall ensured decision produce adverse legal effect person may taken law enforcement authority based solely output post remote biometric identification system paragraph without prejudice article regulation 2016 679 article directive 2016 680 processing biometric data regardless purpose deployer use high risk system shall documented relevant police file shall made available relevant market surveillance authority national data protection authority upon request excluding disclosure sensitive operational data related law enforcement subparagraph shall without prejudice power conferred directive 2016 680 supervisory authority deployers shall submit annual report relevant market surveillance national data protection authority use post remote biometric identification system excluding disclosure sensitive operational data related law enforcement report may aggregated cover one deployment member state may introduce accordance union law restrictive law use post remote biometric identification system without prejudice article regulation deployers high risk system referred annex iii make decision assist making decision related natural person shall inform natural person subject use high risk system high risk system used law enforcement purpose article directive 2016 680 shall apply deployers shall cooperate relevant competent authority action authority take relation high risk system order implement regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 27
|
1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose, deployers shall perform an assessment consisting of:
(a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
(a)
a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
(b) a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
(b)
a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
(c) the categories of natural persons and groups likely to be affected by its use in the specific context;
(c)
the categories of natural persons and groups likely to be affected by its use in the specific context;
(d) the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;
(d)
the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;
(e) a description of the implementation of human oversight measures, according to the instructions for use;
(e)
a description of the implementation of human oversight measures, according to the instructions for use;
(f) the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
(f)
the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.
3. Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the market surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.
4. If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact assessment.
5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner.
|
prior deploying high risk system referred article exception high risk system intended used area listed point annex iii deployers body governed public law private entity providing public service deployers high risk system referred point annex iii shall perform assessment impact fundamental right use system may produce purpose deployers shall perform assessment consisting description deployer process high risk system used line intended purpose description deployer process high risk system used line intended purpose description period time within frequency high risk system intended used description period time within frequency high risk system intended used category natural person group likely affected use specific context category natural person group likely affected use specific context specific risk harm likely impact category natural person group person identified pursuant point paragraph taking account information given provider pursuant article specific risk harm likely impact category natural person group person identified pursuant point paragraph taking account information given provider pursuant article description implementation human oversight measure according instruction use description implementation human oversight measure according instruction use measure taken case materialisation risk including arrangement internal governance complaint mechanism measure taken case materialisation risk including arrangement internal governance complaint mechanism obligation laid paragraph applies first use high risk system deployer may similar case rely previously conducted fundamental right impact assessment existing impact assessment carried provider use high risk system deployer considers element listed paragraph changed longer date deployer shall take necessary step update information assessment referred paragraph article performed deployer shall notify market surveillance authority result submitting filled template referred paragraph article part notification case referred article deployers may exempt obligation notify obligation laid article already met data protection impact assessment conducted pursuant article regulation 2016 679 article directive 2016 680 fundamental right impact assessment referred paragraph article shall complement data protection impact assessment office shall develop template questionnaire including automated tool facilitate deployers complying obligation article simplified manner
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 28
|
1. Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.
3. Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.
4. Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.
5. Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis.
6. Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
7. Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in fields such as information technologies, AI and law, including the supervision of fundamental rights.
|
member state shall designate establish least one notifying authority responsible setting carrying necessary procedure assessment designation notification conformity assessment body monitoring procedure shall developed cooperation notifying authority member state member state may decide assessment monitoring referred paragraph carried national accreditation body within meaning accordance regulation 765 2008 notifying authority shall established organised operated way conflict interest arises conformity assessment body objectivity impartiality activity safeguarded notifying authority shall organised way decision relating notification conformity assessment body taken competent person different carried assessment body notifying authority shall offer provide neither activity conformity assessment body perform consultancy service commercial competitive basis notifying authority shall safeguard confidentiality information obtain accordance article notifying authority shall adequate number competent personnel disposal proper performance task competent personnel shall necessary expertise applicable function field information technology law including supervision fundamental right
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 29
|
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 31.
Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added.
3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 31.
4. For notified bodies which are designated under any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support their designation procedure under this Regulation, as appropriate. The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements laid down in Article 31.
|
conformity assessment body shall submit application notification notifying authority member state established application notification shall accompanied description conformity assessment activity conformity assessment module module type system conformity assessment body claim competent well accreditation certificate one exists issued national accreditation body attesting conformity assessment body fulfils requirement laid article valid document related existing designation applicant notified body union harmonisation legislation shall added conformity assessment body concerned provide accreditation certificate shall provide notifying authority documentary evidence necessary verification recognition regular monitoring compliance requirement laid article notified body designated union harmonisation legislation document certificate linked designation may used support designation procedure regulation appropriate notified body shall update documentation referred paragraph article whenever relevant change occur order enable authority responsible notified body monitor verify continuous compliance requirement laid article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 30
|
1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31.
2. Notifying authorities shall notify the Commission and the other Member States, using the electronic notification tool developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1.
3. The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment activities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of competence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the competence of the conformity assessment body and to the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 31.
4. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3).
5. Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity assessment body.
|
notifying authority may notify conformity assessment body satisfied requirement laid article notifying authority shall notify commission member state using electronic notification tool developed managed commission conformity assessment body referred paragraph notification referred paragraph article shall include full detail conformity assessment activity conformity assessment module module type system concerned relevant attestation competence notification based accreditation certificate referred article notifying authority shall provide commission member state documentary evidence attests competence conformity assessment body arrangement place ensure body monitored regularly continue satisfy requirement laid article conformity assessment body concerned may perform activity notified body objection raised commission member state within two week notification notifying authority includes accreditation certificate referred article within two month notification notifying authority includes documentary evidence referred article objection raised commission shall without delay enter consultation relevant member state conformity assessment body view thereof commission shall decide whether authorisation justified commission shall address decision member state concerned relevant conformity assessment body
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 31
|
1. A notified body shall be established under the national law of a Member State and shall have legal personality.
2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
3. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall ensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies conduct.
4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such high-risk AI systems for personal purposes.
5. Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services.
6. Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.
7. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out.
8. Notified bodies shall have procedures for the performance of activities which take due account of the size of a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.
9. Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability is assumed by the Member State in which they are established in accordance with national law or that Member State is itself directly responsible for the conformity assessment.
10. Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
11. Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and data computing, and relating to the requirements set out in Section 2.
12. Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in respect of relevant standards.
|
notified body shall established national law member state shall legal personality notified body shall satisfy organisational quality management resource process requirement necessary fulfil task well suitable cybersecurity requirement organisational structure allocation responsibility reporting line operation notified body shall ensure confidence performance result conformity assessment activity notified body conduct notified body shall independent provider high risk system relation perform conformity assessment activity notified body shall also independent operator economic interest high risk system assessed well competitor provider shall preclude use assessed high risk system necessary operation conformity assessment body use high risk system personal purpose neither conformity assessment body top level management personnel responsible carrying conformity assessment task shall directly involved design development marketing use high risk system shall represent party engaged activity shall engage activity might conflict independence judgement integrity relation conformity assessment activity notified shall particular apply consultancy service notified body shall organised operated safeguard independence objectivity impartiality activity notified body shall document implement structure procedure safeguard impartiality promote apply principle impartiality throughout organisation personnel assessment activity notified body shall documented procedure place ensuring personnel committee subsidiary subcontractor associated body personnel external body maintain accordance article confidentiality information come possession performance conformity assessment activity except disclosure required law staff notified body shall bound observe professional secrecy regard information obtained carrying task regulation except relation notifying authority member state activity carried notified body shall procedure performance activity take due account size provider sector operates structure degree complexity system concerned notified body shall take appropriate liability insurance conformity assessment activity unless liability assumed member state established accordance national law member state directly responsible conformity assessment notified body shall capable carrying task regulation highest degree professional integrity requisite competence specific field whether task carried notified body behalf responsibility notified body shall sufficient internal competence able effectively evaluate task conducted external party behalf notified body shall permanent availability sufficient administrative technical legal scientific personnel possess experience knowledge relating relevant type system data data computing relating requirement set section notified body shall participate coordination activity referred article shall also take part directly represented european standardisation organisation ensure aware date respect relevant standard
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 32
|
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in theOfficial Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover those requirements.
|
conformity assessment body demonstrates conformity criterion laid relevant harmonised standard part thereof reference published theofficial journal european union shall presumed comply requirement set article far applicable harmonised standard cover requirement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 33
|
1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and shall inform the notifying authority accordingly.
2. Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available.
4. The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of five years from the termination date of the subcontracting.
|
notified body subcontract specific task connected conformity assessment recourse subsidiary shall ensure subcontractor subsidiary meet requirement laid article shall inform notifying authority accordingly notified body shall take full responsibility task performed subcontractor subsidiary activity may subcontracted carried subsidiary agreement provider notified body shall make list subsidiary publicly available relevant document concerning assessment qualification subcontractor subsidiary work carried regulation shall kept disposal notifying authority period five year termination date subcontracting
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 34
|
1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation.
3. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.
|
notified body shall verify conformity high risk system accordance conformity assessment procedure set article notified body shall avoid unnecessary burden provider performing activity take due account size provider sector operates structure degree complexity high risk system concerned particular view minimising administrative burden compliance cost micro small enterprise within meaning recommendation 2003 361 notified body shall nevertheless respect degree rigour level protection required compliance high risk system requirement regulation notified body shall make available submit upon request relevant documentation including provider documentation notifying authority referred article allow authority conduct assessment designation notification monitoring activity facilitate assessment outlined section
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 35
|
1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act.
2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
|
commission shall assign single identification number notified body even body notified one union act commission shall make publicly available list body notified regulation including identification number activity notified commission shall ensure list kept date
|
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all-MiniLM-L6-v2
| 384 |
Article 36
|
1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.
For changes to the notification other than extensions of its scope, the procedures laid down in paragraphs (3) to (9) shall apply.
3. Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its activities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified body’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.
4. Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body no longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw the designation as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned within 10 days.
6. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying authorities in other Member States and to market surveillance authorities at their request.
7. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:
(a) assess the impact on the certificates issued by the notified body;
(a)
assess the impact on the certificates issued by the notified body;
(b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(b)
submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the market;
(c)
require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the market;
(d) inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
(d)
inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
(e) provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal; that authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
(e)
provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal; that authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in one of the following circumstances:
(a) the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline for actions to remedy the suspension or restriction; or
(a)
the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline for actions to remedy the suspension or restriction; or
(b) the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the event that the notifying authority determines that the notified body does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
(b)
the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the event that the notifying authority determines that the notified body does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months under the following circumstances:
(a) the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and
(a)
the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and
(b) another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.
(b)
another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.
In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which the provider of the system covered by the certificate has its place of business may extend the provisional validity of the certificates for additional periods of three months, which shall not exceed 12 months in total.
The national competent authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
|
notifying authority shall notify commission member state relevant change notification notified body via electronic notification tool referred article procedure laid article shall apply extension scope notification change notification extension scope procedure laid paragraph shall apply notified body decides cease conformity assessment activity shall inform notifying authority provider concerned soon possible case planned cessation least one year ceasing activity certificate notified body may remain valid period nine month cessation notified body activity condition another notified body confirmed writing assume responsibility high risk system covered certificate latter notified body shall complete full assessment high risk system affected end nine month period issuing new certificate system notified body ceased activity notifying authority shall withdraw designation notifying authority sufficient reason consider notified body longer meet requirement laid article failing fulfil obligation notifying authority shall without delay investigate matter utmost diligence context shall inform notified body concerned objection raised give possibility make view known notifying authority come conclusion notified body longer meet requirement laid article failing fulfil obligation shall restrict suspend withdraw designation appropriate depending seriousness failure meet requirement fulfil obligation shall immediately inform commission member state accordingly designation suspended restricted fully partially withdrawn notified body shall inform provider concerned within day event restriction suspension withdrawal designation notifying authority shall take appropriate step ensure file notified body concerned kept make available notifying authority member state market surveillance authority request event restriction suspension withdrawal designation notifying authority shall assess impact certificate issued notified body assess impact certificate issued notified body submit report finding commission member state within three month notified change designation submit report finding commission member state within three month notified change designation require notified body suspend withdraw within reasonable period time determined authority certificate unduly issued order ensure continuing conformity high risk system market require notified body suspend withdraw within reasonable period time determined authority certificate unduly issued order ensure continuing conformity high risk system market inform commission member state certificate suspension withdrawal required inform commission member state certificate suspension withdrawal required provide national competent authority member state provider registered place business relevant information certificate required suspension withdrawal authority shall take appropriate measure necessary avoid potential risk health safety fundamental right provide national competent authority member state provider registered place business relevant information certificate required suspension withdrawal authority shall take appropriate measure necessary avoid potential risk health safety fundamental right exception certificate unduly issued designation suspended restricted certificate shall remain valid one following circumstance notifying authority confirmed within one month suspension restriction risk health safety fundamental right relation certificate affected suspension restriction notifying authority outlined timeline action remedy suspension restriction notifying authority confirmed within one month suspension restriction risk health safety fundamental right relation certificate affected suspension restriction notifying authority outlined timeline action remedy suspension restriction notifying authority confirmed certificate relevant suspension issued amended issued course suspension restriction state whether notified body capability continuing monitor remain responsible existing certificate issued period suspension restriction event notifying authority determines notified body capability support existing certificate issued provider system covered certificate shall confirm writing national competent authority member state registered place business within three month suspension restriction another qualified notified body temporarily assuming function notified body monitor remain responsible certificate period suspension restriction notifying authority confirmed certificate relevant suspension issued amended issued course suspension restriction state whether notified body capability continuing monitor remain responsible existing certificate issued period suspension restriction event notifying authority determines notified body capability support existing certificate issued provider system covered certificate shall confirm writing national competent authority member state registered place business within three month suspension restriction another qualified notified body temporarily assuming function notified body monitor remain responsible certificate period suspension restriction exception certificate unduly issued designation withdrawn certificate shall remain valid period nine month following circumstance national competent authority member state provider high risk system covered certificate registered place business confirmed risk health safety fundamental right associated high risk system concerned national competent authority member state provider high risk system covered certificate registered place business confirmed risk health safety fundamental right associated high risk system concerned another notified body confirmed writing assume immediate responsibility system completes assessment within month withdrawal designation another notified body confirmed writing assume immediate responsibility system completes assessment within month withdrawal designation circumstance referred first subparagraph national competent authority member state provider system covered certificate place business may extend provisional validity certificate additional period three month shall exceed month total national competent authority notified body assuming function notified body affected change designation shall immediately inform commission member state notified body thereof
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 37
|
1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.
2. The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78.
4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
|
commission shall necessary investigate case reason doubt competence notified body continued fulfilment notified body requirement laid article applicable responsibility notifying authority shall provide commission request relevant information relating notification maintenance competence notified body concerned commission shall ensure sensitive information obtained course investigation pursuant article treated confidentially accordance article commission ascertains notified body meet longer meet requirement notification shall inform notifying member state accordingly request take necessary corrective measure including suspension withdrawal notification necessary member state fails take necessary corrective measure commission may mean implementing act suspend restrict withdraw designation implementing act shall adopted accordance examination procedure referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 38
|
1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
2. Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in paragraph 1, directly or through designated representatives.
3. The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
|
commission shall ensure regard high risk system appropriate coordination cooperation notified body active conformity assessment procedure pursuant regulation put place properly operated form sectoral group notified body notifying authority shall ensure body notified participate work group referred paragraph directly designated representative commission shall provide exchange knowledge best practice notifying authority
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 39
|
Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of compliance.
|
conformity assessment body established law third country union concluded agreement may authorised carry activity notified body regulation provided meet requirement laid article ensure equivalent level compliance
|
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-0.08858160674571991
] |
all-MiniLM-L6-v2
| 384 |
Article 40
|
1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations.
2. In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of Regulation (EU) No 1025/2012.
3. The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
|
high risk system general purpose model conformity harmonised standard part thereof reference published theofficial journal european unionin accordance regulation 1025 2012 shall presumed conformity requirement set section chapter applicable obligation set chapter section regulation extent standard cover requirement obligation accordance article regulation 1025 2012 commission shall issue without undue delay standardisation request covering requirement set section chapter applicable standardisation request covering obligation set chapter section regulation standardisation request shall also ask deliverable reporting documentation process improve system resource performance reducing high risk system consumption energy resource lifecycle energy efficient development general purpose model preparing standardisation request commission shall consult board relevant stakeholder including advisory forum issuing standardisation request european standardisation organisation commission shall specify standard clear consistent including standard developed various sector product covered existing union harmonisation legislation listed annex aiming ensure high risk system general purpose model placed market put service union meet relevant requirement obligation laid regulation commission shall request european standardisation organisation provide evidence best effort fulfil objective referred first second subparagraph paragraph accordance article regulation 1025 2012 participant standardisation process shall seek promote investment innovation including increasing legal certainty well competitiveness growth union market contribute strengthening global cooperation standardisation taking account existing international standard field consistent union value fundamental right interest enhance multi stakeholder governance ensuring balanced representation interest effective participation relevant stakeholder accordance article regulation 1025 2012
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 41
|
1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:
(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and: (i) the request has not been accepted by any of the European standardisation organisations; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or (iv) the harmonised standards do not comply with the request; and
(a)
the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:
(i) the request has not been accepted by any of the European standardisation organisations; or
(i)
the request has not been accepted by any of the European standardisation organisations; or
(ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
(ii)
the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
(iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
(iii)
the relevant harmonised standards insufficiently address fundamental rights concerns; or
(iv) the harmonised standards do not comply with the request; and
(iv)
the harmonised standards do not comply with the request; and
(b) no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.
(b)
no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.
When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.
3. High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.
4. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in theOfficial Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in theOfficial Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V.
5. Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto.
6. Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.
|
commission may adopt implementing act establishing common specification requirement set section chapter applicable obligation set section chapter following condition fulfilled commission requested pursuant article regulation 1025 2012 one european standardisation organisation draft harmonised standard requirement set section chapter applicable obligation set section chapter request accepted european standardisation organisation harmonised standard addressing request delivered within deadline set accordance article regulation 1025 2012 iii relevant harmonised standard insufficiently address fundamental right concern harmonised standard comply request commission requested pursuant article regulation 1025 2012 one european standardisation organisation draft harmonised standard requirement set section chapter applicable obligation set section chapter request accepted european standardisation organisation request accepted european standardisation organisation harmonised standard addressing request delivered within deadline set accordance article regulation 1025 2012 harmonised standard addressing request delivered within deadline set accordance article regulation 1025 2012 iii relevant harmonised standard insufficiently address fundamental right concern iii relevant harmonised standard insufficiently address fundamental right concern harmonised standard comply request harmonised standard comply request reference harmonised standard covering requirement referred section chapter applicable obligation referred section chapter published theofficial journal european unionin accordance regulation 1025 2012 reference expected published within reasonable period reference harmonised standard covering requirement referred section chapter applicable obligation referred section chapter published theofficial journal european unionin accordance regulation 1025 2012 reference expected published within reasonable period drafting common specification commission shall consult advisory forum referred article implementing act referred first subparagraph paragraph shall adopted accordance examination procedure referred article preparing draft implementing act commission shall inform committee referred article regulation 1025 2012 considers condition laid paragraph article fulfilled high risk system general purpose model conformity common specification referred paragraph part specification shall presumed conformity requirement set section chapter applicable comply obligation referred section chapter extent common specification cover requirement obligation harmonised standard adopted european standardisation organisation proposed commission publication reference theofficial journal european union commission shall assess harmonised standard accordance regulation 1025 2012 reference harmonised standard published theofficial journal european union commission shall repeal implementing act referred paragraph part thereof cover requirement set section chapter applicable obligation set section chapter provider high risk system general purpose model comply common specification referred paragraph shall duly justify adopted technical solution meet requirement referred section chapter applicable comply obligation set section chapter level least equivalent thereto member state considers common specification entirely meet requirement set section applicable comply obligation set section chapter shall inform commission thereof detailed explanation commission shall assess information appropriate amend implementing act establishing common specification concerned
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 42
|
1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4).
2. High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in theOfficial Journal of the European Unionshall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.
|
high risk system trained tested data reflecting specific geographical behavioural contextual functional setting within intended used shall presumed comply relevant requirement laid article high risk system certified statement conformity issued cybersecurity scheme pursuant regulation 2019 881 reference published theofficial journal european unionshall presumed comply cybersecurity requirement set article regulation far cybersecurity certificate statement conformity part thereof cover requirement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 43
|
1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on:
(a) the internal control referred to in Annex VI; or
(a)
the internal control referred to in Annex VI; or
(b) the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.
(b)
the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.
In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where:
(a) harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;
(a)
harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;
(b) the provider has not applied, or has applied only part of, the harmonised standard;
(b)
the provider has not applied, or has applied only part of, the harmonised standard;
(c) the common specifications referred to in point (a) exist, but the provider has not applied them;
(c)
the common specifications referred to in point (a) exist, but the provider has not applied them;
(d) one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.
(d)
one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.
For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in Article 74(8) or (9), as applicable, shall act as a notified body.
2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body.
3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.
For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.
Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.
4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer.
For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.
5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies.
|
high risk system listed point annex iii demonstrating compliance high risk system requirement set section provider applied harmonised standard referred article applicable common specification referred article provider shall opt one following conformity assessment procedure based internal control referred annex internal control referred annex assessment quality management system assessment technical documentation involvement notified body referred annex vii assessment quality management system assessment technical documentation involvement notified body referred annex vii demonstrating compliance high risk system requirement set section provider shall follow conformity assessment procedure set annex vii harmonised standard referred article exist common specification referred article available harmonised standard referred article exist common specification referred article available provider applied applied part harmonised standard provider applied applied part harmonised standard common specification referred point exist provider applied common specification referred point exist provider applied one harmonised standard referred point published restriction part standard restricted one harmonised standard referred point published restriction part standard restricted purpose conformity assessment procedure referred annex vii provider may choose notified body however high risk system intended put service law enforcement immigration asylum authority union institution body office agency market surveillance authority referred article applicable shall act notified body high risk system referred point annex iii provider shall follow conformity assessment procedure based internal control referred annex provide involvement notified body high risk system covered union harmonisation legislation listed section annex provider shall follow relevant conformity assessment procedure required legal act requirement set section chapter shall apply high risk system shall part assessment point fifth paragraph point annex vii shall also apply purpose assessment notified body notified legal act shall entitled control conformity high risk system requirement set section provided compliance notified body requirement laid article assessed context notification procedure legal act legal act listed section annex enables product manufacturer opt third party conformity assessment provided manufacturer applied harmonised standard covering relevant requirement manufacturer may use option also applied harmonised standard applicable common specification referred article covering requirement set section chapter high risk system already subject conformity assessment procedure shall undergo new conformity assessment procedure event substantial modification regardless whether modified system intended distributed continues used current deployer high risk system continue learn placed market put service change high risk system performance pre determined provider moment initial conformity assessment part information contained technical documentation referred point annex shall constitute substantial modification commission empowered adopt delegated act accordance article order amend annex vii updating light technical progress commission empowered adopt delegated act accordance article order amend paragraph article order subject high risk system referred point annex iii conformity assessment procedure referred annex vii part thereof commission shall adopt delegated act taking account effectiveness conformity assessment procedure based internal control referred annex preventing minimising risk health safety protection fundamental right posed system well availability adequate capacity resource among notified body
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 44
|
1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established.
2. Certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may be extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.
3. Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.
An appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.
|
certificate issued notified body accordance annex vii shall drawn language easily understood relevant authority member state notified body established certificate shall valid period indicate shall exceed five year system covered annex four year system covered annex iii request provider validity certificate may extended period exceeding five year system covered annex four year system covered annex iii based assessment accordance applicable conformity assessment procedure supplement certificate shall remain valid provided certificate supplement valid notified body find system longer meet requirement set section shall taking account principle proportionality suspend withdraw certificate issued impose restriction unless compliance requirement ensured appropriate corrective action taken provider system within appropriate deadline set notified body notified body shall give reason decision appeal procedure decision notified body including conformity certificate issued shall available
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 45
|
1. Notified bodies shall inform the notifying authority of the following:
(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(a)
any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(b) any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
(b)
any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
(c) any circumstances affecting the scope of or conditions for notification;
(c)
any circumstances affecting the scope of or conditions for notification;
(d) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d)
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(e) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
(e)
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2. Each notified body shall inform the other notified bodies of:
(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.
4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
|
notified body shall inform notifying authority following union technical documentation assessment certificate supplement certificate quality management system approval issued accordance requirement annex vii union technical documentation assessment certificate supplement certificate quality management system approval issued accordance requirement annex vii refusal restriction suspension withdrawal union technical documentation assessment certificate quality management system approval issued accordance requirement annex vii refusal restriction suspension withdrawal union technical documentation assessment certificate quality management system approval issued accordance requirement annex vii circumstance affecting scope condition notification circumstance affecting scope condition notification request information received market surveillance authority regarding conformity assessment activity request information received market surveillance authority regarding conformity assessment activity request conformity assessment activity performed within scope notification activity performed including cross border activity subcontracting request conformity assessment activity performed within scope notification activity performed including cross border activity subcontracting notified body shall inform notified body quality management system approval refused suspended withdrawn upon request quality system approval issued quality management system approval refused suspended withdrawn upon request quality system approval issued union technical documentation assessment certificate supplement thereto refused withdrawn suspended otherwise restricted upon request certificate supplement thereto issued union technical documentation assessment certificate supplement thereto refused withdrawn suspended otherwise restricted upon request certificate supplement thereto issued notified body shall provide notified body carrying similar conformity assessment activity covering type system relevant information issue relating negative request positive conformity assessment result notified body shall safeguard confidentiality information obtain accordance article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 46
|
1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, taking into account the exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.
2. In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.
3. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities.
4. Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.
5. Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators.
6. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned.
7. For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply.
|
way derogation article upon duly justified request market surveillance authority may authorise placing market putting service specific high risk system within territory member state concerned exceptional reason public security protection life health person environmental protection protection key industrial infrastructural asset authorisation shall limited period necessary conformity assessment procedure carried taking account exceptional reason justifying derogation completion procedure shall undertaken without undue delay duly justified situation urgency exceptional reason public security case specific substantial imminent threat life physical safety natural person law enforcement authority civil protection authority may put specific high risk system service without authorisation referred paragraph provided authorisation requested use without undue delay authorisation referred paragraph refused use high risk system shall stopped immediate effect result output use shall immediately discarded authorisation referred paragraph shall issued market surveillance authority concludes high risk system complies requirement section market surveillance authority shall inform commission member state authorisation issued pursuant paragraph obligation shall cover sensitive operational data relation activity law enforcement authority within calendar day receipt information referred paragraph objection raised either member state commission respect authorisation issued market surveillance authority member state accordance paragraph authorisation shall deemed justified within calendar day receipt notification referred paragraph objection raised member state authorisation issued market surveillance authority another member state commission considers authorisation contrary union law conclusion member state regarding compliance system referred paragraph unfounded commission shall without delay enter consultation relevant member state operator concerned shall consulted possibility present view regard thereto commission shall decide whether authorisation justified commission shall address decision member state concerned relevant operator commission considers authorisation unjustified shall withdrawn market surveillance authority member state concerned high risk system related product covered union harmonisation legislation listed section annex derogation conformity assessment established union harmonisation legislation shall apply
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 47
|
1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request.
2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.
3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.
4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.
|
provider shall draw written machine readable physical electronically signed declaration conformity high risk system keep disposal national competent authority year high risk system placed market put service declaration conformity shall identify high risk system drawn copy declaration conformity shall submitted relevant national competent authority upon request declaration conformity shall state high risk system concerned meet requirement set section declaration conformity shall contain information set annex shall translated language easily understood national competent authority member state high risk system placed market made available high risk system subject union harmonisation legislation also requires declaration conformity single declaration conformity shall drawn respect union law applicable high risk system declaration shall contain information required identify union harmonisation legislation declaration relates drawing declaration conformity provider shall assume responsibility compliance requirement set section provider shall keep declaration conformity date appropriate commission empowered adopt delegated act accordance article order amend annex updating content declaration conformity set annex order introduce element become necessary light technical progress
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 48
|
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.
3. The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate.
4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.
5. Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
|
marking shall subject general principle set article regulation 765 2008 high risk system provided digitally digital marking shall used easily accessed via interface system accessed via easily accessible machine readable code electronic mean marking shall affixed visibly legibly indelibly high risk system possible warranted account nature high risk system shall affixed packaging accompanying documentation appropriate applicable marking shall followed identification number notified body responsible conformity assessment procedure set article identification number notified body shall affixed body instruction provider provider authorised representative identification number shall also indicated promotional material mention high risk system fulfils requirement marking high risk system subject union law also provides affixing marking marking shall indicate high risk system also fulfil requirement law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 49
|
1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71.
2. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.
3. Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.
4. For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in:
(a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(a)
Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(b)
Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(c) Section C, points 1 to 3, of Annex VIII;
(c)
Section C, points 1 to 3, of Annex VIII;
(d) points 1, 2, 3 and 5, of Annex IX.
(d)
points 1, 2, 3 and 5, of Annex IX.
Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph.
5. High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.
|
placing market putting service high risk system listed annex iii exception high risk system referred point annex iii provider applicable authorised representative shall register system database referred article placing market putting service system provider concluded high risk according article provider applicable authorised representative shall register system database referred article putting service using high risk system listed annex iii exception high risk system listed point annex iii deployers public authority union institution body office agency person acting behalf shall register select system register use database referred article high risk system referred point annex iii area law enforcement migration asylum border control management registration referred paragraph article shall secure non public section database referred article shall include following information applicable referred section point annex viii exception point section point annex viii exception point section point point annex viii section point point annex viii section point annex viii section point annex viii point annex point annex commission national authority referred article shall access respective restricted section database listed first subparagraph paragraph high risk system referred point annex iii shall registered national level
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 50
|
1. Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking into account the circumstances and the context of use. This obligation shall not apply to AI systems authorised by law to detect, prevent, investigate or prosecute criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, unless those systems are available for the public to report a criminal offence.
2. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, shall ensure that the outputs of the AI system are marked in a machine-readable format and detectable as artificially generated or manipulated. Providers shall ensure their technical solutions are effective, interoperable, robust and reliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content, the costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical standards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or do not substantially alter the input data provided by the deployer or the semantics thereof, or where authorised by law to detect, prevent, investigate or prosecute criminal offences.
3. Deployers of an emotion recognition system or a biometric categorisation system shall inform the natural persons exposed thereto of the operation of the system, and shall process the personal data in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. This obligation shall not apply to AI systems used for biometric categorisation and emotion recognition, which are permitted by law to detect, prevent or investigate criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in accordance with Union law.
4. Deployers of an AI system that generates or manipulates image, audio or video content constituting a deep fake, shall disclose that the content has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offence. Where the content forms part of an evidently artistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph are limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not hamper the display or enjoyment of the work.
Deployers of an AI system that generates or manipulates text which is published with the purpose of informing the public on matters of public interest shall disclose that the text has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offences or where the AI-generated content has undergone a process of human review or editorial control and where a natural or legal person holds editorial responsibility for the publication of the content.
5. The information referred to in paragraphs 1 to 4 shall be provided to the natural persons concerned in a clear and distinguishable manner at the latest at the time of the first interaction or exposure. The information shall conform to the applicable accessibility requirements.
6. Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III, and shall be without prejudice to other transparency obligations laid down in Union or national law for deployers of AI systems.
7. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content. The Commission may adopt implementing acts to approve those codes of practice in accordance with the procedure laid down in Article 56 (6). If it deems the code is not adequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).
|
provider shall ensure system intended interact directly natural person designed developed way natural person concerned informed interacting system unless obvious point view natural person reasonably well informed observant circumspect taking account circumstance context use obligation shall apply system authorised law detect prevent investigate prosecute criminal offence subject appropriate safeguard right freedom third party unless system available public report criminal offence provider system including general purpose system generating synthetic audio image video text content shall ensure output system marked machine readable format detectable artificially generated manipulated provider shall ensure technical solution effective interoperable robust reliable far technically feasible taking account specificity limitation various type content cost implementation generally acknowledged state art may reflected relevant technical standard obligation shall apply extent system perform assistive function standard editing substantially alter input data provided deployer semantics thereof authorised law detect prevent investigate prosecute criminal offence deployers emotion recognition system biometric categorisation system shall inform natural person exposed thereto operation system shall process personal data accordance regulation 2016 679 2018 1725 directive 2016 680 applicable obligation shall apply system used biometric categorisation emotion recognition permitted law detect prevent investigate criminal offence subject appropriate safeguard right freedom third party accordance union law deployers system generates manipulates image audio video content constituting deep fake shall disclose content artificially generated manipulated obligation shall apply use authorised law detect prevent investigate prosecute criminal offence content form part evidently artistic creative satirical fictional analogous work programme transparency obligation set paragraph limited disclosure existence generated manipulated content appropriate manner hamper display enjoyment work deployers system generates manipulates text published purpose informing public matter public interest shall disclose text artificially generated manipulated obligation shall apply use authorised law detect prevent investigate prosecute criminal offence generated content undergone process human review editorial control natural legal person hold editorial responsibility publication content information referred paragraph shall provided natural person concerned clear distinguishable manner latest time first interaction exposure information shall conform applicable accessibility requirement paragraph shall affect requirement obligation set chapter iii shall without prejudice transparency obligation laid union national law deployers system office shall encourage facilitate drawing code practice union level facilitate effective implementation obligation regarding detection labelling artificially generated manipulated content commission may adopt implementing act approve code practice accordance procedure laid article deems code adequate commission may adopt implementing act specifying common rule implementation obligation accordance examination procedure laid article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 51
|
1. A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the following conditions:
(a) it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks;
(a)
it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks;
(b) based on a decision of the Commission,ex officioor following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
(b)
based on a decision of the Commission,ex officioor following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
2. A general-purpose AI model shall be presumed to have high impact capabilities pursuant to paragraph 1, point (a), when the cumulative amount of computation used for its training measured in floating point operations is greater than 10.
3. The Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in paragraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to reflect the state of the art.
|
general purpose model shall classified general purpose model systemic risk meet following condition high impact capability evaluated basis appropriate technical tool methodology including indicator benchmark high impact capability evaluated basis appropriate technical tool methodology including indicator benchmark based decision commission officioor following qualified alert scientific panel capability impact equivalent set point regard criterion set annex xiii based decision commission officioor following qualified alert scientific panel capability impact equivalent set point regard criterion set annex xiii general purpose model shall presumed high impact capability pursuant paragraph point cumulative amount computation used training measured floating point operation greater commission shall adopt delegated act accordance article amend threshold listed paragraph article well supplement benchmark indicator light evolving technological development algorithmic improvement increased hardware efficiency necessary threshold reflect state art
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 52
|
1. Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider shall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes known that it will be met. That notification shall include the information necessary to demonstrate that the relevant requirement has been met. If the Commission becomes aware of a general-purpose AI model presenting systemic risks of which it has not been notified, it may decide to designate it as a model with systemic risk.
2. The provider of a general-purpose AI model that meets the condition referred to in Article 51(1), point (a), may present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets that requirement, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore should not be classified as a general-purpose AI model with systemic risk.
3. Where the Commission concludes that the arguments submitted pursuant to paragraph 2 are not sufficiently substantiated and the relevant provider was not able to demonstrate that the general-purpose AI model does not present, due to its specific characteristics, systemic risks, it shall reject those arguments, and the general-purpose AI model shall be considered to be a general-purpose AI model with systemic risk.
4. The Commission may designate a general-purpose AI model as presenting systemic risks,ex officioor following a qualified alert from the scientific panel pursuant to Article 90(1), point (a), on the basis of criteria set out in Annex XIII.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIII by specifying and updating the criteria set out in that Annex.
5. Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic risk pursuant to paragraph 4, the Commission shall take the request into account and may decide to reassess whether the general-purpose AI model can still be considered to present systemic risks on the basis of the criteria set out in Annex XIII. Such a request shall contain objective, detailed and new reasons that have arisen since the designation decision. Providers may request reassessment at the earliest six months after the designation decision. Where the Commission, following its reassessment, decides to maintain the designation as a general-purpose AI model with systemic risk, providers may request reassessment at the earliest six months after that decision.
6. The Commission shall ensure that a list of general-purpose AI models with systemic risk is published and shall keep that list up to date, without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.
|
general purpose model meet condition referred article point relevant provider shall notify commission without delay event within two week requirement met becomes known met notification shall include information necessary demonstrate relevant requirement met commission becomes aware general purpose model presenting systemic risk notified may decide designate model systemic risk provider general purpose model meet condition referred article point may present notification sufficiently substantiated argument demonstrate exceptionally although meet requirement general purpose model present due specific characteristic systemic risk therefore classified general purpose model systemic risk commission concludes argument submitted pursuant paragraph sufficiently substantiated relevant provider able demonstrate general purpose model present due specific characteristic systemic risk shall reject argument general purpose model shall considered general purpose model systemic risk commission may designate general purpose model presenting systemic risk officioor following qualified alert scientific panel pursuant article point basis criterion set annex xiii commission empowered adopt delegated act accordance article order amend annex xiii specifying updating criterion set annex upon reasoned request provider whose model designated general purpose model systemic risk pursuant paragraph commission shall take request account may decide reassess whether general purpose model still considered present systemic risk basis criterion set annex xiii request shall contain objective detailed new reason arisen since designation decision provider may request reassessment earliest six month designation decision commission following reassessment decides maintain designation general purpose model systemic risk provider may request reassessment earliest six month decision commission shall ensure list general purpose model systemic risk published shall keep list date without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 53
|
1. Providers of general-purpose AI models shall:
(a) draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of providing it, upon request, to the AI Office and the national competent authorities;
(a)
draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of providing it, upon request, to the AI Office and the national competent authorities;
(b) draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to integrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law, the information and documentation shall: (i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the general-purpose AI model and to comply with their obligations pursuant to this Regulation; and (ii) contain, at a minimum, the elements set out in Annex XII;
(b)
draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to integrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law, the information and documentation shall:
(i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the general-purpose AI model and to comply with their obligations pursuant to this Regulation; and
(i)
enable providers of AI systems to have a good understanding of the capabilities and limitations of the general-purpose AI model and to comply with their obligations pursuant to this Regulation; and
(ii) contain, at a minimum, the elements set out in Annex XII;
(ii)
contain, at a minimum, the elements set out in Annex XII;
(c) put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply with, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790;
(c)
put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply with, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790;
(d) draw up and make publicly available a sufficiently detailed summary about the content used for training of the general-purpose AI model, according to a template provided by the AI Office.
(d)
draw up and make publicly available a sufficiently detailed summary about the content used for training of the general-purpose AI model, according to a template provided by the AI Office.
2. The obligations set out in paragraph 1, points (a) and (b), shall not apply to providers of AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available. This exception shall not apply to general-purpose AI models with systemic risks.
3. Providers of general-purpose AI models shall cooperate as necessary with the Commission and the national competent authorities in the exercise of their competences and powers pursuant to this Regulation.
4. Providers of general-purpose AI models may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.
5. For the purpose of facilitating compliance with Annex XI, in particular points 2 (d) and (e) thereof, the Commission is empowered to adopt delegated acts in accordance with Article 97 to detail measurement and calculation methodologies with a view to allowing for comparable and verifiable documentation.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97(2) to amend Annexes XI and XII in light of evolving technological developments.
7. Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
provider general purpose model shall draw keep date technical documentation model including training testing process result evaluation shall contain minimum information set annex purpose providing upon request office national competent authority draw keep date technical documentation model including training testing process result evaluation shall contain minimum information set annex purpose providing upon request office national competent authority draw keep date make available information documentation provider system intend integrate general purpose model system without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law information documentation shall enable provider system good understanding capability limitation general purpose model comply obligation pursuant regulation contain minimum element set annex xii draw keep date make available information documentation provider system intend integrate general purpose model system without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law information documentation shall enable provider system good understanding capability limitation general purpose model comply obligation pursuant regulation enable provider system good understanding capability limitation general purpose model comply obligation pursuant regulation contain minimum element set annex xii contain minimum element set annex xii put place policy comply union law copyright related right particular identify comply including state art technology reservation right expressed pursuant article directive 2019 790 put place policy comply union law copyright related right particular identify comply including state art technology reservation right expressed pursuant article directive 2019 790 draw make publicly available sufficiently detailed summary content used training general purpose model according template provided office draw make publicly available sufficiently detailed summary content used training general purpose model according template provided office obligation set paragraph point shall apply provider model released free open source licence allows access usage modification distribution model whose parameter including weight information model architecture information model usage made publicly available exception shall apply general purpose model systemic risk provider general purpose model shall cooperate necessary commission national competent authority exercise competence power pursuant regulation provider general purpose model may rely code practice within meaning article demonstrate compliance obligation set paragraph article harmonised standard published compliance european harmonised standard grant provider presumption conformity extent standard cover obligation provider general purpose model adhere approved code practice comply european harmonised standard shall demonstrate alternative adequate mean compliance assessment commission purpose facilitating compliance annex particular point thereof commission empowered adopt delegated act accordance article detail measurement calculation methodology view allowing comparable verifiable documentation commission empowered adopt delegated act accordance article amend annex xii light evolving technological development information documentation obtained pursuant article including trade secret shall treated accordance confidentiality obligation set article
|
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-0.06621657311916351,
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] |
all-MiniLM-L6-v2
| 384 |
Article 54
|
1. Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
2. The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider.
3. The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the AI Office upon request, in one of the official languages of the institutions of the Union. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:
(a) verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in Article 53 and, where applicable, Article 55 have been fulfilled by the provider;
(a)
verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in Article 53 and, where applicable, Article 55 have been fulfilled by the provider;
(b) keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and the contact details of the provider that appointed the authorised representative;
(b)
keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and the contact details of the provider that appointed the authorised representative;
(c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
(c)
provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
(d) cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into service in the Union.
(d)
cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into service in the Union.
4. The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the AI Office or the competent authorities, on all issues related to ensuring compliance with this Regulation.
5. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall also immediately inform the AI Office about the termination of the mandate and the reasons therefor.
6. The obligation set out in this Article shall not apply to providers of general-purpose AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available, unless the general-purpose AI models present systemic risks.
|
prior placing general purpose model union market provider established third country shall written mandate appoint authorised representative established union provider shall enable authorised representative perform task specified mandate received provider authorised representative shall perform task specified mandate received provider shall provide copy mandate office upon request one official language institution union purpose regulation mandate shall empower authorised representative carry following task verify technical documentation specified annex drawn obligation referred article applicable article fulfilled provider verify technical documentation specified annex drawn obligation referred article applicable article fulfilled provider keep copy technical documentation specified annex disposal office national competent authority period year general purpose model placed market contact detail provider appointed authorised representative keep copy technical documentation specified annex disposal office national competent authority period year general purpose model placed market contact detail provider appointed authorised representative provide office upon reasoned request information documentation including referred point necessary demonstrate compliance obligation chapter provide office upon reasoned request information documentation including referred point necessary demonstrate compliance obligation chapter cooperate office competent authority upon reasoned request action take relation general purpose model including model integrated system placed market put service union cooperate office competent authority upon reasoned request action take relation general purpose model including model integrated system placed market put service union mandate shall empower authorised representative addressed addition instead provider office competent authority issue related ensuring compliance regulation authorised representative shall terminate mandate considers reason consider provider acting contrary obligation pursuant regulation case shall also immediately inform office termination mandate reason therefor obligation set article shall apply provider general purpose model released free open source licence allows access usage modification distribution model whose parameter including weight information model architecture information model usage made publicly available unless general purpose model present systemic risk
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 55
|
1. In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall:
(a) perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;
(a)
perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;
(b) assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development, the placing on the market, or the use of general-purpose AI models with systemic risk;
(b)
assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development, the placing on the market, or the use of general-purpose AI models with systemic risk;
(c) keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent authorities, relevant information about serious incidents and possible corrective measures to address them;
(c)
keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent authorities, relevant information about serious incidents and possible corrective measures to address them;
(d) ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the physical infrastructure of the model.
(d)
ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the physical infrastructure of the model.
2. Providers of general-purpose AI models with systemic risk may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.
3. Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
addition obligation listed article provider general purpose model systemic risk shall perform model evaluation accordance standardised protocol tool reflecting state art including conducting documenting adversarial testing model view identifying mitigating systemic risk perform model evaluation accordance standardised protocol tool reflecting state art including conducting documenting adversarial testing model view identifying mitigating systemic risk assess mitigate possible systemic risk union level including source may stem development placing market use general purpose model systemic risk assess mitigate possible systemic risk union level including source may stem development placing market use general purpose model systemic risk keep track document report without undue delay office appropriate national competent authority relevant information serious incident possible corrective measure address keep track document report without undue delay office appropriate national competent authority relevant information serious incident possible corrective measure address ensure adequate level cybersecurity protection general purpose model systemic risk physical infrastructure model ensure adequate level cybersecurity protection general purpose model systemic risk physical infrastructure model provider general purpose model systemic risk may rely code practice within meaning article demonstrate compliance obligation set paragraph article harmonised standard published compliance european harmonised standard grant provider presumption conformity extent standard cover obligation provider general purpose model systemic risk adhere approved code practice comply european harmonised standard shall demonstrate alternative adequate mean compliance assessment commission information documentation obtained pursuant article including trade secret shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
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