CELEX ID: 32024R1689

--- ENGLISH ---

Document:
Official Journal 
of the European Union
EN
L series
2024/1689
12.7.2024
REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 June 2024
laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee 
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,
Having regard to the opinion of the European Central Bank 
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,
Having regard to the opinion of the Committee of the Regions 
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,
Acting in accordance with the ordinary legislative procedure 
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,
Whereas:
(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 
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, and it ensures the protection of ethical principles, as specifically requested by the European Parliament 
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(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 
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, Decision No 768/2008/EC of the European Parliament and of the Council 
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 and Regulation (EU) 2019/1020 of the European Parliament and of the Council 
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 (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 
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 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 
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 and (EU) 2018/1725 
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 of the European Parliament and of the Council and Directive (EU) 2016/680 of the European Parliament and of the Council 
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. Directive 2002/58/EC of the European Parliament and of the Council 
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 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 
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(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 
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, 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 
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, 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 
(
18
)
, 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 
(
19
)
, 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 as 
lex specialis
 in 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’ 
(
20
)
, the general rule is that more than one legal act of Union harmonisation legislation, such as Regulations (EU) 2017/745 
(
21
)
 and (EU) 2017/746 
(
22
)
 of the European Parliament and of the Council or Directive 2006/42/EC of the European Parliament and of the Council 
(
23
)
, 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 
(
24
)
, Regulation (EU) No 167/2013 of the European Parliament and of the Council 
(
25
)
, Regulation (EU) No 168/2013 of the European Parliament and of the Council 
(
26
)
, Directive 2014/90/EU of the European Parliament and of the Council 
(
27
)
, Directive (EU) 2016/797 of the European Parliament and of the Council 
(
28
)
, Regulation (EU) 2018/858 of the European Parliament and of the Council 
(
29
)
, Regulation (EU) 2018/1139 of the European Parliament and of the Council 
(
30
)
, and Regulation (EU) 2019/2144 of the European Parliament and of the Council 
(
31
)
, 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 vitro
 diagnostic 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 check 
ex post
 whether 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 
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, the Directive 2013/32/EU of the European Parliament and of the Council 
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, 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 
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, 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 
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 and 2014/32/EU 
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 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 
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, 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 
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 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 
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, 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 
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(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 
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, 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 the 
Official Journal of the European Union
 should 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 
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 and (EU) 2023/2854 
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 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 
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 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 
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 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 
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 and Directives 2008/48/EC 
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, 2009/138/EC 
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, 2013/36/EU 
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, 2014/17/EU 
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 and (EU) 2016/97 
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 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 our 
ex post
 market 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 
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, 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 apply 
mutatis 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 apply 
mutatis 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 
(
53
)
 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 the 
ne bis in idem
 principle. 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 
(
54
)
 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 
(
55
)
. 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 
(
56
)
.
(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,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter`
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;
(b)
prohibitions of certain AI practices;
(c)
specific requirements for high-risk AI systems and obligations for operators of such systems;
(d)
harmonised transparency rules for certain AI systems;
(e)
harmonised rules for the placing on the market of general-purpose AI models;
(f)
rules on market monitoring, market surveillance, governance and enforcement;
(g)
measures to support innovation, with a particular focus on SMEs, including start-ups.
Article 2
Scope
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;
(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;
(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;
(f)
authorised representatives of providers, which are not established 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.
Article 3
Definitions
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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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;
(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.
Article 4
AI literacy
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.
CHAPTER II
PROHIBITED AI PRACTICES
Article 5
Prohibited AI practices
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;
(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;
(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;
(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;
(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.
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;
(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.
CHAPTER III
HIGH-RISK AI SYSTEMS
SECTION 1
Classification of AI systems as high-risk
Article 6
Classification rules for high-risk AI systems
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;
(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;
(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
(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.
Article 7
Amendments to Annex III
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;
(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;
(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;
(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;
(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;
(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;
(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.
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;
(b)
the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
SECTION 2
Requirements for high-risk AI systems
Article 8
Compliance with the requirements
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.
Article 9
Risk management system
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;
(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;
(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;
(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.
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.
Article 10
Data and data governance
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;
(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;
(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;
(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);
(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;
(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;
(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;
(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.
Article 11
Technical documentation
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.
Article 12
Record-keeping
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;
(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).
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);
(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;
(d)
the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
Article 13
Transparency and provision of information to deployers
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;
(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;
(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;
(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.
Article 14
Human oversight
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;
(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;
(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;
(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.
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.
Article 15
Accuracy, robustness and cybersecurity
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.
SECTION 3
Obligations of providers and deployers of high-risk AI systems and other parties
Article 16
Obligations of providers of high-risk AI systems
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;
(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;
(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;
(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;
(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);
(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;
(l)
ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
Article 17
Quality management system
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;
(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;
(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;
(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;
(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;
(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;
(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.
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.
Article 18
Documentation keeping
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;
(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;
(d)
the decisions and other documents issued by the notified bodies, where applicable;
(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.
Article 19
Automatically generated logs
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.
Article 20
Corrective actions and duty of information
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.
Article 21
Cooperation with competent authorities
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.
Article 22
Authorised representatives of providers of high-risk AI systems
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;
(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;
(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.
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.
Article 23
Obligations of importers
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;
(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;
(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.
Article 24
Obligations of distributors
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.
Article 25
Responsibilities along the AI value chain
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;
(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.
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;
(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.
Article 26
Obligations of deployers of high-risk AI systems
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 apply 
mutatis 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.
Article 27
Fundamental rights impact assessment for high-risk AI systems
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;
(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;
(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;
(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.
SECTION 4
Notifying authorities and notified bodies
Article 28
Notifying authorities
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.
Article 29
Application of a conformity assessment body for notification
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.
Article 30
Notification procedure
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.
Article 31
Requirements relating to notified bodies
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.
Article 32
Presumption of conformity with requirements relating to notified bodies
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 the 
Official 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.
Article 33
Subsidiaries of notified bodies and subcontracting
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.
Article 34
Operational obligations of notified bodies
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.
Article 35
Identification numbers and lists of notified bodies
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.
Article 36
Changes to notifications
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;
(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;
(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.
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
(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
(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.
Article 37
Challenge to the competence of notified bodies
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).
Article 38
Coordination of notified bodies
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.
Article 39
Conformity assessment bodies of third countries
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.
SECTION 5
Standards, conformity assessment, certificates, registration
Article 40
Harmonised standards and standardisation deliverables
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 the 
Official Journal of the European Union
 in 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.
Article 41
Common specifications
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
(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 the 
Official Journal of the European Union
 in 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 the 
Official 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 the 
Official 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.
Article 42
Presumption of conformity with certain requirements
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 the 
Official Journal of the European Union
 shall 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.
Article 43
Conformity assessment
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
(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;
(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;
(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.
Article 44
Certificates
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.
Article 45
Information obligations of notified bodies
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;
(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;
(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.
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;
(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.
Article 46
Derogation from conformity assessment procedure
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.
Article 47
EU declaration of conformity
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.
Article 48
CE marking
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.
Article 49
Registration
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;
(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;
(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.
CHAPTER IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS
Article 50
Transparency obligations for providers and deployers of certain AI systems
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).
CHAPTER V
GENERAL-PURPOSE AI MODELS
SECTION 1
Classification rules
Article 51
Classification of general-purpose AI models as general-purpose AI models with systemic risk
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;
(b)
based on a decision of the Commission, 
ex officio
 or 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
25
.
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.
Article 52
Procedure
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 officio
 or 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.
SECTION 2
Obligations for providers of general-purpose AI models
Article 53
Obligations for providers of general-purpose AI models
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;
(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;
(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.
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.
Article 54
Authorised representatives of providers of general-purpose AI models
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;
(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;
(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.
SECTION 3
Obligations of providers of general-purpose AI models with systemic risk
Article 55
Obligations of providers of general-purpose AI models with systemic risk
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;
(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;
(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.
SECTION 4
Codes of practice
Article 56
Codes of practice
1.   The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches.
2.   The AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in Articles 53 and 55, including the following issues:
(a)
the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments;
(b)
the adequate level of detail for the summary about the content used for training;
(c)
the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
(d)
the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain.
3.   The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent authorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other relevant stakeholders, such as downstream providers and independent experts, may support the process.
4.   The AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and contain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of those objectives, and that they take due account of the needs and interests of all interested parties, including affected persons, at Union level.
5.   The AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the implementation of the commitments and the measures taken and their outcomes, including as measured against the key performance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in size and capacity between various participants.
6.   The AI Office and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The AI Office and the Board shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy of the codes of practice.
The Commission may, by way of an implementing act, approve a code of practice and give it a general validity within the Union. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7.   The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in Article 53, unless they declare explicitly their interest to join the full code.
8.   The AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in particular in light of emerging standards. The AI Office shall assist in the assessment of available standards.
9.   Codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including inviting providers pursuant to paragraph 7.
If, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its assessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
CHAPTER VI
MEASURES IN SUPPORT OF INNOVATION
Article 57
AI regulatory sandboxes
1.   Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes.
The obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that participation provides an equivalent level of national coverage for the participating Member States.
2.   Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of other Member States may also be established.
3.   The European Data Protection Supervisor may also establish an AI regulatory sandbox for Union institutions, bodies, offices and agencies, and may exercise the roles and the tasks of national competent authorities in accordance with this Chapter.
4.   Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient resources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities shall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem. This Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities.
5.   AI regulatory sandboxes established under paragraph 1 shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authority. Such sandboxes may include testing in real world conditions supervised therein.
6.   Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory sandbox with a view to identifying risks, in particular to fundamental rights, health and safety, testing, mitigation measures, and their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union and national law supervised within the sandbox.
7.   Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.
Upon request of the provider or prospective provider of the AI system, the competent authority shall provide a written proof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report detailing the activities carried out in the sandbox and the related results and learning outcomes. Providers may use such documentation to demonstrate their compliance with this Regulation through the conformity assessment process or relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national competent authority shall be taken positively into account by market surveillance authorities and notified bodies, with a view to accelerating conformity assessment procedures to a reasonable extent.
8.   Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider, the Commission and the Board shall be authorised to access the exit reports and shall take them into account, as appropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national competent authority explicitly agree, the exit report may be made publicly available through the single information platform referred to in this Article.
9.   The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:
(a)
improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and national law;
(b)
supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;
(c)
fostering innovation and competitiveness and facilitating the development of an AI ecosystem;
(d)
contributing to evidence-based regulatory learning;
(e)
facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups.
10.   National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers.
11.   The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities supervising the sandboxes, including at regional or local level. Any significant risks to health and safety and fundamental rights identified during the development and testing of such AI systems shall result in an adequate mitigation. National competent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation in the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision. National competent authorities shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers when implementing legal provisions in respect of a specific AI regulatory sandbox project, with the objective of supporting innovation in AI in the Union.
12.   Providers and prospective providers participating in the AI regulatory sandbox shall remain liable under applicable Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective providers observe the specific plan and the terms and conditions for their participation and follow in good faith the guidance given by the national competent authority, no administrative fines shall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for other Union and national law were actively involved in the supervision of the AI system in the sandbox and provided guidance for compliance, no administrative fines shall be imposed regarding that law.
13.   The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate cross-border cooperation between national competent authorities.
14.   National competent authorities shall coordinate their activities and cooperate within the framework of the Board.
15.   National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may ask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.
16.   National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after the establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those reports shall provide information on the progress and results of the implementation of those sandboxes, including best practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible revision of this Regulation, including its delegated and implementing acts, and on the application of other Union law supervised by the competent authorities within the sandbox. The national competent authorities shall make those annual reports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising its tasks under this Regulation.
17.   The Commission shall develop a single and dedicated interface containing all relevant information related to AI regulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with national competent authorities, where relevant.
Article 58
Detailed arrangements for, and functioning of, AI regulatory sandboxes
1.   In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the detailed arrangements for the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. The implementing acts shall include common principles on the following issues:
(a)
eligibility and selection criteria for participation in the AI regulatory sandbox;
(b)
procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox, including the sandbox plan and the exit report;
(c)
the terms and conditions applicable to the participants.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2.   The implementing acts referred to in paragraph 1 shall ensure:
(a)
that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform applicants of their decision within three months of the application;
(b)
that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and prospective providers may also submit applications in partnerships with deployers and other relevant third parties;
(c)
that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
(d)
that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;
(e)
that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application of the codes of conduct referred to in Article 95;
(f)
that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence, individual researchers, in order to allow and facilitate cooperation with the public and private sectors;
(g)
that procedures, processes and administrative requirements for application, selection, participation and exiting the AI regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the Union;
(h)
that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project and that may be extended by the national competent authority;
(i)
that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
3.   Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups, shall be directed, where relevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding services such as help with standardisation documents and certification, testing and experimentation facilities, European Digital Innovation Hubs and centres of excellence.
4.   Where national competent authorities consider authorising testing in real world conditions supervised within the framework of an AI regulatory sandbox to be established under this Article, they shall specifically agree the terms and conditions of such testing and, in particular, the appropriate safeguards with the participants, with a view to protecting fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities with a view to ensuring consistent practices across the Union.
Article 59
Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
1.   In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:
(a)
AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or legal person and in one or more of the following areas:
(i)
public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems;
(ii)
a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection against pollution, green transition measures, climate change mitigation and adaptation measures;
(iii)
energy sustainability;
(iv)
safety and resilience of transport systems and mobility, critical infrastructure and networks;
(v)
efficiency and quality of public administration and public services;
(b)
the data processed are necessary for complying with one or more of the requirements referred to in Chapter III, Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other non-personal data;
(c)
there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where necessary, stop the processing;
(d)
any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the prospective provider and only authorised persons have access to those data;
(e)
providers can further share the originally collected data only in accordance with Union data protection law; any personal data created in the sandbox cannot be shared outside the sandbox;
(f)
any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;
(g)
any personal data processed in the context of the sandbox are protected by means of appropriate technical and organisational measures and deleted once the participation in the sandbox has terminated or the personal data has reached the end of its retention period;
(h)
the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in the sandbox, unless provided otherwise by Union or national law;
(i)
a complete and detailed description of the process and rationale behind the training, testing and validation of the AI system is kept together with the testing results as part of the technical documentation referred to in Annex IV;
(j)
a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the website of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
2.   For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security, under the control and responsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.
3.   Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data for other purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the processing of personal data which is necessary for the purpose of developing, testing or training of innovative AI systems or any other legal basis, in compliance with Union law on the protection of personal data.
Article 60
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
1.   Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.
The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
This paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI systems related to products covered by Union harmonisation legislation listed in Annex I.
2.   Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world conditions at any time before the placing on the market or the putting into service of the AI system on their own or in partnership with one or more deployers or prospective deployers.
3.   The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical review that is required by Union or national law.
4.   Providers or prospective providers may conduct the testing in real world conditions only where all of the following conditions are met:
(a)
the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted;
(b)
the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be understood to have been approved; where national law does not provide for a tacit approval, the testing in real world conditions shall remain subject to an authorisation;
(c)
the provider or prospective provider, with the exception of providers or prospective providers of 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, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the information specified in Annex IX; the provider or prospective provider of 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, has registered the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point (d), with a Union-wide unique single identification number and with the information specified therein; the provider or prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world conditions in accordance with Article 49(5);
(d)
the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;
(e)
data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented;
(f)
the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months, which may be extended for an additional period of six months, subject to prior notification by the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need for such an extension;
(g)
the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;
(h)
where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions under this Regulation and under other applicable Union and national law;
(i)
the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed;
(j)
the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;
(k)
the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
5.   Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out.
6.   In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world conditions.
7.   Any serious incident identified in the course of the testing in real world conditions shall be reported to the national market surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or otherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI system upon such termination of the testing in real world conditions.
8.   Providers or prospective providers shall notify the national market surveillance authority in the Member State where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and of the final outcomes.
9.   The provider or prospective provider shall be liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions.
Article 61
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
1.   For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:
(a)
the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
(b)
the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
(c)
their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;
(d)
the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
(e)
the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.
2.   The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.
Article 62
Measures for providers and deployers, in particular SMEs, including start-ups
1.   Member States shall undertake the following actions:
(a)
provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;
(b)
organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of SMEs including start-ups, deployers and, as appropriate, local public authorities;
(c)
utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;
(d)
facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.
2.   The specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other relevant indicators.
3.   The AI Office shall undertake the following actions:
(a)
provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;
(b)
develop and maintain a single information platform providing easy to use information in relation to this Regulation for all operators across the Union;
(c)
organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;
(d)
evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.
Article 63
Derogations for specific operators
1.   Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of that Recommendation. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of microenterprises, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.
2.   Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.
CHAPTER VII
GOVERNANCE
SECTION 1
Governance at Union level
Article 64
AI Office
1.   The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
2.   Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
Article 65
Establishment and structure of the European Artificial Intelligence Board
1.   A European Artificial Intelligence Board (the ‘Board’) is hereby established.
2.   The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the issues discussed are of relevance for them.
3.   Each representative shall be designated by their Member State for a period of three years, renewable once.
4.   Member States shall ensure that their representatives on the Board:
(a)
have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66;
(b)
are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;
(c)
are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.
5.   The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the Board’s activities and those of its sub-groups.
6.   The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively.
The standing sub-group 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.
The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups or to specific meetings of those subgroups as observers.
7.   The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
8.   The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and its rules of procedure.
Article 66
Tasks of the Board
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular:
(a)
contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11);
(b)
collect and share technical and regulatory expertise and best practices among Member States;
(c)
provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models;
(d)
contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(e)
at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including:
(i)
on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines;
(ii)
the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I;
(iii)
on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
(iv)
on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(v)
trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills;
(vi)
trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;
(vii)
on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(f)
support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;
(g)
facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks;
(h)
cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection;
(i)
contribute to effective cooperation with the competent authorities of third countries and with international organisations;
(j)
assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation;
(k)
assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(l)
contribute to, and provide relevant advice on, the development of guidance documents;
(m)
advise the Commission in relation to international matters on AI;
(n)
provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(o)
receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.
Article 67
Advisory forum
1.   An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation.
2.   The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other undertakings.
3.   The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in paragraph 2, from amongst stakeholders with recognised expertise in the field of AI.
4.   The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more than four years.
5.   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) shall be permanent members of the advisory forum.
6.   The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.
7.   The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other stakeholders to its meetings.
8.   The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or the Commission.
9.   The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.
10.   The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.
Article 68
Scientific panel of independent experts
1.   The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2.   The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions:
(a)
having particular expertise and competence and scientific or technical expertise in the field of AI;
(b)
independence from any provider of AI systems or general-purpose AI models;
(c)
an ability to carry out activities diligently, accurately and objectively.
The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with the required needs and shall ensure fair gender and geographical representation.
3.   The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:
(a)
supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by:
(i)
alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90;
(ii)
contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks;
(iii)
providing advice on the classification of general-purpose AI models with systemic risk;
(iv)
providing advice on the classification of various general-purpose AI models and systems;
(v)
contributing to the development of tools and templates;
(b)
supporting the work of market surveillance authorities, at their request;
(c)
supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities;
(d)
supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81.
4.   The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
5.   The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the performance of the tasks of the scientific panel.
Article 69
Access to the pool of experts by the Member States
1.   Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation.
2.   The Member States may be required to pay fees for the advice and support provided by the experts. The structure and the level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in Article 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and the necessity of ensuring effective access to experts for all Member States.
3.   The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to this Article is efficiently organised and provides the best possible added value.
SECTION 2
National competent authorities
Article 70
Designation of national competent authorities and single points of contact
1.   Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be performed by one or more designated authorities, in accordance with the organisational needs of the Member State.
2.   Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single points of contact can be contacted, through electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact. The Commission shall make a list of the single points of contact publicly available.
3.   Member States shall ensure that their national competent authorities are provided with adequate technical, financial and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of AI technologies, data and data computing, personal data protection, cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements. Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on an annual basis.
4.   National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.
5.   When performing their tasks, the national competent authorities shall act in accordance with the confidentiality obligations set out in Article 78.
6.   By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The Commission shall transmit that information to the Board for discussion and possible recommendations.
7.   The Commission shall facilitate the exchange of experience between national competent authorities.
8.   National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as appropriate.
9.   Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.
CHAPTER VIII
EU DATABASE FOR HIGH-RISK AI SYSTEMS
Article 71
EU database for high-risk AI systems listed in Annex III
1.   The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional specifications of such database, the Commission shall consult the relevant experts, and when updating the functional specifications of such database, the Commission shall consult the Board.
2.   The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where applicable, by the authorised representative.
3.   The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4).
4.   With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in the EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner. The information should be easily navigable and machine-readable. The information registered in accordance with Article 60 shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for also making the information accessible the public.
5.   The EU database shall contain personal data only in so far as necessary for collecting and processing information in accordance with this Regulation. That information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable.
6.   The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility requirements.
CHAPTER IX
POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
SECTION 1
Post-market monitoring
Article 72
Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
1.   Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system.
2.   The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities.
3.   The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
4.   For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection.
The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes.
SECTION 2
Sharing of information on serious incidents
Article 73
Reporting of serious incidents
1.   Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
2.   The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
3.   Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
4.   Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.
5.   Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.
6.   Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action.
The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
7.   Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly.
8.   The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation.
9.   For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
10.   For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.
11.   National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.
SECTION 3
Enforcement
Article 74
Market surveillance and control of AI systems in the Union market
1.   Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
(a)
any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(b)
any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
2.   As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
3.   For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
4.   The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
5.   Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6.   For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services.
7.   By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by 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 prudential supervisory tasks of the European Central Bank specified in that Regulation.
8.   For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
9.   Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
10.   Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
11.   Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or 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 in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations.
12.   Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
13.   Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled:
(a)
access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(b)
testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
14.   Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.
Article 75
Mutual assistance, market surveillance and control of general-purpose AI systems
1.   Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and Regulation (EU) 2019/1020.
2.   Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
3.   Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall apply 
mutatis mutandis
.
Article 76
Supervision of testing in real world conditions by market surveillance authorities
1.   Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation.
2.   Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article 60(4), points (f) and (g).
3.   Where a market surveillance authority has been informed by the prospective provider, the provider or any third party of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate:
(a)
to suspend or terminate the testing in real world conditions;
(b)
to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
4.   Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the provider or prospective provider can challenge the decision or objection.
5.   Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system has been tested in accordance with the testing plan.
Article 77
Powers of authorities protecting fundamental rights
1.   National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation created or maintained under this Regulation in accessible language and format when access to that documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance authority of the Member State concerned of any such request.
2.   By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member States, and shall keep the list up to date.
3.   Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI system through technical means. The market surveillance authority shall organise the testing with the close involvement of the requesting public authority or body within a reasonable time following the request.
4.   Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
Article 78
Confidentiality
1.   The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
(a)
the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council 
(
57
)
;
(b)
the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(c)
public and national security interests;
(d)
the conduct of criminal or administrative proceedings;
(e)
information classified pursuant to Union or national law.
2.   The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3.   Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national competent authorities or between national competent authorities and the Commission shall not be disclosed without prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or any copy thereof.
4.   Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned to provide information under criminal law of the Member States.
5.   The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of international and trade agreements, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.
Article 79
Procedure at national level for dealing with AI systems presenting a risk
1.   AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
2.   Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other national public authorities or bodies referred to in Article 77(1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.
The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
3.   Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
4.   The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
5.   Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures.
6.   The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following:
(a)
non-compliance with the prohibition of the AI practices referred to in Article 5;
(b)
a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(c)
shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
(d)
non-compliance with Article 50.
7.   The market surveillance authorities other than the market surveillance authority of the Member State initiating the procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.
8.   Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
9.   The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.
Article 80
Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
1.   Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article 6(3) and the Commission guidelines.
2.   Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action within a period the market surveillance authority may prescribe.
3.   Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the provider to take.
4.   The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this Article, the provider shall be subject to fines in accordance with Article 99.
5.   The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
6.   Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
7.   Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
8.   In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular information stored in the EU database referred to in Article 71 of this Regulation.
Article 81
Union safeguard procedure
1.   Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of its decision.
2.   Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure and shall inform the Commission accordingly.
3.   Where the national measure is considered justified and the non-compliance of the AI system is attributed to shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Article 82
Compliant AI systems which present a risk
1.   Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue delay, within a period it may prescribe.
2.   The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market within the timeline prescribed by the market surveillance authority of the Member State referred to in paragraph 1.
3.   The Member States shall immediately inform the Commission and the other Member States of a finding under paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken.
4.   The Commission shall without undue delay enter into consultation with the Member States concerned and the relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.
5.   The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform the other Member States.
Article 83
Formal non-compliance
1.   Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:
(a)
the CE marking has been affixed in violation of Article 48;
(b)
the CE marking has not been affixed;
(c)
the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d)
the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e)
the registration in the EU database referred to in Article 71 has not been carried out;
(f)
where applicable, no authorised representative has been appointed;
(g)
technical documentation is not available.
2.   Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.
Article 84
Union AI testing support structures
1.   The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
2.   Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.
SECTION 4
Remedies
Article 85
Right to lodge a complaint with a market surveillance authority
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority.
In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market surveillance authorities.
Article 86
Right to explanation of individual decision-making
1.   Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI system in the decision-making procedure and the main elements of the decision taken.
2.   Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under that paragraph follow from Union or national law in compliance with Union law.
3.   This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under Union law.
Article 87
Reporting of infringements and protection of reporting persons
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
SECTION 5
Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models
Article 88
Enforcement of the obligations of providers of general-purpose AI models
1.   The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of competences between Member States and the Union based on the Treaties.
2.   Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under this Regulation.
Article 89
Monitoring actions
1.   For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice.
2.   Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation. A complaint shall be duly reasoned and indicate at least:
(a)
the point of contact of the provider of the general-purpose AI model concerned;
(b)
a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(c)
any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.
Article 90
Alerts of systemic risks by the scientific panel
1.   The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:
(a)
a general-purpose AI model poses concrete identifiable risk at Union level; or
(b)
a general-purpose AI model meets the conditions referred to in Article 51.
2.   Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any measure according to Articles 91 to 94.
3.   A qualified alert shall be duly reasoned and indicate at least:
(a)
the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(b)
a description of the relevant facts and the reasons for the alert by the scientific panel;
(c)
any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.
Article 91
Power to request documentation and information
1.   The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation.
2.   Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
3.   Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment of the tasks of the scientific panel under Article 68(2).
4.   The request for information shall state the legal basis and the purpose of the request, specify what information is required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for supplying incorrect, incomplete or misleading information.
5.   The provider of the general-purpose AI model concerned, or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.
Article 92
Power to conduct evaluations
1.   The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:
(a)
to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or
(b)
to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
2.   The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria outlined in Article 68(2).
3.   For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools, including source code.
4.   The request for access shall state the legal basis, the purpose and reasons of the request and set the period within which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
5.   The providers of the general-purpose AI model concerned or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the general-purpose AI model concerned.
6.   The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7.   Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate such risks.
Article 93
Power to request measures
1.   Where necessary and appropriate, the Commission may request providers to:
(a)
take appropriate measures to comply with the obligations set out in Articles 53 and 54;
(b)
implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;
(c)
restrict the making available on the market, withdraw or recall the model.
2.   Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
3.   If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.
Article 94
Procedural rights of economic operators of the general-purpose AI model
Article 18 of Regulation (EU) 2019/1020 shall apply 
mutatis mutandis
 to the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
CHAPTER X
CODES OF CONDUCT AND GUIDELINES
Article 95
Codes of conduct for voluntary application of specific requirements
1.   The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and industry best practices allowing for the application of such requirements.
2.   The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators to measure the achievement of those objectives, including elements such as, but not limited to:
(a)
applicable elements provided for in Union ethical guidelines for trustworthy AI;
(b)
assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI;
(c)
promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;
(d)
facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse development teams and the promotion of stakeholders’ participation in that process;
(e)
assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons, including as regards accessibility for persons with a disability, as well as on gender equality.
3.   Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations representing them or by both, including with the involvement of any interested stakeholders and their representative organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems.
4.   The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, when encouraging and facilitating the drawing up of codes of conduct.
Article 96
Guidelines from the Commission on the implementation of this Regulation
1.   The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:
(a)
the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;
(b)
the prohibited practices referred to in Article 5;
(c)
the practical implementation of the provisions related to substantial modification;
(d)
the practical implementation of transparency obligations laid down in Article 50;
(e)
detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement;
(f)
the application of the definition of an AI system as set out in Article 3, point (1).
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of local public authorities and of the sectors most likely to be affected by this Regulation.
The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union harmonisation law.
2.   At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.
CHAPTER XI
DELEGATION OF POWER AND COMMITTEE PROCEDURE
Article 97
Exercise of the delegation
1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.   The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for a period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3.   The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the 
Official Journal of the European Union
 or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6.   Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Article 98
Committee procedure
1.   The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
CHAPTER XII
PENALTIES
Article 99
Penalties
1.   In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs, including start-ups, and their economic viability.
2.   The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them.
3.   Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
4.   Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:
(a)
obligations of providers pursuant to Article 16;
(b)
obligations of authorised representatives pursuant to Article 22;
(c)
obligations of importers pursuant to Article 23;
(d)
obligations of distributors pursuant to Article 24;
(e)
obligations of deployers pursuant to Article 26;
(f)
requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
(g)
transparency obligations for providers and deployers pursuant to Article 50.
5.   The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
6.   In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
7.   When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following:
(a)
the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(b)
whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;
(c)
whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;
(d)
the size, the annual turnover and market share of the operator committing the infringement;
(e)
any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;
(f)
the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;
(g)
the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it;
(h)
the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;
(i)
the intentional or negligent character of the infringement;
(j)
any action taken by the operator to mitigate the harm suffered by the affected persons.
8.   Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.
9.   Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.
10.   The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process.
11.   Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.
Article 100
Administrative fines on Union institutions, bodies, offices and agencies
1.   The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:
(a)
the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(b)
the degree of responsibility of the Union institution, body, office or agency, taking into account technical and organisational measures implemented by them;
(c)
any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;
(d)
the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned with regard to the same subject matter;
(e)
any similar previous infringements by the Union institution, body, office or agency;
(f)
the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;
(g)
the annual budget of the Union institution, body, office or agency.
2.   Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 1 500 000.
3.   The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Article 5, shall be subject to administrative fines of up to EUR 750 000.
4.   Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned have been able to comment. Complainants, if any, shall be associated closely with the proceedings.
5.   The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets.
6.   Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines shall not affect the effective operation of the Union institution, body, office or agency fined.
7.   The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.
Article 101
Fines for providers of general-purpose AI models
1.   The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds that the provider intentionally or negligently:
(a)
infringed the relevant provisions of this Regulation;
(b)
failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect, incomplete or misleading information;
(c)
failed to comply with a measure requested under Article 93;
(d)
failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with systemic risk with a view to conducting an evaluation pursuant to Article 92.
In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with Article 56.
2.   Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to the provider of the general-purpose AI model and give it an opportunity to be heard.
3.   Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
4.   Information on fines imposed under this Article shall also be communicated to the Board as appropriate.
5.   The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission fixing a fine under this Article. It may cancel, reduce or increase the fine imposed.
6.   The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for proceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
CHAPTER XIII
FINAL PROVISIONS
Article 102
Amendment to Regulation (EC) No 300/2008
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:
‘When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
Article 103
Amendment to Regulation (EU) No 167/2013
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
Article 104
Amendment to Regulation (EU) No 168/2013
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
Article 105
Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added:
‘5.   For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, when carrying out its activities pursuant to paragraph 1 and when adopting technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.
Article 106
Amendment to Directive (EU) 2016/797
In Article 5 of Directive (EU) 2016/797, the following paragraph is added:
‘12.   When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
Article 107
Amendment to Regulation (EU) 2018/858
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:
‘4.   When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
Article 108
Amendments to Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is amended as follows:
(1)
in Article 17, the following paragraph is added:
‘3.   Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(
*
)
  Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (
OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj
).’;"
(2)
in Article 19, the following paragraph is added:
‘4.   When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
;
(3)
in Article 43, the following paragraph is added:
‘4.   When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
;
(4)
in Article 47, the following paragraph is added:
‘3.   When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
;
(5)
in Article 57, the following subparagraph is added:
‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
;
(6)
in Article 58, the following paragraph is added:
‘3.   When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.
Article 109
Amendment to Regulation (EU) 2019/2144
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:
‘3.   When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council
 (
*
)
, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
Article 110
Amendment to Directive (EU) 2020/1828
In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council 
(
58
)
, the following point is added:
‘(68)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (
OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj
).’.
Article 111
AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
1.   Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.
The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts are replaced or amended.
2.   Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before 2 August 2026, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations of this Regulation by 2 August 2030.
3.   Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.
Article 112
Evaluation and review
1.   The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council.
2.   By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the following:
(a)
the need for amendments extending existing area headings or adding new area headings in Annex III;
(b)
amendments to the list of AI systems requiring additional transparency measures in Article 50;
(c)
amendments enhancing the effectiveness of the supervision and governance system.
3.   By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The reports shall be made public.
4.   The reports referred to in paragraph 2 shall pay specific attention to the following:
(a)
the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;
(b)
the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;
(c)
adopted harmonised standards and common specifications developed to support this Regulation;
(d)
the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.
5.   By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council.
6.   By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the European Parliament and to the Council, and it shall be made public.
7.   By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems, including as regards environmental sustainability.
8.   For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay.
9.   In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
10.   The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society.
11.   To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in:
(a)
the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;
(b)
the list of prohibited practices set out in Article 5; and
(c)
the list of AI systems requiring additional transparency measures pursuant to Article 50.
12.   Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein.
13.   By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for a Union agency to resolve any identified shortcomings.
Article 113
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the 
Official Journal of the European Union
.
It shall apply from 2 August 2026.
However:
(a)
Chapters I and II shall apply from 2 February 2025;
(b)
Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;
(c)
Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 June 2024.
For the European Parliament
The President
R. METSOLA
For the Council
The President
M. MICHEL
(
1
)
  
            
OJ C 517, 22.12.2021, p. 56
.
(
2
)
  
            
OJ C 115, 11.3.2022, p. 5
.
(
3
)
  
            
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.
(
4
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(
5
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(
6
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).
(
8
)
  Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (
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).
(
9
)
  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (
OJ L 169, 25.6.2019, p. 1
).
(
10
)
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).
(
11
)
  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (
OJ L 119, 4.5.2016, p. 1
).
(
12
)
  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (
OJ L 295, 21.11.2018, p. 39
).
(
13
)
  Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (
OJ L 119, 4.5.2016, p. 89
).
(
14
)
  Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (
OJ L 201, 31.7.2002, p. 37
).
(
15
)
  Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (
OJ L 277, 27.10.2022, p. 1
).
(
16
)
  Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (
OJ L 151, 7.6.2019, p. 70
).
(
17
)
  Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (
OJ L 149, 11.6.2005, p. 22
).
(
18
)
  Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (
OJ L 190, 18.7.2002, p. 1
).
(
19
)
  Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of critical entities and repealing Council Directive 2008/114/EC (
OJ L 333, 27.12.2022, p. 164
).
(
20
)
  
            
OJ C 247, 29.6.2022, p. 1
.
(
21
)
  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (
OJ L 117, 5.5.2017, p. 1
).
(
22
)
  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on 
in vitro
 diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (
OJ L 117, 5.5.2017, p. 176
).
(
23
)
  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (
OJ L 157, 9.6.2006, p. 24
).
(
24
)
  Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (
OJ L 97, 9.4.2008, p. 72
).
(
25
)
  Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (
OJ L 60, 2.3.2013, p. 1
).
(
26
)
  Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (
OJ L 60, 2.3.2013, p. 52
).
(
27
)
  Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (
OJ L 257, 28.8.2014, p. 146
).
(
28
)
  Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (
OJ L 138, 26.5.2016, p. 44
).
(
29
)
  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (
OJ L 151, 14.6.2018, p. 1
).
(
30
)
  Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (
OJ L 212, 22.8.2018, p. 1
).
(
31
)
  Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (
OJ L 325, 16.12.2019, p. 1
).
(
32
)
  Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (
OJ L 243, 15.9.2009, p. 1
).
(
33
)
  Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (
OJ L 180, 29.6.2013, p. 60
).
(
34
)
  Regulation (EU) 2024/900 of the European parliament and of the Council of 13 March 2024 on the transparency and targeting of political advertising (
OJ L, 2024/900, 20.3.2024, ELI: http://data.europa.eu/eli/reg/2024/900/oj
).
(
35
)
  Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (
OJ L 96, 29.3.2014, p. 107
).
(
36
)
  Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (
OJ L 96, 29.3.2014, p. 149
).
(
37
)
  Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (
OJ L 151, 7.6.2019, p. 15
).
(
38
)
  Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (
OJ L 327, 2.12.2016, p. 1
).
(
39
)
  Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community (
OJ L 80, 23.3.2002, p. 29
).
(
40
)
  Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (
OJ L 130, 17.5.2019, p. 92
).
(
41
)
  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (
OJ L 316, 14.11.2012, p. 12
).
(
42
)
  Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (
OJ L 152, 3.6.2022, p. 1
).
(
43
)
  Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (
OJ L, 2023/2854, 22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj
).
(
44
)
  Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (
OJ L 124, 20.5.2003, p. 36
).
(
45
)
  Commission Decision of 24.1.2024 establishing the European Artificial Intelligence Office C(2024) 390.
(
46
)
  Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (
OJ L 176, 27.6.2013, p. 1
).
(
47
)
  Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (
OJ L 133, 22.5.2008, p. 66
).
(
48
)
  Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (
OJ L 335, 17.12.2009, p. 1
).
(
49
)
  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (
OJ L 176, 27.6.2013, p. 338
).
(
50
)
  Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (
OJ L 60, 28.2.2014, p. 34
).
(
51
)
  Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016 on insurance distribution (
OJ L 26, 2.2.2016, p. 19
).
(
52
)
  Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (
OJ L 287, 29.10.2013, p. 63
).
(
53
)
  Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (
OJ L 135, 23.5.2023, p. 1
).
(
54
)
  Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (
OJ L 305, 26.11.2019, p. 17
).
(
55
)
  
            
OJ L 123, 12.5.2016, p. 1
.
(
56
)
  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (
OJ L 55, 28.2.2011, p. 13
).
(
57
)
  Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (
OJ L 157, 15.6.2016, p. 1
).
(
58
)
  Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (
OJ L 409, 4.12.2020, p. 1
).
ANNEX I
List of Union harmonisation legislation
Section A. List of Union harmonisation legislation based on the New Legislative Framework
1.
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (
OJ L 157, 9.6.2006, p. 24
);
2.
Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (
OJ L 170, 30.6.2009, p. 1
);
3.
Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (
OJ L 354, 28.12.2013, p. 90
);
4.
Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (
OJ L 96, 29.3.2014, p. 251
);
5.
Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (
OJ L 96, 29.3.2014, p. 309
);
6.
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (
OJ L 153, 22.5.2014, p. 62
);
7.
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (
OJ L 189, 27.6.2014, p. 164
);
8.
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (
OJ L 81, 31.3.2016, p. 1
);
9.
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (
OJ L 81, 31.3.2016, p. 51
);
10.
Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (
OJ L 81, 31.3.2016, p. 99
);
11.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (
OJ L 117, 5.5.2017, p. 1
);
12.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on 
in vitro
 diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (
OJ L 117, 5.5.2017, p. 176
).
Section B. List of other Union harmonisation legislation
13.
Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (
OJ L 97, 9.4.2008, p. 72
);
14.
Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (
OJ L 60, 2.3.2013, p. 52
);
15.
Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (
OJ L 60, 2.3.2013, p. 1
);
16.
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (
OJ L 257, 28.8.2014, p. 146
);
17.
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (
OJ L 138, 26.5.2016, p. 44
);
18.
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (
OJ L 151, 14.6.2018, p. 1
);
19.
Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (
OJ L 325, 16.12.2019, p. 1
);
20.
Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (
OJ L 212, 22.8.2018, p. 1
), in so far as the design, production and placing on the market of aircrafts referred to in Article 2(1), points (a) and (b) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.
ANNEX II
List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii):
—
terrorism,
—
trafficking in human beings,
—
sexual exploitation of children, and child pornography,
—
illicit trafficking in narcotic drugs or psychotropic substances,
—
illicit trafficking in weapons, munitions or explosives,
—
murder, grievous bodily injury,
—
illicit trade in human organs or tissue,
—
illicit trafficking in nuclear or radioactive materials,
—
kidnapping, illegal restraint or hostage-taking,
—
crimes within the jurisdiction of the International Criminal Court,
—
unlawful seizure of aircraft or ships,
—
rape,
—
environmental crime,
—
organised or armed robbery,
—
sabotage,
—
participation in a criminal organisation involved in one or more of the offences listed above.
ANNEX III
High-risk AI systems referred to in Article 6(2)
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:
1.
Biometrics, in so far as their use is permitted under relevant Union or national law:
(a)
remote biometric identification systems.
This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be;
(b)
AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;
(c)
AI systems intended to be used for emotion recognition.
2.
Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.
3.
Education and vocational training:
(a)
AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;
(b)
AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;
(c)
AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels;
(d)
AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.
4.
Employment, workers’ management and access to self-employment:
(a)
AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;
(b)
AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.
5.
Access to and enjoyment of essential private services and essential public services and benefits:
(a)
AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;
(b)
AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud;
(c)
AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance;
(d)
AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to 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.
6.
Law enforcement, in so far as their use is permitted under relevant Union or national law:
(a)
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 or on their behalf to assess the risk of a natural person becoming the victim of criminal offences;
(b)
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 as polygraphs or similar tools;
(c)
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 to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences;
(d)
AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;
(e)
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 the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.
7.
Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law:
(a)
AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools;
(b)
AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State;
(c)
AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence;
(d)
AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
8.
Administration of justice and democratic processes:
(a)
AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution;
(b)
AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.
ANNEX IV
Technical documentation referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system:
1.
A general description of the AI system including:
(a)
its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions;
(b)
how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI systems, that are not part of the AI system itself, where applicable;
(c)
the versions of relevant software or firmware, and any requirements related to version updates;
(d)
the description of all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads, or APIs;
(e)
the description of the hardware on which the AI system is intended to run;
(f)
where the AI system is a component of products, photographs or illustrations showing external features, the marking and internal layout of those products;
(g)
a basic description of the user-interface provided to the deployer;
(h)
instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable;
2.
A detailed description of the elements of the AI system and of the process for its development, including:
(a)
the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider;
(b)
the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key design choices including the rationale and assumptions made, including with regard to persons or groups of persons in respect of who, the system is intended to be used; the main classification choices; what the system is designed to optimise for, and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Chapter III, Section 2;
(c)
the description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing; the computational resources used to develop, train, test and validate the AI system;
(d)
where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including a general description of these data sets, information about their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures (e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);
(e)
assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in accordance with Article 13(3), point (d);
(f)
where applicable, a detailed description of pre-determined changes to the AI system and its performance, together with all the relevant information related to the technical solutions adopted to ensure continuous compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;
(g)
the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f);
(h)
cybersecurity measures put in place;
3.
Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to: its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of persons on which the system is intended to be used and the overall expected level of accuracy in relation to its intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights and discrimination in view of the intended purpose of the AI system; the human oversight measures needed in accordance with Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the deployers; specifications on input data, as appropriate;
4.
A description of the appropriateness of the performance metrics for the specific AI system;
5.
A detailed description of the risk management system in accordance with Article 9;
6.
A description of relevant changes made by the provider to the system through its lifecycle;
7.
A list of the harmonised standards applied in full or in part the references of which have been published in the 
Official Journal of the European Union
; where no such harmonised standards have been applied, a detailed description of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant standards and technical specifications applied;
8.
A copy of the EU declaration of conformity referred to in Article 47;
9.
A detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).
ANNEX V
EU declaration of conformity
The EU declaration of conformity referred to in Article 47, shall contain all of the following information:
1.
AI system name and type and any additional unambiguous reference allowing the identification and traceability of the AI system;
2.
The name and address of the provider or, where applicable, of their authorised representative;
3.
A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of the provider;
4.
A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
5.
Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;
6.
References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;
7.
Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued;
8.
The place and date of issue of the declaration, the name and function of the person who signed it, as well as an indication for, or on behalf of whom, that person signed, a signature.
ANNEX VI
Conformity assessment procedure based on internal control
1.
The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2, 3 and 4.
2.
The provider verifies that the established quality management system is in compliance with the requirements of Article 17.
3.
The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Chapter III, Section 2.
4.
The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 72 is consistent with the technical documentation.
ANNEX VII
Conformity based on an assessment of the quality management system and an assessment of the technical documentation
1.   Introduction
Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessment procedure based on points 2 to 5.
2.   Overview
The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5. The technical documentation of the AI system shall be examined in accordance with point 4.
3.   Quality management system
3.1.
The application of the provider shall include:
(a)
the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address;
(b)
the list of AI systems covered under the same quality management system;
(c)
the technical documentation for each AI system covered under the same quality management system;
(d)
the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;
(e)
a description of the procedures in place to ensure that the quality management system remains adequate and effective;
(f)
a written declaration that the same application has not been lodged with any other notified body.
3.2.
The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the requirements referred to in Article 17.
The decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.
3.3.
The quality management system as approved shall continue to be implemented and maintained by the provider so that it remains adequate and efficient.
3.4.
Any intended change to the approved quality management system or the list of AI systems covered by the latter shall be brought to the attention of the notified body by the provider.
The proposed changes shall be examined by the notified body, which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.
4.   Control of the technical documentation.
4.1.
In addition to the application referred to in point 3, an application with a notified body of their choice shall be lodged by the provider for the assessment of the technical documentation relating to the AI system which the provider intends to place on the market or put into service and which is covered by the quality management system referred to under point 3.
4.2.
The application shall include:
(a)
the name and address of the provider;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
the technical documentation referred to in Annex IV.
4.3.
The technical documentation shall be examined by the notified body. Where relevant, and limited to what is necessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical means and tools enabling remote access.
4.4.
In examining the technical documentation, the notified body may require that the provider supply further evidence or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the requirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by the provider, the notified body shall itself directly carry out adequate tests, as appropriate.
4.5.
Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III, Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets.
4.6.
The decision of the notified body shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment decision.
Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be evaluated, and to allow for control of the AI system while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the Union technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI system, in particular on the reasons for non-compliance.
4.7.
Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended purpose shall be assessed by the notified body which issued the Union technical documentation assessment certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed by the notified body, which shall decide whether those changes require a new conformity assessment in accordance with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the provider of its decision and, where the changes are approved, issue to the provider a supplement to the Union technical documentation assessment certificate.
5.   Surveillance of the approved quality management system.
5.1.
The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the provider duly complies with the terms and conditions of the approved quality management system.
5.2.
For assessment purposes, the provider shall allow the notified body to access the premises where the design, development, testing of the AI systems is taking place. The provider shall further share with the notified body all necessary information.
5.3.
The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality management system and shall provide the provider with an audit report. In the context of those audits, the notified body may carry out additional tests of the AI systems for which a Union technical documentation assessment certificate was issued.
ANNEX VIII
Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1)
The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 49(1):
1.
The name, address and contact details of the provider;
2.
Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;
3.
The name, address and contact details of the authorised representative, where applicable;
4.
The AI system trade name and any additional unambiguous reference allowing the identification and traceability of the AI system;
5.
A description of the intended purpose of the AI system and of the components and functions supported through this AI system;
6.
A basic and concise description of the information used by the system (data, inputs) and its operating logic;
7.
The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
8.
The type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, where applicable;
9.
A scanned copy of the certificate referred to in point 8, where applicable;
10.
Any Member States in which the AI system has been placed on the market, put into service or made available in the Union;
11.
A copy of the EU declaration of conformity referred to in Article 47;
12.
Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law enforcement or migration, asylum and border control management referred to in Annex III, points 1, 6 and 7;
13.
A URL for additional information (optional).
Section B — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(2)
The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in accordance with Article 49(2):
1.
The name, address and contact details of the provider;
2.
Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;
3.
The name, address and contact details of the authorised representative, where applicable;
4.
The AI system trade name and any additional unambiguous reference allowing the identification and traceability of the AI system;
5.
A description of the intended purpose of the AI system;
6.
The condition or conditions under Article 6(3)based on which the AI system is considered to be not-high-risk;
7.
A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the procedure under Article 6(3);
8.
The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
9.
Any Member States in which the AI system has been placed on the market, put into service or made available in the Union.
Section C — Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3)
The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 49(3):
1.
The name, address and contact details of the deployer;
2.
The name, address and contact details of the person submitting information on behalf of the deployer;
3.
The URL of the entry of the AI system in the EU database by its provider;
4.
A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27;
5.
A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in Article 26(8) of this Regulation, where applicable.
ANNEX IX
Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60
The following information shall be provided and thereafter kept up to date with regard to testing in real world conditions to be registered in accordance with Article 60:
1.
A Union-wide unique single identification number of the testing in real world conditions;
2.
The name and contact details of the provider or prospective provider and of the deployers involved in the testing in real world conditions;
3.
A brief description of the AI system, its intended purpose, and other information necessary for the identification of the system;
4.
A summary of the main characteristics of the plan for testing in real world conditions;
5.
Information on the suspension or termination of the testing in real world conditions.
ANNEX X
Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
1.   Schengen Information System
(a)
Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (
OJ L 312, 7.12.2018, p. 1
).
(b)
Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (
OJ L 312, 7.12.2018, p. 14
).
(c)
Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (
OJ L 312, 7.12.2018, p. 56
).
2.   Visa Information System
(a)
Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of the conditions for accessing other EU information systems for the purposes of the Visa Information System (
OJ L 248, 13.7.2021, p. 1
).
(b)
Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the Council and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the Visa Information System (
OJ L 248, 13.7.2021, p. 11
).
3.   Eurodac
Regulation (EU) 2024/1358 of the European Parliament and of the Council of 14 May 2024 on the establishment of ‘Eurodac’ for the comparison of biometric data in order to effectively apply Regulations (EU) 2024/1315 and (EU) 2024/1350 of the European Parliament and of the Council and Council Directive 2001/55/EC and to identify illegally staying third-country nationals and stateless persons and on requests for the comparison with Eurodac data by Member States’ law enforcement authorities and Europol for law enforcement purposes, amending Regulations (EU) 2018/1240 and (EU) 2019/818 of the European Parliament and of the Council and repealing Regulation (EU) No 603/2013 of the European Parliament and of the Council (
OJ L, 2024/1358, 22.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1358/oj
).
4.   Entry/Exit System
Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (
OJ L 327, 9.12.2017, p. 20
).
5.   European Travel Information and Authorisation System
(a)
Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (
OJ L 236, 19.9.2018, p. 1
).
(b)
Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation System (ETIAS) (
OJ L 236, 19.9.2018, p. 72
).
6.   European Criminal Records Information System on third-country nationals and stateless persons
Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (
OJ L 135, 22.5.2019, p. 1
).
7.   Interoperability
(a)
Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (
OJ L 135, 22.5.2019, p. 27
).
(b)
Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (
OJ L 135, 22.5.2019, p. 85
).
ANNEX XI
Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
Section 1
Information to be provided by all providers of general-purpose AI models
The technical documentation referred to in Article 53(1), point (a) shall contain at least the following information as appropriate to the size and risk profile of the model:
1.
A general description of the general-purpose AI model including:
(a)
the tasks that the model is intended to perform and the type and nature of AI systems in which it can be integrated;
(b)
the acceptable use policies applicable;
(c)
the date of release and methods of distribution;
(d)
the architecture and number of parameters;
(e)
the modality (e.g. text, image) and format of inputs and outputs;
(f)
the licence.
2.
A detailed description of the elements of the model referred to in point 1, and relevant information of the process for the development, including the following elements:
(a)
the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to be integrated in AI systems;
(b)
the design specifications of the model and training process, including training methodologies and techniques, the key design choices including the rationale and assumptions made; what the model is designed to optimise for and the relevance of the different parameters, as applicable;
(c)
information on the data used for training, testing and validation, where applicable, including the type and provenance of data and curation methodologies (e.g. cleaning, filtering, etc.), the number of data points, their scope and main characteristics; how the data was obtained and selected as well as all other measures to detect the unsuitability of data sources and methods to detect identifiable biases, where applicable;
(d)
the computational resources used to train the model (e.g. number of floating point operations), training time, and other relevant details related to the training;
(e)
known or estimated energy consumption of the model.
With regard to point (e), where the energy consumption of the model is unknown, the energy consumption may be based on information about computational resources used.
Section 2
Additional information to be provided by providers of general-purpose AI models with systemic risk
1.
A detailed description of the evaluation strategies, including evaluation results, on the basis of available public evaluation protocols and tools or otherwise of other evaluation methodologies. Evaluation strategies shall include evaluation criteria, metrics and the methodology on the identification of limitations.
2.
Where applicable, a detailed description of the measures put in place for the purpose of conducting internal and/or external adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning.
3.
Where applicable, a detailed description of the system architecture explaining how software components build or feed into each other and integrate into the overall processing.
ANNEX XII
Transparency information referred to in Article 53(1), point (b) — technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system
The information referred to in Article 53(1), point (b) shall contain at least the following:
1.
A general description of the general-purpose AI model including:
(a)
the tasks that the model is intended to perform and the type and nature of AI systems into which it can be integrated;
(b)
the acceptable use policies applicable;
(c)
the date of release and methods of distribution;
(d)
how the model interacts, or can be used to interact, with hardware or software that is not part of the model itself, where applicable;
(e)
the versions of relevant software related to the use of the general-purpose AI model, where applicable;
(f)
the architecture and number of parameters;
(g)
the modality (e.g. text, image) and format of inputs and outputs;
(h)
the licence for the model.
2.
A description of the elements of the model and of the process for its development, including:
(a)
the technical means (e.g. instructions for use, infrastructure, tools) required for the general-purpose AI model to be integrated into AI systems;
(b)
the modality (e.g. text, image, etc.) and format of the inputs and outputs and their maximum size (e.g. context window length, etc.);
(c)
information on the data used for training, testing and validation, where applicable, including the type and provenance of data and curation methodologies.
ANNEX XIII
Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
For the purpose of determining that a general-purpose AI model has capabilities or an impact equivalent to those set out in Article 51(1), point (a), the Commission shall take into account the following criteria:
(a)
the number of parameters of the model;
(b)
the quality or size of the data set, for example measured through tokens;
(c)
the amount of computation used for training the model, measured in floating point operations or indicated by a combination of other variables such as estimated cost of training, estimated time required for the training, or estimated energy consumption for the training;
(d)
the input and output modalities of the model, such as text to text (large language models), text to image, multi-modality, and the state of the art thresholds for determining high-impact capabilities for each modality, and the specific type of inputs and outputs (e.g. biological sequences);
(e)
the benchmarks and evaluations of capabilities of the model, including considering the number of tasks without additional training, adaptability to learn new, distinct tasks, its level of autonomy and scalability, the tools it has access to;
(f)
whether it has a high impact on the internal market due to its reach, which shall be presumed when it has been made available to at least 10 000 registered business users established in the Union;
(g)
the number of registered end-users.
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
ISSN 1977-0677 (electronic edition)

Summary:
Rules for trustworthy artificial intelligence in the EU
SUMMARY OF:
Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act)
WHAT IS THE AIM OF THE REGULATION?
Regulation (EU) 2024/1689 aims to encourage the development and uptake of 
safe
 and 
trustworthy
 artificial intelligence (AI) systems across the 
European Union
 (EU) 
single market
 in both the private and public sectors, while ensuring EU citizens’ health and safety and respect for 
fundamental rights
. The 
regulation
 sets out risk-based rules on:
placing on the market, putting into service and using certain AI systems;
banning certain AI practices;
requirements and obligations around high-risk AI systems;
transparency for certain AI systems;
transparency and risk management for general-purpose AI models (powerful AI models that underpin AI systems capable of carrying out a wide range of tasks);
market monitoring, market surveillance, governance and enforcement;
supporting innovation, focusing on 
small and medium-sized enterprises
 (SMEs) and start-ups.
There are some exemptions, such as for systems used exclusively for 
military and defence
 or for 
research
 purposes.
KEY POINTS
What is an AI system?
An AI system is a machine-based system designed to operate with some level of autonomy that can:
adapt
 after it is deployed; and
generate outputs
 such as predictions, content, recommendations or decisions from input it receives (to achieve explicit or implicit objectives).
A risk-based approach
The legislation follows a risk-based approach, which means the higher the risk of causing harm to society, the stricter the rules. The regulation 
defines the use of AI in the following areas as high risk
, due to the potential impact on fundamental rights, safety and well-being:
safety components
 in products subject to EU harmonisation legislation (or as stand-alone products) that are required to undergo a third-party conformity assessment under the same EU harmonisation legislation;
biometrics
, when used for remote identification, categorising individuals by sensitive attributes (such as race or religion), or emotion recognition, except where used to simply verify identity;
critical infrastructure
, when the AI is a safety component in areas such as digital infrastructure, traffic, water, gas, heating and electricity;
education and vocational training
, including access to education issues, evaluating learning outcomes, assessing education levels or monitoring behaviour during tests;
employment
, including recruiting, selecting candidates, making decisions on employment terms (promotions, terminations), task allocation or performance monitoring;
essential services
 – AI systems used by public authorities for evaluating eligibility for public services (healthcare, benefits), credit scoring, insurance risk assessment and prioritising emergency responses;
law enforcement
 – AI systems used for assessing crime risks, polygraphs, evaluating evidence reliability, predicting recidivism or profiling individuals for criminal investigations;
migration and border control
 – AI systems used to assess risks related to 
migration, asylum
 and visa applications, or to detect and identify individuals in migration contexts;
administration of justice and democratic processes
 – AI systems used by judicial authorities for legal research and interpretation or systems that could influence election outcomes.
The regulation prohibits the following AI practices with an unacceptable level of risk
Subliminal or deceptive techniques
 to manipulate individual or group behaviour, impairing their ability to make informed decisions and potentially causing harm.
Exploiting vulnerabilities
 based on age, disability, or socioeconomic situations to manipulate individuals or groups, leading to potential harm.
Social scoring
, evaluating or classifying people based on behaviour or characteristics, resulting in unfair treatment unrelated to the context in which the data were collected or in a manner disproportionate to the behaviour’s severity.
Criminal risk assessment
, predicting the likelihood of committing a crime solely based on profiling or personality traits, except in objective, fact-based criminal investigations.
Facial recognition database scraping
 from the internet or security cameras without specific targeting.
Inferring emotions in sensitive areas
, such as workplaces or educational institutions, unless used for medical or safety purposes.
Biometric categorisation
 based on data to infer sensitive attributes like race, religion or political opinions, except for lawful use in law enforcement.
Real-time biometric identification in public by law enforcement
, unless strictly necessary for particular situations (e.g. finding missing persons, preventing imminent threats or identifying suspects of serious crimes). This must follow strict legal procedures, including prior authorisation, a limited scope and safeguards to protect rights and freedoms.
The regulation introduces disclosure obligations where a risk could arise from a lack of 
transparency around the use of AI
:
AI designed to impersonate humans (e.g. a chatbot) needs to inform the human it is interacting with;
the output of generative AI needs to be marked as AI-generated in a machine-readable way;
in certain cases, the output of generative AI needs to be visibly labelled, namely deepfakes and text that is intended to inform the public of matters of public interest.
All other AI systems are deemed to have 
limited risk
 and therefore the regulation does not introduce any further rules.
Trustworthy use of large AI models
General-purpose AI models are AI models that are trained on large amounts of data and can perform a wide range of tasks. They can be components of AI systems.
The regulation introduces 
transparency obligations
 for providers of such general-purpose AI models, namely technical documentation, the provision of information to downstream developers of AI systems and the disclosure of data used in training the model.
The most powerful general-purpose AI models can pose 
systemic risks
. If a model meets a certain threshold of capability, the provider of that model must fulfill additional risk management and cybersecurity obligations.
Governance
The regulation sets up several governing bodies active from 
2 August 2025
:
national competent authorities
 that will oversee and enforce the rules for AI systems;
an 
AI Office
 within the 
European Commission
 that will coordinate the coherent application of the common rules across the EU and act as regulator for general-purpose AI models.
The EU 
Member States
 and the AI Office will cooperate closely on an 
AI Board
, comprising Member States’ representatives, to ensure the consistent and effective application of the regulation.
The regulation sets up two advisory bodies for the AI Office and the AI Board:
a 
scientific panel of independent experts
 to provide scientific advice;
an 
advisory forum for stakeholders
 to provide technical expertise to the AI Board and the Commission.
Penalties
The fines for infringements are set as a percentage of the offending company’s 
annual turnover
 or a predetermined amount, whichever is higher. Small and medium-sized enterprises and start-ups are subject to proportional administrative fines.
Transparency and protecting fundamental rights
Increased transparency applies to the development and use of high-risk AI systems:
before a high-risk AI system is deployed by entities providing public services, its 
fundamental rights impact
 must be assessed;
high-risk AI systems and entities using them must be registered in an 
EU database
.
Innovation
The regulation provides for an innovation-friendly legal framework and aims to promote evidence-based regulatory learning. It envisages 
AI regulatory sandboxes
, enabling a controlled environment in which innovative AI systems can be developed, tested and validated, including in real-world conditions. Furthermore, the regulation allows real-world testing of high-risk AI systems under certain conditions.
Evaluation and review
The Commission assesses the need for amendments to the list of high-risk uses of AI and the list of prohibited practices every year. By 
2 August 2028
, and every four years thereafter, the Commission will evaluate and report on the following:
adding to or extending the list of 
high-risk categories
;
amendments to the list of AI systems requiring 
additional transparency
 measures;
amendments to improve 
supervision and governance
.
FROM WHEN DOES THE REGULATION APPLY?
The regulation will apply from 
2 August 2026
. However, there are some exceptions:
the prohibitions, definitions and obligations regarding AI literacy have applied since 
2 February 2025
;
some rules will take effect on 
2 August 2025
, including those on governance structure, penalties, and obligations for providers of general-purpose AI models.
BACKGROUND
For further information, see:
AI Act
 (European Commission)
European AI Office
 (European Commission).
MAIN DOCUMENT
Regulation (EU) 
2024/1689
 of the European Parliament and of the Council of 
13 June 2024
 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 
12.7.2024
).
RELATED DOCUMENTS
Regulation (EU) 
2022/2065
 of the European Parliament and of the Council of 
19 October 2022
 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 
27.10.2022
, 
pp. 1–102
).
Directive (EU) 
2020/1828
 of the European Parliament and of the Council of 
25 November 2020
 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 
4.12.2020
, 
pp. 1–27
).
Successive amendments to Directive (EU) 2020/1828 have been incorporated into the original text. This 
consolidated version
 is of documentary value only.
Regulation (EU) 
2019/881
 of the European Parliament and of the Council of 
17 April 2019
 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 
7.6.2019
, 
pp. 15–69
).
Directive (EU) 
2019/882
 of the European Parliament and of the Council of 
17 April 2019
 on the accessibility requirements for products and services (OJ L 151, 
7.6.2019
, 
pp. 70–115
).
Regulation (EU) 
2019/1020
 of the European Parliament and of the Council of 
20 June 2019
 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 
25.6.2019
, 
pp. 1–44
).
See 
consolidated version
.
Regulation (EU) 
2019/2144
 of the European Parliament and of the Council of 
27 November 2019
 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 
16.12.2019
, 
pp. 1–40
).
See 
consolidated version
.
Regulation (EU) 
2018/858
 of the European Parliament and of the Council of 
30 May 2018
 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 
14.6.2018
, 
pp. 1–218
).
See 
consolidated version
.
Regulation (EU) 
2018/1139
 of the European Parliament and of the Council of 
4 July 2018
 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 
22.8.2018
, 
pp. 1–122
).
See 
consolidated version
.
Regulation (EU) 
2018/1725
 of the European Parliament and of the Council of 
23 October 2018
 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 
21.11.2018
, 
pp. 39–98
).
Regulation (EU) 
2016/679
 of the European Parliament and of the Council of 
27 April 2016
 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 
4.5.2016
, 
pp. 1–88
).
See 
consolidated version
.
Directive (EU) 
2016/680
 of the European Parliament and of the Council of 
27 April 2016
 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 
4.5.2016
, 
pp. 89–131
).
See 
consolidated version
.
Directive (EU) 
2016/797
 of the European Parliament and of the Council of 
11 May 2016
 on the interoperability of the rail system within the European Union (recast) (OJ L 138, 
26.5.2016
, 
pp. 44–101
).
See 
consolidated version
.
Directive (EU) 
2016/2102
 of the European Parliament and of the Council of 
26 October 2016
 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 
2.12.2016
, 
pp. 1–15
).
Directive 
2014/90/EU
 of the European Parliament and of the Council of 
23 July 2014
 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 
28.8.2014
, 
pp. 146–185
).
See 
consolidated version
.
Regulation (EU) No 
167/2013
 of the European Parliament and of the Council of 
5 February 2013
 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 
2.3.2013
, 
pp. 1–51
).
See 
consolidated version
.
Regulation (EU) No 
168/2013
 of the European Parliament and of the Council of 
15 January 2013
 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 
2.3.2013
, 
pp. 52–128
).
See 
consolidated version
.
Regulation (EU) No 
1025/2012
 of the European Parliament and of the Council of 
25 October 2012
 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 
14.11.2012
, 
pp. 12–33
).
See 
consolidated version
.
Regulation (EC) No 
300/2008
 of the European Parliament and of the Council of 
11 March 2008
 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 
9.4.2008
, 
pp. 72–84
).
See 
consolidated version
.
Regulation (EC) No 
765/2008
 of the European Parliament and of the Council of 
9 July 2008
 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 
13.8.2008
, 
pp. 30–47
).
See 
consolidated version
.
last update 
11.3.2025

--- DANISH ---

Document:
Den Europæiske Unions 
Tidende
DA
L-udgaven
2024/1689
12.7.2024
EUROPA-PARLAMENTETS OG RÅDETS FORORDNING (EU) 2024/1689
af 13. juni 2024
om harmoniserede regler for kunstig intelligens og om ændring af forordning (EF) nr. 300/2008, (EU) nr. 167/2013, (EU) nr. 168/2013, (EU) 2018/858, (EU) 2018/1139 og (EU) 2019/2144 samt direktiv 2014/90/EU, (EU) 2016/797 og (EU) 2020/1828 (forordningen om kunstig intelligens)
(EØS-relevant tekst)
EUROPA-PARLAMENTET OG RÅDET FOR DEN EUROPÆISKE UNION HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde, særlig artikel 16 og 114,
under henvisning til forslag fra Europa-Kommissionen,
efter fremsendelse af udkast til lovgivningsmæssig retsakt til de nationale parlamenter,
under henvisning til udtalelse fra Det Europæiske Økonomiske og Sociale Udvalg 
(
1
)
,
under henvisning til udtalelse fra Den Europæiske Centralbank 
(
2
)
,
under henvisning til udtalelse fra Regionsudvalget 
(
3
)
,
efter den almindelige lovgivningsprocedure 
(
4
)
, og
ud fra følgende betragtninger:
(1)
Formålet med denne forordning er at forbedre det indre markeds funktion ved at fastlægge ensartede retlige rammer, navnlig for udvikling, omsætning, ibrugtagning og anvendelse af kunstig intelligens-systemer (»AI-systemer«) i Unionen i overensstemmelse med Unionens værdier, at fremme udbredelsen af menneskecentreret og troværdig kunstig intelligens (»AI«), samtidig med at der sikres et højt beskyttelsesniveau for sundhed, sikkerhed og grundlæggende rettigheder som nedfældet i Den Europæiske Unions charter om grundlæggende rettigheder (»chartret«), herunder demokrati, retsstatsprincippet og miljøbeskyttelse, at beskytte mod skadelige virkninger af AI-systemer i Unionen og at støtte innovation. Denne forordning sikrer fri bevægelighed for AI-baserede varer og tjenesteydelser og forhindrer således medlemsstaterne i at indføre restriktioner for udvikling, markedsføring og anvendelse af AI-systemer, medmindre det udtrykkeligt er tilladt i henhold til denne forordning.
(2)
Denne forordning bør anvendes i overensstemmelse med Unionens værdier som nedfældet i chartret, der letter beskyttelsen af fysiske personer, virksomheder, demokrati, retsstatsprincippet og miljøbeskyttelse, samtidig med at innovation og beskæftigelse fremmes, og Unionen gøres førende inden for udbredelsen af troværdig AI.
(3)
AI-systemer kan nemt idriftsættes i en lang række sektorer af økonomien og i mange dele af samfundet, herunder på tværs af grænserne, og kan nemt udspredes i hele Unionen. Visse medlemsstater har allerede undersøgt, om det er muligt at vedtage nationale regler til sikring af, at AI er troværdig og sikker, og at den udvikles og anvendes i overensstemmelse med forpligtelserne vedrørende grundlæggende rettigheder. Forskellige nationale regler kan føre til fragmenteringen af det indre marked og kan mindske retssikkerheden for operatører, der udvikler, importerer eller anvender AI-systemer. Der bør derfor sikres et ensartet og højt beskyttelsesniveau i hele Unionen med henblik på at opnå troværdig AI, samtidig med at forskelle, der hæmmer den frie bevægelighed for samt innovation, idriftsættelse og udbredelse af AI-systemer og relaterede produkter og tjenesteydelser på det indre marked, bør forhindres ved at fastsætte ensartede forpligtelser for operatører og sikre en ensartet beskyttelse af tvingende hensyn til samfundsinteresser og personers rettigheder i hele det indre marked på grundlag af artikel 114 i traktaten om Den Europæiske Unions funktionsmåde (TEUF). For så vidt som denne forordning indeholder specifikke regler om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger vedrørende begrænsninger i anvendelsen af AI-systemer til biometrisk fjernidentifikation med henblik på retshåndhævelse, i anvendelsen af AI-systemer til risikovurderinger af fysiske personer med henblik på retshåndhævelse og i anvendelsen af AI-systemer til biometrisk kategorisering med henblik på retshåndhævelse, er det desuden hensigtsmæssigt at basere denne forordning på artikel 16 i TEUF for så vidt angår disse specifikke regler. I lyset af disse specifikke regler og anvendelsen af artikel 16 i TEUF bør Det Europæiske Databeskyttelsesråd høres.
(4)
AI er en vifte af teknologier i hurtig udvikling, som bidrager til brede økonomiske, miljømæssige og samfundsmæssige fordele på tværs af hele spektret af industrier og sociale aktiviteter. Ved at forbedre forudsigelser, optimere operationer og ressourceallokering og skræddersy de digitale løsninger, der er tilgængelige for enkeltpersoner og organisationer, kan anvendelsen af AI give virksomheder vigtige konkurrencemæssige fordele og fremme socialt og miljømæssigt gavnlige resultater, f.eks. inden for sundhedspleje, landbrug, fødevaresikkerhed, uddannelse, medier, sport, kultur, infrastrukturforvaltning, energi, transport og logistik, offentlige tjenester, sikkerhed, retsvæsen, ressource- og energieffektivitet, miljøovervågning, bevarelse og genopretning af biodiversitet og økosystemer samt modvirkning af og tilpasning til klimaændringer.
(5)
Samtidig kan AI, afhængigt af omstændighederne med hensyn til dens specifikke anvendelse, brug og teknologiske udviklingsniveau, skabe risici og skade samfundsinteresser og grundlæggende rettigheder, der er beskyttet af EU-retten. En sådan skade kan være af materiel eller immateriel karakter, herunder fysisk, psykisk, samfundsmæssig eller økonomisk.
(6)
I betragtning af den store indvirkning, som AI kan have på samfundet, og behovet for at opbygge tillid er det afgørende, at AI og de lovgivningsmæssige rammer herfor udvikles i overensstemmelse med Unionens værdier, der er nedfældet i artikel 2 i traktaten om Den Europæiske Union (TEU), og de grundlæggende rettigheder og friheder, der er nedfældet i traktaterne og, i henhold til artikel 6 i TEU, chartret. Det bør være en forudsætning, at AI er en menneskecentreret teknologi. Det bør tjene som et redskab for mennesker med det endelige mål at øge menneskers trivsel.
(7)
For at sikre et ensartet højt beskyttelsesniveau for samfundsinteresser med hensyn til sundhed, sikkerhed og grundlæggende rettigheder bør der fastsættes fælles regler for højrisiko-AI-systemer. Disse regler bør være i overensstemmelse med chartret, være ikkeforskelsbehandlende og i overensstemmelse med Unionens internationale handelsforpligtelser. De bør også tage hensyn til den europæiske erklæring om digitale rettigheder og principper for det digitale årti og de etiske retningslinjer for troværdig AI fra Ekspertgruppen på Højt Niveau vedrørende Kunstig Intelligens (AI-ekspertgruppen).
(8)
Der er derfor behov for en EU-retlig ramme, der fastsætter harmoniserede regler for AI, for at fremme udviklingen, brugen og udbredelsen af AI på det indre marked, som samtidig opfylder et højt beskyttelsesniveau for samfundsinteresser såsom sundhed og sikkerhed og beskyttelse af grundlæggende rettigheder, herunder demokrati, retsstatsprincippet og miljøbeskyttelse, som anerkendt og beskyttet i EU-retten. For at nå dette mål bør der fastsættes regler for omsætning, ibrugtagning og anvendelse af visse AI-systemer for at sikre et velfungerende indre marked og lade disse systemer drage fordel af princippet om fri bevægelighed for varer og tjenesteydelser. Disse regler bør være klare og robuste med hensyn til at beskytte de grundlæggende rettigheder, støtte nye innovative løsninger og muliggøre et europæisk økosystem af offentlige og private aktører, der skaber AI-systemer i overensstemmelse med Unionens værdier og frigør potentialet ved den digitale omstilling i alle regioner i Unionen. Med fastsættelsen af disse regler samt foranstaltninger til støtte for innovation med et særligt fokus på små og mellemstore virksomheder (SMV'er), herunder iværksættervirksomheder, støtter denne forordning målet om at fremme en europæisk menneskecentreret tilgang til AI og om at være førende på verdensplan inden for udvikling af sikker, troværdig og etisk AI som anført af Det Europæiske Råd 
(
5
)
, og den sikrer beskyttelse af etiske principper, således som Europa-Parlamentet specifikt har anmodet om 
(
6
)
.
(9)
Der bør fastsættes harmoniserede regler for omsætning, ibrugtagning og anvendelse af højrisiko-AI-systemer i overensstemmelse med Europa-Parlamentets og Rådets forordning (EF) nr. 765/2008 
(
7
)
, Europa-Parlamentets og Rådets afgørelse nr. 768/2008/EF 
(
8
)
 og Europa-Parlamentets og Rådets forordning (EU) 2019/1020 
(
9
)
 (den nye lovgivningsmæssige ramme for markedsføring af produkter). De harmoniserede regler, der er fastsat i nærværende forordning, bør finde anvendelse på tværs af sektorer og bør i overensstemmelse med den nye lovgivningsmæssige ramme ikke berøre gældende EU-ret, navnlig om databeskyttelse, forbrugerbeskyttelse, grundlæggende rettigheder, beskæftigelse og beskyttelse af arbejdstagere og produktsikkerhed, som nærværende forordning supplerer. Som følge heraf forbliver alle rettigheder og retsmidler, som er fastsat i en sådan EU-ret for forbrugere og andre personer, som AI-systemer kan have en negativ indvirkning på, herunder for så vidt angår erstatning for eventuelle skader i henhold til Rådets direktiv 85/374/EØF 
(
10
)
, uberørte og finder fuldt ud anvendelse. Endvidere bør denne forordning i forbindelse med beskæftigelse og beskyttelse af arbejdstagere derfor ikke berøre EU-retten om socialpolitik og national arbejdsret, der overholder EU-retten, vedrørende ansættelsesvilkår og arbejdsforhold, herunder sundhed og sikkerhed på arbejdspladsen, og forholdet mellem arbejdsgivere og arbejdstagere. Denne forordning bør heller ikke påvirke udøvelsen af de grundlæggende rettigheder, der anerkendes i medlemsstaterne og på EU-plan, herunder retten eller friheden til at strejke eller til at foretage andre tiltag, der er omfattet af specifikke ordninger for arbejdsmarkedsrelationer i medlemsstaterne, samt retten til at forhandle, indgå og håndhæve kollektive overenskomster eller retten til at foretage kollektive tiltag i overensstemmelse med national ret. Denne forordning bør ikke berøre de bestemmelser, der tilstræber at forbedre arbejdsvilkårene for platformsarbejde, der er fastsat i et direktiv vedtaget af Europa-Parlamentets og Rådets direktiv om forbedring af arbejdsvilkårene for platformsarbejde. Derudover har denne forordning til formål at styrke effektiviteten af sådanne eksisterende rettigheder og retsmidler ved at fastsætte specifikke krav og forpligtelser, herunder med hensyn til AI-systemers gennemsigtighed, tekniske dokumentation og registrering. Desuden bør de forpligtelser, der pålægges forskellige operatører, der er involveret i AI-værdikæden i henhold til denne forordning, finde anvendelse, uden at det berører national ret, der overholder EU-retten, hvorved anvendelsen af visse AI-systemer begrænses, hvis sådan national ret falder uden for denne forordnings anvendelsesområde eller forfølger andre legitime mål af samfundsmæssig interesse end dem, der forfølges med denne forordning. For eksempel bør national arbejdsret og national ret om beskyttelse af mindreårige, dvs. personer under 18 år, under hensyntagen til generel bemærkning nr. 25 (2021) om børns rettigheder vedrørende det digitale miljø fra FN's Komité for Barnets Rettigheder, for så vidt de ikke er specifikke for AI-systemer og forfølger andre legitime mål af samfundsmæssig interesse, ikke berøres af denne forordning.
(10)
Den grundlæggende ret til beskyttelse af personoplysninger er navnlig sikret ved Europa-Parlamentets og Rådets forordning (EU) 2016/679 
(
11
)
 og (EU) 2018/1725 
(
12
)
 samt Europa-Parlamentets og Rådets direktiv (EU) 2016/680 
(
13
)
. Europa-Parlamentets og Rådets direktiv 2002/58/EF 
(
14
)
 beskytter desuden privatlivets fred og kommunikationshemmeligheden, herunder med fastsættelse af betingelser for lagring af personoplysninger og andre oplysninger end personoplysninger i terminaludstyr og for adgang til terminaludstyr. Disse EU-retsakter danner grundlaget for bæredygtig og ansvarlig databehandling, herunder når datasæt omfatter en blanding af personoplysninger og andre data end personoplysninger. Nærværende forordning har ikke til formål at påvirke anvendelsen af gældende EU-ret om behandling af personoplysninger, herunder de opgaver og beføjelser, der påhviler de uafhængige tilsynsmyndigheder med kompetence til at overvåge, at disse instrumenter overholdes.Den berører heller ikke de forpligtelser for udbydere og idriftsættere af AI-systemer i deres rolle som dataansvarlige eller databehandlere, der følger af EU-retten eller national ret om beskyttelse af personoplysninger, for så vidt udformningen, udviklingen eller anvendelsen af AI-systemer omfatter behandling af personoplysninger. Det er også hensigtsmæssigt at præcisere, at registrerede bevarer alle de rettigheder og garantier, som de har i henhold til EU-retten, herunder rettigheder i forbindelse med helt automatiseret individuel beslutningstagning, herunder profilering. Harmoniserede regler for omsætning, ibrugtagning og anvendelse af AI-systemer, der er fastsat i henhold til nærværende forordning, bør lette en effektiv gennemførelse og muliggøre udøvelsen af de registreredes rettigheder og andre retsmidler, der er sikret i medfør af EU-retten om beskyttelse af personoplysninger og andre grundlæggende rettigheder.
(11)
Denne forordning berører ikke bestemmelserne om ansvar for udbydere af formidlingstjenester som fastsat i Europa-Parlamentets og Rådets forordning (EU) 2022/2065 
(
15
)
.
(12)
Begrebet »AI-system« i denne forordning bør defineres klart og bør nøje afstemmes med det arbejde, der udføres af internationale organisationer, som arbejder med AI, for at sikre retssikkerhed, lette international konvergens og bred accept, og samtidig være fleksibelt nok til at tage højde for den hurtige teknologiske udvikling på dette område. Desuden bør definitionen baseres på centrale egenskaber ved AI-systemer, der adskiller det fra enklere traditionelle softwaresystemer eller programmeringstilgange, og bør ikke omfatte systemer, der er baseret på de regler, der udelukkende er defineret af fysiske personer til automatisk at udføre operationer. En central egenskab ved AI-systemer er deres evne til at udlede. Denne evne til at udlede henviser til processen med at opnå output såsom forudsigelser, indhold, anbefalinger eller beslutninger, der kan påvirke fysiske og virtuelle miljøer, og til AI-systemernes evne til at udlede modeller eller algoritmer, eller begge dele, fra input eller data. De teknikker, der muliggør udledning ved opbygningen af et AI-system, omfatter maskinlæringstilgange, der af data lærer, hvordan bestemte mål kan nås, og logik- og videnbaserede tilgange, der udleder indhold fra indkodet viden eller symbolsk repræsentation af den opgave, der skal løses. Et AI-systems evne til at udlede går videre end grundlæggende databehandling ved at muliggøre læring, ræsonnement eller modellering. Udtrykket »maskinbaseret« henviser til det forhold, at AI-systemer kører på maskiner. Henvisningen til eksplicitte eller implicitte mål understreger, at AI-systemer kan fungere i overensstemmelse med eksplicit definerede mål eller implicitte mål. AI-systemets mål kan adskille sig fra det tilsigtede formål med AI-systemet i en specifik sammenhæng. Med henblik på denne forordning bør miljøer forstås som de sammenhænge, hvori AI-systemerne fungerer, mens output genereret af AI-systemet afspejler forskellige funktioner, der udføres af AI-systemer og omfatter forudsigelser, indhold, anbefalinger eller beslutninger. AI-systemer er udformet til at fungere med varierende grader af autonomi, hvilket betyder, at de har en vis grad af uafhængighed fra menneskelig medvirken og har evnen til at fungere uden menneskelig indgriben. Den tilpasningsevne, som et AI-system kan udvise efter idriftsættelsen, henviser til selvlæringskapacitet, der gør det muligt for systemet at ændre sig, mens det er i brug. AI-systemer kan anvendes selvstændigt eller som en del af et produkt, uanset om systemet er fysisk integreret i produktet (indlejret), eller tjene produktets funktionalitet uden at være integreret deri (ikke indlejret).
(13)
Begrebet »idriftsætter«, der er omhandlet i denne forordning, bør fortolkes som enhver fysisk eller juridisk person, herunder en offentlig myndighed, et agentur eller et andet organ, der anvender et AI-system under sin myndighed, medmindre AI-systemet anvendes som led i en personlig ikkeerhvervsmæssig aktivitet. Afhængigt af typen af AI-system kan anvendelsen af systemet påvirke andre personer end idriftsætteren.
(14)
Begrebet »biometriske data«, der anvendes i denne forordning, bør fortolkes i lyset af begrebet biometriske data som defineret i artikel 4, nr. 14), i forordning (EU) 2016/679, artikel 3, nr. 18), i forordning (EU) 2018/1725 og artikel 3, nr. 13), i direktiv (EU) 2016/680. Biometriske data kan muliggøre autentifikation, identifikation eller kategorisering af fysiske personer og genkendelse af fysiske personers følelser.
(15)
Begrebet »biometrisk identifikation«, der er omhandlet i denne forordning, bør defineres som automatiseret genkendelse af fysiske, fysiologiske og adfærdsmæssige menneskelige egenskaber som f.eks. ansigt, øjenbevægelser, kropsform, stemme, prosodi, gangart, kropsholdning, hjerterytme, blodtryk, lugt og tasteanslagskarakteristika med det formål at fastslå en persons identitet ved at sammenligne personens biometriske data med de biometriske data om personer, der er lagret i en referencedatabase, uanset om denne person har givet sit samtykke hertil eller ej. Dette udelukker AI-systemer, der tilsigtes anvendt til biometrisk verifikation, som omfatter autentifikation, hvis eneste formål er at bekræfte, at en bestemt fysisk person er den person, vedkommende hævder at være, og bekræfte en fysisk persons identitet udelukkende med det formål at få adgang til en tjeneste, låse udstyr op eller have sikker adgang til lokaler.
(16)
Begrebet »biometrisk kategorisering«, der er omhandlet i denne forordning, bør defineres som placering af fysiske personer i bestemte kategorier på grundlag af deres biometriske data. Sådanne specifikke kategorier kan vedrøre aspekter som køn, alder, hårfarve, øjenfarve, tatoveringer, adfærdsmønstre eller personlighedstræk, sprog, religion, tilhørsforhold til et nationalt mindretal samt seksuel eller politisk orientering. Dette omfatter ikke systemer til biometrisk kategorisering, som er en rent accessorisk funktion, der er uløseligt forbundet med en anden kommerciel tjeneste, og som indebærer, at funktionen af objektive tekniske grunde ikke kan anvendes uden den primære tjeneste, og at integrationen af denne funktion eller funktionalitet ikke er et middel til at omgå anvendelsen af reglerne i denne forordning. Eksempelvis kan filtre, der kategoriserer ansigts- eller kropstræk, som anvendes på onlinemarkedspladser, udgøre en sådan accessorisk funktion, da de kun kan anvendes i forbindelse med den primære tjeneste, der består i at sælge et produkt ved at give forbrugeren mulighed for se visningen af produktet på sig selv og hjælpe forbrugeren med at træffe en købsbeslutning. Filtre, der anvendes på sociale onlinenetværkstjenester, og som kategoriserer ansigts- eller kropstræk for at give brugerne mulighed for at tilføje eller ændre billeder eller videoer, kan også betragtes som en accessorisk funktion, da et sådant filter ikke kan anvendes uden den primære tjeneste i de sociale netværkstjenester, der består i deling af indhold online.
(17)
Begrebet »system til biometrisk fjernidentifikation«, der er omhandlet i denne forordning, bør defineres funktionelt som et AI-system, der er tilsigtet identifikation af fysiske personer uden deres aktive medvirken, typisk på afstand, ved at sammenligne en persons biometriske data med de biometriske data i en referencedatabase, uanset hvilken specifik teknologi, hvilke specifikke processer eller hvilke specifikke typer biometriske data der anvendes. Sådanne systemer til biometrisk fjernidentifikation anvendes typisk til at opfatte flere personer eller deres adfærd samtidigt for i væsentlig grad at lette identifikationen af fysiske personer uden deres aktive medvirken. Dette udelukker AI-systemer, der tilsigtes anvendt til biometrisk verifikation, som omfatter autentifikation, hvis eneste formål er at bekræfte, at en bestemt fysisk person er den person, vedkommende hævder at være, og bekræfte en fysisk persons identitet udelukkende med det formål at få adgang til en tjeneste, låse udstyr op eller have sikkerhedsadgang til lokaler. Denne udelukkelse begrundes med, at sådanne systemer sandsynligvis vil have en mindre indvirkning på fysiske personers grundlæggende rettigheder sammenlignet med systemerne til biometrisk fjernidentifikation, der kan anvendes til behandling af et stort antal personers biometriske data uden deres aktive medvirken. Hvis der er tale om realtidssystemer, sker optagelsen af de biometriske data, sammenligningen og identifikationen øjeblikkeligt, næsten øjeblikkeligt eller under alle omstændigheder uden væsentlig forsinkelse. I denne forbindelse bør der ikke være mulighed for at omgå denne forordnings bestemmelser om realtidsanvendelse af de pågældende AI-systemer ved at foranledige mindre forsinkelser. Realtidssystemer omfatter anvendelse af direkte eller lettere forskudt materiale såsom videooptagelser, der genereres af et kamera eller andet udstyr med tilsvarende funktioner. Er der derimod tale om systemer til efterfølgende biometrisk identifikation, er de biometriske data allerede blevet optaget, og sammenligningen og identifikationen finder først sted efter en væsentlig forsinkelse. Der er tale om materiale såsom billeder eller videooptagelser, der genereres af TV-overvågningskameraer eller privat udstyr, og som er genereret inden systemets anvendelse for så vidt angår de pågældende fysiske personer.
(18)
Begrebet »system til følelsesgenkendelse«, der er omhandlet i denne forordning, bør defineres som et AI-system, der har til formål at identificere eller udlede fysiske personers følelser eller hensigter på grundlag af deres biometriske data. Begrebet henviser til følelser eller hensigter såsom lykke, sorgfuldhed, vrede, forbavselse, afsky, forlegenhed, begejstring, skam, foragt, tilfredshed og morskab. Det omfatter ikke fysiske tilstande såsom smerte eller træthed, herunder f.eks. systemer, der anvendes til at påvise træthedstilstanden hos professionelle piloter eller førere med henblik på at forebygge ulykker. Det omfatter heller ikke den blotte påvisning af umiddelbart synlige udtryk, fagter eller bevægelser, medmindre de anvendes til at identificere eller udlede følelser. Disse udtryk kan være simple ansigtsudtryk såsom en panderynken eller et smil eller fagter såsom bevægelse af hænder, arme eller hoved eller karakteristika ved en persons stemme såsom en hævet stemme eller hvisken.
(19)
I denne forordning bør begrebet offentligt sted forstås som ethvert fysisk sted, der er tilgængeligt for et ubestemt antal fysiske personer, og uanset om det pågældende sted er privatejet eller offentligt ejet, og uanset den aktivitet, som stedet kan anvendes til, såsom til handel, f.eks. butikker, restauranter og caféer, til tjenesteydelser, f.eks. banker, erhvervsmæssige aktiviteter og hotel-, restaurations- og oplevelsesbranchen, til sport, f.eks. svømmebassiner, fitnesscentre og stadioner, til transport, f.eks. bus-, metro- og jernbanestationer, lufthavne og transportmidler, til underholdning, f.eks. biografer, teatre, museer og koncert- og konferencesale, eller til fritid eller andet, f.eks. offentlige veje og pladser, parker, skove og legepladser. Et sted bør også klassificeres som værende offentligt tilgængeligt, hvis adgangen, uanset eventuelle kapacitets- eller sikkerhedsrestriktioner, er underlagt visse forud fastsatte betingelser, som kan opfyldes af et ubestemt antal personer, såsom køb af en billet eller et rejsebevis, forudgående registrering eller det at have en bestemt alder. Derimod bør et sted ikke anses for at være offentligt tilgængeligt, hvis adgangen er begrænset til specifikke og definerede fysiske personer i henhold til enten EU-retten eller national ret, der er direkte knyttet til den offentlige sikkerhed, eller gennem en klar viljestilkendegivelse fra den person, der har den relevante myndighed over stedet. Den faktiske mulighed for adgang alene såsom en ulåst dør eller en åben låge i et hegn indebærer ikke, at stedet er et offentligt sted, hvis der er indikationer eller omstændigheder, der tyder på det modsatte, såsom skilte, der forbyder eller begrænser adgangen. Virksomheds- og fabrikslokaler samt kontorer og arbejdspladser, der kun tilsigtes at være tilgængelige for relevante medarbejdere og tjenesteydere, er ikke offentlige steder. Offentlige steder bør ikke omfatte fængsler eller grænsekontrol. Visse andre områder kan bestå af både offentlige steder og ikkeoffentlige steder såsom forhallen til en privat beboelsesejendom, som det er nødvendigt at gå igennem for at få adgang til en læges kontor, eller en lufthavn. Online steder er ikke omfattet, da der ikke er tale om fysiske steder. Om et givet sted betragtes som offentligt, bør imidlertid afgøres fra sag til sag under hensyntagen til de særlige forhold i den enkelte situation.
(20)
For at opnå de største fordele ved AI-systemer, samtidig med at de grundlæggende rettigheder, sundheden og sikkerheden beskyttes, og for at muliggøre demokratisk kontrol bør AI-færdigheder udstyre udbydere, idriftsættere og berørte personer med de nødvendige begreber til at træffe informerede beslutninger vedrørende AI-systemer. Disse begreber kan variere med hensyn til den relevante kontekst og kan omfatte forståelse af den korrekte anvendelse af tekniske elementer i AI-systemets udviklingsfase, de foranstaltninger, der skal anvendes under dets anvendelse, passende måder at fortolke AI-systemets output på, og i tilfælde af berørte personer den viden, der er nødvendig for at forstå, hvordan beslutninger truffet med hjælp fra AI vil have indvirkning på dem. I forbindelse med anvendelsen af denne forordning bør AI-færdigheder give alle relevante aktører i AI-værdikæden den indsigt, der er nødvendig for at sikre passende overholdelse og korrekt håndhævelse heraf. Desuden kan den brede gennemførelse af foranstaltninger vedrørende AI-færdigheder og indførelsen af passende opfølgende tiltag bidrage til at forbedre arbejdsvilkårene og i sidste ende understøtte konsoliderings- og innovationsstien for troværdig AI i Unionen. Det Europæiske Udvalg for Kunstig Intelligens (»AI-udvalget«) bør støtte Kommissionen med henblik på at fremme AI-færdighedsværktøjer samt offentlighedens kendskab til og forståelse af fordele, risici, sikkerhedsforanstaltninger, rettigheder og forpligtelser i forbindelse med anvendelsen af AI-systemer. I samarbejde med de relevante interessenter bør Kommissionen og medlemsstaterne lette udarbejdelsen af frivillige adfærdskodekser for at fremme AI-færdigheder blandt personer, der beskæftiger sig med udvikling, drift og anvendelse af AI.
(21)
For at sikre lige vilkår og en effektiv beskyttelse af fysiske personers rettigheder og friheder i hele Unionen bør de regler, der fastsættes ved denne forordning, finde anvendelse på udbydere af AI-systemer på en ikkeforskelsbehandlende måde, uanset om de er etableret i Unionen eller i et tredjeland, og på idriftsættere af AI-systemer, der er etableret i Unionen.
(22)
I betragtning af deres digitale karakter bør visse AI-systemer være omfattet af denne forordnings anvendelsesområde, selv når de ikke bringes i omsætning, ibrugtages eller anvendes i Unionen. Dette er f.eks. tilfældet, når en operatør, der er etableret i Unionen, indgår kontrakter om visse tjenesteydelser med en operatør, der er etableret i et tredjeland, i forbindelse med en aktivitet, der skal udføres af et AI-system, der kan betegnes som højrisiko. Under disse omstændigheder ville det AI-system, der anvendes i tredjelandet af operatøren, kunne behandle data, der lovligt er indsamlet i og overført fra Unionen, og levere outputtet fra dette AI-systems behandling til den kontraherende operatør i Unionen, uden at dette AI-system bringes i omsætning, ibrugtages eller anvendes i Unionen. For at forhindre omgåelse af denne forordning og sikre en effektiv beskyttelse af fysiske personer i Unionen, bør denne forordning også finde anvendelse på udbydere og idriftsættere af AI-systemer, der er etableret i et tredjeland, i det omfang det output, der produceres af disse systemer, tilsigtes anvendt i Unionen.For at tage hensyn til eksisterende ordninger og særlige behov for fremtidigt samarbejde med udenlandske partnere, med hvem der udveksles oplysninger og bevismateriale, bør denne forordning ikke finde anvendelse på offentlige myndigheder i et tredjeland og internationale organisationer, når disse handler inden for rammerne af samarbejdsaftaler eller internationale aftaler indgået på EU-plan eller nationalt plan om retshåndhævelse og retligt samarbejde med Unionen eller medlemsstaterne, forudsat at det relevante tredjeland eller den relevante internationale organisation giver tilstrækkelige sikkerhedsforanstaltninger med hensyn til beskyttelsen af fysiske personers grundlæggende rettigheder og friheder. Dette kan, hvor relevant, omfatte aktiviteter udført af enheder, som af tredjelande har fået overdraget ansvaret for at udføre specifikke opgaver til støtte for en sådan retshåndhævelse og et sådant retligt samarbejde. Sådanne samarbejdsrammer eller aftaler er oprettet bilateralt mellem medlemsstaterne og tredjelande eller mellem Den Europæiske Union, Europol og andre EU-agenturer og tredjelande og internationale organisationer. De myndigheder, der har kompetence til at føre tilsyn med de retshåndhævende og retslige myndigheder i henhold til denne forordning, bør vurdere, om disse samarbejdsrammer eller internationale aftaler indeholder tilstrækkelige sikkerhedsforanstaltninger med hensyn til beskyttelse af fysiske personers grundlæggende rettigheder og friheder. De modtagende nationale myndigheder og EU-institutioner, -organer, -kontorer og -agenturer, der anvender sådanne output i Unionen, forbliver ansvarlige for at sikre, at deres anvendelse overholder EU-retten. Når disse internationale aftaler revideres, eller der indgås nye i fremtiden, bør de kontraherende parter gøre deres yderste for at tilpasse disse aftaler til kravene i denne forordning.
(23)
Denne forordning bør også finde anvendelse på EU-institutioner, -organer, -kontorer og -agenturer, når de fungerer som udbyder eller idriftsætter af et AI-system.
(24)
Hvis og i det omfang AI-systemer bringes i omsætning, ibrugtages eller anvendes med eller uden ændringer af sådanne systemer til militære formål, forsvarsformål eller formål vedrørende national sikkerhed, bør disse udelukkes fra denne forordnings anvendelsesområde, uanset hvilken type enhed der udfører disse aktiviteter, f.eks. om det er en offentlig eller privat enhed. For så vidt angår militære og forsvarsmæssige formål begrundes en sådan udelukkelse både i medfør af artikel 4, stk. 2, i TEU, og i de særlige forhold, der gør sig gældende for medlemsstaternes forsvarspolitik og den fælles EU-forsvarspolitik, der er omfattet af afsnit V, kapitel 2, i TEU, og som er underlagt folkeretten, og som derfor er den mest hensigtsmæssige retlige ramme for regulering af AI-systemer i forbindelse med anvendelsen af dødbringende magtanvendelse og andre AI-systemer i forbindelse med militære og forsvarsmæssige aktiviteter. For så vidt angår formål vedrørende den nationale sikkerhed begrundes udelukkelsen både i den omstændighed, at den nationale sikkerhed forbliver medlemsstaternes eneansvar i overensstemmelse med artikel 4, stk. 2, i TEU, og i den særlige karakter af og de operationelle behov i forbindelse med aktiviteter vedrørende den nationale sikkerhed og specifikke nationale regler, der finder anvendelse på disse aktiviteter. Hvis et AI-system, der er udviklet, bragt i omsætning, ibrugtaget eller anvendt til militære formål, forsvarsformål eller formål vedrørende den nationale sikkerhed, anvendes uden for disse midlertidigt eller permanent til andre formål, f.eks. civile eller humanitære formål, retshåndhævelsesformål eller hensynet til den offentlige sikkerhed, vil et sådant system ikke desto mindre være omfattet af denne forordnings anvendelsesområde. I så fald bør den enhed, der anvender AI-systemet til andre formål end militære formål, forsvarsformål eller formål vedrørende den nationale sikkerhed, sikre, at AI-systemet overholder denne forordning, medmindre systemet allerede overholder denne forordning. AI-systemer, der bringes i omsætning eller ibrugtages til et udelukket formål, dvs. militært formål, forsvarsformål eller formål vedrørende den nationale sikkerhed, og et eller flere ikkeudelukkede formål, f.eks. civile formål eller retshåndhævelse, falder ind under denne forordnings anvendelsesområde, og udbydere af disse systemer bør sikre overholdelse af denne forordning. I disse tilfælde bør det forhold, at et AI-system kan være omfattet af denne forordnings anvendelsesområde, ikke berøre muligheden for, at enheder, der udfører aktiviteter vedrørende den nationale sikkerhed, forsvarsaktiviteter og militæraktiviteter, uanset hvilken type enhed der udfører disse aktiviteter, anvender AI-systemer til formål vedrørende den nationale sikkerhed, militære formål og forsvarsformål, idet en sådan anvendelse er udelukket fra denne forordnings anvendelsesområde. Et AI-system, der bringes i omsætning til civile formål eller retshåndhævelsesformål, og som anvendes med eller uden ændringer til militære formål, forsvarsformål eller formål vedrørende den nationale sikkerhed, bør ikke være omfattet af denne forordnings anvendelsesområde, uanset hvilken type enhed der udfører disse aktiviteter.
(25)
Denne forordning bør støtte innovation, bør respektere forskningsfriheden og bør ikke undergrave forsknings- og udviklingsaktivitet. Det er derfor nødvendigt at udelukke AI-systemer og -modeller, der specifikt er udviklet og ibrugtaget udelukkende med henblik på videnskabelig forskning og udvikling. Det er desuden nødvendigt at sikre, at denne forordning ikke på anden måde påvirker videnskabelig forsknings- og udviklingsaktivitet med AI-systemer eller -modeller, inden de bringes i omsætning eller ibrugtages. Med hensyn til produktorienteret forsknings-, afprøvnings- og udviklingsaktivitet vedrørende AI-systemer eller -modeller bør bestemmelserne i denne forordning heller ikke finde anvendelse, inden disse systemer og modeller ibrugtages eller bringes i omsætning. Denne udelukkelse berører ikke forpligtelsen til at overholde denne forordning, når et AI-system, der falder ind under denne forordnings anvendelsesområde, bringes i omsætning eller ibrugtages som følge af en sådan forsknings- og udviklingsaktivitet, eller anvendelsen af bestemmelser om reguleringsmæssige AI-sandkasser og afprøvning under faktiske forhold. Uden at det berører udelukkelsen af AI-systemer, der specifikt er udviklet og ibrugtaget udelukkende med henblik på videnskabelig forskning og udvikling, bør ethvert andet AI-system, der kan anvendes til udførelse af enhver forsknings- og udviklingsaktivitet, desuden fortsat være omfattet af bestemmelserne i denne forordning. Under alle omstændigheder bør enhver forsknings- og udviklingsaktivitet udføres i overensstemmelse med anerkendte etiske og professionelle standarder for videnskabelig forskning og bør gennemføres i overensstemmelse med gældende EU-ret.
(26)
For at indføre et forholdsmæssigt og effektivt sæt bindende regler for AI-systemer bør der anvendes en klart defineret risikobaseret tilgang. Denne tilgang bør tilpasse typen og indholdet af sådanne regler til graden og omfanget af de risici, som AI-systemer kan generere. Det er derfor nødvendigt at forbyde visse former for uacceptabel AI-praksis, at fastsætte krav til højrisiko-AI-systemer og forpligtelser for de relevante operatører og at fastsætte gennemsigtighedsforpligtelser for visse AI-systemer.
(27)
Selv om den risikobaserede tilgang danner grundlag for et forholdsmæssigt og effektivt sæt bindende regler, er det vigtigt at minde om de etiske retningslinjer for troværdig kunstig intelligens fra 2019, der er udarbejdet af den uafhængige AI-ekspertgruppe, som Kommissionen har udpeget. I disse retningslinjer udviklede AI-ekspertgruppen syv ikkebindende etiske principper for AI, som tilsigter at bidrage til at sikre, at AI er troværdig og etisk forsvarlig. De syv principper omfatter: menneskelig handlemulighed og menneskeligt tilsyn, teknologisk robusthed og sikkerhed, privatlivets fred og datastyring, gennemsigtighed, mangfoldighed, ikkeforskelsbehandling og retfærdighed, social og miljømæssig velfærd samt ansvarlighed. Uden at det berører de retligt bindende krav i denne forordning og anden gældende EU-ret, bidrager disse retningslinjer til udformningen af sammenhængende, troværdig og menneskecentreret AI i overensstemmelse med chartret og med de værdier, som Unionen bygger på. Ifølge AI-ekspertgruppens retningslinjer forstås der ved menneskelig handlemulighed og menneskeligt tilsyn, at AI-systemer udvikles og anvendes som et redskab, der betjener mennesker, respekterer menneskers værdighed og personlige uafhængighed, og som fungerer på en måde, der kan styres og tilses af mennesker på passende vis. Ved teknisk robusthed og sikkerhed forstås, at AI-systemer udvikles og anvendes på en måde, der giver mulighed for robusthed i tilfælde af problemer og modstandsdygtighed over for forsøg på at ændre AI-systemets anvendelse eller ydeevne, således at tredjeparters ulovlige anvendelse tillades, og minimerer utilsigtet skade. Ved privatlivets fred og datastyring forstås, at AI-systemer udvikles og anvendes i overensstemmelse med reglerne for beskyttelse af privatlivets fred og databeskyttelse, samtidig med at behandlingen af data lever op til høje standarder for kvalitet og integritet. Ved gennemsigtighed forstås, at AI-systemer udvikles og anvendes på en måde, der giver mulighed for passende sporbarhed og forklarlighed, samtidig med at personer gøres opmærksom på, at de kommunikerer eller interagerer med et AI-system, og at idriftsætterne informeres behørigt om det pågældende AI-systems kapacitet og begrænsninger og berørte personer om deres rettigheder. Ved mangfoldighed, ikkeforskelsbehandling og retfærdighed forstås, at AI-systemer udvikles og anvendes på en måde, der inkluderer forskellige aktører og fremmer lige adgang, ligestilling mellem kønnene og kulturel mangfoldighed, samtidig med at forskelsbehandlende virkninger og urimelige bias, der er forbudt i henhold til EU-retten eller national ret, undgås. Ved social og miljømæssig velfærd forstås, at AI-systemer udvikles og anvendes på en bæredygtig og miljøvenlig måde og på en måde, der gavner alle mennesker, samtidig med at de langsigtede virkninger for den enkelte, samfundet og demokratiet overvåges og vurderes. Anvendelsen af disse principper bør så vidt muligt omsættes i udformningen og anvendelsen af AI-modeller. De bør under alle omstændigheder tjene som grundlag for udarbejdelsen af adfærdskodekser i henhold til denne forordning. Alle interessenter, herunder industrien, den akademiske verden, civilsamfundet og standardiseringsorganisationer, opfordres til i relevant omfang at tage hensyn til de etiske principper ved udviklingen af frivillig bedste praksis og standarder.
(28)
Ud over de mange nyttige anvendelser af AI kan den også misbruges og resultere i nye og effektive værktøjer til manipulerende, udnyttende og socialt kontrollerende former for praksis. Sådanne former for praksis er særlig skadelige og krænkende og bør forbydes, fordi de er i modstrid med Unionens værdier om respekt for menneskelig værdighed, frihed, ligestilling, demokrati og retsstatsprincippet og de grundlæggende rettigheder, der er nedfældet i chartret, herunder retten til beskyttelse mod forskelsbehandling, retten til databeskyttelse og retten til privatlivets fred og børns rettigheder.
(29)
AI-baserede manipulerende teknikker kan anvendes til at overtale personer til at udvise uønsket adfærd eller til at vildlede dem ved at nudge dem til at træffe beslutninger på en måde, der undergraver og hæmmer deres autonomi, beslutningstagning og frie valg. Omsætning, ibrugtagning eller anvendelse af visse AI-systemer med det formål eller den virkning i væsentlig grad at fordreje menneskers adfærd, hvorved der sandsynligvis vil opstå betydelige skader, der navnlig kan have tilstrækkeligt vigtige negative indvirkninger på fysisk eller psykisk sundhed eller finansielle interesser, er særligt farlige og bør derfor forbydes. Sådanne AI-systemer anvender subliminale komponenter såsom lyd-, billed- eller videostimuli, som mennesker ikke kan opfatte, eftersom disse stimuli ligger uden for den menneskelige opfattelsesevne, eller andre manipulerende eller vildledende teknikker, der undergraver eller svækker menneskers autonomi, beslutningstagning eller frie valg på måder, hvor mennesker ikke er bevidste om disse teknikker, eller, hvis de er bevidste om dem, stadig kan blive vildledt eller ikke er i stand til at kontrollere eller modstå dem. Dette kan lettes f.eks. ved hjælp af maskine-hjerne-grænseflader eller virtuel virkelighed, da de giver mulighed for en højere grad af kontrol over, hvilke stimuli der præsenteres for personer, for så vidt som de i væsentlig grad kan fordreje deres adfærd på betydelig skadelig vis. Desuden kan AI-systemer også på anden måde udnytte sårbarheder hos en person eller en specifik gruppe af mennesker på grund af deres alder, handicap som omhandlet i Europa-Parlamentets og Rådets direktiv (EU) 2019/882 
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 eller en specifik social eller økonomisk situation, der sandsynligvis vil gøre disse personer mere sårbare over for udnyttelse, såsom personer, der lever i ekstrem fattigdom, og etniske eller religiøse mindretal.Sådanne AI-systemer kan bringes i omsætning, ibrugtages eller anvendes med den hensigt eller det resultat i væsentlig grad at fordreje en persons adfærd og på en måde, der forvolder eller med rimelig sandsynlighed kan forventes at ville forvolde den pågældende eller en anden person eller persongrupper betydelig skade, herunder skade, der kan akkumuleres over tid, og bør derfor forbydes. Det er ikke nødvendigvis muligt at antage, at der er en hensigt om at fordreje adfærd, hvis fordrejningen skyldes faktorer uden for AI-systemet, som er uden for udbyderens eller idriftsætterens kontrol, dvs. faktorer, der ikke med rimelighed kan forudses, og som udbyderen eller idriftsætteren af AI-systemet derfor ikke kan afbøde. Under alle omstændigheder er det ikke nødvendigt, at udbyderen eller idriftsætteren har til hensigt at forvolde betydelig skade, forudsat at en sådan skade er resultatet af AI-baserede manipulerende eller udnyttende former for praksis. Forbuddene mod sådanne former for AI-praksis supplerer bestemmelserne i Europa-Parlamentets og Rådets direktiv 2005/29/EF 
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, navnlig at urimelig handelspraksis, der forårsager økonomisk eller finansiel skade for forbrugerne, er forbudt under alle omstændigheder, uanset om den indføres ved hjælp af AI-systemer eller på anden måde. Forbuddene mod manipulerende og udnyttende former for praksis i denne forordning bør ikke berøre lovlig praksis i forbindelse med lægebehandling såsom psykologbehandling af psykisk sygdom eller fysisk rehabilitering, når disse former for praksis udføres i overensstemmelse med gældende ret og medicinske standarder, for eksempel enkeltpersoners eller deres retlige repræsentanters udtrykkelige samtykke. Desuden bør almindelig og legitim handelspraksis, for eksempel på reklameområdet, der overholder gældende ret, ikke i sig selv anses for at udgøre skadelige AI-baserede manipulerende former for praksis.
(30)
Systemer til biometrisk kategorisering, der er baseret på fysiske personers biometriske data, såsom en persons ansigt eller fingeraftryk, med henblik på at udlede en persons politiske anskuelser, fagforeningsmedlemskab, religiøse eller filosofiske overbevisning, race, seksuelle forhold eller seksuelle orientering, bør forbydes. Dette forbud bør ikke omfatte lovlig mærkning, filtrering eller kategorisering af biometriske datasæt, der er indhentet i overensstemmelse med EU-retten eller national ret i henhold til biometriske data, såsom sortering af billeder efter hårfarve eller øjenfarve, som f.eks. kan anvendes inden for retshåndhævelse.
(31)
AI-systemer, hvor offentlige eller private aktører gør brug af social bedømmelse af fysiske personer, kan føre til forskelsbehandlende resultater og udelukkelse af visse grupper. De kan dermed krænke retten til værdighed og ikkeforskelsbehandling og værdierne lighed og retfærdighed. Sådanne AI-systemer evaluerer eller klassificerer fysiske personer eller grupper heraf på grundlag af en lang række datapunkter i tilknytning til deres sociale adfærd i flere sammenhænge eller kendte, udledte eller forudsagte personlige egenskaber eller personlighedstræk over en vis periode. Den sociale bedømmelse, der leveres af sådanne AI-systemer, kan føre til skadelig eller ugunstig behandling af fysiske personer eller hele grupper heraf i sociale sammenhænge, som ikke har noget at gøre med den sammenhæng, i hvilken dataene oprindeligt blev genereret eller indsamlet, eller til skadelig behandling, der er uforholdsmæssig eller uberettiget i forhold til betydningen af deres sociale adfærd. AI-systemer, der indebærer sådanne uacceptable former for bedømmelsespraksis, og som fører til et sådant skadeligt eller ugunstigt udfald, bør derfor forbydes. Dette forbud bør ikke berøre lovlige former for praksis med evaluering af fysiske personer, der udføres med et specifikt formål i overensstemmelse med EU-retten og national ret.
(32)
Anvendelsen af AI-systemer til biometrisk fjernidentifikation i realtid af fysiske personer på offentlige steder med henblik på retshåndhævelse er særligt indgribende i de berørte personers rettigheder og friheder, for så vidt som det kan påvirke privatlivets fred for en stor del af befolkningen, skabe en følelse af konstant overvågning og indirekte afskrække fra udøvelsen af forsamlingsfriheden og andre grundlæggende rettigheder. Tekniske unøjagtigheder i AI-systemer, der er tilsigtet biometrisk fjernidentifikation af fysiske personer, kan føre til resultater behæftet med bias og have forskelsbehandlende virkning. Sådanne mulige resultater behæftet med bias og forskelsbehandlende virkninger er særligt relevante med hensyn til alder, etnicitet, race, køn og handicap. Desuden indebærer den øjeblikkelige virkning og de begrænsede muligheder for yderligere kontrol eller justeringer i forbindelse med anvendelsen af sådanne systemer, der fungerer i realtid, øgede risici for rettigheder og friheder for de berørte personer i forbindelse med eller påvirket af retshåndhævelsesaktiviteter.
(33)
Anvendelsen af disse systemer med henblik på retshåndhævelse bør derfor forbydes, undtagen i udtømmende opregnede og snævert definerede situationer, hvor anvendelsen er strengt nødvendig for at opfylde en væsentlig samfundsinteresse, hvis betydning vejer tungere end risiciene. Disse situationer omfatter eftersøgning af visse ofre for kriminalitet, herunder forsvundne personer, visse trusler mod fysiske personers liv eller fysiske sikkerhed eller om et terrorangreb, samt lokalisering eller identifikation af gerningsmænd, der har begået, eller af personer, der mistænkes for at have begået, de strafbare handlinger, der er opført i et bilag til denne forordning, hvis disse strafbare handlinger i den berørte medlemsstat kan straffes med frihedsstraf eller en anden frihedsberøvende foranstaltning af en maksimal varighed på mindst fire år, og som de er defineret i denne medlemsstats ret. En sådan tærskel for frihedsstraf eller anden frihedsberøvende foranstaltning i overensstemmelse med national ret bidrager til at sikre, at lovovertrædelsen er af tilstrækkelig alvorlig karakter til potentielt at berettige anvendelsen af systemer til biometrisk fjernidentifikation i realtid. Desuden er listen over strafbare handlinger fastlagt i et bilag til denne forordning baseret på de 32 strafbare handlinger, der er opregnet i Rådets rammeafgørelse 2002/584/RIA 
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, og tager hensyn til, at nogle af disse strafbare handlinger i praksis er mere relevante end andre, idet anvendelsen af biometrisk fjernidentifikation i realtid sandsynligvis i meget varierende grad kan være nødvendig og forholdsmæssig med henblik på lokalisering eller identifikation af en gerningsmand, der har begået, eller af en person, der mistænkes for at have begået, strafbare handlinger, der er opført på listen, og under hensyntagen til de sandsynlige forskelle i alvorligheden, sandsynligheden og omfanget af skaden eller mulige negative konsekvenser. En overhængende fare for fysiske personers liv eller fysiske sikkerhed kan også hidrøre fra en alvorlig afbrydelse af kritisk infrastruktur som defineret i artikel 2, nr. 4), i Europa-Parlamentets og Rådets direktiv (EU) 2022/2557 
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, hvor afbrydelse eller ødelæggelse af en sådan kritisk infrastruktur ville medføre overhængende fare for en persons liv eller fysiske sikkerhed, herunder gennem alvorlig skade på forsyningen af befolkningen med grundlæggende fornødenheder eller på udøvelsen af statens centrale funktion. Desuden bør denne forordning bevare de retshåndhævende myndigheders, grænsekontrolmyndighedernes, indvandringsmyndighedernes eller asylmyndighedernes mulighed for at foretage identitetskontrol under tilstedeværelse af den pågældende person i overensstemmelse med de betingelser, der er fastsat i EU-retten og national ret for en sådan kontrol. Navnlig bør retshåndhævende myndigheder, grænsekontrolmyndigheder, indvandringsmyndigheder eller asylmyndigheder kunne anvende informationssystemer i overensstemmelse med EU-retten eller national ret til at identificere personer, der under en identitetskontrol enten nægter at blive identificeret eller ikke er i stand til at oplyse eller bevise deres identitet, uden at det i henhold til denne forordning kræves, at der indhentes forhåndstilladelse. Dette kan f.eks. være en person, der er involveret i en forbrydelse, og som er uvillig eller ude af stand til på grund af en ulykke eller en helbredstilstand at afsløre sin identitet over for de retshåndhævende myndigheder.
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For at sikre at disse systemer anvendes på en ansvarlig og forholdsmæssig måde, er det også vigtigt at fastslå, at der i hver af disse udtømmende opregnede og snævert definerede situationer bør tages hensyn til visse elementer, navnlig med hensyn til situationens karakter, som ligger til grund for anmodningen, og konsekvenserne af anvendelsen for alle berørte personers rettigheder og friheder samt de sikkerhedsforanstaltninger og betingelser, der er fastsat for brugen. Anvendelsen af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse bør kun idriftsættes til at bekræfte den specifikt målrettede persons identitet og bør begrænses til, hvad der er strengt nødvendigt for så vidt angår tidsperioden samt det geografiske og personmæssige anvendelsesområde, navnlig med hensyn til beviserne eller indikationerne vedrørende truslerne, ofrene eller gerningsmanden. Anvendelsen af systemet til biometrisk fjernidentifikation i realtid på offentlige steder bør kun tillades, hvis den relevante retshåndhævende myndighed har gennemført en konsekvensanalyse vedrørende grundlæggende rettigheder og, medmindre andet er fastsat i denne forordning, har registreret systemet i databasen som fastsat i denne forordning. Referencedatabasen over personer bør være passende for hvert enkelt anvendelsestilfælde i hver af de ovennævnte situationer.
(35)
Enhver anvendelse af et system til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse bør være betinget af en udtrykkelig og specifik tilladelse fra en medlemsstats judicielle myndighed eller uafhængige administrative myndighed, hvis afgørelse er bindende. En sådan tilladelse bør i princippet indhentes forud for anvendelsen af AI- systemet med henblik på at identificere en eller flere personer. Undtagelser fra denne regel bør tillades i behørigt begrundede hastende tilfælde, dvs. i situationer, hvor behovet for at anvende de pågældende systemer er af en sådan art, at det er praktisk og objektivt umuligt at indhente en tilladelse, inden anvendelsen af AI-systemet påbegyndes. I sådanne hastende situationer bør anvendelsen af AI-systemet begrænses til det absolut nødvendige minimum og bør være underlagt passende sikkerhedsforanstaltninger og betingelser som fastsat i national ret og præciseret i forbindelse med hver enkelt hastesag af den retshåndhævende myndighed selv. Desuden bør den retshåndhævende myndighed i sådanne situationer anmode om en sådan tilladelse og samtidig begrunde, hvorfor den ikke har været i stand til at anmode om den tidligere, uden unødigt ophold og senest inden for 24 timer. Hvis en sådan tilladelse afvises, bør anvendelsen af systemer til biometrisk identifikation i realtid, der er knyttet til den pågældende tilladelse, indstilles med øjeblikkelig virkning, og alle data vedrørende en sådan anvendelse bør kasseres og slettes. Sådanne data omfatter inputdata, der er erhvervet direkte af et AI-system ved anvendelsen af et sådant system, samt resultater og output af den anvendelse, der er knyttet til den pågældende tilladelse. Det bør ikke omfatte input, der er erhvervet lovligt i overensstemmelse med anden EU-ret eller national ret. Under alle omstændigheder bør der ikke træffes nogen afgørelse, der har negative retsvirkninger for en person, udelukkende baseret på outputtet af systemet til biometrisk fjernidentifikation.
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Den relevante markedsovervågningsmyndighed og den nationale databeskyttelsesmyndighed bør for at kunne udføre deres opgaver i overensstemmelse med kravene fastsat i denne forordning og i de nationale regler underrettes om hver anvendelse af »systemet til biometrisk identifikation i realtid«. Markedsovervågningsmyndighederne og de nationale databeskyttelsesmyndigheder, der er blevet underrettet, bør forelægge Kommissionen en årlig rapport om anvendelsen af systemer til biometrisk identifikation i realtid.
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Endvidere bør det inden for denne forordnings udtømmende rammer fastsættes, at en sådan anvendelse på en medlemsstats område i overensstemmelse med denne forordning kun bør være mulig, hvis og i det omfang den pågældende medlemsstat har besluttet udtrykkeligt at give mulighed for at tillade en sådan anvendelse i sine detaljerede bestemmelser i national ret. Det står derfor medlemsstaterne frit for i henhold til denne forordning slet ikke at fastsætte en sådan mulighed eller kun at fastsætte en sådan mulighed med hensyn til nogle af de mål, der i henhold til denne forordning kan begrunde en godkendt anvendelse. Sådanne nationale regler bør meddeles Kommissionen inden for 30 dage efter deres vedtagelse.
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Anvendelsen af AI-systemer til biometrisk fjernidentifikation i realtid af fysiske personer på offentlige steder med henblik på retshåndhævelse indebærer nødvendigvis behandling af biometriske data. De bestemmelser i denne forordning, der med forbehold af visse undtagelser forbyder en sådan anvendelse, og som har grundlag i artikel 16 i TEUF, bør finde anvendelse som lex specialis, for så vidt angår reglerne om behandling af biometriske data i artikel 10 i direktiv (EU) 2016/680 og således regulere anvendelsen og behandlingen af biometriske data på en udtømmende måde. En sådan anvendelse og behandling bør derfor kun være mulig, i det omfang det er foreneligt med den ramme, der er fastsat i denne forordning, uden at der uden for denne ramme er mulighed for, at de kompetente myndigheder, når de handler med henblik på retshåndhævelse, kan anvende sådanne systemer og i forbindelse hermed behandle sådanne data af de grunde, der er anført i artikel 10 i direktiv (EU) 2016/680. I denne sammenhæng har denne forordning ikke til formål at tilvejebringe retsgrundlaget for behandling af personoplysninger i henhold til artikel 8 i direktiv (EU) 2016/680. Anvendelsen af systemer til biometrisk fjernidentifikation i realtid på offentlige steder til andre formål end retshåndhævelse, herunder af kompetente myndigheder, bør imidlertid ikke være omfattet af den specifikke ramme for en sådan anvendelse med henblik på retshåndhævelse som fastsat i denne forordning. En sådan anvendelse til andre formål end retshåndhævelse bør derfor ikke være underlagt kravet om en tilladelse i henhold til denne forordning og de gældende detaljerede bestemmelser i national ret, der kan give denne tilladelse virkning.
(39)
Enhver behandling af biometriske data og andre personoplysninger i forbindelse med anvendelsen af AI-systemer til biometrisk identifikation, undtagen i forbindelse med anvendelsen af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse som reguleret ved denne forordning, bør fortsat overholde alle de krav, der følger af artikel 10 i direktiv (EU) 2016/680. Med henblik på andre formål end retshåndhævelse forbyder artikel 9, stk. 1, i forordning (EU) 2016/679 og artikel 10, stk. 1, i forordning (EU) 2018/1725 behandling af biometriske data med begrænsede undtagelser som fastsat i disse artikler. I henhold til artikel 9, stk. 1, i forordning (EU) 2016/679 har anvendelsen af biometrisk fjernidentifikation til andre formål end retshåndhævelse allerede været genstand for forbudsafgørelser fra nationale databeskyttelsesmyndigheder.
(40)
I medfør af artikel 6a i protokol nr. 21 om Det Forenede Kongeriges og Irlands stilling, for så vidt angår området med frihed, sikkerhed og retfærdighed, der er knyttet som bilag til TEU og TEUF, er Irland ikke bundet af regler fastsat i denne forordnings artikel 5, stk. 1, første afsnit, litra g), i det omfang den finder anvendelse på brugen af systemer til biometrisk kategorisering til aktiviteter inden for politisamarbejde og retligt samarbejde i straffesager, artikel 5, stk. 1, første afsnit, litra d), i det omfang den finder anvendelse på brugen af AI-systemer, der er omfattet af nævnte bestemmelse, artikel 5, stk. 1, første afsnit, litra h), og stk. 2-6, og artikel 26, stk. 10, der er vedtaget på grundlag af artikel 16 i TEUF vedrørende medlemsstaternes behandling af personoplysninger under udøvelsen af aktiviteter, der er omfattet af tredje del, afsnit V, kapitel 4 eller 5, i TEUF, når Irland ikke er bundet af regler vedrørende former for strafferetligt samarbejde eller politisamarbejde, der kræver overholdelse af de bestemmelser, der er fastsat på grundlag af artikel 16 i TEUF.
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I medfør af artikel 2 og 2a i protokol nr. 22 om Danmarks stilling, der er knyttet som bilag til TEU og TEUF, er de regler, der er fastsat i denne forordnings artikel 5, stk. 1, første afsnit, litra g), i det omfang den finder anvendelse på brugen af systemer til biometrisk kategorisering til aktiviteter inden for politisamarbejde og retligt samarbejde i straffesager, artikel5, stk. 1, første afsnit, litra d), i det omfang den finder anvendelse på brugen af AI-systemer, der er omfattet af nævnte bestemmelse, artikel 5, stk. 1, første afsnit, litra h), og stk. 2-6, og artikel 26, stk. 10, der er vedtaget på grundlag af artikel 16 i TEUF vedrørende medlemsstaternes behandling af personoplysninger under udøvelsen af aktiviteter, der er omfattet af tredje del, afsnit V, kapitel 4 eller 5, i TEUF, ikke bindende for og finder ikke anvendelse i Danmark.
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I overensstemmelse med uskyldsformodningen bør fysiske personer i Unionen altid dømmes på grundlag af deres faktiske adfærd. Fysiske personer bør aldrig dømmes på grundlag af AI-forudsagt adfærd, der alene er baseret på deres profilering, personlighedstræk eller personlige egenskaber såsom nationalitet, fødested, bopæl, antal børn, gældsbyrde eller biltype, uden at der er begrundet mistanke om, at den pågældende person er involveret i kriminel aktivitet baseret på objektive verificerbare kendsgerninger, og uden menneskelig vurdering heraf. Risikovurderinger, der udføres med hensyn til fysiske personer med det formål at vurdere risikoen for, at de begår lovovertrædelser, eller forudsige forekomsten af en faktisk eller potentiel strafbar handling alene baseret på profilering af dem eller vurdering af deres personlighedstræk og personlige egenskaber, bør derfor forbydes. Under alle omstændigheder henviser dette forbud ikke til eller berører ikke risikoanalyser, der ikke er baseret på profilering af enkeltpersoner eller på enkeltpersoners personlighedstræk og personlige egenskaber, såsom AI-systemer, der anvender risikoanalyser til at vurdere sandsynligheden for virksomheders økonomiske svig på grundlag af mistænkelige transaktioner eller risikoanalyseværktøjer til at forudsige sandsynligheden for toldmyndighedernes lokalisering af narkotika eller ulovlige varer, f.eks. på grundlag af kendte narkotikaruter.
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Omsætning, ibrugtagning til dette specifikke formål eller anvendelse af AI-systemer, der opretter eller udvider ansigtsgenkendelsesdatabaser gennem ikkemålrettet indsamling af ansigtsbilleder fra internettet eller kameraovervågning, bør forbydes, da denne praksis øger følelsen af masseovervågning og kan føre til grove krænkelser af de grundlæggende rettigheder, herunder retten til privatlivets fred.
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Der er alvorlig bekymring over det videnskabelige grundlag for AI-systemer, der har til formål at identificere eller udlede følelser, navnlig da følelser varierer betydeligt på tværs af kulturer og situationer og endda hos en enkelt person. Blandt de vigtigste mangler ved sådanne systemer er den begrænsede pålidelighed, manglen på specificitet og den begrænsede generaliserbarhed. AI-systemer, der identificerer eller udleder fysiske personers følelser eller hensigter på grundlag af deres biometriske data, kan derfor føre til forskelsbehandlende resultater og kan være indgribende i de berørte personers rettigheder og friheder. Sådanne systemer kan i betragtning af den ulige magtfordeling på arbejdspladsen eller uddannelsesstedet, kombineret med disse systemers indgribende karakter, føre til skadelig eller ugunstig behandling af visse fysiske personer eller hele grupper heraf. Omsætningen, ibrugtagningen eller anvendelsen af AI-systemer, der er tilsigtet at påvise enkeltpersoners følelsesmæssige tilstand i situationer, der vedrører arbejdspladsen og uddannelsesstedet, bør derfor forbydes. Dette forbud bør ikke omfatte AI-systemer, der bringes i omsætning udelukkende af medicinske eller sikkerhedsmæssige årsager, såsom systemer tilsigtet terapeutisk brug.
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Former for praksis, der er forbudt i henhold til EU-retten, herunder databeskyttelsesretten, retten om ikkeforskelsbehandling, forbrugerbeskyttelsesretten og konkurrenceretten, bør ikke berøres af denne forordning.
(46)
Højrisiko-AI-systemer bør kun bringes i omsætning på EU-markedet, ibrugtages eller anvendes, hvis de overholder visse obligatoriske krav. Disse krav bør sikre, at højrisiko-AI-systemer, der er tilgængelige i Unionen, eller hvis output på anden måde anvendes i Unionen, ikke udgør uacceptable risici for vigtige samfundsinteresser i Unionen som anerkendt og beskyttet i EU-retten. På grundlag af den nye lovgivningsmæssige ramme, som præciseret i Kommissionens meddelelse om den blå vejledning om gennemførelsen af EU's produktregler 2022 
(
20
)
, er den generelle regel, at mere end én EU-harmoniseringslovgivningsretsakt såsom Europa-Parlamentets og Rådets forordning (EU) 2017/745 
(
21
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 og (EU) 2017/746 
(
22
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 eller Europa-Parlamentets og Rådets direktiv 2006/42/EF 
(
23
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 kan finde anvendelse på ét produkt, da tilgængeliggørelsen eller ibrugtagningen kun kan finde sted, når produktet overholder al gældende EU-harmoniseringslovgivning. For at sikre konsekvens og undgå unødvendige administrative byrder eller omkostninger bør udbydere af et produkt, der indeholder et eller flere højrisiko-AI-systemer, som kravene i nærværende forordning og kravene i EU-harmoniseringslovgivningen opført i et bilag til nærværende forordning, finder anvendelse på, have fleksibilitet med hensyn til at træffe operationelle beslutninger om, hvordan det sikres, at et produkt, der indeholder et eller flere AI-systemer, overholder alle gældende krav i EU-harmoniseringslovgivningen på en optimal måde. AI-systemer, der identificeres som højrisiko, bør begrænses til systemer, der har en betydelig skadelig indvirkning på personers sundhed, sikkerhed og grundlæggende rettigheder i Unionen, og en sådan begrænsning bør minimere enhver potentiel restriktion for international handel.
(47)
AI-systemer kan have negative virkninger for personers sundhed og sikkerhed, navnlig når sådanne systemer anvendes som produkters sikkerhedskomponenter. I overensstemmelse med målene for EU-harmoniseringslovgivningen om at lette den frie bevægelighed for produkter i det indre marked og sørge for, at kun sikre produkter, der desuden overholder alle de stillede krav, kommer ind på markedet, er det vigtigt, at de sikkerhedsrisici, som et produkt som helhed kan udgøre på grund af dets digitale komponenter, herunder AI-systemer, behørigt forebygges og afbødes. F.eks. bør stadig mere autonome robotter, hvad enten det er i forbindelse med fremstilling eller personlig bistand og pleje, være i stand til at fungere sikkert og udføre deres funktioner i komplekse miljøer. Også i sundhedssektoren, hvor det drejer sig direkte om liv og sundhed, bør stadig mere avancerede diagnosesystemer og systemer, der understøtter menneskers beslutninger, være pålidelige og nøjagtige.
(48)
Omfanget af et AI-systems negative indvirkning på de grundlæggende rettigheder, der er beskyttet af chartret, er særlig relevant, når et AI-system klassificeres som højrisiko. Disse rettigheder omfatter retten til menneskelig værdighed, respekt for privatliv og familieliv, beskyttelse af personoplysninger, ytrings- og informationsfrihed, forsamlings- og foreningsfrihed, retten til ikkeforskelsbehandling, retten til uddannelse, forbrugerbeskyttelse, arbejdstagerrettigheder, rettigheder for personer med handicap, ligestilling mellem kønnene, intellektuelle ejendomsrettigheder, retten til effektive retsmidler og til en retfærdig rettergang, retten til et forsvar og uskyldsformodningen samt retten til god forvaltning. Ud over disse rettigheder er det vigtigt at fremhæve det forhold, at børn har specifikke rettigheder som fastsat i artikel 24 i chartret og i De Forenede Nationers konvention om barnets rettigheder, yderligere udviklet i generel bemærkning nr. 25 vedrørende det digitale miljø fra FN's Komité for Barnets Rettigheder, som begge kræver, at der tages hensyn til børns sårbarhed, og at der ydes den beskyttelse og omsorg, der er nødvendig for deres trivsel. Den grundlæggende ret til et højt miljøbeskyttelsesniveau, der er nedfældet i chartret og gennemført i Unionens politikker, bør også tages i betragtning ved vurderingen af alvorligheden af den skade, som et AI-system kan forvolde, herunder i forbindelse med personers sundhed og sikkerhed.
(49)
For så vidt angår højrisiko-AI-systemer, der er sikkerhedskomponenter i produkter eller systemer, eller som selv er produkter eller systemer, der er omfattet af anvendelsesområdet for Europa-Parlamentets og Rådets forordning (EF) nr. 300/2008 
(
24
)
, Europa-Parlamentets og Rådets forordning (EU) nr. 167/2013 
(
25
)
, Europa-Parlamentets og Rådets forordning (EU) nr. 168/2013 
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26
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, Europa-Parlamentets og Rådets direktiv 2014/90/EU 
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27
)
, Europa-Parlamentets og Rådets direktiv (EU) 2016/797 
(
28
)
, Europa-Parlamentets og Rådets forordning (EU) 2018/858 
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29
)
, Europa-Parlamentets og Rådets forordning (EU) 2018/1139 
(
30
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 og Europa-Parlamentets og Rådets forordning (EU) 2019/2144 
(
31
)
, bør disse retsakter ændres for at sikre, at Kommissionen, på grundlag af de særlige tekniske og reguleringsmæssige forhold i hver enkelt sektor og uden at gribe ind i de eksisterende forvaltnings-, overensstemmelsesvurderings- og håndhævelsesmekanismer og myndigheder, der er fastsat heri, tager hensyn til de obligatoriske krav til højrisiko-AI-systemer, der er fastsat i nærværende forordning, når den vedtager relevante delegerede retsakter eller gennemførelsesretsakter på grundlag af disse retsakter.
(50)
For så vidt angår AI-systemer, der er sikkerhedskomponenter i produkter, eller som selv er produkter, der er omfattet af anvendelsesområdet for en vis EU-harmoniseringslovgivning, der er opført i et bilag til denne forordning, er det hensigtsmæssigt at klassificere dem som højrisiko i henhold til denne forordning, hvis det pågældende produkt overensstemmelsesvurderes af en tredjeparts overensstemmelsesvurderingsorgan i henhold til den relevante EU-harmoniseringslovgivning. Sådanne produkter er navnlig maskiner, legetøj, elevatorer, udstyr og sikringssystemer tilsigtet anvendelse i eksplosionsfarlig atmosfære, radioudstyr, trykudstyr, udstyr til fritidsfartøjer, tovbaneanlæg, gasapparater, medicinsk udstyr, in vitro-diagnostisk medicinsk udstyr, bilindustrien og luftfart.
(51)
Klassificeringen af et AI-system som højrisiko i henhold til denne forordning bør ikke nødvendigvis betyde, at det produkt, hvori AI-systemet indgår som sikkerhedskomponent, eller selve AI-systemet som produkt betragtes som højrisiko i henhold til de kriterier, der er fastsat i den relevante EU-harmoniseringslovgivning, der finder anvendelse på produktet. Dette er navnlig tilfældet med forordning (EU) 2017/745 og (EU) 2017/746, hvor en tredjepart foretager overensstemmelsesvurderinger af mellemrisiko- og højrisikoprodukter.
(52)
For så vidt angår selvstændige AI-systemer, dvs. andre højrisiko-AI-systemer end dem, der er produkters sikkerhedskomponenter, eller selv er produkter, bør de klassificeres som højrisiko, hvis de set i lyset af deres tilsigtede formål udgør en høj risiko for skade på sundhed og sikkerhed eller personers grundlæggende rettigheder, idet der tages hensyn til både sandsynligheden for den mulige skade og dens alvorlighed, og hvis de anvendes på en række specifikt foruddefinerede områder, der er angivet i denne forordning. Disse systemer udpeges ved hjælp af den samme metode og ud fra de samme kriterier som i forbindelse med eventuelle fremtidige ændringer af listen over højrisiko-AI-systemer, som Kommissionen bør tillægges beføjelser til at vedtage ved hjælp af delegerede retsakter for at tage hensyn til den hurtige teknologiske udvikling samt de potentielle ændringer i anvendelsen af AI-systemer.
(53)
Det er også vigtigt at præcisere, at der kan være særlige tilfælde, hvor AI-systemer, der henvises til i foruddefinerede områder som angivet i denne forordning, ikke medfører en væsentlig risiko for at skade de retlige interesser, der beskyttes på disse områder, fordi de ikke i væsentlig grad påvirker beslutningstagningen eller ikke skader disse interesser væsentligt. Med henblik på denne forordning bør et AI-system, der ikke i væsentlig grad påvirker resultatet af beslutningstagning, forstås som et AI-system, der ikke har indvirkning på substansen og dermed resultatet af beslutningstagning, uanset om den er menneskelig eller automatiseret. Et AI-system, der ikke i væsentlig grad påvirker resultatet af beslutningstagning, kan omfatte situationer, hvor en eller flere af følgende betingelser er opfyldt. Den første sådanne betingelse bør være, at AI-systemet er tilsigtet at udføre en snæver proceduremæssig opgave, f.eks. et AI-system, der omdanner ustrukturerede data til strukturerede data, et AI-system, der klassificerer indgående dokumenter i kategorier, eller et AI-system, der anvendes til at påvise duplikater blandt et stort antal ansøgninger. Disse opgaver er så snævre og begrænsede, at de kun udgør begrænsede risici, som ikke øges som følge af anvendelsen af et AI-system i en af de sammenhænge, der er opført som en højrisikoanvendelse i et bilag til denne forordning. Den anden betingelse bør være, at den opgave, AI-systemet udfører, er tilsigtet at forbedre resultatet af en tidligere afsluttet menneskelig aktivitet, der kan være relevant med henblik på de højrisikoanvendelser, der er opført i et bilag til denne forordning. I betragtning af disse karakteristika tilføjer AI-systemet kun et ekstra lag til en menneskelig aktivitet og udgør dermed en lavere risiko. Denne betingelse ville f.eks. gælde AI-systemer, der er tilsigtet at forbedre det sprog, der er anvendt i tidligere udarbejdede dokumenter, f.eks. hvad angår professionel tone og akademisk sprogbrug eller ved at tilpasse teksten til et bestemt produktbudskab. Den tredje betingelse bør være, at AI-systemet er tilsigtet at påvise beslutningsmønstre eller afvigelser fra tidligere beslutningsmønstre. Risikoen vil være lavere, fordi anvendelsen af AI-systemet følger efter en tidligere afsluttet menneskelig vurdering, som det ikke er tiltænkt at skulle erstatte eller påvirke uden en ordentlig menneskelig gennemgang. Sådanne AI-systemer omfatter f.eks. systemer, der ud fra en lærers bestemte bedømmelsesmønster kan anvendes til efterfølgende at kontrollere, om læreren kan have afveget fra bedømmelsesmønstret, således at potentielle uoverensstemmelser eller uregelmæssigheder identificeres. Den fjerde betingelse bør være, at AI-systemet er tilsigtet kun at udføre en forberedende opgave inden en vurdering, der er relevant med henblik på de AI-systemer, der er opført i et bilag til denne forordning, hvilket gør den mulige virkning af systemets output meget lav med hensyn til at udgøre en risiko for den efterfølgende vurdering. Denne betingelse omfatter bl.a. intelligente løsninger til filhåndtering, som indeholder forskellige funktioner såsom indeksering, søgning, tekst- og talebehandling eller sammenkobling af data til andre datakilder, eller AI-systemer, der anvendes til oversættelse af oprindelige dokumenter. Under alle omstændigheder bør AI-systemer, som anvendes i tilfælde af højrisikoanvendelser, der er opført i et bilag til denne forordning, betragtes som at udgøre en betydelig risiko for skade på fysiske personers sundhed, sikkerhed eller grundlæggende rettigheder, hvis AI-systemet indebærer profilering som omhandlet i artikel 4, nr. 4), i forordning (EU) 2016/679, eller artikel 3, nr. 4), i direktiv (EU) 2016/680 eller artikel 3, nr. 5), i forordning (EU) 2018/1725. For at sikre sporbarhed og gennemsigtighed bør en udbyder, der skønner, at et AI-system ikke udgør en høj risiko på grundlag af de ovenfor omhandlede betingelser, udarbejde dokumentation for vurderingen, inden systemet bringes i omsætning eller ibrugtages, og bør efter anmodning forelægge denne dokumentation for de nationale kompetente myndigheder. En sådan udbyder bør være forpligtet til at registrere AI-systemet i den EU-database, der oprettes i henhold til nærværende forordning. Med henblik på at give yderligere vejledning om den praktiske gennemførelse af de betingelser, i henhold til hvilke de AI-systemer, der er opført i et bilag til nærværende forordning, undtagelsesvis er ikkehøjrisiko, bør Kommissionen efter høring af AI-udvalget udarbejde retningslinjer, der præciserer denne praktiske gennemførelse, suppleret med en omfattende liste over praktiske eksempler på anvendelsestilfælde af AI-systemer, der er højrisiko, og anvendelsestilfælde, der ikke er.
(54)
Da biometriske data udgør en særlig kategori af personoplysninger, er det hensigtsmæssigt at klassificere flere kritiske anvendelsestilfælde af biometriske systemer som højrisiko, for så vidt som deres anvendelse er tilladt i henhold til relevant EU-ret og national ret. Tekniske unøjagtigheder i AI-systemer, der er tilsigtet biometrisk fjernidentifikation af fysiske personer, kan føre til resultater behæftet med bias og have forskelsbehandlende virkning. Risikoen for sådanne mulige resultater behæftet med bias og forskelsbehandlende virkninger er særligt relevante med hensyn til alder, etnicitet, race, køn og handicap. Systemer til biometrisk fjernidentifikation bør derfor klassificeres som højrisiko i betragtning af de risici, systemerne udgør. En sådan klassificering udelukker AI-systemer, der tilsigtes anvendt til biometrisk verifikation, herunder autentifikation, hvis eneste formål er at bekræfte, at en bestemt fysisk person er den person, vedkommende hævder at være, og bekræfte en fysisk persons identitet udelukkende med det formål at få adgang til en tjeneste, låse udstyr op eller have sikker adgang til lokaler. Desuden bør AI-systemer, der tilsigtes anvendt til biometrisk kategorisering ifølge følsomme egenskaber eller karakteristika, som er beskyttet i henhold til artikel 9, stk. 1, i forordning (EU) 2016/679, på grundlag af biometriske data, for så vidt som disse ikke er forbudt i henhold til nærværende forordning, og systemer til følelsesgenkendelse, der ikke er forbudt i henhold til nærværende forordning, klassificeres som højrisiko. Biometriske systemer, der udelukkende er tilsigtet anvendt til at muliggøre cybersikkerhedsforanstaltninger og foranstaltninger til beskyttelse af personoplysninger, bør ikke betragtes som højrisiko-AI-systemer.
(55)
For så vidt angår forvaltning og drift af kritisk infrastruktur bør AI-systemer, der tilsigtes anvendt som sikkerhedskomponenter i forvaltningen og driften af kritisk digital infrastruktur som opført i bilaget, punkt 8, til direktiv (EU) 2022/2557, vejtrafik og forsyning af vand, gas, varme og elektricitet, klassificeres som højrisiko, da svigt eller funktionsfejl i disse systemer kan bringe menneskers liv og sundhed i fare i stor målestok og føre til betydelige forstyrrelser i de sociale og økonomiske aktiviteter. Sikkerhedskomponenter i kritisk infrastruktur, herunder kritisk digital infrastruktur, er systemer, der anvendes til direkte at beskytte den kritiske infrastrukturs fysiske integritet eller personers sundhed og sikkerhed og ejendom, men som ikke er nødvendige for, at systemet kan fungere. Svigt eller funktionsfejl i sådanne komponenter kan direkte medføre risici for den kritiske infrastrukturs fysiske integritet og dermed risici for personers sundhed og sikkerhed og ejendom. Komponenter, der udelukkende tilsigtes anvendt til cybersikkerhedsformål, bør ikke betragtes som sikkerhedskomponenter. Eksempler på sikkerhedskomponenter i en sådan kritisk infrastruktur kan omfatte systemer til overvågning af vandtryk eller brandalarmkontrolsystemer i cloudcomputingcentre.
(56)
Det er vigtigt at idriftsætte AI-systemer inden for uddannelse for at fremme digital uddannelse og træning af høj kvalitet og for at give alle lærende og lærere mulighed for at tilegne sig og dele de nødvendige digitale færdigheder og kompetencer, herunder mediekendskab, og kritisk tænkning, til at deltage aktivt i økonomien, samfundet og de demokratiske processer. AI-systemer, der anvendes inden for uddannelse eller erhvervsuddannelse, navnlig til at bestemme adgang eller optagelse, til at fordele personer på uddannelsesinstitutioner eller uddannelser på alle niveauer, til at evaluere personers læringsudbytte, til at bedømme en persons nødvendige uddannelsesniveau og væsentligt påvirke den uddannelse, som den pågældende person vil modtage eller vil kunne få adgang til, eller til at overvåge og opdage forbudt adfærd blandt studerende under prøver, bør dog klassificeres som højrisiko-AI-systemer, da de kan afgøre en persons uddannelsesmæssige og arbejdsmæssige livsforløb og dermed kan påvirke denne persons mulighed for at sikre sig et livsgrundlag. Hvis sådanne systemer udformes og anvendes forkert, kan de være særligt indgribende og krænke retten til uddannelse samt retten til ikke at blive forskelsbehandlet og gøre historiske forskelsbehandlingsmønstre permanente, f.eks. mod kvinder, bestemte aldersgrupper, personer med handicap eller personer af bestemt racemæssig eller etnisk oprindelse eller med en bestemt seksuel orientering.
(57)
AI-systemer, der anvendes inden for beskæftigelse, forvaltning af arbejdskraft og adgang til selvstændig erhvervsvirksomhed, navnlig til rekruttering og udvælgelse af personer, til at træffe beslutninger, der påvirker vilkårene for det arbejdsrelaterede forhold, forfremmelse og ophør af arbejdsmæssige kontraktforhold, til fordeling af opgaver på grundlag af individuel adfærd, personlighedstræk eller personlige egenskaber og til overvågning og evaluering af personer i arbejdsmæssige kontraktforhold, bør også klassificeres som højrisiko, da de kan have en betydelig indvirkning på disse personers fremtidige karrieremuligheder, livsgrundlag og arbejdstagerrettigheder. De relevante arbejdsmæssige kontraktforhold bør på en meningsfuld måde omfatte ansatte og personer, der leverer tjenesteydelser via platforme som omhandlet i Kommissionens arbejdsprogram for 2021. Gennem hele rekrutteringsprocessen og i forbindelse med evaluering, forfremmelse eller fastholdelse af personer i arbejdsrelaterede kontraktforhold kan sådanne systemer gøre historiske forskelsbehandlingsmønstre permanente, f.eks. mod kvinder, bestemte aldersgrupper, personer med handicap eller personer af bestemt racemæssig eller etnisk oprindelse eller med en bestemt seksuel orientering. AI-systemer, der anvendes til at overvåge disse personers præstationer og adfærd, kan også underminere deres grundlæggende ret til databeskyttelse og ret til privatlivets fred.
(58)
Et andet område, hvor anvendelsen af AI-systemer kræver særlig opmærksomhed, er adgangen til og benyttelsen af visse væsentlige private og offentlige tjenester og de ydelser, der er nødvendige for, at mennesker kan deltage fuldt ud i samfundet eller forbedre deres levestandard. Navnlig er fysiske personer, der ansøger om eller modtager væsentlige offentlige bistandsydelser og -tjenester fra offentlige myndigheder, dvs. sundhedstjenester, socialsikringsydelser, sociale tjenester, der yder beskyttelse i tilfælde af barsel, sygdom, arbejdsulykker, afhængighed eller alderdom og tab af beskæftigelse samt social bistand og boligstøtte, typisk afhængige af sådanne ydelser og tjenester og befinder sig i en sårbar situation i forhold til de ansvarlige myndigheder. Hvis der anvendes AI-systemer til at afgøre, om der skal gives afslag på sådanne ydelser og tjenester, eller om de skal tildeles, nedsættes, tilbagekaldes eller kræves tilbagebetalt af myndighederne, herunder om modtagerne reelt er berettigede til disse ydelser eller tjenester, kan disse systemer have en betydelig indvirkning på menneskers livsgrundlag og kan krænke deres grundlæggende rettigheder såsom retten til social beskyttelse, ikkeforskelsbehandling, menneskelig værdighed eller adgang til effektive retsmidler, og de bør derfor klassificeres som højrisiko. Ikke desto mindre bør denne forordning ikke hindre udviklingen eller anvendelsen af innovative tilgange i den offentlige forvaltning, som står til at kunne drage fordel af en bredere anvendelse af AI-systemer, der er i overensstemmelse med reglerne og er sikre, forudsat at de ikke indebærer en høj risiko for juridiske og fysiske personer. Desuden bør AI-systemer, der anvendes til at evaluere fysiske personers kreditvurdering eller kreditværdighed, klassificeres som højrisiko-AI-systemer, da de afgør menneskers adgang til finansielle ressourcer eller væsentlige tjenester såsom bolig, elektricitet og telekommunikationstjenester. AI-systemer, der anvendes til disse formål, kan føre til forskelsbehandling mellem personer eller grupper og kan gøre historiske forskelsbehandlingsmønstre permanente, f.eks. på grundlag af racemæssig eller etnisk oprindelse, køn, handicap, alder eller seksuel orientering, eller være med til at skabe nye former for forskelsbehandlende virkning. AI-systemer, der er fastsat i EU-retten med henblik på at afsløre svig i forbindelse med tilbud af finansielle tjenesteydelser og for i tilsynsøjemed at beregne kreditinstitutters og forsikringsselskabers kapitalkrav, bør dog ikke betragtes som højrisiko i henhold til denne forordning. Desuden kan AI-systemer, der tilsigtes anvendt til risikovurdering og prisfastsættelse i forbindelse med fysiske personer for så vidt angår syge- og livsforsikring, også have en betydelig indvirkning på menneskers livsgrundlag og kan, hvis de ikke udformes, udvikles og anvendes behørigt, krænke deres grundlæggende rettigheder og have alvorlige konsekvenser for menneskers liv og sundhed, herunder økonomisk udstødelse og forskelsbehandling. Endelig bør AI-systemer, der anvendes til at vurdere og klassificere fysiske personers nødopkald eller til at udsende beredskabstjenester i nødsituationer eller til at tildele prioriteter i forbindelse hermed, herunder fra politi, brandmænd og lægehjælp, samt patientsorteringssystemer for førstehjælp, også klassificeres som højrisiko, da de træffer beslutninger i situationer, der er meget kritiske for menneskers liv og sundhed og for deres ejendom.
(59)
I betragtning af deres rolle og ansvar, er retshåndhævende myndigheders tiltag, der omfatter visse anvendelser af AI-systemer, kendetegnet ved en betydelig magtubalance og kan føre til overvågning, anholdelse eller frihedsberøvelse af fysiske personer samt have andre negative indvirkninger på de grundlæggende rettigheder, der er sikret i chartret. Navnlig kan AI-systemer udvælge personer på forskelsbehandlende eller anden ukorrekt eller uretfærdig måde, hvis de ikke er trænet med data af høj kvalitet, ikke opfylder passende krav med hensyn til deres ydeevne, nøjagtighed og robusthed eller ikke er korrekt udformet og afprøvet, før de bringes i omsætning eller på anden måde ibrugtages. Desuden kan udøvelsen af vigtige processuelle grundlæggende rettigheder såsom retten til adgang til effektive retsmidler, retten til en retfærdig rettergang og retten til et forsvar samt uskyldsformodningen hindres, navnlig hvis sådanne AI-systemer ikke er tilstrækkeligt gennemsigtige, forklarlige og dokumenterede. Derfor bør en række AI-systemer, der tilsigtes anvendt i retshåndhævelsesmæssig sammenhæng, hvor det er særlig vigtigt med nøjagtighed, pålidelighed og gennemsigtighed for at undgå negative virkninger, bevare offentlighedens tillid og sikre ansvarlighed og effektive retsmidler, klassificeres som højrisiko, for så vidt som deres anvendelse er tilladt i henhold til relevant EU-ret og national ret. I betragtning af aktiviteternes karakter og de risici, der er forbundet hermed, bør disse højrisiko-AI-systemer navnlig omfatte AI-systemer, der er tilsigtet anvendt af eller på vegne af retshåndhævende myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til støtte for retshåndhævende myndigheder til vurdering af risikoen for, at en fysisk person bliver offer for strafbare handlinger, som polygrafer og lignende værktøjer, til vurdering af pålideligheden af bevismateriale i forbindelse med efterforskning eller retsforfølgning af strafbare handlinger og, for så vidt som det ikke er forbudt i henhold til denne forordning, til vurdering af risikoen for, at en fysisk person begår eller på ny begår lovovertrædelser, der ikke udelukkende er baseret på profilering af fysiske personer eller vurdering af fysiske personers eller gruppers personlighedstræk og personlige egenskaber eller tidligere kriminelle adfærd, samt til profilering i forbindelse med afsløring, efterforskning eller retsforfølgelse af strafbare handlinger. AI-systemer, der specifikt er tilsigtet anvendt til skatte- og toldmyndigheders administrative procedurer og til finansielle efterretningstjenesters udførelse af administrative opgaver, der omfatter analyse af oplysninger i henhold til EU-retten om bekæmpelse af hvidvask af penge, bør ikke klassificeres som højrisiko-AI-systemer, der anvendes af retshåndhævende myndigheder med henblik på forebyggelse, afsløring, efterforskning og retsforfølgning af strafbare handlinger. Retshåndhævende og andre relevante myndigheders anvendelse af AI-værktøjer bør ikke blive en faktor, der bidrager til ulighed eller eksklusion. Den indvirkning, som anvendelsen af AI-værktøjer har på mistænktes ret til forsvar, bør ikke ignoreres, navnlig vanskelighederne ved at skaffe meningsfulde oplysninger om, hvordan disse systemer fungerer, og de deraf følgende vanskeligheder ved at anfægte resultaterne heraf i retten, navnlig for fysiske personer, der efterforskes.
(60)
AI-systemer, der anvendes inden for migrationsstyring, asylforvaltning og grænsekontrol, berører personer, der ofte befinder sig i en særlig sårbar situation, og som er afhængige af resultatet af de kompetente offentlige myndigheders tiltag. Nøjagtigheden, den ikkeforskelsbehandlende karakter og gennemsigtigheden af de AI-systemer, der anvendes i disse sammenhænge, har derfor særlig betydning med hensyn til at sikre, at de berørte personers grundlæggende rettigheder respekteres, navnlig deres ret til fri bevægelighed, ikkeforskelsbehandling, beskyttelse af privatlivets fred og personoplysninger, international beskyttelse og god forvaltning. Derfor bør der, for så vidt som deres anvendelse er tilladt i henhold til relevant EU-ret og national ret, foretages en højrisikoklassificering af AI-systemer, der er tilsigtet anvendt af eller på vegne af de kompetente offentlige myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer, der er ansvarlige for opgaver inden for migrationsstyring, asylforvaltning og grænsekontrol, som polygrafer og lignende værktøjer, til at vurdere visse risici, som fysiske personer, der indrejser til en medlemsstats område eller ansøger om visum eller asyl, udgør, til at bistå de kompetente offentlige myndigheder i behandlingen, herunder tilhørende vurdering af pålideligheden af bevismateriale, af ansøgninger om asyl, visum og opholdstilladelse og hertil relaterede klager med henblik på at fastslå, om de fysiske personer, der ansøger, er berettigede, med henblik på at opdage, genkende eller identificere fysiske personer i forbindelse med migrationsstyring, asylforvaltning og grænsekontrolforvaltning, bortset fra verificering af rejselegitimation. AI-systemer, der anvendes inden for migrationsstyring, asylforvaltning og grænsekontrol, og som er omfattet af denne forordning, bør overholde de relevante proceduremæssige krav i Europa-Parlamentets og Rådets forordning (EF) nr. 810/2009 
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, Europa-Parlamentets og Rådets direktiv 2013/32/EU 
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 og anden relevant EU-ret. Anvendelsen af AI-systemer inden for migrationsstyring, asylforvaltning og grænsekontrol bør under ingen omstændigheder benyttes af medlemsstater eller EU-institutioner, -organer, -kontorer eller -agenturer som en måde at omgå deres internationale forpligtelser i henhold til FN's konvention om flygtninges retsstilling indgået i Genève den 28. juli 1951, som ændret ved protokollen af 31. januar 1967, og de bør heller ikke anvendes på en måde, der krænker princippet om non-refoulement eller nægter sikre og effektive lovlige adgangsveje til Unionens område, herunder retten til international beskyttelse.
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Visse AI-systemer, der er tilsigtet anvendelse inden for retspleje og i demokratiske processer, bør klassificeres som højrisiko i betragtning af deres potentielt betydelige indvirkning på demokratiet, retsstatsprincippet, individets frihedsrettigheder samt retten til adgang til effektive retsmidler og retten til en retfærdig rettergang. Navnlig for at imødegå risikoen for bias, fejl og uigennemsigtighed bør de AI-systemer, der tilsigtes anvendt af judicielle myndigheder eller på deres vegne for at bistå judicielle myndigheder med at fortolke fakta og lovgivningen og anvende lovgivningen på konkrete sagsforhold, klassificeres som højrisiko. AI-systemer, der tilsigtes anvendt af alternative tvistbilæggelsesorganer til disse formål, bør også betragtes som højrisiko, når resultaterne af den alternative tvistbilæggelsesprocedure har retsvirkninger for parterne. Anvendelsen af AI-værktøjer kan understøtte, men bør ikke erstatte dommernes beslutningskompetence eller retsvæsenets uafhængighed, da den endelige beslutningstagning fortsat skal være en menneskedrevet aktivitet. Klassificeringen af AI-systemer som højrisiko bør dog ikke omfatte AI-systemer, der kun tilsigtes supplerende administrative aktiviteter, som ikke har indflydelse på den egentlige retspleje i de enkelte sager, som f.eks. anonymisering eller pseudonymisering af retsafgørelser, dokumenter eller data, kommunikation mellem personale eller administrative opgaver.
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Uden at det berører de regler, der er fastsat i Europa-Parlamentets og Rådets forordning (EU) 2024/900 
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, og for at imødegå risikoen for unødig ekstern indblanding i retten til at stemme, der er nedfældet i chartrets artikel 39, og for negative indvirkninger på demokratiet og retsstatsprincippet bør AI-systemer, der tilsigtes anvendt til at påvirke resultatet af et valg eller en folkeafstemning eller fysiske personers stemmeadfærd i forbindelse med udøvelsen af deres stemme ved valg eller folkeafstemninger, klassificeres som højrisiko-AI-systemer med undtagelse af AI-systemer, hvis output fysiske personer ikke er direkte eksponeret for, såsom værktøjer, der anvendes til at organisere, optimere og strukturere politiske kampagner ud fra et administrativt og logistisk synspunkt.
(63)
Klassificeringen af et AI-system som et højrisiko-AI-system i henhold til denne forordning bør ikke fortolkes således, at anvendelsen af systemet er lovlig i medfør af andre EU-retsakter eller i medfør af national ret, der er forenelig med EU-retten, som f.eks. om beskyttelsen af personoplysninger, brug af polygrafer og lignende værktøjer eller andre systemer til at påvise fysiske personers følelsesmæssige tilstand. Enhver sådan anvendelse bør fortsat udelukkende ske i overensstemmelse med de gældende krav, der følger af chartret og gældende afledt EU-ret og national ret. Denne forordning bør ikke forstås som et retsgrundlag for behandling af personoplysninger, herunder særlige kategorier af personoplysninger, hvis det er relevant, medmindre andet specifikt er fastsat i denne forordning.
(64)
For at begrænse risiciene fra højrisiko-AI-systemer, der bringes i omsætning eller ibrugtages og for at sikre en høj grad af troværdighed, bør der gælde visse obligatoriske krav for højrisiko-AI-systemer, under hensyntagen til det tilsigtede formål og i forbindelse med anvendelsen af AI-systemet og i overensstemmelse med det risikostyringssystem, som udbyderen skal indføre. De foranstaltninger, som udbyderne vedtager for at overholde de obligatoriske krav i denne forordning, bør tage højde for det generelt anerkendte aktuelle teknologiske niveau inden for AI og være forholdsmæssige og effektive med hensyn til at nå denne forordnings mål. På grundlag af den nye lovgivningsmæssige ramme, som præciseret i Kommissionens meddelelse om den blå vejledning om gennemførelsen af EU's produktregler 2022, er den generelle regel, at mere end én EU-harmoniseringslovgivningsretsakt kan finde anvendelse på ét produkt, da tilgængeliggørelsen eller ibrugtagningen kun kan finde sted, når produktet overholder al gældende EU-harmoniseringslovgivning. Farerne ved de AI-systemer, der er omfattet af kravene i denne forordning, vedrører andre aspekter end den gældende EU-harmoniseringslovgivning, og kravene i denne forordning vil derfor supplere den gældende EU-harmoniseringslovgivning. Maskiner eller medicinsk udstyr, der indeholder et AI-system, kan f.eks. udgøre risici, der ikke er omfattet af de væsentlige sikkerheds- og sundhedskrav i den relevante EU-harmoniseringslovgivning, da denne sektorspecifikke ret ikke omhandler risici, der er specifikke for AI-systemer. Dette kræver, at de forskellige retsakter anvendes samtidigt og på supplerende vis. For at sikre konsekvens og undgå en unødvendig administrativ byrde eller unødvendige omkostninger bør udbydere af et produkt, der indeholder et eller flere højrisiko-AI-systemer, som kravene i denne forordning samt kravene i EU-harmoniseringslovgivningen baseret på den nye lovgivningsmæssige ramme og opført i et bilag til denne forordning finder anvendelse på, have fleksibilitet med hensyn til at træffe operationelle beslutninger om, hvordan det sikres, at et produkt, der indeholder et eller flere AI-systemer, overholder alle gældende krav i denne EU-harmoniseringslovgivning på en optimal måde. Denne fleksibilitet kan f.eks. betyde, at udbyderen beslutter at integrere en del af de nødvendige afprøvnings- og rapporteringsprocesser, oplysninger og dokumentation, der kræves i henhold til denne forordning, i allerede eksisterende dokumentation og procedurer, som kræves i henhold til den gældende EU-harmoniseringslovgivning, der er baseret på den nye lovgivningsmæssige ramme, og som er opført i et bilag til denne forordning. Dette bør på ingen måde underminere udbyderens forpligtelse til at overholde alle gældende krav.
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Risikostyringssystemet bør bestå af en kontinuerlig iterativ proces, der er planlagt og løber i hele højrisiko-AI-systemets livscyklus. Denne proces bør sigte mod at identificere og afbøde de relevante risici ved AI-systemer for sundheden, sikkerheden og de grundlæggende rettigheder. Risikostyringssystemet bør regelmæssigt revideres og ajourføres for at sikre dets fortsatte effektivitet samt begrundelse og dokumentation for eventuelle væsentlige beslutninger og tiltag, der træffes eller foretages i henhold til denne forordning. Denne proces bør sikre, at udbyderen identificerer risici eller negative indvirkninger og gennemfører afbødende foranstaltninger for kendte og rimeligt forudsigelige risici ved AI-systemer for sundheden, sikkerheden og de grundlæggende rettigheder i lyset af deres tilsigtede formål og fejlanvendelse, der med rimelighed kan forudses, herunder de mulige risici som følge af interaktionen mellem AI-systemet og det miljø, som systemet fungerer i. Risikostyringssystemet bør indføre de mest hensigtsmæssige risikostyringsforanstaltninger i lyset af det aktuelle teknologiske niveau inden for AI. Udbyderen bør ved identifikation af de mest hensigtsmæssige risikostyringsforanstaltninger dokumentere og forklare de valg, der er truffet, og, hvis det er relevant, inddrage eksperter og eksterne interessenter. I forbindelse med identifikation af fejlanvendelse, der med rimelighed kan forudses, af højrisiko-AI-systemer bør udbyderen medtage anvendelser af AI-systemer, som, selv om de ikke er direkte omfattet af det tilsigtede formål og fastsat i brugsanvisningen, ikke desto mindre med rimelighed kan forventes at skyldes let forudsigelig menneskelig adfærd i forbindelse med et bestemt AI-systems specifikke karakteristika og anvendelse. Alle kendte eller forudsigelige omstændigheder, som i forbindelse med anvendelse af højrisiko-AI-systemet i overensstemmelse med dets tilsigtede formål eller ved fejlanvendelse, der med rimelighed kan forudses, kan medføre risici for menneskers sundhed og sikkerhed eller grundlæggende rettigheder, bør medtages i den brugsanvisning, som leveres af udbyderen. Dette skal sikre, at idriftsætteren er bekendt med og tager hensyn hertil, når vedkommende anvender højrisiko-AI-systemet. Identifikation og gennemførelse af risikobegrænsende foranstaltninger for forudsigelig fejlanvendelse i henhold til denne forordning bør ikke kræve specifikke yderligere træning for højrisiko-AI-systemet fra udbyderens side for at afhjælpe forudsigelig fejlanvendelse. Udbyderne opfordres imidlertid til at overveje sådanne yderligere træningsforanstaltninger for at afbøde fejlanvendelser, der med rimelighed kan forudses, når det er nødvendigt og hensigtsmæssigt.
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Der bør gælde krav for højrisiko-AI-systemer med hensyn til risikostyring, kvaliteten og relevansen af anvendte datasæt, teknisk dokumentation og registrering, gennemsigtighed og formidling af oplysninger til idriftsætterne, menneskeligt tilsyn og robusthed, nøjagtighed og cybersikkerhed. Disse krav er nødvendige for effektivt at mindske risiciene for sundhed, sikkerhed og grundlæggende rettigheder. Da ingen foranstaltninger, der er mindre begrænsende for handelen, er tilgængelige på rimelig vis, er disse krav ikke uberettigede handelsrestriktioner.
(67)
Data af høj kvalitet og adgang til data af høj kvalitet spiller en afgørende rolle med hensyn til at skabe struktur og sikre mange AI-systemers ydeevne, navnlig når der anvendes teknikker, der omfatter træning af modeller, så det sikres, at højrisiko-AI-systemet yder som tilsigtet og på sikker vis og ikke bliver en kilde til forskelsbehandling, som er forbudt i henhold til EU-retten. Datasæt af høj kvalitet til træning, validering og afprøvning kræver, at der indføres passende former for datastyrings- og dataforvaltningspraksis. Datasæt til træning, validering og afprøvning, herunder mærkninger, bør være relevante, tilstrækkeligt repræsentative og i videst muligt omfang fejlfrie og fuldstændige i lyset af AI-systemets tilsigtede formål. For at lette overholdelsen af EU-databeskyttelsesretten såsom forordning (EU) 2016/679 bør datastyrings- og -forvaltningspraksis i tilfælde af personoplysninger omfatte gennemsigtighed med hensyn til det oprindelige formål med dataindsamlingen. Datasættene bør også have de tilstrækkelige statistiske egenskaber, herunder med hensyn til de personer eller grupper af personer, som højrisiko-AI-systemet er tilsigtet at blive anvendt på, med særlig vægt på afbødning af mulige bias i datasættene, som sandsynligvis vil påvirke menneskers sundhed og sikkerhed, have en negativ indvirkning på grundlæggende rettigheder eller føre til forskelsbehandling, der er forbudt i henhold til EU-retten, navnlig hvis dataoutput påvirker input til fremtidige operationer (»feedbacksløjfer«). Bias kan f.eks. være en iboende del af de underliggende datasæt, navnlig når der anvendes historiske data, eller kan genereres, når systemerne implementeres under virkelige forhold. De resultater, der leveres af AI-systemer, kan påvirkes af sådanne iboende bias, som er tilbøjelige til gradvist at øges og derved videreføre og forstærke eksisterende forskelsbehandling, navnlig for personer, der tilhører bestemte sårbare grupper, herunder racemæssige eller etniske grupper. Kravet om, at datasættene så vidt muligt skal være fuldstændige og fejlfrie, bør ikke påvirke anvendelsen af teknikker til beskyttelse af privatlivets fred i forbindelse med udvikling og afprøvning af AI-systemer. Navnlig bør datasæt, i det omfang det er nødvendigt af hensyn til deres tilsigtede formål, tage hensyn til de karakteristiske træk, egenskaber eller elementer, der er særlige for den specifikke geografiske, kontekstuelle, adfærdsmæssige eller funktionelle ramme, inden for hvilken AI-systemet tiltænkes anvendt. Kravene vedrørende datastyring kan overholdes ved at gøre brug af tredjeparter, der tilbyder certificerede overholdelsestjenester, herunder verifikation af datastyring og datasætintegritet samt datatrænings-, validerings- og afprøvningspraksis, for så vidt som det sikres, at datakravene i denne forordning overholdes.
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Med henblik på udvikling og vurdering af højrisiko-AI-systemer bør visse aktører, som for eksempel udbydere, bemyndigede organer og andre relevante enheder såsom europæiske digitale innovationsknudepunkter, afprøvnings- og forsøgsfaciliteter og forskere, have adgang til og kunne anvende datasæt af høj kvalitet inden for aktivitetsområderne for de aktører, som er relateret til denne forordning. Fælles europæiske dataområder, som Kommissionen har oprettet, og lette af datadeling mellem virksomheder og med myndigheder i samfundets interesse vil være afgørende for at sikre pålidelig, ansvarlig og ikkeforskelsbehandlende adgang til data af høj kvalitet til træning, validering og afprøvning af AI-systemer. På sundhedsområdet vil det europæiske sundhedsdataområde for eksempel lette ikkeforskelsbehandlende adgang til sundhedsdata og træning af AI-algoritmer på disse datasæt på en måde, der beskytter privatlivets fred, er sikker, rettidig, gennemsigtig og troværdig og underlagt en passende institutionel styring. Relevante kompetente myndigheder, herunder sektorspecifikke myndigheder, der giver eller understøtter adgang til data, kan også understøtte tilvejebringelsen af data af høj kvalitet til træning, validering og afprøvning af AI-systemer.
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Retten til privatlivets fred og til beskyttelse af personoplysninger skal sikres i hele AI-systemets livscyklus. I den forbindelse finder principperne om dataminimering og databeskyttelse gennem design og databeskyttelse gennem standardindstillinger som fastsat i EU-databeskyttelsesretten anvendelse, når personoplysninger behandles. Foranstaltninger, der træffes af udbydere for at sikre overholdelse af disse principper, kan ikke blot omfatte anonymisering og kryptering, men også anvendelse af teknologi, der gør det muligt at overføre algoritmer til data og opnå oplæring af AI-systemer uden overførsel mellem parterne eller kopiering af de rå eller strukturerede data, uden at dette berører kravene til datastyring i denne forordning.
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For at beskytte andres ret mod den forskelsbehandling, der kan opstå som følge af bias i AI-systemer, bør udbyderne undtagelsesvis, i det omfang det er strengt nødvendigt for at sikre påvisning og korrektion af bias i forbindelse med højrisiko-AI-systemer, med forbehold af passende sikkerhedsforanstaltninger for fysiske personers grundlæggende rettigheder og friheder og efter anvendelse af alle gældende betingelser, der er fastsat i denne forordning, ud over betingelserne i forordning (EU) 2016/679 og (EU) 2018/1725 samt direktiv (EU) 2016/680, også kunne behandle særlige kategorier af personoplysninger som et spørgsmål af væsentlig samfundsinteresse som omhandlet i artikel 9, stk. 2, litra g), i forordning (EU) 2016/679 og artikel 10, stk. 2, litra g), i forordning (EU) 2018/1725.
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Det er afgørende, at der foreligger forståelige oplysninger om, hvordan højrisiko-AI-systemer er blevet udviklet, og hvordan de yder i hele deres levetid for at gøre det muligt at spore disse systemer, kontrollere overholdelsen af kravene i denne forordning samt sikre overvågning af deres operationer og overvågning efter omsætningen. Det kræver, at der føres fortegnelser og stilles en teknisk dokumentation til rådighed, som indeholder de oplysninger, der er nødvendige for at vurdere AI-systemets overholdelse af de relevante krav og letter overvågning efter omsætningen. Sådanne oplysninger bør omfatte systemets generelle egenskaber, kapacitet og begrænsninger, algoritmer, data, trænings-, afprøvnings- og valideringsprocesser samt dokumentation for det relevante risikostyringssystem og være udarbejdet på en klar og forståelig måde. Den tekniske dokumentation skal holdes tilstrækkeligt ajour i hele AI-systemets levetid. Højrisiko-AI-systemer bør teknisk muliggøre automatisk registrering af hændelser ved hjælp af logfiler under systemets levetid.
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For at imødegå bekymringer vedrørende visse AI-systemers uigennemsigtighed og kompleksitet og hjælpe idriftsættere med at opfylde deres forpligtelser i henhold til denne forordning bør der kræves gennemsigtighed for højrisiko-AI-systemer, inden de bringes i omsætning eller ibrugtages. Højrisiko-AI-systemer bør udformes på en måde, der gør det muligt for idriftsættere at forstå, hvordan AI-systemet fungerer, evaluere dets funktionalitet og forstå dets styrker og begrænsninger. Højrisiko-AI-systemer bør ledsages af passende oplysninger i form af brugsanvisninger. Sådanne oplysninger bør omfatte AI-systemets egenskaber, kapacitet og begrænsninger for dets ydeevne. Disse kan omfatte oplysninger om mulige kendte og forudsigelige omstændigheder i forbindelse med anvendelse af højrisiko-AI-systemet, herunder udbredelsestiltag, der kan påvirke systemets adfærd og ydeevne, under hvilke AI-systemet kan medføre risici for sundhed, sikkerhed og grundlæggende rettigheder, om de ændringer, som udbyderen på forhånd har fastlagt og vurderet med henblik på overensstemmelse, og om de relevante foranstaltninger til menneskeligt tilsyn, herunder foranstaltninger til at lette idriftsætteres fortolkning af AI-systemets output. Gennemsigtighed, herunder den ledsagende brugsanvisning, bør hjælpe idriftsættere med at anvende systemet og støtte deres informerede beslutningstagning. Idriftsættere bør bl.a. være bedre i stand til at træffe det korrekte valg af det system, de har til hensigt at anvende, i lyset af de forpligtelser, der gælder for dem, være informeret om de tilsigtede og udelukkede anvendelser og anvende AI-systemet korrekt og som det er hensigtsmæssigt. For at gøre oplysningerne i brugsanvisningen mere læsbare og tilgængelige, bør der, hvis det er relevant, medtages illustrative eksempler, f.eks. om begrænsninger og om AI-systemets tilsigtede og udelukkede anvendelser. Udbyderne bør sikre, at al dokumentation, herunder brugsanvisningen, indeholder meningsfulde, omfattende, tilgængelige og forståelige oplysninger, der tager hensyn til behov for målgruppen af idriftsættere og deres forventede viden. Brugsanvisningen bør stilles til rådighed på et for målgruppen af idriftsættere letforståeligt sprog, som fastsat af den pågældende medlemsstat.
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Højrisiko-AI-systemer bør udformes og udvikles på en sådan måde, at fysiske personer kan overvåge deres funktion og sikre, at de anvendes som tilsigtet, og at deres virkninger håndteres i hele systemets livscyklus. Med henblik herpå bør udbyderen af systemet fastlægge passende foranstaltninger til menneskeligt tilsyn, inden systemet bringes i omsætning eller ibrugtages. Hvis det er relevant, bør sådanne foranstaltninger navnlig sikre, at systemet er underlagt indbyggede driftsmæssige begrænsninger, som ikke kan tilsidesættes af systemet selv, og reagerer på den menneskelige operatør, og at de fysiske personer, som har fået til opgave at varetage det menneskelige tilsyn, har den nødvendige kompetence, uddannelse og myndighed til at varetage rollen. Det er også afgørende i relevant omfang at sikre, at højrisiko-AI-systemer indeholder mekanismer, der kan vejlede og informere en fysisk person, som har fået til opgave at varetage det menneskelige tilsyn, til at træffe informerede beslutninger om, hvorvidt, hvornår og hvordan der skal gribes ind for at undgå negative konsekvenser eller risici, eller standse systemet, hvis det ikke fungerer som tilsigtet. I betragtning af de betydelige konsekvenser for personer i tilfælde af et ukorrekt match fra visse systemer til biometrisk identifikation er det hensigtsmæssigt at fastsætte et skærpet krav om menneskeligt tilsyn for disse systemer, således at idriftsætteren ikke foretager tiltag eller træffer beslutninger på grundlag af den identifikation, der er frembragt af systemet, medmindre den er blevet verificeret og bekræftet separat af mindst to fysiske personer. Disse personer kan være fra en eller flere enheder og omfatte den person, der driver eller anvender systemet. Dette krav bør ikke medføre unødvendige byrder eller forsinkelser, og det kan være tilstrækkeligt, at de forskellige personers særskilte verifikationer automatisk registreres i de logfiler, der genereres af systemet. I betragtning af de særlige forhold, der gør sig gældende inden for retshåndhævelse, migration, grænsekontrol og asyl, bør dette krav ikke finde anvendelse, når EU-retten eller national ret anser anvendelsen af dette krav for at være uforholdsmæssig.
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Højrisiko-AI-systemer bør yde konsistent i hele deres livscyklus og have et passende niveau af nøjagtighed, robusthed og cybersikkerhed i lyset af deres tilsigtede formål og i overensstemmelse med det generelt anerkendte aktuelle teknologiske niveau. Kommissionen og relevante organisationer og interessenter opfordres til at tage behørigt hensyn til afbødningen af risici og de negative indvirkninger ved AI-systemet. Det forventede niveau for ydeevneparametre bør angives i den ledsagende brugsanvisning. Udbyderne opfordres indtrængende til at videregive disse oplysninger til idriftsætterne på en klar og letforståelig måde uden misforståelser eller vildledende udsagn. EU-ret om retslig metrologi, herunder Europa-Parlamentets og Rådets direktiv 2014/31/EU 
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 og 2014/32/EU 
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, har til formål at sikre målingernes nøjagtighed og bidrage til gennemsigtighed og retfærdighed i handelstransaktioner. I denne forbindelse bør Kommissionen, alt efter hvad der er relevant og i samarbejde med relevante interessenter og organisationer såsom metrologi- og benchmarkingmyndigheder, tilskynde til udvikling af benchmarks og målemetoder for AI-systemer. Kommissionen bør herved notere sig og samarbejde med internationale partnere, der arbejder med metrologi og relevante måleindikatorer vedrørende AI.
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Teknisk robusthed er et centralt krav for højrisiko-AI-systemer. De bør være modstandsdygtige i forbindelse med skadelig eller på anden vis uønsket adfærd, der kan skyldes begrænsninger i systemerne eller det miljø, som systemerne fungerer i (f.eks. fejl, svigt, uoverensstemmelser og uventede situationer). Der bør derfor træffes tekniske og organisatoriske foranstaltninger for at sikre højrisiko-AI-systemers robusthed, f.eks. ved at udforme og udvikle passende tekniske løsninger for at forebygge eller minimere denne skadelige eller på anden måde uønskede adfærd. Disse tekniske løsninger kan f.eks. omfatte mekanismer, der gør det muligt for systemet på sikker vis at afbryde dets drift (»fail-safe plans«), hvis der opstår visse uregelmæssigheder, eller hvis driften ligger uden for visse forudbestemte grænser. Manglende beskyttelse mod disse risici kan have sikkerhedsmæssige konsekvenser eller en negativ indvirkning på de grundlæggende rettigheder, f.eks. som følge af fejlagtige beslutninger eller forkerte output eller output behæftet med bias genereret af AI-systemet.
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Cybersikkerhed spiller en afgørende rolle med hensyn til at sikre, at AI-systemer er modstandsdygtige over for ondsindede tredjeparters forsøg på at ændre deres anvendelse, adfærd eller ydeevne eller bringe deres sikkerhedsegenskaber i fare ved at udnytte systemets sårbarheder. Cyberangreb mod AI-systemer kan udnytte AI-specifikke aktiver såsom træningsdatasæt (f.eks. dataforgiftning) eller trænede modeller (f.eks. ondsindede angreb eller »membership inference«) eller udnytte sårbarheder i AI-systemets digitale aktiver eller den underliggende IKT-infrastruktur. For at sikre et cybersikkerhedsniveau, der er passende i forhold til risiciene, bør udbydere af højrisiko-AI-systemer træffe passende foranstaltninger såsom sikkerhedskontroller, idet der også i relevant omfang tages hensyn til den underliggende IKT-infrastruktur.
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Uden at det berører de krav til robusthed og nøjagtighed, der er fastsat i denne forordning, kan højrisiko-AI-systemer, der er omfattet af anvendelsesområdet for en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer, i overensstemmelse med nævnte forordning påvise overholdelse af cybersikkerhedskravene i nærværende forordning ved at opfylde de væsentlige cybersikkerhedskrav, der er fastsat i nævnte forordning. Når højrisiko-AI-systemer opfylder de væsentlige krav i en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer, bør de anses for at overholde cybersikkerhedskravene i nærværende forordning, for så vidt opfyldelsen af disse krav påvises ved EU-overensstemmelseserklæringen eller dele heraf udstedt i henhold til nævnte forordning. Med henblik herpå bør vurderingen af de cybersikkerhedsrisici, der er forbundet med et produkt med digitale elementer klassificeret som et højrisiko-AI-system i henhold til nærværende forordning, og som foretages i henhold til en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer tage hensyn til risici for et AI-systems cyberrobusthed for så vidt angår uautoriserede tredjeparters forsøg på at ændre dets anvendelse, adfærd eller ydeevne, herunder AI-specifikke sårbarheder såsom dataforgiftning eller ondsindede angreb, samt, hvis det er relevant, risici for grundlæggende rettigheder som krævet i nærværende forordning.
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Overensstemmelsesvurderingsproceduren i denne forordning bør finde anvendelse i forbindelse med de væsentlige cybersikkerhedskrav til et produkt med digitale elementer, der er omfattet af en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer og klassificeret som et højrisiko-AI-system i henhold til nærværende forordning. Denne regel bør dog ikke resultere i en reduktion af det nødvendige sikkerhedsniveau for kritiske produkter med digitale elementer, der er omfattet af en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer. Uanset denne regel bør højrisiko-AI-systemer, der er omfattet af anvendelsesområdet for nærværende forordning og også betragtes som vigtige og kritiske produkter med digitale elementer i henhold til en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer, og som proceduren for overensstemmelsesvurdering baseret på intern kontrol fastsat i et bilag til nærværende forordning finder anvendelse på, derfor være omfattet af bestemmelserne om overensstemmelsesvurdering i en forordning vedtaget af Europa-Parlamentet og Rådet om horisontale cybersikkerhedskrav til produkter med digitale elementer for så vidt angår de væsentlige cybersikkerhedskrav i nævnte forordning. I så fald bør de respektive bestemmelser om overensstemmelsesvurdering baseret på intern kontrol, der er fastsat i et bilag til nærværende forordning, finde anvendelse på alle de øvrige aspekter, der er omfattet af nærværende forordning. På grundlag af ENISA's viden og ekspertise om cybersikkerhedspolitik og de opgaver, som ENISA har fået tildelt i henhold til Europa-Parlamentets og Rådets forordning (EU) 2019/881 
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, bør Kommissionen samarbejde med ENISA om spørgsmål vedrørende cybersikkerhed i forbindelse med AI-systemer.
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Det er passende, at en bestemt fysisk eller juridisk person, defineret som udbyderen, påtager sig ansvar for omsætningen eller ibrugtagningen af et højrisiko-AI-system, uanset om denne fysiske eller juridiske person er den person, der har udformet eller udviklet systemet.
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Unionen og alle medlemsstaterne er som underskrivere af De Forenede Nationers konvention om rettigheder for personer med handicap juridisk forpligtede til at beskytte personer med handicap mod forskelsbehandling og fremme deres ligestilling med henblik på at sikre, at personer med handicap har adgang på lige fod med andre til informations- og kommunikationsteknologier og -systemer, og med henblik på at sikre respekten for personer med handicaps privatliv. På grund af den voksende betydning og brug af AI-systemer bør anvendelsen af universelle designprincipper på alle nye teknologier og tjenesteydelser sikre en fuldstændig og ligelig adgang for alle, der potentielt berøres af eller benytter AI-teknologier, herunder personer med handicap, på en måde, der fuldt ud tager hensyn til deres iboende værdighed og mangfoldighed. Det er derfor afgørende, at udbyderne sikrer fuld overholdelse af tilgængelighedskravene, herunder Europa-Parlamentets og Rådets direktiv (EU) 2016/2102 
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 og direktiv (EU) 2019/882. Udbyderne bør sikre overholdelsen af disse krav gennem design. Derfor bør de nødvendige foranstaltninger så vidt muligt integreres i udformningen af højrisiko-AI-systemet.
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Udbyderen bør etablere et solidt kvalitetsstyringssystem, sikre gennemførelsen af den påkrævede overensstemmelsesvurderingsprocedure, udarbejde den relevante dokumentation og etablere et robust system til overvågning efter omsætningen. Udbydere af højrisiko-AI-systemer, der er underlagt forpligtelser vedrørende kvalitetsstyringssystemer i henhold til relevant sektorspecifik EU-ret, bør have mulighed for at medtage elementerne i det kvalitetsstyringssystem, der er fastsat i denne forordning, som en del af det eksisterende kvalitetsstyringssystem, der er fastsat i denne anden sektorspecifikke EU-ret. Komplementariteten mellem denne forordning og eksisterende sektorspecifik EU-ret bør også tages i betragtning i fremtidige standardiseringsaktiviteter eller retningslinjer vedtaget af Kommissionen. Offentlige myndigheder, der ibrugtager højrisiko-AI-systemer til egen brug, kan vedtage og gennemføre reglerne for kvalitetsstyringssystemet som en del af det kvalitetsstyringssystem, der er vedtaget på nationalt eller regionalt plan, alt efter hvad der er relevant, under hensyntagen til de særlige forhold i sektoren og den pågældende offentlige myndigheds kompetencer og organisation.
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For at muliggøre håndhævelsen af denne forordning og skabe lige vilkår for operatørerne og under hensyntagen til de forskellige former for tilgængeliggørelse af digitale produkter er det vigtigt at sikre, at en person, der er etableret i Unionen, under alle omstændigheder kan give myndighederne alle de nødvendige oplysninger om et AI-systems overensstemmelse med reglerne. Udbydere, der er etableret i tredjelande, bør, inden deres AI-systemer gøres tilgængelige i Unionen, derfor ved skriftligt mandat udpege en bemyndiget repræsentant, der er etableret i Unionen. Denne bemyndigede repræsentant spiller en central rolle med hensyn til at sikre, at højrisiko-AI-systemer, der bringes i omsætning eller ibrugtages i Unionen af disse udbydere, der ikke er etableret i Unionen, overholder kravene, og som deres kontaktperson i Unionen.
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I lyset af arten og kompleksiteten af værdikæden for AI-systemer og i overensstemmelse med den nye lovgivningsmæssige ramme er det vigtigt at sikre retssikkerheden og lette overholdelsen af denne forordning. Det er derfor nødvendigt at præcisere den rolle og de specifikke forpligtelser, der påhviler relevante operatører i denne værdikæde såsom importører og distributører, der kan bidrage til udviklingen af AI-systemer. I visse situationer kan disse operatører optræde i mere end én rolle på samme tid og bør derfor kumulativt opfylde alle relevante forpligtelser, der er forbundet med disse roller. F.eks. kan en operatør fungere som distributør og importør på samme tid.
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For at sikre retssikkerheden er det nødvendigt at præcisere, at enhver distributør, importør, idriftsætter eller anden tredjepart under visse særlige omstændigheder bør betragtes som udbyder af et højrisiko-AI-system og derfor påtage sig alle de relevante forpligtelser. Dette vil være tilfældet, hvis den pågældende part anbringer sit navn eller varemærke på et højrisiko-AI-system, der allerede er bragt i omsætning eller ibrugtaget, uden at det berører kontraktlige ordninger om, at forpligtelserne er fordelt anderledes. Dette vil også være tilfældet, hvis den pågældende part foretager en væsentlig ændring af et højrisiko-AI-system, der allerede er bragt i omsætning eller allerede er ibrugtaget på en sådan måde, at det forbliver et højrisiko-AI-system i overensstemmelse med denne forordning, eller hvis denne ændrer det tilsigtede formål med et AI-system, herunder et AI-system til almen brug, der ikke er blevet klassificeret som højrisiko, og som allerede er bragt i omsætning eller ibrugtaget, på en sådan måde, at AI-systemet bliver et højrisiko-AI-system i overensstemmelse med denne forordning. Disse bestemmelser bør finde anvendelse, uden at det berører mere specifikke bestemmelser, der er fastsat i særlig EU-harmoniseringslovgivning baseret på den nye lovgivningsmæssige ramme, som denne forordning bør finde anvendelse sammen med. F.eks. bør artikel 16, stk. 2, i forordning (EU) 2017/745, der fastsætter, at visse ændringer ikke bør betragtes som ændringer af udstyr, der kan påvirke dets overholdelse af gældende krav, fortsat finde anvendelse på højrisiko-AI-systemer, der er medicinsk udstyr som omhandlet i nævnte forordning.
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AI-systemer til almen brug kan anvendes som højrisiko-AI-systemer i sig selv eller som komponenter i andre højrisiko-AI-systemer. Derfor bør udbydere af sådanne systemer på grund af deres særlige karakter og for at sikre en rimelig ansvarsfordeling i hele AI-værdikæden, uanset om de kan anvendes som højrisiko-AI-systemer som sådan af andre udbydere eller som komponenter i højrisiko-AI-systemer, og medmindre andet er fastsat i denne forordning, arbejde tæt sammen med udbyderne af de relevante højrisiko-AI-systemer, så de kan overholde de relevante forpligtelser i henhold til denne forordning og med de kompetente myndigheder, der er fastsat i henhold til denne forordning.
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Hvis den udbyder, der oprindeligt bragte AI-systemet i omsætning eller ibrugtog det, på de betingelser, der er fastsat i denne forordning, ikke længere bør anses for at være udbyder i denne forordnings forstand, og når denne udbyder ikke udtrykkeligt har udelukket ændringen af AI-systemet til et højrisiko-AI-system, bør den tidligere udbyder ikke desto mindre arbejde tæt sammen og stille de nødvendige oplysninger til rådighed og give den tekniske adgang og anden bistand, som med rimelighed kan forventes, og som kræves for at opfylde forpligtelserne i denne forordning, navnlig hvad angår overholdelse af overensstemmelsesvurderingen af højrisiko-AI-systemer.
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Hvis et højrisiko-AI-system, som er en sikkerhedskomponent i et produkt, der er omfattet af anvendelsesområdet for EU-harmoniseringslovgivning baseret på den nye lovgivningsmæssige ramme, desuden ikke bringes i omsætning eller ibrugtages uafhængigt af produktet, bør producenten af produktet defineret i den pågældende lovgivning overholde de forpligtelser, der påhviler udbyderen i henhold til denne forordning, og bør navnlig sikre, at det AI-system, der er indlejret i slutproduktet, overholder kravene i denne forordning.
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I AI-værdikæden leverer flere parter ofte AI-systemer, værktøjer og tjenester, men også komponenter eller processer, som udbyderen indarbejder i AI-systemet til forskellige formål, herunder modeltræning, fornyet modeltræning, modelafprøvning og -evaluering, integration i software eller andre aspekter af modeludvikling. Disse parter spiller en vigtig rolle i værdikæden over for udbyderen af det højrisiko-AI-system, som deres AI-systemer, værktøjer, tjenester, komponenter eller processer er integreret i, og bør ved skriftlig aftale give denne udbyder den nødvendige information, kapacitet, tekniske adgang og anden bistand på grundlag af det generelt anerkendte aktuelle teknologiske niveau, således at udbyderen er i stand til fuldt ud at overholde forpligtelserne i denne forordning uden at bringe deres egne intellektuelle ejendomsrettigheder eller forretningshemmeligheder i fare.
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Tredjeparter, der gør andre værktøjer, tjenester, processer eller AI-komponenter tilgængelige for offentligheden end AI-modeller til almen brug, bør ikke være forpligtet til at overholde krav rettet mod ansvar i hele AI-værdikæden, navnlig mod den udbyder, der har anvendt eller integreret dem, når disse værktøjer, tjenester, processer eller AI-komponenter gøres tilgængelige i henhold til en gratis open source-licens. Udviklere af andre gratis open source-værktøjer, -tjenester, -processer eller -AI-komponenter end AI-modeller til almen brug bør dog tilskyndes til at gennemføre bredt indførte former for dokumentationspraksis såsom modelkort og datablade som en måde at fremskynde informationsdeling i hele AI-værdikæden på og derved fremme troværdige AI-systemer i Unionen.
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Kommissionen kan udvikle og anbefale frivillige standardaftalevilkår mellem udbydere af højrisiko-AI-systemer og tredjeparter, der leverer værktøjer, tjenester, komponenter eller processer, som anvendes eller integreres i højrisiko-AI-systemer, for at lette samarbejdet i hele værdikæden. Når Kommissionen udarbejder frivillige standardaftalevilkår, tager den også hensyn til eventuelle kontraktlige krav, der gælder i specifikke sektorer eller forretningsscenarier.
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I betragtning af AI-systemers karakter og de risici for sikkerheden og de grundlæggende rettigheder, der kan være forbundet med deres anvendelse, herunder behovet for at sikre korrekt overvågning af et AI-systems ydeevne i virkelige rammer, bør der fastsættes specifikke ansvarsområder for idriftsættere. Idriftsættere bør navnlig træffe passende tekniske og organisatoriske foranstaltninger for at sikre, at de anvender højrisiko-AI-systemer i overensstemmelse med brugsanvisningen, og der bør fastsættes visse andre forpligtelser med hensyn til overvågning af AI-systemernes funktion og med hensyn til registrering, alt efter hvad der er relevant. Idriftsættere bør desuden sikre, at de personer, som har fået til opgave at gennemføre brugsanvisningen og det menneskelige tilsyn som fastsat i denne forordning, har den nødvendige kompetence, navnlig et passende niveau af AI-færdigheder, -træning og -myndighed til at udføre disse opgaver korrekt. Disse forpligtelser bør ikke berøre andre af idriftsætterens forpligtelser i forbindelse med højrisiko-AI-systemer i henhold til EU-retten eller national ret.
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Denne forordning berører ikke arbejdsgivernes forpligtelser til at informere eller høre arbejdstagerne eller deres repræsentanter i henhold til EU-retten og EU-praksis eller national ret og praksis, herunder Europa-Parlamentets og Rådets direktiv 2002/14/EF 
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, om beslutninger om at ibrugtage eller anvende AI-systemer. Det er fortsat nødvendigt at sikre, at arbejdstagerne og deres repræsentanter informeres om den planlagte idriftsættelse af højrisiko-AI-systemer på arbejdspladsen, hvis betingelserne for disse informations- eller informations- og høringsforpligtelser i andre retlige instrumenter ikke er opfyldt. En sådan ret til information er desuden accessorisk og nødvendig i forhold til målet om at beskytte de grundlæggende rettigheder, der ligger til grund for denne forordning. Der bør derfor fastsættes et informationskrav med henblik herpå i denne forordning, uden at det berører arbejdstagernes eksisterende rettigheder.
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Risici i forbindelse med AI-systemer kan være resultatet af den måde, sådanne systemer er udformet på, men risici kan også stamme fra måden, hvorpå sådanne AI-systemer anvendes. Idriftsættere af højrisiko-AI-systemer spiller derfor en afgørende rolle i at sikre, at de grundlæggende rettigheder beskyttes og i at supplere udbyderens forpligtelser i forbindelse med udviklingen af AI-systemet. Idriftsætterne er bedst i stand til at forstå, hvordan højrisiko-AI-systemet vil blive anvendt konkret, og kan derfor afdække potentielle risici, der ikke var forudset i udviklingsfasen, takket være et mere præcist kendskab til anvendelseskonteksten, de personer eller grupper af personer, der kan blive berørt, herunder sårbare grupper. Idriftsættere af de højrisiko-AI-systemer, der er opført i et bilag til denne forordning, spiller også en afgørende rolle med hensyn til at informere fysiske personer og bør, når de træffer beslutninger eller bistår med at træffe beslutninger vedrørende fysiske personer, om nødvendigt underrette de fysiske personer om, at de er omfattet af anvendelsen af højrisiko-AI-systemet. Disse oplysninger bør omfatte det tilsigtede formål og typen af beslutninger, det træffer. Idriftsætteren bør ligeledes oplyse de fysiske personer om deres ret til en forklaring som fastsat i denne forordning. For så vidt angår højrisiko-AI-systemer, der anvendes til retshåndhævelsesformål, bør denne forpligtelse gennemføres i overensstemmelse med artikel 13 i direktiv (EU) 2016/680.
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Enhver behandling af biometriske data, der indgår i anvendelsen af AI-systemer til biometrisk identifikation med henblik på retshåndhævelse, skal overholde artikel 10 i direktiv (EU) 2016/680, som kun tillader en sådan behandling, når det er strengt nødvendigt, forudsat at behandlingen er omfattet af de fornødne sikkerhedsforanstaltninger for den registreredes rettigheder og frihedsrettigheder, og hvis hjemlet i EU-retten eller medlemsstaternes nationale ret. En sådan anvendelse skal, når den er tilladt, også overholde principperne i artikel 4, stk. 1, i direktiv (EU) 2016/680, herunder lovlighed, rimelighed og gennemsigtighed, formålsbegrænsning, rigtighed og begrænsning af opbevaring.
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Uden at det berører gældende EU-ret, navnlig forordning (EU) 2016/679 og direktiv (EU) 2016/680, bør brugen af systemer til efterfølgende biometrisk fjernidentifikation, i betragtning af den indgribende karakter af systemer til efterfølgende biometrisk fjernidentifikation, være underlagt sikkerhedsforanstaltninger. Systemer til efterfølgende biometrisk fjernidentifikation bør altid anvendes på en måde, der er forholdsmæssig, legitim og strengt nødvendig, og dermed, for så vidt angår de personer, der skal identificeres, være målrettet stedet og den tidsmæssige rækkevidde og være baseret på et lukket datasæt af lovligt erhvervede videooptagelser. Under alle omstændigheder bør systemer til efterfølgende biometrisk fjernidentifikation ikke anvendes inden for retshåndhævelse til at føre vilkårlig overvågning. Betingelserne for efterfølgende biometrisk fjernidentifikation bør under alle omstændigheder ikke danne grundlag for at omgå betingelserne for forbuddet mod og de strenge undtagelser for biometrisk fjernidentifikation i realtid.
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For effektivt at sikre, at de grundlæggende rettigheder beskyttes, bør idriftsættere af højrisiko-AI-systemer, der er offentligretlige organer, eller private enheder, der leverer offentlige tjenester, og idriftsættere af visse højrisiko-AI-systemer, der er opført i et bilag til denne forordning, såsom banker eller forsikringsselskaber, foretage en konsekvensanalyse vedrørende grundlæggende rettigheder inden ibrugtagning. Tjenester, der er vigtige for enkeltpersoner, og som er af offentlig karakter, kan også leveres af private enheder. Private enheder, der leverer sådanne offentlige tjenester, er knyttet til samfundsnyttige opgaver såsom. inden for uddannelse, sundhedspleje, sociale tjenester, boliger og retspleje. Formålet med konsekvensanalysen vedrørende grundlæggende rettigheder er, at idriftsætteren skal identificere de specifikke risici for rettighederne for enkeltpersoner eller grupper af enkeltpersoner, der sandsynligvis vil blive berørt, og identificere de foranstaltninger, der skal træffes, hvis disse risici skulle opstå. Konsekvensanalysen bør udføres før idriftsættelse af højrisiko-AI-systemet og bør ajourføres, når idriftsætteren vurderer, at de relevante faktorer har ændret sig. Konsekvensanalysen bør identificere idriftsætterens relevante processer, i hvilke højrisiko-AI-systemet vil blive anvendt i overensstemmelse med dets tilsigtede formål, og bør indeholde en beskrivelse af den periode og hyppighed, hvori systemet tilsigtes anvendt, samt af specifikke kategorier af fysiske personer og grupper, der sandsynligvis vil blive berørt i den specifikke anvendelsessammenhæng. Analysen bør også omfatte kortlægning af specifikke risici for skade, der sandsynligvis vil påvirke disse personers eller gruppers grundlæggende rettigheder. I forbindelse med denne analyse bør idriftsætteren tage hensyn til oplysninger, der er relevante for en korrekt analyse af konsekvenser, herunder, men ikke begrænset til, de oplysninger, som udbyderen af højrisiko-AI-systemet giver i brugsanvisningen. I lyset af de kortlagte risici bør idriftsætteren afgøre, hvilke foranstaltninger der skal træffes, hvis disse risici skulle opstå, herunder f.eks. ledelsesordninger i den specifikke anvendelsessammenhæng, såsom ordninger for menneskeligt tilsyn i henhold til brugsanvisningen eller klagebehandlings- og erstatningsprocedurer, da de kan bidrage til at afbøde risici for grundlæggende rettigheder i konkrete anvendelsestilfælde. Efter at have foretaget denne konsekvensanalyse bør idriftsætteren underrette den relevante markedsovervågningsmyndighed. For at indsamle de relevante oplysninger, der er nødvendige for at foretage konsekvensanalysen, kan idriftsættere af højrisiko-AI-systemer, navnlig når AI-systemer anvendes i den offentlige sektor, inddrage relevante interessenter, herunder repræsentanter for grupper af personer, der sandsynligvis vil blive berørt af AI-systemet, uafhængige eksperter og civilsamfundsorganisationer i gennemførelsen af sådanne konsekvensanalyser og udformningen af foranstaltninger, der skal træffes, hvis risiciene opstår. Det Europæiske Kontor for Kunstig Intelligens (»AI-kontoret«) bør udvikle en skabelon til et spørgeskema for at lette overholdelsen og mindske den administrative byrde for idriftsættere.
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Begrebet AI-modeller til almen brug bør af hensyn til retssikkerheden defineres klart og adskilles fra begrebet AI-systemer. Definitionen bør baseres på de vigtigste funktionelle karakteristika ved en AI-model til almen brug, navnlig generaliteten og kapaciteten til med kompetence at udføre en lang række forskellige opgaver. Disse modeller trænes typisk med store mængder data ved hjælp af forskellige metoder såsom ved selvovervåget, ikkeovervåget eller forstærket læring. AI-modeller til almen brug kan bringes i omsætning på forskellige måder, herunder via biblioteker eller programmeringsgrænseflader for applikationer (API'er), som direkte download eller som fysisk kopi. Disse modeller kan ændres yderligere eller finjusteres til nye modeller. Selv om AI-modeller er væsentlige komponenter i AI-systemer, udgør de ikke i sig selv AI-systemer. AI-modeller kræver, at der tilføjes yderligere komponenter, f.eks. en brugergrænseflade, for at blive til AI-systemer. AI-modeller er typisk integreret i og udgør en del af AI-systemer. Denne forordning fastsætter specifikke regler for AI-modeller til almen brug og for AI-modeller til almen brug, der udgør systemiske risici, som også bør finde anvendelse, når disse modeller integreres eller indgår i et AI-system. Det forudsættes, at forpligtelserne for udbydere af AI-modeller til almen brug bør finde anvendelse, når AI-modellerne til almen brug er bragt i omsætning.Når udbyderen af en AI-model til almen brug integrerer en egen model i sit eget AI-system, der gøres tilgængeligt på markedet eller ibrugtages, bør den pågældende model betragtes som at være bragt i omsætning, og derfor bør forpligtelserne i denne forordning for modeller fortsat finde anvendelse foruden forpligtelserne for AI-systemer. De forpligtelser, der er fastsat for modeller, bør under alle omstændigheder ikke finde anvendelse, når en egen model anvendes til rent interne processer, som ikke er væsentlige for leveringen af et produkt eller en tjeneste til tredjeparter, og fysiske personers rettigheder ikke berøres. I betragtning af deres potentielt væsentlige negative virkninger bør AI-modeller til almen brug med systemisk risiko altid være underlagt de relevante forpligtelser i henhold til denne forordning. Definitionen bør ikke omfatte AI-modeller, der anvendes, inden de bringes i omsætning, udelukkende med henblik på forsknings-, udviklings- og prototypeaktiviteter. Dette berører ikke forpligtelsen til at overholde denne forordning, når en model bringes i omsætning efter sådanne aktiviteter.
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Mens en models generalitet blandt andet også kan bestemmes af en række parametre, bør modeller med mindst en milliard parametre, og som er trænet med en stor mængde data ved hjælp af selvovervågning, i stor skala betragtes som at udvise betydelig generalitet og kompetence til at udføre en lang række forskellige opgaver.
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Store generative AI-modeller er et typisk eksempel på en AI-model til almen brug, da de giver mulighed for fleksibel generering af indhold, f.eks. i form af tekst, lyd, billeder eller video, der let kan tilpasses en lang række forskellige opgaver.
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Hvis en AI-model til almen brug integreres i eller udgør en del af et AI-system, bør dette system betragtes som at være et AI-system til almen brug, når dette system som følge af denne integration har kapacitet til at tjene en række forskellige formål. Et AI-system til almen brug kan anvendes direkte, eller det kan integreres i andre AI-systemer.
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Udbydere af AI-modeller til almen brug har en særlig rolle og et særligt ansvar i AI-værdikæden, da de modeller, de leverer, kan danne grundlag for en række downstreamsystemer, der ofte leveres af downstreamudbydere, og som kræver en god forståelse af modellerne og deres kapacitet, både for at gøre det muligt at integrere sådanne modeller i deres produkter og for at opfylde deres forpligtelser i henhold til denne eller andre forordninger. Der bør derfor fastsættes forholdsmæssige gennemsigtighedsforanstaltninger, herunder udarbejdelse og ajourføring af dokumentation og formidling af oplysninger om AI-modellen til almen brug med henblik på downstreamudbydernes anvendelse heraf. Den tekniske dokumentation bør udarbejdes og ajourføres af udbyderen af AI-modellen til almen brug med henblik på efter anmodning at stille den til rådighed for AI-kontoret og de nationale kompetente myndigheder. Minimumssættet af elementer, der skal medtages i sådan dokumentation, bør fastsættes i særlige bilag til denne forordning. Kommissionen bør have beføjelse til at ændre disse bilag ved hjælp af delegerede retsakter i lyset af den teknologiske udvikling.
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Software og data, herunder modeller frigivet i henhold til en gratis open source-licens, der gør det muligt at dele dem åbent, og hvor brugerne frit kan få adgang til, anvende, ændre og videregive dem eller ændrede versioner heraf, kan bidrage til forskning og innovation på markedet og skabe betydelige vækstmuligheder for Unionens økonomi. AI-modeller til almen brug, som er frigivet i henhold til gratis open source-licenser, bør betragtes som at sikre en høj grad af gennemsigtighed og åbenhed, hvis deres parametre, herunder vægtene, oplysningerne om modelarkitekturen og oplysningerne om modelanvendelsen, gøres offentligt tilgængelige. Licensen bør også betragtes som gratis og open source, når den giver brugerne mulighed for at køre, kopiere, distribuere, undersøge, ændre og forbedre software og data, herunder modeller, forudsat at den oprindelige udbyder af modellen krediteres, og at de identiske eller sammenlignelige distributionsvilkår overholdes.
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Gratis open source-AI-komponenter omfatter software og data, herunder modeller og AI-modeller til almen brug, værktøjer, tjenester eller processer i et AI-system. Gratis open source-AI-komponenter kan leveres gennem forskellige kanaler, herunder deres udvikling i åbne databaser. Med henblik på denne forordning bør AI-komponenter, der leveres mod en pris, eller som der på anden vis tjenes penge på, herunder gennem levering af teknisk støtte eller andre tjenester, bl.a. gennem en softwareplatform, i forbindelse med AI-komponenten, eller anvendelse af personoplysninger af andre årsager end udelukkende for at forbedre softwarens sikkerhed, kompatibilitet eller interoperabilitet, med undtagelse af transaktioner mellem mikrovirksomheder, ikke være omfattet af undtagelserne for gratis open source-AI-komponenter. Det forhold, at AI-komponenter stilles til rådighed gennem åbne databaser, bør ikke i sig selv udgøre en monetarisering.
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Udbydere af AI-modeller til almen brug, der frigives i henhold til en gratis open source-licens, og hvis parametre, herunder vægtene, oplysningerne om modelarkitekturen og oplysningerne om modelanvendelsen, gøres offentligt tilgængelige, bør være omfattet af undtagelser for så vidt angår de krav om gennemsigtighed, der stilles til AI-modeller til almen brug, medmindre de kan anses for at udgøre en systemisk risiko, i hvilket tilfælde det forhold, at modellen er gennemsigtig og ledsaget af en open source-licens, ikke bør betragtes som tilstrækkelig grund til at udelukke, at forpligtelserne i henhold til denne forordning overholdes. I betragtning af at frigivelsen af AI-modeller til almen brug i henhold til en gratis open source-licens ikke nødvendigvis afslører væsentlige oplysninger om det datasæt, der anvendes til træning eller finjustering af modellen, og om hvordan overholdelsen af ophavsretten derved blev sikret, bør undtagelsen for AI-modeller til almen brug fra overholdelse af krav om gennemsigtighed under alle omstændigheder ikke vedrøre forpligtelsen til at udarbejde en sammenfatning af det indhold, der anvendes til modeltræning, og forpligtelsen til at indføre en politik, der overholder EU-retten om ophavsret, navnlig med hensyn til at identificere og overholde forbeholdet af rettigheder i henhold til artikel 4, stk. 3, i Europa-Parlamentets og Rådets direktiv (EU) 2019/790 
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AI-modeller til almen brug, navnlig store generative AI-modeller, der kan generere tekst, billeder og andet indhold, giver unikke innovationsmuligheder, men også udfordringer for kunstnere, forfattere og andre skabere og den måde, hvorpå deres kreative indhold skabes, distribueres, anvendes og forbruges. Udviklingen og træningen af sådanne modeller kræver adgang til store mængder tekst, billeder, videoer og andre data. Tekst- og dataminingteknikker kan anvendes i vid udstrækning i denne forbindelse til søgning og analyse af sådant indhold, som kan være beskyttet af ophavsret og beslægtede rettigheder. Enhver anvendelse af ophavsretligt beskyttet indhold kræver tilladelse fra den pågældende rettighedshaver, medmindre der gælder relevante undtagelser og indskrænkninger i ophavsretten. Direktiv (EU) 2019/790 indførte undtagelser og indskrænkninger, der tillader reproduktion og udtræk af værker eller andre frembringelser med henblik på tekst- og datamining på visse betingelser. I henhold til disse regler kan rettighedshavere vælge at forbeholde deres rettigheder til deres værker eller andre frembringelser for at forhindre tekst- og datamining, medmindre dette sker med henblik på videnskabelig forskning. Hvis retten til fravalg udtrykkeligt er blevet forbeholdt på passende vis, skal udbydere af AI-modeller til almen brug indhente en tilladelse fra rettighedshaverne, hvis de ønsker at udføre tekst- og datamining i forbindelse med sådanne værker.
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Udbydere, der bringer AI-modeller til almen brug i omsætning på EU-markedet, bør sikre overholdelse af de relevante forpligtelser i denne forordning. Med henblik herpå bør udbydere af AI-modeller til almen brug indføre en politik, der overholder EU-retten om ophavsret og beslægtede rettigheder, navnlig med hensyn til at identificere og overholde det forbehold af rettigheder, som rettighedshaverne har givet udtryk for i henhold til artikel 4, stk. 3, i direktiv (EU) 2019/790. Enhver udbyder, der bringer en AI-model til almen brug i omsætning på EU-markedet, bør overholde denne forpligtelse, uanset i hvilken jurisdiktion de ophavsretligt relevante handlinger, der ligger til grund for træningen af disse AI-modeller til almen brug, finder sted. Dette er nødvendigt for at sikre lige vilkår for udbydere af AI-modeller til almen brug, da ingen udbyder bør kunne opnå en konkurrencemæssig fordel på EU-markedet ved at anvende lavere ophavsretlige standarder end dem, der er fastsat i Unionen.
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For at øge gennemsigtigheden af de data, der anvendes i forbindelse med forhåndstræning og træning af AI-modeller til almen brug, herunder tekst og data, der er beskyttet af ophavsret, er det tilstrækkeligt, at udbydere af sådanne modeller udarbejder og offentliggør en tilstrækkeligt detaljeret sammenfatning af det indhold, der anvendes til træning af AI-modellen til almen brug. Under behørig hensyntagen til behovet for at beskytte forretningshemmeligheder og fortrolige forretningsoplysninger bør denne sammenfatning generelt have et bredt anvendelsesområde i stedet for at være teknisk detaljeret, så det bliver lettere for parter med legitime interesser, herunder indehavere af ophavsret, at udøve og håndhæve deres rettigheder i henhold til EU-retten, f.eks. ved at opregne de vigtigste datasamlinger eller datasæt, der er gået til at træne modellen, såsom store private eller offentlige databaser eller dataarkiver, og ved at give en beskrivende redegørelse for andre anvendte datakilder. Det er hensigtsmæssigt, at AI-kontoret tilvejebringer en skabelon for sammenfatningen, som bør være enkel og effektiv, og giver udbyderen mulighed for at fremsende den krævede sammenfatning i beskrivende tekst.
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Hvad angår de forpligtelser, der pålægges udbydere af AI-modeller til almen brug, til at indføre en politik med henblik på at overholde EU-retten om ophavsret og offentliggøre en sammenfatning af det indhold, der anvendes til træningen, bør AI-kontoret overvåge, om udbyderen har opfyldt disse forpligtelser uden at verificere eller vurdere træningsdataene for hvert enkelt værk med hensyn til overholdelse af ophavsretten. Denne forordning berører ikke håndhævelsen af ophavsretsreglerne som fastsat i EU-retten.
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Overholdelsen af de forpligtelser, der gælder for udbydere af AI-modeller til almen brug, bør stå i et rimeligt forhold til og være proportionalt med typen af modeludbyder, bortset fra behovet for overholdelse for personer, der udvikler eller anvender modeller til ikkeprofessionelle eller videnskabelige forskningsformål, og som ikke desto mindre bør tilskyndes til frivilligt at overholde disse krav. Uden at det berører EU-retten om ophavsret, bør der ved overholdelsen af disse forpligtelser tages behørigt hensyn til udbyderens størrelse, og SMV'er, herunder iværksættervirksomheder, bør have mulighed for forenklede måder at overholde reglerne på, som ikke bør indebære uforholdsmæssigt store omkostninger og ikke modvirke anvendelsen af sådanne modeller. I tilfælde af en ændring eller finjustering af en model bør forpligtelserne for udbydere af AI-modeller til almen brug begrænses til denne ændring eller finjustering, f.eks. ved at supplere den allerede eksisterende tekniske dokumentation med oplysninger om ændringerne, herunder nye træningsdatakilder, som et middel til at overholde værdikædeforpligtelserne i denne forordning.
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AI-modeller til almen brug kan udgøre systemiske risici, som omfatter, men ikke er begrænset til, faktiske negative virkninger, der med rimelighed kan forudses, i forbindelse med større ulykker, forstyrrelser i kritiske sektorer og alvorlige konsekvenser for folkesundheden og sikkerheden, enhver faktisk negativ virkning, der med rimelighed kan forudses, for demokratiske processer, offentlig og økonomisk sikkerhed samt formidling af ulovligt, falsk eller forskelsbehandlende indhold. Det skal forstås sådan, at systemiske risici øges med modelkapaciteter og modelrækkevidde, kan opstå i hele modellens livscyklus og påvirkes af betingelser for misbrug, modelpålidelighed, modelrimelighed og modelsikkerhed, graden af modellens autonomi, dens adgang til værktøjer, nye eller kombinerede metoder, frigivelses- og distributionsstrategier, potentialet til at fjerne beskyttelsesforanstaltninger og andre faktorer. Navnlig har internationale tilgange hidtil vist, at det er nødvendigt at være opmærksom på risici fra potentielt bevidst misbrug eller utilsigtede problemer med kontrol i forbindelse med tilpasning til menneskelig hensigt, kemiske, biologiske, radiologiske og nukleare risici, f.eks. hvordan adgangsbarrierer kan sænkes, herunder for udvikling, erhvervelse eller anvendelse af våben, offensive cyberkapaciteter, f.eks. hvordan metoder til opdagelse, udnyttelse eller operationel brug af sårbarheder kan muliggøres, virkningerne af interaktion og brug af værktøjer, herunder f.eks. kapaciteten til at kontrollere fysiske systemer og gribe ind i kritisk infrastruktur, risici fra modeller, der fremstiller kopier af sig selv eller bliver »selvkopierende« eller træner andre modeller, hvordan modeller kan medføre skadelig bias og forskelsbehandling med risici for enkeltpersoner, lokalsamfund eller samfund, lettelse af desinformation eller krænkelse af privatlivets fred med trusler mod demokratiske værdier og menneskerettighederne samt risiko for, at en bestemt hændelse kan skabe en kædereaktion med betydelige negative virkninger, der kan påvirke en hel by, en hel domæneaktivitet eller et helt fællesskab.
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Der bør fastlægges en metode til klassificering af AI-modeller til almen brug som AI-modeller til almen brug med systemiske risici. Da systemiske risici skyldes særlig høj kapacitet, bør en AI-model til almen brug betragtes som at udgøre systemiske risici, hvis de har kapaciteter med stor virkning, vurderet på grundlag af passende tekniske værktøjer og metoder, eller en betydelig indvirkning på det indre marked på grund af dens omfang. Ved kapaciteter med stor virkning i AI-modeller til almen brug forstås kapaciteter, som svarer til eller overstiger de kapaciteter, der er registreret i de mest avancerede AI-modeller til almen brug. Hele spektret af kapaciteter i en model kan bedre forstås, efter at den er blevet bragt i omsætning på markedet, eller når idriftsætterne interagerer med modellen. Ifølge det aktuelle teknologiske niveau på tidspunktet for denne forordnings ikrafttræden er den kumulerede mængde beregningskraft, der anvendes til træning af AI-modellen til almen brug, målt i flydende kommatalsberegninger, en af de relevante tilnærmelser for modelkapaciteter. Den kumulerede mængde beregningskraft, der anvendes til træning, omfatter den beregningskraft, der anvendes på tværs af de aktiviteter og metoder, der er tilsigtet at forbedre modellens kapaciteter forud for idriftsættelsen, såsom forhåndstræning, generering af syntetiske data og finjustering. Der bør derfor fastsættes en foreløbig tærskel for flydende kommatalsberegninger, som, hvis den opnås af en AI-model til almen brug, fører til en formodning om, at modellen er en AI-model til almen brug med systemiske risici. Denne tærskel bør justeres over tid for at afspejle teknologiske og industrielle ændringer såsom algoritmiske forbedringer eller øget hardwareeffektivitet og bør suppleres med benchmarks og indikatorer for modelkapacitet.For at kvalificere dette bør AI-kontoret samarbejde med det videnskabelige samfund, industrien, civilsamfundet og andre eksperter. Tærskler samt værktøjer og benchmarks til vurdering af kapaciteter med stor virkning bør være stærke forudsigelsesfaktorer for generaliteten, kapaciteterne og den dermed forbundne systemiske risiko ved AI-modeller til almen brug og kan tage hensyn til måden, hvorpå modellen vil blive bragt i omsætning, eller antallet af brugere, den kan påvirke. For at supplere dette system bør Kommissionen have mulighed for at træffe individuelle beslutninger om, at en AI-model til almen brug udpeges som en AI-model til almen brug med systemisk risiko, hvis det konstateres, at en sådan model har samme kapaciteter eller en virkning som dem, der fremgår af den fastsatte tærskel. Denne beslutning bør træffes på grundlag af en samlet vurdering af kriterierne for udpegelse af en AI-model til almen brug med systemisk risiko, der er fastsat i et bilag til denne forordning, såsom kvaliteten eller størrelsen af træningsdatasættet, antallet af virksomheds- og slutbrugere, dens input- og outputmetoder, dens grad af autonomi og skalerbarhed eller de værktøjer, den har adgang til. Efter en begrundet anmodning fra en udbyder, hvis model er blevet udpeget som en AI-model til almen brug med systemisk risiko, bør Kommissionen tage hensyn til anmodningen og kan beslutte på ny at vurdere, om AI-modellen til almen brug stadig kan anses for at frembyde systemiske risici.
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Det er også nødvendigt at klargøre en procedure til klassificering af en AI-model til almen brug med systemiske risici. En AI-model til almen brug, som opfylder den gældende tærskel for kapaciteter med stor virkning, må formodes at være en AI-model til almen brug med systemisk risiko. Udbyderen bør underrette AI-kontoret senest to uger efter, at kravene er opfyldt, eller det bliver kendt, at en AI-model til almen brug vil opfylde de krav, der fører til formodningen. Dette er navnlig relevant i forbindelse med tærsklen for flydende kommatalsberegninger, eftersom træning af AI-modeller til almen brug kræver betydelig planlægning, som omfatter forhåndsallokering af beregningskraftsressourcer, og udbydere af AI-modeller til almen brug kan derfor have kendskab til, om deres model opfylder tærsklen, inden træningen afsluttes. I forbindelse med denne notifikation bør udbyderen kunne påvise, at en AI-model til almen brug som følge af dens specifikke karakteristika undtagelsesvis ikke udgør systemiske risici, og at den derfor ikke bør klassificeres som en AI-model til almen brug med systemiske risici. Denne oplysning er nyttig for AI-kontoret med henblik på at foregribe omsætningen af AI-modeller til almen brug med systemiske risici, så udbyderne tidligt kan begynde at samarbejde med AI-kontoret. Denne oplysning er navnlig vigtig for så vidt angår AI-modeller til almen brug, som efter planen skal frigives som open source, eftersom de nødvendige foranstaltninger til at sikre overholdelse af forpligtelserne i medfør af denne forordning kan være vanskeligere at gennemføre efter frigivelsen af modellen som open source.
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Hvis Kommissionen får kendskab til, at en AI-model til almen brug opfylder kravene til klassificering som en AI-model til almen brug med systemisk risiko, som tidligere enten ikke var kendt, eller som den relevante udbyder har undladt at underrette Kommissionen om, bør Kommissionen have beføjelse til at udpege den som sådan. I tillæg til AI-kontorets overvågningsaktiviteter bør et system med kvalificerede varslinger sikre, at AI-kontoret af det videnskabelige panel får kendskab til AI-modeller til almen brug, som eventuelt bør klassificeres som AI-modeller til almen brug med systemisk risiko.
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Udbydere af AI-modeller til almen brug, som udgør systemiske risici, bør foruden de forpligtelser, der er fastsat for udbydere af AI-modeller til almen brug, være underlagt forpligtelser med det formål at identificere og afbøde disse risici og sikre et tilstrækkeligt cybersikkerhedsbeskyttelsesniveau, uanset om de leveres som en selvstændig model eller er indlejret i et AI-system eller et produkt. For at nå disse mål bør denne forordning kræve, at udbydere foretager de nødvendige modelevalueringer, navnlig inden de første gang bringes i omsætning, herunder gennemførelse og dokumentation af afprøvning af modeller mod ondsindet brug, herunder også i relevant omfang, gennem intern eller uafhængig ekstern afprøvning. Udbydere af AI-modeller til almen brug med systemiske risici bør desuden løbende vurdere og afbøde systemiske risici, herunder f.eks. ved at indføre risikostyringspolitikker såsom ansvarligheds- og forvaltningsprocesser, gennemføre overvågning efter omsætningen, træffe passende foranstaltninger i hele modellens livscyklus og samarbejde med relevante aktører i AI-værdikæden.
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Udbydere af AI-modeller til almen brug med systemiske risici bør vurdere og afbøde eventuelle systemiske risici. Hvis udviklingen eller anvendelsen af modellen trods bestræbelser på at identificere og forebygge risici forbundet med en AI-model til almen brug, som kan udgøre systemiske risici, forårsager en alvorlig hændelse, bør udbyderen af AI-modellen til almen brug uden unødigt ophold spore hændelsen og indberette alle relevante oplysninger og eventuelle korrigerende foranstaltninger til Kommissionen og de nationale kompetente myndigheder. Udbydere bør desuden sikre et tilstrækkeligt cybersikkerhedsbeskyttelsesniveau for modellen og dens fysiske infrastruktur, hvis det er relevant, i hele modellens livscyklus. Cybersikkerhedsbeskyttelse i forbindelse med systemiske risici, der er knyttet til ondsindet brug af eller angreb, bør tage behørigt hensyn til utilsigtet modellækage, uautoriserede frigivelser, omgåelse af sikkerhedsforanstaltninger og forsvar mod cyberangreb, uautoriseret adgang eller modeltyveri. Denne beskyttelse kan lettes ved at sikre modelvægte, algoritmer, servere og datasæt såsom gennem operationelle sikkerhedsforanstaltninger med henblik på informationssikkerhed, specifikke cybersikkerhedspolitikker, passende tekniske og etablerede løsninger samt cyberadgangskontroller og fysiske adgangskontroller, der er tilpasset de relevante forhold og de involverede risici.
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AI-kontoret bør tilskynde til og lette udarbejdelsen, gennemgangen og tilpasningen af praksiskodekser under hensyntagen til internationale tilgange. Alle udbydere af AI-modeller til almen brug kan indbydes til at deltage. For at sikre at praksiskodekser afspejler det aktuelle teknologiske niveau og tager behørigt hensyn til en række forskellige perspektiver, bør AI-kontoret samarbejde med relevante nationale kompetente myndigheder og kan, hvis det er relevant, høre civilsamfundsorganisationer og andre relevante interessenter og eksperter, herunder det videnskabelige panel, om udarbejdelsen af sådanne kodekser. Praksiskodekser bør omfatte forpligtelser for udbydere af AI-modeller til almen brug og af modeller til almen brug, der udgør systemiske risici. Hvad angår systemiske risici, bør praksiskodekser derudover bidrage til at opstille en risikotaksonomi for typen og arten af de systemiske risici på EU-plan, herunder deres kilder. Praksiskodekser bør også fokusere på specifikke risikovurderinger og risikobegrænsende foranstaltninger.
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Praksiskodekser bør udgøre et centralt redskab med henblik på korrekt overholdelse af de forpligtelser, der er fastsat i medfør af denne forordning, og som gælder for udbydere af AI-modeller til almen brug. Udbydere bør kunne forlade sig på praksiskodekser for at påvise overholdelse af forpligtelserne. Kommissionen kan ved hjælp af gennemførelsesretsakter beslutte at godkende en praksiskodeks og tillægge den almen gyldighed i Unionen eller alternativt fastsætte fælles regler for gennemførelsen af de relevante forpligtelser, hvis en praksiskodeks på tidspunktet for denne forordnings ikrafttræden ikke kan færdiggøres eller af AI-kontoret anses for at være utilstrækkelig. Når en harmoniseret standard er offentliggjort, og AI-kontoret har vurderet den som egnet til at dække de relevante forpligtelser, bør overholdelse af en europæisk harmoniseret standard medføre en formodning om overensstemmelse hermed fra udbydernes side. Udbydere af AI-modeller til almen brug bør desuden kunne påvise overensstemmelse ved hjælp af alternative passende metoder, hvis der ikke findes praksiskodekser eller harmoniserede standarder, eller de vælger ikke at anvende sådanne.
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Denne forordning regulerer AI-systemer og AI-modeller, idet den indfører visse krav og forpligtelser for relevante markedsaktører, som bringer dem i omsætning, ibrugtager dem eller anvender dem i Unionen, og derved supplerer forpligtelserne for udbydere af formidlingstjenester, som indlejrer sådanne systemer eller modeller i deres tjenester, som er reguleret ved forordning (EU) 2022/2065. I det omfang sådanne systemer eller modeller er indlejret i udpegede meget store onlineplatforme eller meget store onlinesøgemaskiner, er de underlagt den ramme for risikostyring, som er fastsat i forordning (EU) 2022/2065. De tilsvarende forpligtelser i nærværende forordning må derfor formodes at være opfyldt, medmindre betydelige systemiske risici, der ikke er omfattet af forordning (EU) 2022/2065, forekommer og identificeres i sådanne modeller. Inden for disse rammer er udbydere af meget store onlineplatforme forpligtet til at vurdere potentielle systemiske risici, der hidrører fra udformningen, funktionen og anvendelsen af deres tjenester, herunder hvordan udformningen af algoritmiske systemer, der anvendes i tjenesten, kan bidrage til sådanne risici, samt systemiske risici, der hidrører fra potentielt misbrug. Disse udbydere er også forpligtet til at træffe afbødende foranstaltninger for at overholde de grundlæggende rettigheder.
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I betragtning af innovationshastigheden og den teknologiske udvikling inden for digitale tjenester, som er omfattet af forskellige EU-retlige instrumenters anvendelsesområde, navnlig under hensyntagen til anvendelsen og opfattelsen af modtagerne heraf, kan de AI-systemer, der er omfattet af denne forordning, leveres som formidlingstjenester eller dele heraf som omhandlet i forordning (EU) 2022/2065, som bør fortolkes på en teknologineutral måde. AI-systemer kan f.eks. anvendes til at levere onlinesøgemaskiner, navnlig i det omfang et AI-system såsom en onlinechatbot i princippet foretager søgninger på alle websteder, dernæst indarbejder resultaterne i sin eksisterende viden og anvender den ajourførte viden til at generere et enkelt output, der kombinerer forskellige informationskilder.
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De forpligtelser, der pålægges udbydere og idriftsættere af visse AI-systemer i denne forordning, for at give mulighed for at påvise og oplyse, at outputtet af disse systemer er blevet genereret kunstigt eller manipuleret, er desuden særlig relevante for at lette en effektiv gennemførelse af forordning (EU) 2022/2065. Dette gælder navnlig for forpligtelserne for udbydere af meget store onlineplatforme eller meget store onlinesøgemaskiner til at identificere og afbøde systemiske risici, der kan opstå som følge af formidlingen af indhold, der er blevet kunstigt genereret eller manipuleret, navnlig risikoen for de faktiske eller forventede negative virkninger for demokratiske processer, samfundsdebatten og valgprocesser, herunder gennem desinformation.
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Standardisering bør spille en central rolle med hensyn til at levere tekniske løsninger til udbyderne for at sikre overholdelse af denne forordning i overensstemmelse med det aktuelle teknologiske niveau og fremme innovation samt konkurrenceevnen og væksten på det indre marked. Overholdelse af harmoniserede standarder som defineret i artikel 2, nr. 1), litra c), i Europa-Parlamentets og Rådets forordning (EU) nr. 1025/2012 
(
41
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, der sædvanligvis forventes at afspejle det aktuelle teknologiske niveau, bør være et middel for udbydere til at påvise overensstemmelse med kravene i nærværende forordning. Der bør derfor tilskyndes til en afbalanceret repræsentation af interesser, der inddrager alle relevante interessenter i udviklingen af standarder, navnlig SMV'er, forbrugerorganisationer og miljøorganisationer og sociale interessenter i overensstemmelse med artikel 5 og 6 i forordning (EU) nr. 1025/2012. For at lette overholdelsen bør standardiseringsanmodningerne fremsættes af Kommissionen uden unødigt ophold. I forbindelse med udarbejdelsen af standardiseringsanmodninger bør Kommissionen høre det rådgivende forum og AI-udvalget med henblik på at indsamle relevant ekspertise. I mangel af relevante referencer til harmoniserede standarder bør Kommissionen dog ved hjælp af gennemførelsesretsakter og efter høring af det rådgivende forum kunne fastsætte fælles specifikationer for visse krav i henhold til nærværende forordning. Den fælles specifikation bør være en ekstraordinær nødløsning for at lette udbyderens forpligtelse til at overholde kravene i nærværende forordning, når standardiseringsanmodningen ikke er blevet accepteret af de europæiske standardiseringsorganisationer, eller når de relevante harmoniserede standarder i utilstrækkelig grad tager hensyn til betænkeligheder vedrørende grundlæggende rettigheder, eller når de harmoniserede standarder ikke er i overensstemmelse med anmodningen, eller når der er forsinkelser i vedtagelsen af en passende harmoniseret standard. Hvis en sådan forsinkelse i vedtagelsen af en harmoniseret standard skyldes den pågældende standards tekniske kompleksitet, bør Kommissionen tage dette i betragtning, inden det overvejes at udarbejde fælles specifikationer. Ved udarbejdelsen af fælles specifikationer tilskyndes Kommissionen til at samarbejde med internationale partnere og internationale standardiseringsorganer.
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Uden at det berører anvendelsen af harmoniserede standarder og fælles specifikationer, bør udbydere af et højrisiko-AI-system, som er blevet trænet og afprøvet på data, der afspejler de specifikke geografiske, adfærdsmæssige, kontekstuelle eller funktionelle rammer, som AI-systemet tilsigtes anvendt inden for, formodes at være i overensstemmelse med den relevante foranstaltning, der er fastsat i kravet til datastyring i denne forordning. Uden at det berører kravene til robusthed og nøjagtighed i denne forordning og i overensstemmelse med artikel 54, stk. 3, i forordning (EU) 2019/881 formodes højrisiko-AI-systemer, der er certificeret, eller for hvilke der er udstedt en overensstemmelseserklæring inden for rammerne af en cybersikkerhedsordning i henhold til nævnte forordning, og hvis referencer er offentliggjort i 
Den Europæiske Unions Tidende
, at overholde cybersikkerhedskravene i nærværende forordning, såfremt cybersikkerhedsattesten eller overensstemmelseserklæringen eller dele heraf dækker cybersikkerhedskravet i nærværende forordning. Dette berører ikke den pågældende cybersikkerhedsordnings frivillige karakter.
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For at sikre en høj grad af troværdighed i højrisiko-AI-systemer bør disse systemer underkastes en overensstemmelsesvurdering, inden de bringes i omsætning eller ibrugtages.
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For så vidt angår højrisiko-AI-systemer, der vedrører produkter, der er omfattet af gældende EU-harmoniseringslovgivning baseret på den nye lovgivningsmæssige ramme, bør disse AI-systemers overholdelse af kravene i denne forordning vurderes som led i den overensstemmelsesvurdering, der allerede er fastsat i nævnte ret, for at minimere byrden for operatørerne og undgå ethvert muligt overlap. Anvendeligheden af kravene i denne forordning bør derfor ikke påvirke den specifikke logik, metode eller generelle struktur i overensstemmelsesvurderingen i henhold til den relevante EU-harmoniseringslovgivning.
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I betragtning af højrisiko-AI-systemers kompleksitet og de med disse forbundne risici er det vigtigt at udvikle en passende overensstemmelsesvurderingsprocedure for højrisiko-AI-systemer, der involverer bemyndigede organer, en såkaldt overensstemmelsesvurdering udført af tredjepart. I betragtning af den aktuelle erfaring, som professionelle, der udfører certificering forud for omsætning, har inden for produktsikkerhed og de relevante risicis forskellige karakter, bør anvendelsesområdet for tredjeparters overensstemmelsesvurderinger af andre højrisiko-AI-systemer end dem, der vedrører produkter, dog begrænses, i det mindste i den indledende fase af anvendelsen af denne forordning. Overensstemmelsesvurderinger af sådanne systemer bør derfor som hovedregel foretages af udbyderen på dennes eget ansvar, med undtagelse af AI-systemer, der tilsigtes anvendt til biometri.
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Med henblik på tredjeparters overensstemmelsesvurderinger, når der er behov for sådanne, bør bemyndigede organer notificeres i henhold til denne forordning af de nationale kompetente myndigheder, forudsat at de overholder en række krav, navnlig med hensyn til uafhængighed, kompetencer, interessekonflikter og passende cybersikkerhedskrav. De nationale kompetente myndigheder bør sende notifikationen af disse organer til Kommissionen og de andre medlemsstater ved hjælp af det elektroniske notifikationsværktøj, der er udviklet og forvaltes af Kommissionen i henhold til artikel R23 i bilag I til afgørelse nr. 768/2008/EF.
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I overensstemmelse med Unionens forpligtelser i henhold til Verdenshandelsorganisationens aftale om tekniske handelshindringer er det hensigtsmæssigt at lette den gensidige anerkendelse af resultater af overensstemmelsesvurderinger udarbejdet af de kompetente overensstemmelsesvurderingsorganer, uafhængigt af hvor de er etableret, forudsat at disse overensstemmelsesvurderingsorganer, der er oprettet i henhold til retten i et tredjeland, opfylder de gældende krav i denne forordning, og Unionen har indgået aftale herom. I denne forbindelse bør Kommissionen aktivt undersøge mulige internationale instrumenter til dette formål og navnlig søge at indgå aftaler om gensidig anerkendelse med tredjelande.
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I overensstemmelse med det almindeligt anerkendte begreb væsentlig ændring for produkter, der er reguleret af EU-harmoniseringslovgivningen, bør AI-systemet, når der sker en ændring, som kan have indflydelse på højrisiko-AI-systemets overensstemmelse med denne forordning (f.eks. ændring af styresystem eller softwarearkitektur), eller hvis systemets tilsigtede formål ændrer sig, betragtes som et nyt AI-system, der bør underkastes en ny overensstemmelsesvurdering. Ændringer i algoritmen og ydeevnen af AI-systemer, der fortsætter med at »lære« efter, at de er bragt i omsætning eller ibrugtaget, dvs. at de automatisk tilpasser, hvordan funktionerne udføres, bør ikke udgøre en væsentlig ændring, forudsat at disse ændringer er fastlagt på forhånd af udbyderen og vurderet på tidspunktet for overensstemmelsesvurderingen.
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Højrisiko-AI-systemer bør være forsynet med CE-mærkning for at vise, at de er i overensstemmelse med denne forordning, således at de sikres fri bevægelighed på det indre marked. For højrisiko-AI-systemer, der er indlejret i et produkt, bør der anbringes en fysisk CE-mærkning, som kan suppleres med en digital CE-mærkning. For højrisiko-AI-systemer, der kun leveres digitalt, bør der anvendes en digital CE-mærkning. Medlemsstaterne bør ikke skabe uberettigede hindringer for omsætningen eller ibrugtagningen af højrisiko-AI-systemer, der overholder kravene i denne forordning, og som er forsynet med CE-mærkning.
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Under visse omstændigheder kan hurtig adgang til innovative teknologier være afgørende for personers sundhed og sikkerhed, miljøbeskyttelse og klimaændringer og for samfundet som helhed. Markedsovervågningsmyndighederne kan derfor af ekstraordinære hensyn til den offentlige sikkerhed eller beskyttelsen af fysiske personers liv og sundhed, miljøbeskyttelse og beskyttelse af centrale industrielle og infrastrukturmæssige aktiver tillade omsætning eller ibrugtagning af AI-systemer, der ikke har været genstand for en overensstemmelsesvurdering. I behørigt begrundede situationer som fastsat i denne forordning kan de retshåndhævende myndigheder eller civilbeskyttelsesmyndighederne tage et specifikt højrisiko-AI-system i brug uden tilladelse fra markedsovervågningsmyndigheden, forudsat at der under eller efter anvendelsen anmodes om en sådan tilladelse uden unødigt ophold.
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For at lette Kommissionens og medlemsstaternes arbejde inden for AI og øge gennemsigtigheden for offentligheden bør udbydere af andre højrisiko-AI-systemer end dem, der vedrører produkter, der er omfattet af relevant gældende EU-harmoniseringslovgivning, og udbydere, der finder, at et AI-system, der er opført som tilfælde af højrisikoanvendelser i et bilag til denne forordning, ikke er højrisiko på grundlag af en undtagelse, pålægges at registrere sig selv og oplysninger om deres AI-system i en EU-database, der skal oprettes og forvaltes af Kommissionen. Inden anvendelse af et AI-system, der er opført som tilfælde af højrisikoanvendelser i et bilag til denne forordning, bør idriftsættere af højrisiko-AI-systemer, der er offentlige myndigheder, agenturer eller organer, registrere sig selv i en sådan database og udvælge det system, de påtænker at anvende.Andre idriftsættere bør have ret til at gøre dette frivilligt. Denne del af EU-databasen bør være offentligt tilgængelig og gratis, og oplysningerne bør være lettilgængelige, forståelige og maskinlæsbare. EU-databasen bør også være brugervenlig, f.eks. ved at råde over søgefunktioner, herunder gennem nøgleord, der gør det muligt for offentligheden at finde relevante oplysninger, der skal indsendes ved registrering af højrisiko-AI-systemer, og om højrisiko-AI-systemers anvendelsestilfælde fastsat i et bilag til denne forordning, som højrisiko-AI-systemerne svarer til. Enhver væsentlig ændring af højrisiko-AI-systemer bør også registreres i EU-databasen. For højrisiko-AI-systemer inden for retshåndhævelse og migrationsstyring, asylforvaltning og grænsekontrol bør registreringsforpligtelserne opfyldes i en sikker ikkeoffentlig del af EU-databasen. Adgang til den sikre ikkeoffentlige del bør være strengt begrænset til Kommissionen og til markedsovervågningsmyndighederne for så vidt angår deres nationale del af den pågældende database. Højrisiko-AI-systemer inden for kritisk infrastruktur bør kun registreres på nationalt plan. Kommissionen bør være dataansvarlig for EU-databasen i overensstemmelse med forordning (EU) 2018/1725. For at sikre at EU-databasen fungerer efter hensigten, når den tages i idriftsættes, bør proceduren for oprettelse af databasen omfatte, at Kommissionen udarbejder funktionsspecifikationer, samt en uafhængig revisionsrapport. Kommissionen bør tage hensyn til cybersikkerhedsrisici, når den udfører sine opgaver som dataansvarlig for EU-databasen. For at maksimere offentlighedens tilgængelighed og anvendelse af EU-databasen bør EU-databasen, herunder oplysninger, der stilles til rådighed igennem den, overholde kravene i medfør af direktiv (EU) 2019/882.
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Visse AI-systemer, der er tilsigtet at interagere med fysiske personer eller generere indhold, kan indebære særlige risici for imitation eller vildledning, uanset om de er klassificeret som højrisiko eller ej. Under visse omstændigheder bør anvendelsen af disse systemer derfor være underlagt særlige gennemsigtighedsforpligtelser, uden at dette berører kravene og forpligtelserne for højrisiko-AI-systemer, og målrettede undtagelser for at tage hensyn til særlige behov inden for retshåndhævelse. Fysiske personer bør navnlig underrettes om, at de interagerer med et AI-system, medmindre dette er indlysende ud fra en rimelig oplyst, opmærksom og velunderrettet fysisk persons synspunkt under hensyntagen til omstændighederne og anvendelsessammenhængen. Ved gennemførelsen af denne forpligtelse bør der tages hensyn til egenskaber hos fysiske personer, der tilhører sårbare grupper på grund af deres alder eller handicap, i det omfang AI-systemet er tilsigtet også at interagere med disse grupper. Fysiske personer bør desuden underrettes, når de udsættes for AI-systemer, der ved at behandle personernes biometriske data kan genkende eller udlede følelserne eller hensigterne hos disse personer eller placere dem i specifikke kategorier. Sådanne specifikke kategorier kan vedrøre aspekter såsom køn, alder, hårfarve, øjenfarve, tatoveringer, personlighedstræk, etnisk oprindelse, personlige præferencer og interesser. Sådanne oplysninger og underretninger bør gives i formater, der er tilgængelige for personer med handicap.
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En række AI-systemer kan generere store mængder syntetisk indhold, som bliver stadig vanskeligere for mennesker at adskille fra menneskegenereret og autentisk indhold. Disse systemers brede tilgængelighed og øgede kapaciteter har en betydelig indvirkning på integriteten af og tilliden til informationsøkosystemet, hvilket skaber nye risici for misinformation og manipulation i stor målestok, svig, imitation eller vildledning af forbrugerne. I lyset af disse virkninger, det hurtige teknologiske tempo og behovet for nye metoder og teknikker til sporing af oplysningernes oprindelse bør udbydere af disse systemer pålægges at indlejre tekniske løsninger, som muliggør markering i et maskinlæsbart format og påvisning af, at outputtet er blevet genereret eller manipuleret af et AI-system og ikke af et menneske. Sådanne teknikker og metoder bør være tilstrækkeligt pålidelige, interoperable, effektive og robuste, i det omfang dette er teknisk muligt, under hensyntagen til tilgængelige teknikker eller en kombination af sådanne teknikker såsom vandmærker, metadataidentifikationer, kryptografiske metoder til påvisning af indholdets oprindelse og ægthed, registreringsmetoder, fingeraftryk eller andre teknikker, alt efter hvad der kan være relevant. Udbydere bør ved gennemførelsen af denne forpligtelse tage hensyn til de forskellige typer indholds særlige forhold og begrænsninger og markedsudviklinger på området, som er afspejlet i det generelt anerkendte aktuelle teknologiske niveau. Sådanne teknikker og metoder kan gennemføres på AI-systemniveau eller AI-modelniveau, som omfatter AI-modeller til almen brug, der genererer indhold, og derved gøre det nemmere for AI-systemets downstreamudbyder at opfylde denne forpligtelse. Det bør fastsættes, at hvis denne mærkningsforpligtelse skal forblive forholdsmæssig, bør den ikke omfatte AI-systemer, der primært udfører en hjælpefunktion med henblik på standardredigering, eller AI-systemer, der ikke i væsentlig grad ændrer de inputdata, der leveres af idriftsætteren, eller semantikken heraf.
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I forlængelse af de tekniske løsninger, som udbydere af AI-systemet anvender, bør de idriftsættere, der anvender et AI-system til at generere eller manipulere billed-, lyd- eller videoindhold, der i væsentlig grad ligner faktiske personer, genstande, steder, enheder eller begivenheder, og som fejlagtigt vil fremstå ægte eller sandfærdigt for en person (»deepfakes«), også klart og synligt oplyse, at indholdet er kunstigt skabt eller manipuleret, ved at mærke AI-outputtet i overensstemmelse hermed og oplyse om dets kunstige oprindelse. Overholdelse af denne gennemsigtighedsforpligtelse bør ikke fortolkes således, at anvendelse af AI-systemet eller dets output hindrer ytringsfriheden eller retten til frihed for kunst og videnskab, der er sikret ved chartret, navnlig når indholdet er en del af et åbenlyst kreativt, satirisk, kunstnerisk, fiktivt eller tilsvarende arbejde eller program, med forbehold af passende sikkerhedsforanstaltninger for tredjemands rettigheder og friheder. I disse tilfælde er gennemsigtighedsforpligtelsen for deepfakes fastsat i denne forordning begrænset til oplysning om eksistensen af sådant genereret eller manipuleret indhold på en passende måde, der ikke er til gene for visningen eller nydelsen af værket, herunder den normale udnyttelse og anvendelse heraf, samtidig med at værkets nytteværdi og kvalitet bevares. En lignende oplysningspligt bør desuden tilstræbes for AI-genereret eller manipuleret tekst, for så vidt den offentliggøres med det formål at informere offentligheden om spørgsmål af offentlig interesse, medmindre det AI-genererede indhold har gennemgået en proces med menneskelig gennemgang eller redaktionel kontrol, og en fysisk eller juridisk person har det redaktionelle ansvar for offentliggørelsen af indholdet.
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Uden at det berører disse gennemsigtighedsforpligtelsers obligatoriske karakter og fulde anvendelighed, kan Kommissionen også tilskynde til og lette udarbejdelsen af praksiskodekser på EU-plan for at lette en effektiv gennemførelse af forpligtelserne til påvisning og mærkning af kunstigt genereret eller manipuleret indhold, herunder til støtte for praktiske ordninger for i relevant omfang at gøre sporingsmekanismerne tilgængelige og lette samarbejdet med andre aktører i værdikæden, formidle indhold eller kontrollere dets ægthed og oprindelse, så offentligheden effektivt kan adskille AI-genereret indhold.
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De forpligtelser, der pålægges udbydere og idriftsættere af visse AI-systemer i denne forordning, for at gøre det muligt at påvise og oplyse, at outputtet af disse systemer er blevet genereret kunstigt eller manipuleret, er særlig relevante for at lette en effektiv gennemførelse af forordning (EU) 2022/2065. Dette gælder navnlig for forpligtelserne for udbydere af meget store onlineplatforme eller meget store onlinesøgemaskiner til at identificere og afbøde systemiske risici, der kan opstå som følge af formidlingen af indhold, der er blevet kunstigt genereret eller manipuleret, navnlig risikoen for de faktiske eller forventede negative virkninger for demokratiske processer, samfundsdebatten og valgprocesser, herunder gennem desinformation. Kravet om mærkning af indhold genereret af AI-systemer i henhold til nærværende forordning berører ikke forpligtelsen i artikel 16, stk. 6, i forordning (EU) 2022/2065 for udbydere af oplagringstjenester til at behandle anmeldelser om ulovligt indhold, som er modtaget i henhold til nævnte forordnings artikel 16, stk. 1, og bør ikke påvirke vurderingen af og afgørelsen om det specifikke indholds lovlighed. Denne vurdering bør udelukkende foretages under henvisning til reglerne om lovligheden af indholdet.
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Overholdelse af de gennemsigtighedsforpligtelser for AI-systemer, som er omfattet af denne forordning, bør ikke fortolkes således, at anvendelsen af systemet eller dets output er lovlig i henhold til denne forordning eller anden EU-ret eller ret i medlemsstaterne, og bør ikke berøre andre gennemsigtighedsforpligtelser for idriftsættere af AI-systemer i EU-retten eller national ret.
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AI er en hurtigt voksende familie af teknologier, der kræver myndighedstilsyn og et sikkert og kontrolleret miljø til forsøg, samtidig med at der sikres ansvarlig innovation og integration af passende sikkerhedsforanstaltninger og risikobegrænsende foranstaltninger. For at sikre en lovgivningsmæssig ramme, der fremmer innovation og er fremtidssikret og modstandsdygtig over for forstyrrelser, bør medlemsstaterne sikre, at deres nationale kompetente myndigheder opretter mindst én reguleringsmæssig AI-sandkasse på nationalt plan for at lette udviklingen og afprøvningen af innovative AI-systemer under strengt myndighedstilsyn, før disse systemer bringes i omsætning eller på anden måde ibrugtages. Medlemsstaterne kan også opfylde denne forpligtelse ved at deltage i allerede eksisterende reguleringsmæssige sandkasser eller oprette en sandkasse sammen med én eller flere medlemsstaters kompetente myndigheder, for så vidt som denne deltagelse giver de deltagende medlemsstater et tilsvarende nationalt dækningsniveau. Reguleringsmæssige AI-sandkasser kan oprettes i fysisk, digital eller hybrid form og kan tilpasses fysiske såvel som digitale produkter. De oprettende myndigheder bør også sikre de reguleringsmæssige AI-sandkasser tilstrækkelige ressourcer, herunder finansielle og menneskelige ressourcer, til at fungere.
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Formålet med de reguleringsmæssige AI-sandkasser bør være at fremme innovation inden for kunstig intelligens ved at skabe et kontrolleret forsøgs- og afprøvningsmiljø i udviklingsfasen forud for omsætning med henblik på at sikre, at de innovative AI-systemer er i overensstemmelse med denne forordning og anden relevant EU-ret og national ret. De reguleringsmæssige AI-sandkasser bør endvidere øge retssikkerheden for innovatorer og de kompetente myndigheders tilsyn og forståelse af de muligheder, nye risici og virkninger, der er forbundet med anvendelsen af AI, lette lovgivningsmæssig læring for myndigheder og virksomheder, herunder med henblik på fremtidige tilpasninger af den retlige ramme, støtte samarbejdet og udvekslingen af bedste praksis med de myndigheder, der er involveret i den reguleringsmæssige AI-sandkasse, samt fremskynde adgangen til markeder, herunder ved at fjerne hindringer for SMV'er, herunder iværksættervirksomheder. Reguleringsmæssige AI-sandkasser bør være bredt tilgængelige i hele Unionen, og der bør lægges særlig vægt på deres tilgængelighed for SMV'er, herunder iværksættervirksomheder. Deltagelsen i den reguleringsmæssige AI-sandkasse bør fokusere på spørgsmål, der skaber retsusikkerhed for udbydere og potentielle udbydere med hensyn til at innovere, eksperimentere med kunstig intelligens i Unionen og bidrage til evidensbaseret lovgivningsmæssig læring. Tilsynet med AI-systemerne i den reguleringsmæssige AI-sandkasse bør derfor omfatte deres udvikling, træning, afprøvning og validering, inden systemerne bringes i omsætning eller ibrugtages samt begrebet og forekomsten af væsentlige ændringer, der kan kræve en ny overensstemmelsesvurderingsprocedure. Enhver væsentlig risiko, der konstateres under udviklingen og afprøvningen af sådanne AI-systemer, bør afbødes i tilstrækkelig grad, og hvis dette ikke er muligt, bør udviklings- og afprøvningsprocessen suspenderes. Hvis det er relevant, bør de nationale kompetente myndigheder, der opretter reguleringsmæssige AI-sandkasser, samarbejde med andre relevante myndigheder, herunder dem, der fører tilsyn med beskyttelsen af grundlæggende rettigheder, og de kan muliggøre inddragelse af andre aktører i AI-økosystemet såsom nationale eller europæiske standardiseringsorganisationer, bemyndigede organer, afprøvnings- og forsøgsfaciliteter, forsknings- og forsøgslaboratorier, europæiske digitale innovationsknudepunkter og relevante interessenter og civilsamfundsorganisationer. For at sikre en ensartet gennemførelse i hele Unionen samt stordriftsfordele bør der fastsættes fælles regler for gennemførelsen af de reguleringsmæssige AI-sandkasser og en ramme for samarbejde mellem de relevante myndigheder, der er involveret i tilsynet med sandkasserne. Reguleringsmæssige AI-sandkasser, der oprettes i henhold til denne forordning, bør ikke berøre anden ret, der giver mulighed for at oprette andre sandkasser, der har til formål at sikre overholdelse af anden ret end denne forordning. Hvis det er relevant, bør de relevante kompetente myndigheder med ansvar for disse andre reguleringsmæssige sandkasser også overveje fordelene ved at anvende disse sandkasser med henblik på at sikre AI-systemers overensstemmelse med denne forordning. Efter aftale mellem de nationale kompetente myndigheder og deltagerne i den reguleringsmæssige AI-sandkasse kan der også gennemføres og føres tilsyn med afprøvning under faktiske forhold inden for rammerne af den reguleringsmæssige AI-sandkasse.
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Denne forordning bør udgøre retsgrundlaget for udbyderne og de potentielle udbydere i den reguleringsmæssige AI-sandkasse til kun på bestemte betingelser at anvende personoplysninger, der er indsamlet til andre formål med henblik på udvikling af visse samfundsnyttige AI-systemer inden for rammerne af den reguleringsmæssige AI-sandkasse, jf. artikel 6, stk. 4, og artikel 9, stk. 2, litra g), i forordning (EU) 2016/679 og artikel 5, 6 og 10 i forordning (EU) 2018/1725, og uden at det berører artikel 4, stk. 2, og artikel 10 i direktiv (EU) 2016/680. Alle andre forpligtelser for databehandlere og rettigheder for registrerede i henhold til forordning (EU) 2016/679 og (EU) 2018/1725 samt direktiv (EU) 2016/680 finder fortsat anvendelse. Især bør nærværende forordning ikke udgøre et retsgrundlag som omhandlet i artikel 22, stk. 2, litra b), i forordning (EU) 2016/679 og artikel 24, stk. 2, litra b), i forordning (EU) 2018/1725. Udbydere og potentielle udbydere i den reguleringsmæssige AI-sandkasse bør sørge for passende sikkerhedsforanstaltninger og samarbejde med de kompetente myndigheder, herunder ved at følge deres vejledning og handle hurtigt og i god tro for i tilstrækkelig grad at afbøde eventuelle konstaterede betydelige risici med hensyn til sikkerhed, sundhed og de grundlæggende rettigheder, som måtte opstå under udviklingen, afprøvningen og forsøgene i denne sandkasse.
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For at fremskynde udviklingen og omsætningen af de højrisiko-AI-systemer, der er opført i et bilag til denne forordning, er det vigtigt, at udbydere eller potentielle udbydere af sådanne systemer også kan drage fordel af en særlig ordning for afprøvning af disse systemer under faktiske forhold uden at deltage i en reguleringsmæssig AI-sandkasse. I sådanne tilfælde og under hensyntagen til de mulige konsekvenser af en sådan afprøvning for enkeltpersoner bør det imidlertid sikres, at denne forordning indfører passende og fornødne sikkerhedsforanstaltninger og betingelser for udbydere eller potentielle udbydere. Sådanne garantier bør bl.a. omfatte anmodning om fysiske personers informerede samtykke til at deltage i afprøvninger under faktiske forhold med undtagelse af retshåndhævelse, hvis indhentning af informeret samtykke ville forhindre AI-systemet i at blive afprøvet. Registreredes samtykke til at deltage i sådanne afprøvninger i henhold til denne forordning adskiller sig fra og berører ikke de registreredes samtykke til behandling af deres personoplysninger i henhold til den relevante databeskyttelsesret. Det er også vigtigt at minimere risiciene og give de kompetente myndigheder mulighed for at føre tilsyn og dermed kræve, at potentielle udbydere har en plan for afprøvning under faktiske forhold, som forelægges for den kompetente markedsovervågningsmyndighed, registrerer afprøvningen i særlige dele i EU-databasen med forbehold af visse begrænsede undtagelser, fastsætter begrænsninger for den periode, inden for hvilken afprøvningen kan finde sted, og stiller krav om yderligere sikkerhedsforanstaltninger for personer, der tilhører visse sårbare grupper, samt om en skriftlig aftale, der definerer potentielle udbyderes og idriftsætteres rolle og ansvarsområder og et effektivt tilsyn fra det kompetente personales side, som er involveret i afprøvningen under faktiske forhold. Der bør desuden tilstræbes yderligere sikkerhedsforanstaltninger for at sikre, at AI-systemets forudsigelser, anbefalinger eller beslutninger reelt kan omgøres og ses bort fra, og at personoplysninger beskyttes og slettes, når de registrerede har trukket deres samtykke til at deltage i afprøvningen tilbage, uden at det berører deres rettigheder som registrerede i henhold til EU-databeskyttelsesretten. For så vidt angår overførsel af data bør det tilstræbes, at data, der indsamles og behandles med henblik på afprøvning under faktiske forhold, kun bør overføres til tredjelande, hvis der gennemføres passende og gældende sikkerhedsforanstaltninger i henhold til EU-retten, navnlig i overensstemmelse med grundlag for overførsel af personoplysninger i henhold til EU-databeskyttelsesretten, mens der for andre data end personoplysninger indføres passende sikkerhedsforanstaltninger i overensstemmelse med EU-retten såsom Europa-Parlamentets og Rådets forordning (EU) 2022/868 
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For at sikre at AI fører til socialt og miljømæssigt gavnlige resultater, tilskyndes medlemsstaterne til at støtte og fremme forskning i og udvikling af AI-løsninger til støtte for socialt og miljømæssigt gavnlige resultater såsom AI-baserede løsninger for at øge tilgængeligheden for personer med handicap, bekæmpe socioøkonomiske uligheder eller opfylde miljømål ved at afsætte tilstrækkelige ressourcer, herunder offentlig finansiering og EU-finansiering, og, hvis det er relevant, og forudsat at støtteberettigelses- og udvælgelseskriterierne er opfyldt, ved navnlig at tage højde for projekter, der forfølger sådanne mål. Sådanne projekter bør baseres på princippet om tværfagligt samarbejde mellem AI-udviklere, eksperter i ulighed og ikkeforskelsbehandling, tilgængelighed, forbrugerrettigheder, miljørettigheder og digitale rettigheder samt akademikere.
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For at fremme og beskytte innovation er det vigtigt at tage særligt hensyn til interesserne hos SMV'er, herunder iværksættervirksomheder, som er udbydere eller idriftsættere af AI-systemer. Med henblik herpå bør medlemsstaterne udarbejde initiativer, der er rettet mod disse operatører, herunder vedrørende oplysning og informationsformidling. Medlemsstaterne bør give SMV'er, herunder iværksættervirksomheder, der har vedtægtsmæssigt hjemsted eller en filial i Unionen, prioriteret adgang til de reguleringsmæssige AI-sandkasser, forudsat at de opfylder støtteberettigelsesbetingelserne og udvælgelseskriterierne, og uden at andre udbydere og potentielle udbydere udelukkes fra at få adgang til sandkasserne, såfremt de samme betingelser og kriterier er opfyldt. Medlemsstaterne bør udnytte eksisterende kanaler og, hvis det er relevant, etablere nye særlige kanaler for kommunikation med SMV'er, herunder iværksættervirksomheder, idriftsættere, andre innovatorer og, alt efter hvad der er relevant, lokale offentlige myndigheder, med henblik på at støtte SMV'er gennem hele deres udviklingsforløb ved at yde vejledning og besvare spørgsmål om gennemførelsen af denne forordning. Hvis det er relevant, bør disse kanaler arbejde sammen om at skabe synergier og sikre ensartethed i deres vejledning til SMV'er, herunder iværksættervirksomheder, og idriftsættere. Medlemsstaterne bør desuden lette deltagelse af SMV'er og andre relevante interessenter i standardiseringsudviklingsprocessen. Desuden bør der tages hensyn til de særlige interesser og behov hos udbydere, der er SMV'er, herunder iværksættervirksomheder, når bemyndigede organer fastsætter gebyrer for overensstemmelsesvurderinger. Kommissionen bør regelmæssigt vurdere certificerings- og efterlevelsesomkostningerne for SMV'er, herunder iværksættervirksomheder, gennem gennemsigtige høringer og arbejde sammen med medlemsstaterne om at nedbringe disse omkostninger. Omkostninger forbundet med oversættelse af obligatorisk dokumentation og kommunikation med myndigheder kan f.eks. udgøre en betydelig omkostning for udbydere og andre operatører, navnlig mindre udbydere og operatører. Medlemsstaterne bør eventuelt sørge for, at et af de sprog, som de bestemmer sig for og accepterer til de relevante udbyderes dokumentation og til kommunikation med operatørerne, er et sprog, der forstås bredt af flest mulige idriftsættere på tværs af grænserne. For at imødekomme SMV'ers, herunder iværksættervirksomheder, specifikke behov bør Kommissionen efter anmodning fra AI-udvalget tilvejebringe standardiserede skabeloner for de områder, der er omfattet af denne forordning. Desuden bør Kommissionen supplere medlemsstaternes indsats ved at stille en central informationsplatform med brugervenlige oplysninger om denne forordning til rådighed for alle udbydere og idriftsættere, idet den tilrettelægger passende kommunikationskampagner for at øge bevidstheden om de forpligtelser, der følger af denne forordning, og evaluerer og fremmer konvergensen af bedste praksis i offentlige udbudsprocedurer i forbindelse med AI-systemer. Mellemstore virksomheder, der indtil for nylig var små virksomheder som omhandlet i bilaget til Kommissionens henstilling 2003/361/EF 
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, bør have adgang til disse støtteforanstaltninger, eftersom disse nye mellemstore virksomheder undertiden kan mangle de juridiske ressourcer og den uddannelse, der er nødvendig for at sikre en korrekt forståelse og overholdelse af denne forordning.
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For at fremme og beskytte innovation bør AI-on-demand-platformen og alle relevante EU-finansieringsprogrammer og -projekter såsom programmet for et digitalt Europa og Horisont Europa, der gennemføres af Kommissionen og medlemsstaterne på EU-plan eller nationalt plan, i relevant omfang bidrage til at nå denne forordnings mål.
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For at minimere risiciene i gennemførelsen som følge af manglende viden og ekspertise på markedet samt for at gøre det lettere for udbydere, navnlig SMV'er, herunder iværksættervirksomheder, og bemyndigede organer at overholde deres forpligtelser i medfør af denne forordning bør navnlig AI-on-demand-platformen, de europæiske digitale innovationsknudepunkter og de afprøvnings- og forsøgsfaciliteter, som Kommissionen og medlemsstaterne har oprettet på EU-plan eller nationalt plan, bidrage til gennemførelsen af denne forordning. Inden for rammerne af deres respektive opgave- og kompetenceområde kan AI-on-demand-platformen, de europæiske digitale innovationsknudepunkter og afprøvnings- og forsøgsfaciliteterne navnlig yde teknisk og videnskabelig støtte til udbydere og bemyndigede organer.
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I lyset af nogle operatørers meget beskedne størrelse og for at sikre proportionalitet med hensyn til innovationsomkostninger er det desuden hensigtsmæssigt at give mikrovirksomheder mulighed for at opfylde en af de dyreste forpligtelser, nemlig etablering af et kvalitetsstyringssystem, der på en forenklet måde vil mindske den administrative byrde og omkostningerne for disse virksomheder uden at påvirke beskyttelsesniveauet og behovet for overholdelse af kravene til højrisiko-AI-systemer. Kommissionen bør udarbejde retningslinjer med henblik på at præcisere, hvilke elementer i kvalitetsstyringssystemet mikrovirksomheder skal opfylde på denne forenklede måde.
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Kommissionen bør så vidt muligt lette adgangen til afprøvnings- og forsøgsfaciliteter for organer, grupper eller laboratorier, der er oprettet eller akkrediteret i henhold til relevant EU-harmoniseringslovgivning, og som udfører opgaver i forbindelse med overensstemmelsesvurderinger af produkter eller udstyr, der er omfattet af EU-harmoniseringslovgivningen. Dette er navnlig tilfældet for ekspertpaneler, ekspertlaboratorier og referencelaboratorier på området for medicinsk udstyr, jf. forordning (EU) 2017/745 og (EU) 2017/746.
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Denne forordning bør fastsætte en forvaltningsramme, som gør det muligt både at koordinere og støtte anvendelsen af denne forordning på nationalt plan samt opbygge kapaciteter på EU-plan og inddrage interessenter inden for AI. En effektiv gennemførelse og håndhævelse af denne forordning kræver en forvaltningsramme, som gør det muligt at koordinere og opbygge central ekspertise på EU-plan. AI-kontoret blev oprettet ved Kommissionens afgørelse 
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 og har som mission at udvikle Unionens ekspertise og kapaciteter inden for AI og bidrage til gennemførelsen af EU-ret om AI. Medlemsstaterne bør lette AI-kontorets opgaver med henblik på at støtte udviklingen af Unionens ekspertise og kapaciteter på EU-plan og styrke det digitale indre markeds funktion. Der bør endvidere oprettes et AI-udvalg bestående af repræsentanter for medlemsstaterne, et videnskabeligt panel til at integrere det videnskabelige samfund og et rådgivende forum, der skal bidrage med input fra interessenter til gennemførelsen af denne forordning, både på EU-plan og nationalt plan. Udviklingen af Unionens ekspertise og kapaciteter bør også indebære, at eksisterende ressourcer og ekspertise udnyttes, navnlig gennem synergier med strukturer, der er opbygget i forbindelse med håndhævelse på EU-plan af anden ret, og synergier med tilhørende initiativer på EU-plan såsom fællesforetagendet EuroHPC og AI-afprøvnings- og -forsøgsfaciliteter under programmet for et digitalt Europa.
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For at lette en gnidningsløs, effektiv og harmoniseret gennemførelse af denne forordning bør der nedsættes et AI-udvalg. AI-udvalget bør afspejle AI-økosystemets forskellige interesser og bestå af repræsentanter for medlemsstaterne. AI-udvalget bør være ansvarligt for en række rådgivningsopgaver såsom udtalelser, henstillinger, rådgivning eller bidrag til vejledning om spørgsmål vedrørende gennemførelsen af denne forordning, herunder med hensyn til håndhævelsesspørgsmål, tekniske specifikationer eller eksisterende standarder i forbindelse med de krav, der er fastsat i denne forordning, samt rådgive og bistå Kommissionen og medlemsstaterne og deres nationale kompetente myndigheder i forbindelse med specifikke spørgsmål vedrørende AI. For at give medlemsstaterne en vis fleksibilitet med hensyn til udpegelsen af deres repræsentanter i AI-udvalget kan sådanne repræsentanter være alle personer tilhørende offentlige enheder, som bør have de relevante kompetencer og beføjelser til at lette koordinering på nationalt plan og bidrage til udførelsen af AI-udvalgets opgaver. AI-udvalget bør nedsætte to stående undergrupper for at tilvejebringe en platform for samarbejde og udveksling mellem markedsovervågningsmyndigheder og bemyndigende myndigheder om spørgsmål vedrørende henholdsvis markedsovervågning og bemyndigede organer. Den stående undergruppe for markedsovervågning bør fungere som den administrative samarbejdsgruppe (ADCO) i forbindelse med denne forordning som omhandlet i artikel 30 i forordning (EU) 2019/1020. I overensstemmelse med artikel 33 i nævnte forordning bør Kommissionen støtte aktiviteterne i den stående undergruppe for markedsovervågning ved at foretage markedsevalueringer eller -undersøgelser, navnlig med henblik på at identificere aspekter af nærværende forordning, der kræver specifik og hurtig koordinering mellem markedsovervågningsmyndighederne. AI-udvalget kan nedsætte andre stående eller midlertidige undergrupper, alt efter hvad der er relevant, med henblik på at behandle specifikke spørgsmål. AI-udvalget bør også i relevant omfang samarbejde med relevante EU-organer, -ekspertgrupper og -netværk, der er aktive inden for rammerne af relevant EU-ret, herunder navnlig dem, der er aktive i henhold til den relevante EU-ret om data, digitale produkter og tjenester.
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Med henblik på at sikre inddragelse af interessenter i gennemførelsen og anvendelsen af denne forordning bør der oprettes et rådgivende forum, som skal rådgive og yde teknisk ekspertise til AI-udvalget og Kommissionen. For at sikre en varieret og afbalanceret repræsentation af interessenter med kommercielle og ikkekommercielle interesser og inden for kategorien af kommercielle interesser for så vidt angår SMV'er og andre virksomheder bør det rådgivende forum bl.a. bestå af industrien, iværksættervirksomheder, SMV'er, den akademiske verden, civilsamfundet, herunder arbejdsmarkedets parter, samt Agenturet for Grundlæggende Rettigheder, ENISA, Den Europæiske Standardiseringsorganisation (CEN), Den Europæiske Komité for Elektroteknisk Standardisering (Cenelec) og Det Europæiske Standardiseringsinstitut for Telekommunikation (ETSI).
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For at støtte gennemførelsen og håndhævelsen af denne forordning, navnlig AI-kontorets overvågningsaktiviteter med hensyn til AI-modeller til almen brug, bør der oprettes et videnskabeligt panel af uafhængige eksperter. De uafhængige eksperter, der udgør det videnskabelige panel, bør udvælges på grundlag af ajourført videnskabelig eller teknisk ekspertise inden for AI og varetage deres opgaver upartisk og objektivt og sikre fortroligheden af oplysninger og data, der indhentes under udførelsen af deres opgaver og aktiviteter. For at gøre det muligt at styrke de nationale kapaciteter, der er nødvendige for en effektiv håndhævelse af denne forordning, bør medlemsstaterne kunne anmode om støtte til deres håndhævelsesaktiviteter fra den pulje af eksperter, der udgør det videnskabelige panel.
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For at støtte passende håndhævelse af AI-systemer og styrke medlemsstaternes kapaciteter bør der oprettes EU-støttestrukturer for afprøvning af AI, som stilles til rådighed for medlemsstaterne.
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Medlemsstaterne spiller en central rolle i anvendelsen og håndhævelsen af denne forordning. I den forbindelse bør hver medlemsstat udpege mindst én bemyndigende myndighed og mindst én markedsovervågningsmyndighed som nationale kompetente myndigheder til at føre tilsyn med anvendelsen og gennemførelsen af denne forordning. Medlemsstaterne kan beslutte at udpege enhver type offentlig enhed til at udføre de nationale kompetente myndigheders opgaver som omhandlet i denne forordning i overensstemmelse med deres specifikke nationale organisatoriske karakteristika og behov. For at øge organisationseffektiviteten for medlemsstaternes vedkommende og oprette et centralt kontaktpunkt for offentligheden og andre modparter på nationalt plan og EU-plan bør hver medlemsstat udpege en markedsovervågningsmyndighed, der skal fungere som centralt kontaktpunkt.
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De nationale kompetente myndigheder bør udøve deres beføjelser uafhængigt, upartisk og uden bias for derved at beskytte principperne om objektivitet i deres aktiviteter og opgaver og for at sikre anvendelsen og gennemførelsen af denne forordning. Medlemmerne af disse myndigheder bør afholde sig fra ethvert tiltag, der er uforenelig med deres beføjelser, og være underlagt fortrolighedsreglerne i denne forordning.
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For at sikre at udbydere af højrisiko-AI-systemer tager erfaringerne med anvendelse af højrisiko-AI-systemer i betragtning, når de vil forbedre deres systemer og udformnings- og udviklingsprocessen, eller kan foretage eventuelle korrigerende tiltag rettidigt, bør alle udbydere have indført et system til overvågning efter omsætningen. Hvis det er relevant, bør overvågning efter omsætningen omfatte en analyse af interaktionen med andre AI-systemer, herunder andet udstyr og software. Overvågning efter omsætningen bør ikke omfatte følsomme operationelle data fra idriftsættere, som er retshåndhævende myndigheder. Dette system er også afgørende for at sikre, at eventuelle risici som følge af AI-systemer, der fortsætter med at »lære« efter at være bragt i omsætning eller ibrugtaget, kan imødegås mere effektivt og rettidigt. I den forbindelse bør udbyderne også forpligtes til at have indført et system til at indberette alvorlige hændelser til de relevante myndigheder, som skyldes anvendelsen af deres AI-systemer, dvs. en hændelse eller funktionsfejl, der fører til dødsfald eller alvorlig sundhedsskade, alvorlig og uoprettelig forstyrrelse i forvaltningen og driften af kritisk infrastruktur, overtrædelser af forpligtelser i henhold til den del af EU-retten, der har til formål at beskytte de grundlæggende rettigheder, eller alvorlig skade på ejendom eller miljøet.
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For at sikre en hensigtsmæssig og effektiv håndhævelse af de krav og forpligtelser, der er fastsat i denne forordning, som repræsenterer Unionens harmoniseringslovgivning, bør det system til markedsovervågning og produktoverensstemmelse, der er indført ved forordning (EU) 2019/1020, finde anvendelse i sin helhed. Markedsovervågningsmyndigheder, der er udpeget i henhold til nærværende forordning, bør alle have håndhævelsesbeføjelser som fastsat i nærværende forordning og i forordning (EU) 2019/1020 og bør udøve deres beføjelser og udføre deres opgaver uafhængigt, upartisk og uden bias. Selv om de fleste AI-systemer ikke er underlagt specifikke krav og forpligtelser i henhold til nærværende forordning, kan markedsovervågningsmyndighederne træffe foranstaltninger vedrørende alle AI-systemer, når de udgør en risiko i overensstemmelse med nærværende forordning. På grund af den særlige karakter af EU-institutioner, -agenturer og -organer, der er omfattet af nærværende forordnings anvendelsesområde, er det hensigtsmæssigt at udpege Den Europæiske Tilsynsførende for Databeskyttelse som kompetent markedsovervågningsmyndighed for dem. Dette bør ikke berøre medlemsstaternes udpegelse af nationale kompetente myndigheder. Markedsovervågningsaktiviteter bør ikke påvirke de tilsynsbelagte enheders evne til at udføre deres opgaver uafhængigt, når en sådan uafhængighed er påbudt i henhold til EU-retten.
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Denne forordning berører ikke kompetencerne, opgaverne, beføjelserne og uafhængigheden hos relevante nationale offentlige myndigheder eller organer, der fører tilsyn med anvendelsen af EU-retten om beskyttelse af grundlæggende rettigheder, herunder ligestillingsorganer og databeskyttelsesmyndigheder. Hvis det er nødvendigt for deres mandat, bør disse nationale offentlige myndigheder eller organer også have adgang til al den dokumentation, der er udarbejdet i henhold til denne forordning. Der bør fastsættes en særlig beskyttelsesprocedure for at sikre passende og rettidig håndhævelse over for AI-systemer, som udgør en risiko for sundhed, sikkerhed og grundlæggende rettigheder. Proceduren for sådanne AI-systemer, som udgør en risiko, bør anvendes på højrisiko-AI-systemer, der udgør en risiko, forbudte systemer, der er bragt i omsætning, ibrugtaget eller anvendt i strid med de forbudte former for praksis, der er fastsat i denne forordning, og AI-systemer, der er gjort tilgængelige i strid med de gennemsigtighedskrav, der er fastsat i denne forordning, og som udgør en risiko.
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EU-retten om finansielle tjenesteydelser omfatter regler og krav vedrørende intern ledelse og risikostyring, som finder anvendelse på regulerede finansielle institutioner i forbindelse med leveringen af sådanne tjenester, også når de gør brug af AI-systemer. For at sikre en sammenhængende anvendelse og håndhævelse af forpligtelserne i henhold til denne forordning og de relevante regler og krav i EU-retsakter om finansielle tjenesteydelser bør de kompetente myndigheder for tilsyn med og håndhævelse af disse retsakter, navnlig kompetente myndigheder som defineret i Europa-Parlamentets og Rådets forordning (EU) nr. 575/2013 
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 og Europa-Parlamentets og Rådets direktiv 2008/48/EF 
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, 2009/138/EF 
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, 2013/36/EU 
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, 2014/17/EU 
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 og (EU) 2016/97 
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, udpeges som kompetente myndigheder inden for deres respektive kompetenceområder med henblik på at føre tilsyn med gennemførelsen af nærværende forordning, herunder også markedsovervågningsaktiviteter, for så vidt angår AI-systemer, der leveres eller anvendes af finansielle institutioner, som er regulerede, og som der føres tilsyn med, medmindre medlemsstaterne beslutter at udpege en anden myndighed til at udføre disse markedsovervågningsopgaver. Disse kompetente myndigheder bør have alle beføjelser i henhold til denne forordning og forordning (EU) 2019/1020 til at håndhæve nærværende forordnings krav og forpligtelser, herunder beføjelser til at udføre ex post-markedsovervågningsaktiviteter, der, alt efter hvad der er relevant, kan integreres i deres eksisterende tilsynsmekanismer og -procedurer i henhold til den relevante EU-ret om finansielle tjenesteydelser. Det bør fastsættes, at de nationale myndigheder, der er ansvarlige for tilsynet med kreditinstitutter, som er reguleret ved direktiv 2013/36/EU, og som deltager i den fælles tilsynsmekanisme, der er oprettet ved Rådets forordning (EU) nr. 1024/2013 
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, når de fungerer som markedsovervågningsmyndigheder i henhold til nærværende forordning, straks bør indberette alle oplysninger, som identificeres i forbindelse med deres markedsovervågningsaktiviteter, og som kan være af potentiel interesse for Den Europæiske Centralbanks tilsynsopgaver som fastsat i nævnte forordning, til Den Europæiske Centralbank. For yderligere at styrke sammenhængen mellem nærværende forordning og de regler, der gælder for kreditinstitutter, der er reguleret ved direktiv 2013/36/EU, bør nogle af udbydernes proceduremæssige forpligtelser i forbindelse med risikostyring, overvågning efter omsætningen og dokumentation indarbejdes i de eksisterende forpligtelser og procedurer i henhold i direktiv 2013/36/EU. For at undgå overlapninger bør der også overvejes begrænsede undtagelser for så vidt angår udbydernes kvalitetsstyringssystem og den overvågningsforpligtelse, der pålægges idriftsættere af højrisiko-AI-systemer, i det omfang disse gælder for kreditinstitutter, der er reguleret ved direktiv 2013/36/EU. Den samme ordning bør gælde for forsikrings- og genforsikringsselskaber og forsikringsholdingselskaber i henhold til direktiv 2009/138/EF og forsikringsformidlere i henhold til direktiv (EU) 2016/97 og andre typer finansielle institutioner, der er underlagt krav vedrørende intern ledelse, ordninger eller processer, der er fastsat i henhold til den relevante EU-ret om finansielle tjenesteydelser, for at sikre konsekvens og ligebehandling i den finansielle sektor.
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Hver markedsovervågningsmyndighed for højrisiko-AI-systemer inden for biometri som opført i et bilag til denne forordning, for så vidt disse systemer anvendes med henblik på retshåndhævelse og migrationsstyring, asylforvaltning og grænsekontrol eller retspleje og demokratiske processer, bør have undersøgelsesbeføjelser og korrigerende beføjelser, herunder som minimum beføjelse til at få adgang til alle personoplysninger, der behandles, og til alle de oplysninger, der er nødvendige for at varetage sine opgaver. Markedsovervågningsmyndighederne bør kunne udøve deres beføjelser i fuld uafhængighed. Enhver begrænsning i deres adgang til følsomme operationelle data i henhold til denne forordning bør ikke berøre de beføjelser, som de har fået tillagt ved direktiv (EU) 2016/680. Ingen undtagelse om videregivelse af data til de nationale databeskyttelsesmyndigheder i henhold til denne forordning bør påvirke disse myndigheders nuværende eller fremtidige beføjelser uden for denne forordnings anvendelsesområde.
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Markedsovervågningsmyndighederne og Kommissionen bør kunne foreslå fælles aktiviteter, herunder fælles undersøgelser, som skal gennemføres af markedsovervågningsmyndigheder eller af markedsovervågningsmyndigheder sammen med Kommissionen, og som har til formål at fremme overholdelse, identificere manglende overholdelse, øge bevidstheden og yde vejledning for så vidt angår denne forordning med hensyn til specifikke kategorier af højrisiko-AI-systemer, der anses for at udgøre en alvorlig risiko i to eller flere medlemsstater. Der bør gennemføres fælles aktiviteter til fremme af overholdelse i overensstemmelse med artikel 9 i forordning (EU) 2019/1020. AI-kontoret bør sørge for koordinerende støtte til de fælles undersøgelser.
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Det er nødvendigt at præcisere ansvarsområder og kompetenceområder på EU-plan og nationalt plan for så vidt angår AI-systemer, der bygger på AI-modeller til almen brug. For at undgå, at kompetenceområderne overlapper med hinanden, hvis et AI-system bygger på en AI-model til almen brug, og modellen og systemet leveres af den samme udbyder, bør tilsynet finde sted på EU-plan gennem AI-kontoret, som i den forbindelse bør have markedsovervågningsmyndighedens beføjelser som omhandlet i forordning (EU) 2019/1020. I alle andre tilfælde er de nationale markedsovervågningsmyndigheder fortsat ansvarlige for tilsynet med AI-systemer. Hvad angår AI-systemer til almen brug, som kan anvendes direkte af idriftsættere til mindst ét formål, der er klassificeret som højrisiko, bør markedsovervågningsmyndighederne dog samarbejde med AI-Kontoret om at foretage evalueringer af overholdelsen og underrette AI-udvalget og andre markedsovervågningsmyndigheder i overensstemmelse hermed. Markedsovervågningsmyndighederne bør desuden kunne anmode AI-kontoret om bistand, hvis markedsovervågningsmyndigheden ikke er i stand til at afslutte en undersøgelse af et højrisiko-AI-system som følge af manglende adgang til visse oplysninger vedrørende AI-modeller til almen brug, som højrisiko-AI-systemet er bygget på. I sådanne tilfælde bør proceduren for gensidig bistand i grænseoverskridende sager i kapitel VI i forordning (EU) 2019/1020 finde tilsvarende anvendelse.
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For at udnytte den centraliserede EU-ekspertise og synergier bedst muligt på EU-plan bør Kommissionen tillægges beføjelser til at føre tilsyn med og håndhæve forpligtelserne for udbydere af AI-modeller til almen brug. AI-kontoret bør kunne foretage alle nødvendige tiltag for at overvåge, om denne forordning gennemføres effektivt for så vidt angår AI-modeller til almen brug. Det bør både på eget initiativ på baggrund af resultaterne af sine overvågningsaktiviteter eller efter anmodning fra markedsovervågningsmyndigheder i overensstemmelse med de betingelser, der er fastsat i denne forordning, kunne undersøge mulige overtrædelser af reglerne for udbydere af AI-modeller til almen brug. For at understøtte AI-kontoret med at foretage en effektiv overvågning bør det give downstreamudbydere mulighed for at indgive klager over mulige overtrædelser af reglerne om udbydere af AI-modeller og -systemer til almen brug.
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Med henblik på at supplere forvaltningssystemerne for AI-modeller til almen brug bør det videnskabelige panel støtte AI-kontorets overvågningsaktiviteter og kan i visse tilfælde sende kvalificerede varslinger til AI-kontoret, hvilket udløser opfølgende foranstaltninger såsom undersøgelser. Dette bør være tilfældet, hvis det videnskabelige panel har begrundet mistanke om, at en AI-model til almen brug udgør en konkret og identificerbar risiko på EU-plan. Dette bør desuden være tilfældet, hvis det videnskabelige panel har begrundet mistanke om, at en AI-model til almen brug opfylder de kriterier, der medfører en klassificering som en AI-model til almen brug med systemisk risiko. For at give det videnskabelige panel de oplysninger, der er nødvendige for at varetage disse opgaver, bør der findes en mekanisme, hvorved det videnskabelige panel kan anmode Kommissionen om at kræve dokumentation eller oplysninger fra en udbyder.
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AI-kontoret bør kunne foretage de nødvendige tiltag til at overvåge, at de forpligtelser for udbydere af AI-modeller til almen brug, der er fastsat i denne forordning, gennemføres og overholdes effektivt. AI-kontoret bør kunne undersøge mulige overtrædelser i overensstemmelse med de beføjelser, der er fastsat i denne forordning, herunder ved at anmode om dokumentation og oplysninger, foretage evalueringer samt ved at anmode udbydere af AI-modeller til almen brug om at træffe foranstaltninger. For at gøre brug af uafhængig ekspertise bør AI-kontoret ved gennemførelse af evalueringer kunne inddrage uafhængige eksperter, som foretager evalueringer på dets vegne. Overholdelse af forpligtelserne bør bl.a. kunne håndhæves gennem anmodninger om at træffe passende foranstaltninger, herunder risikobegrænsende foranstaltninger i tilfælde af konstaterede systemiske risici samt tilgængeliggørelse på markedet, tilbagetrækning eller tilbagekaldelse af modellen. Såfremt der skulle opstå behov ud over de procedurerettigheder, der er fastsat i denne forordning, bør udbydere af AI-modeller til almen brug som en sikkerhedsforanstaltning råde over de procedurerettigheder, der er fastsat i artikel 18 i forordning (EU) 2019/1020, som bør finde tilsvarende anvendelse, uden at dette berører de mere specifikke procedurerettigheder fastsat i nærværende forordning.
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Udviklingen af andre AI-systemer end højrisiko-AI-systemer i overensstemmelse med kravene i denne forordning kan føre til en større udbredelse af etisk og troværdig AI i Unionen. Udbydere af AI-systemer, der ikke er højrisiko, bør tilskyndes til at udarbejde adfærdskodekser, herunder tilhørende forvaltningsmekanismer, med det formål at fremme frivillig anvendelse af visse af eller alle de obligatoriske krav, der gælder for højrisiko-AI-systemer, og som er tilpasset i lyset af det tilsigtede formål med systemerne og den lavere risiko, og under hensyntagen til de tilgængelige tekniske løsninger og industriens bedste praksis såsom model og datakort. Udbydere og, alt efter hvad der er relevant, idriftsættere af alle AI-systemer, højrisiko eller ej, og AI-modeller bør også tilskyndes til på frivillig basis at anvende yderligere krav vedrørende f.eks. elementerne i Unionens etiske retningslinjer for troværdig AI, miljømæssig bæredygtighed, foranstaltninger vedrørende AI-færdigheder, inklusiv og mangfoldig udformning og udvikling af AI-systemer, herunder med fokus på sårbare personer og tilgængelighed for personer med handicap, deltagelse af interessenter med inddragelse i relevant omfang af relevante interessenter såsom erhvervslivet og civilsamfundsorganisationer, den akademiske verden, forskningsorganisationer, fagforeninger og forbrugerbeskyttelsesorganisationer i udformning og udvikling af AI-systemer og mangfoldighed i udviklingsteamene, herunder kønsbalance. For at sikre at de frivillige adfærdskodekser er effektive, bør de baseres på klare mål og centrale resultatindikatorer til måling af realiseringen af disse mål. De bør også udvikles på en inklusiv måde og i relevant omfang med inddragelse af relevante interessenter såsom erhvervslivet og civilsamfundsorganisationer, den akademiske verden, forskningsorganisationer, fagforeninger og forbrugerbeskyttelsesorganisationer. Kommissionen kan udvikle initiativer, bl.a. på sektorniveau, for at lette mindskelsen af tekniske hindringer for grænseoverskridende udveksling af data til AI-udvikling, herunder med hensyn til dataadgangsinfrastruktur og semantisk og teknisk interoperabilitet af forskellige typer data.
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Det er vigtigt, at AI-systemer vedrørende produkter, der ikke er højrisikoprodukter i overensstemmelse med denne forordning og derfor ikke skal overholde kravene for højrisiko-AI-systemer, ikke desto mindre er sikre, når de bringes i omsætning eller ibrugtages. Med henblik på at bidrage til dette mål vil Europa-Parlamentets og Rådets forordning (EU) 2023/988 
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 finde anvendelse som sikkerhedsnet.
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For at sikre et tillidsfuldt og konstruktivt samarbejde mellem de kompetente myndigheder på EU-plan og nationalt plan bør alle de parter, der er involveret i anvendelsen af denne forordning, respektere fortroligheden af oplysninger og data, der er indhentet under udførelsen af deres opgaver i overensstemmelse med EU-retten eller national ret. De bør udføre deres opgaver og aktiviteter på en sådan måde, at de navnlig beskytter intellektuelle ejendomsrettigheder, fortrolige forretningsoplysninger og forretningshemmeligheder, en effektiv gennemførelse af denne forordning, offentlige og nationale sikkerhedsinteresser, strafferetlige og administrative procedurers integritet og klassificerede informationers integritet.
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Overholdelsen af denne forordning bør kunne håndhæves ved pålæg af sanktioner og andre håndhævelsesforanstaltninger. Medlemsstaterne bør træffe alle nødvendige foranstaltninger til at sikre, at bestemmelserne i denne forordning gennemføres, herunder ved at fastsætte sanktioner for overtrædelse heraf, som er effektive, står i et rimeligt forhold til overtrædelsen og har afskrækkende virkning, og at princippet om ne bis in idem respekteres. For at styrke og harmonisere de administrative sanktioner for overtrædelse af denne forordning bør der fastsættes øvre grænser for fastsættelse af administrative bøder for visse specifikke overtrædelser. Ved vurdering af bødernes størrelse bør medlemsstaterne i hvert enkelt tilfælde tage hensyn til alle relevante omstændigheder i den specifikke situation, navnlig under behørig hensyntagen til overtrædelsens art, grovhed og varighed og dens konsekvenser samt til udbyderens størrelse, navnlig hvis udbyderen er en SMV, herunder en iværksættervirksomhed. Den Europæiske Tilsynsførende for Databeskyttelse bør have beføjelse til at pålægge de EU-institutioner, -agenturer og -organer, der er omfattet af denne forordnings anvendelsesområde, bøder.
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Overholdelse af de forpligtelser for udbydere af AI-modeller til almen brug, der pålægges i henhold til denne forordning, bør bl.a. kunne håndhæves ved hjælp af bøder. Med henblik herpå bør der også fastsættes passende bødeniveauer for overtrædelse af disse forpligtelser, herunder manglende overholdelse af de foranstaltninger, som Kommissionen har anmodet om i overensstemmelse med denne forordning, som er genstand for passende forældelsesfrister i overensstemmelse med proportionalitetsprincippet. Alle afgørelser, der træffes af Kommissionen i medfør af denne forordning, underkastes fornyet prøvelse ved EU-Domstolen i overensstemmelse med TEUF, herunder EU-Domstolens fulde prøvelsesret vedrørende sanktioner i henhold til artikel 261 i TEUF.
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EU-retten og national ret indeholder allerede bestemmelser om effektive retsmidler for fysiske og juridiske personer, hvis rettigheder og frihedsrettigheder påvirkes negativt af anvendelsen af AI-systemer. Uden at det berører disse retsmidler, bør enhver fysisk eller juridisk person, der har grund til at mene, at der er sket en overtrædelse af denne forordning, have ret til at indgive en klage til den relevante markedsovervågningsmyndighed.
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De berørte personer bør have ret til at få en forklaring, hvis en idriftsætters afgørelse hovedsagelig er baseret på output fra visse højrisiko-AI-systemer, der er omfattet af anvendelsesområdet for denne forordning, og hvis afgørelsen har retsvirkninger eller på tilsvarende måde i væsentlig grad påvirker disse personer på en måde, som de anser for at have negativ indvirkning på deres sundhed, sikkerhed eller grundlæggende rettigheder. Denne forklaring bør være klar og meningsfuld og danne et grundlag, ud fra hvilket de berørte personer kan udøve deres rettigheder. Retten til at få en forklaring bør ikke gælde for anvendelsen af AI-systemer, for hvilke undtagelser eller begrænsninger følger af EU-retten eller national ret, og bør kun gælde, for så vidt denne rettighed ikke allerede er fastsat i EU-retten.
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Personer, der fungerer som »whistleblowere« i forbindelse med overtrædelser af denne forordning, bør beskyttes i henhold til EU-retten. Europa-Parlamentets og Rådets direktiv (EU) 2019/1937 
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 bør derfor finde anvendelse på indberetning af overtrædelser af denne forordning og på beskyttelsen af personer, der indberetter sådanne overtrædelser.
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For at den lovgivningsmæssige ramme om nødvendigt kan tilpasses, bør beføjelsen til at vedtage retsakter delegeres til Kommissionen i overensstemmelse med artikel 290 i TEUF for at ændre betingelserne for, at et AI-system ikke skal betragtes som værende højrisiko, listen over højrisiko-AI-systemer, bestemmelserne vedrørende teknisk dokumentation, indholdet af EU-overensstemmelseserklæringen, bestemmelserne vedrørende overensstemmelsesvurderingsprocedurer, bestemmelserne om fastsættelse af de højrisiko-AI-systemer, på hvilke overensstemmelsesvurderingsproceduren på grundlag af en vurdering af kvalitetsstyringssystemet og en vurdering af den tekniske dokumentation bør finde anvendelse, tærsklen, benchmarks og indikatorer, herunder ved at supplere disse benchmarks og indikatorer, i reglerne om klassificering af AI-modeller til almen brug med systemisk risiko, kriterierne for udpegelse af AI-modeller til almen brug med systemisk risiko, den tekniske dokumentation for udbydere af AI-modeller til almen brug og gennemsigtighedsoplysningerne for udbydere af AI-modeller til almen brug. Det er navnlig vigtigt, at Kommissionen gennemfører relevante høringer under sit forberedende arbejde, herunder på ekspertniveau, og at disse høringer gennemføres i overensstemmelse med principperne i den interinstitutionelle aftale af 13. april 2016 om bedre lovgivning 
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. For at sikre lige deltagelse i forberedelsen af delegerede retsakter modtager Europa-Parlamentet og Rådet navnlig alle dokumenter på samme tid som medlemsstaternes eksperter, og deres eksperter har systematisk adgang til møder i Kommissionens ekspertgrupper, der beskæftiger sig med forberedelse af delegerede retsakter.
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I betragtning af den hastige teknologiske udvikling og den tekniske ekspertise, der er nødvendig for effektivt at anvende denne forordning, bør Kommissionen evaluere og revidere denne forordning senest den 2. august 2029 og derefter hvert fjerde år og aflægge rapport til Europa-Parlamentet og Rådet. Under hensyntagen til konsekvenserne for denne forordnings anvendelsesområde bør Kommissionen desuden foretage en vurdering af behovet for at ændre listen over højrisiko-AI-systemer og listen over forbudte praksisser én gang om året. Senest den 2. august 2028 og derefter hvert fjerde år bør Kommissionen ydermere evaluere og aflægge rapport til Europa-Parlamentet og Rådet om behovet for at ændre listen over højrisikoområdeoverskrifter i bilaget til denne forordning, de AI-systemer, der er omfattet af gennemsigtighedsforpligtelserne, effektiviteten af tilsyns- og forvaltningssystemet og fremskridt med udviklingen af standardiseringsdokumentation om en energieffektiv udvikling af AI-modeller til almen brug, herunder behovet for yderligere foranstaltninger eller tiltag. Endelig bør Kommissionen senest den 2. august 2028 og derefter hvert tredje år evaluere virkningen og effektiviteten af frivillige adfærdskodekser med henblik på at fremme anvendelsen af de fastsatte krav til højrisiko-AI-systemer i tilfælde af andre AI-systemer end højrisiko-AI-systemer og eventuelt andre yderligere krav til sådanne AI-systemer.
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For at sikre ensartede betingelser for gennemførelsen af denne forordning bør Kommissionen tillægges gennemførelsesbeføjelser. Disse beføjelser bør udøves i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 
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Målet for denne forordning, nemlig at forbedre det indre markeds funktion og fremme udbredelsen af menneskecentreret og troværdig AI og samtidig sikre et højt niveau af beskyttelse af sundhed, sikkerhed og de grundlæggende rettigheder, der er nedfældet i chartret, herunder demokratiet, retsstatsprincippet og miljøbeskyttelse, mod skadelige virkninger af AI-systemer i Unionen og støtte innovation, kan ikke i tilstrækkelig grad opfyldes af medlemsstaterne, men kan på grund af handlingens omfang eller virkninger bedre nås på EU-plan; Unionen kan derfor vedtage foranstaltninger i overensstemmelse med nærhedsprincippet, jf. artikel 5 i TEU. I overensstemmelse med proportionalitetsprincippet, jf. nævnte artikel, går denne forordning ikke videre, end hvad der er nødvendigt for at nå dette mål.
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Med henblik på at sikre retssikkerheden, sikre en passende tilpasningsperiode for operatører og undgå markedsforstyrrelser, herunder ved at sikre kontinuitet i anvendelsen af AI-systemer, bør denne forordning kun finde anvendelse på højrisiko-AI-systemer, der er bragt i omsætning eller ibrugtaget inden den generelle anvendelsesdato, hvis disse systemer fra denne dato er genstand for betydelige ændringer af deres udformning eller tilsigtede formål. Det er hensigtsmæssigt at præcisere, at begrebet betydelig ændring i denne henseende bør forstås som indholdsmæssigt ækvivalent med begrebet væsentlig ændring, som kun anvendes i forbindelse med højrisiko-AI-systemer i medfør af denne forordning. Undtagelsesvist og i lyset af offentlig ansvarlighed bør operatører af AI-systemer, som er komponenter i de store IT-systemer, der er oprettet ved de retsakter, der er opført i et bilag til denne forordning, og operatører af højrisiko-AI-systemer, der er tilsigtet anvendt af offentlige myndigheder, henholdsvis tage de nødvendige skridt til at overholde kravene i denne forordning inden udgangen af 2030 og senest den 2. august 2030.
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Udbydere af højrisiko-AI-systemer tilskyndes til frivilligt at begynde at overholde de relevante forpligtelser i denne forordning allerede i overgangsperioden.
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Denne forordning bør finde anvendelse fra den 2. august 2026. Under hensyntagen til den uacceptable risiko, der på visse måder er forbundet med anvendelsen af AI, bør forbuddene og de almindelige bestemmelser i denne forordning dog finde anvendelse allerede fra den 2. februar 2025. Selv om den fulde virkning af disse forbud følger med indførelsen af forvaltningen og håndhævelsen af denne forordning, er det vigtigt at foregribe anvendelsen af forbuddene for at tage hensyn til uacceptable risici, som har indvirkning på andre procedurer såsom i civilretten. Infrastrukturen i forbindelse med forvaltnings- og overensstemmelsesvurderingssystemet bør desuden være operationel inden den 2. august 2026, og bestemmelserne om bemyndigede organer og forvaltningsstruktur bør derfor finde anvendelse fra den 2. august 2025. I betragtning af de hastige teknologiske fremskridt og udbredelsen af AI-modeller til almen brug bør forpligtelserne for udbydere af AI-modeller til almen brug finde anvendelse fra den 2. august 2025. Praksiskodekser skal være klar senest den 2. maj 2025 med henblik på at gøre det muligt for udbyderne rettidigt at påvise overholdelse. AI-kontoret bør sikre, at klassificeringsregler og -procedurer er ajourførte i lyset af den teknologiske udvikling. Desuden bør medlemsstaterne fastsætte og meddele Kommissionen bestemmelserne om sanktioner, herunder administrative bøder, og sikre, at de er gennemført korrekt og effektivt på datoen for denne forordnings anvendelse. Bestemmelserne om sanktioner bør derfor finde anvendelse fra den 2. august 2025.
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Den Europæiske Tilsynsførende for Databeskyttelse og Det Europæiske Databeskyttelsesråd er blevet hørt i overensstemmelse med artikel 42, stk. 1 og 2, i forordning (EU) 2018/1725 og afgav deres fælles udtalelse den 18. juni 2021 —
VEDTAGET DENNE FORORDNING:
KAPITEL I
ALMINDELIGE BESTEMMELSER
Artikel 1
Genstand
1.   Formålet med denne forordning er at forbedre det indre markeds funktion og fremme udbredelsen af menneskecentreret og troværdig kunstig intelligens (AI) og samtidig sikre et højt niveau af beskyttelse af sundhed, sikkerhed og de grundlæggende rettigheder, der er nedfældet i chartret, herunder demokratiet, retsstatsprincippet og miljøbeskyttelse, mod de skadelige virkninger af AI-systemer i Unionen og støtte innovation.
2.   Ved denne forordning fastsættes:
a)
harmoniserede regler for omsætning, ibrugtagning og anvendelse af AI-systemer i Unionen
b)
forbud mod visse former for AI-praksis
c)
specifikke krav til højrisiko-AI-systemer og forpligtelser for operatører af sådanne systemer
d)
harmoniserede gennemsigtighedsregler for bestemte AI-systemer
e)
harmoniserede regler for omsætning af AI-modeller til almen brug
f)
regler om overvågning efter omsætningen, markedsovervågning, forvaltning og håndhævelse
g)
foranstaltninger til støtte for innovation med særligt fokus på SMV'er, herunder iværksættervirksomheder.
Artikel 2
Anvendelsesområde
1.   Denne forordning finder anvendelse på:
a)
udbydere, der bringer AI-systemer i omsætning eller ibrugtager sådanne eller bringer AI-modeller til almen brug i omsætning i Unionen, uanset om disse udbydere er etableret eller befinder sig i Unionen eller i et tredjeland
b)
idriftsættere af AI-systemer, der er etableret eller befinder sig i Unionen
c)
udbydere og idriftsættere af AI-systemer, der er etableret eller befinder sig i et tredjeland, hvis det output, der produceres af systemet, anvendes i Unionen
d)
importører og distributører af AI-systemer
e)
producenter af et produkt, der sammen med deres produkt og under eget navn eller varemærke bringer et AI-system i omsætning eller ibrugtager det
f)
bemyndigede repræsentanter for udbydere, der ikke er etableret i Unionen
g)
berørte personer, der befinder sig i Unionen.
2.   For så vidt angår AI-systemer, der er klassificeret som højrisiko-AI-systemer i overensstemmelse med artikel 6, stk. 1, i forbindelse med produkter, der er omfattet af EU-harmoniseringslovgivningen opført i bilag I, afsnit B, finder kun artikel 6, stk. 1, og artikel 102-109 og 112 anvendelse. Artikel 57 finder kun anvendelse, for så vidt kravene til højrisiko-AI-systemer i henhold til denne forordning er blevet integreret i den pågældende EU-harmoniseringslovgivning.
3.   Denne forordning finder ikke anvendelse på områder, der falder uden for EU-rettens anvendelsesområde, og berører under alle omstændigheder ikke medlemsstaternes kompetencer vedrørende national sikkerhed, uanset hvilken type enhed medlemsstaterne har bemyndiget til at udføre opgaver i forbindelse med disse kompetencer.
Denne forordning finder ikke anvendelse på AI-systemer, hvis og i det omfang de bringes i omsætning, ibrugtages eller anvendes med eller uden ændring til formål, der udelukkende vedrører militær, forsvar eller national sikkerhed, uanset hvilken type enhed der udfører disse aktiviteter.
Denne forordning finder ikke anvendelse på AI-systemer, der ikke bringes i omsætning eller ibrugtages i Unionen, hvis outputtet anvendes i Unionen til formål, der udelukkende vedrører militær, forsvar eller national sikkerhed, uanset hvilken type enhed der udfører disse aktiviteter.
4.   Denne forordning finder hverken anvendelse på offentlige myndigheder i tredjelande eller internationale organisationer, der er omfattet af denne forordnings anvendelsesområde, jf. stk. 1, hvis disse myndigheder eller organisationer anvender AI-systemer inden for rammerne af internationalt samarbejde eller internationale aftaler om retshåndhævelse og retligt samarbejde med Unionen eller med en eller flere medlemsstater, forudsat at et sådant tredjeland eller en sådan international organisation træffer tilstrækkelige sikkerhedsforanstaltninger med hensyn til beskyttelsen af fysiske personers grundlæggende rettigheder og friheder.
5.   Denne forordning berører ikke anvendelsen af bestemmelserne om udbydere af formidlingstjenesters ansvar som fastsat i kapitel II i forordning (EU) 2022/2065.
6.   Denne forordning finder ikke anvendelse på AI-systemer eller AI-modeller, herunder deres output, som specifikt er udviklet og ibrugtaget udelukkende med henblik på videnskabelig forskning og udvikling.
7.   EU-retten om beskyttelse af personoplysninger, privatlivets fred og kommunikationshemmeligheden finder anvendelse på personoplysninger, som behandles i forbindelse med de rettigheder og forpligtelser, der er fastsat i denne forordning. Denne forordning berører ikke forordning (EU) 2016/679 eller (EU) 2018/1725 eller direktiv 2002/58/EF eller (EU) 2016/680, uden at det berører nærværende forordnings artikel 10, stk. 5, og artikel 59.
8.   Denne forordning finder ikke anvendelse på forsknings-, afprøvnings- eller udviklingsaktiviteter vedrørende AI-systemer eller AI-modeller, inden de bringes i omsætning eller ibrugtages. Sådanne aktiviteter gennemføres i overensstemmelse med gældende EU-ret. Afprøvning under faktiske forhold er ikke omfattet af denne undtagelse.
9.   Denne forordning berører ikke de regler, der er fastsat i andre EU-retsakter vedrørende forbrugerbeskyttelse og produktsikkerhed.
10.   Denne forordning finder ikke anvendelse på forpligtelser for idriftsættere, som er fysiske personer, der anvender AI-systemer som led i rent personlige ikkeerhvervsmæssige aktiviteter.
11.   Denne forordning er ikke til hinder for, at Unionen eller medlemsstaterne opretholder eller indfører love, forskrifter eller administrative bestemmelser, der er gunstigere for arbejdstagerne med hensyn til beskyttelse af deres rettigheder i forbindelse med arbejdsgivernes anvendelse af AI-systemer, eller tilskynder til eller tillader anvendelse af kollektive overenskomster, der er gunstigere for arbejdstagerne.
12.   Denne forordning finder ikke anvendelse på AI-systemer, der frigives i henhold til gratis open source-licenser, medmindre de bringes i omsætning eller ibrugtages som højrisiko-AI-systemer eller et AI-system, der er omfattet af artikel 5 eller 50.
Artikel 3
Definitioner
I denne forordning forstås ved:
1)
»AI-system«: et maskinbaseret system, som er udformet med henblik på at fungere med en varierende grad af autonomi, og som efter idriftsættelsen kan udvise en tilpasningsevne, og som til eksplicitte eller implicitte mål af det input, det modtager, udleder, hvordan det kan generere output såsom forudsigelser, indhold, anbefalinger eller beslutninger, som kan påvirke fysiske eller virtuelle miljøer
2)
»risiko«: kombinationen af sandsynligheden for, at der opstår en skade, og den pågældende skades alvor
3)
»udbyder«: en fysisk eller juridisk person, en offentlig myndighed, et agentur eller et andet organ, der udvikler eller får udviklet et AI-system eller en AI-model til almen brug og bringer dem i omsætning eller ibrugtager AI-systemet under eget navn eller varemærke, enten mod betaling eller gratis
4)
»idriftsætter«: en fysisk eller juridisk person, en offentlig myndighed, et agentur eller et andet organ, der anvender et AI-system under sin myndighed, medmindre AI-systemet anvendes som led i en personlig ikkeerhvervsmæssig aktivitet
5)
»bemyndiget repræsentant«: en fysisk eller juridisk person, der befinder sig eller er etableret i Unionen, og som har modtaget og accepteret et skriftligt mandat fra en udbyder af et AI-system eller en AI-model til almen brug til på dennes vegne at opfylde og udføre de forpligtelser og procedurer, der er fastsat i denne forordning
6)
»importør«: en fysisk eller juridisk person, som befinder sig eller er etableret i Unionen, og som bringer et AI-system i omsætning, der bærer en i et tredjeland etableret fysisk eller juridisk persons navn eller varemærke
7)
»distributør«: en fysisk eller juridisk person i forsyningskæden, bortset fra udbyderen eller importøren, som gør et AI-system tilgængeligt på EU-markedet
8)
»operatør«: en udbyder, producent af et produkt, idriftsætter, bemyndiget repræsentant, importør eller distributør
9)
»omsætning«: den første tilgængeliggørelse af et AI-system eller en AI-model til almen brug på EU-markedet
10)
»tilgængeliggørelse på markedet«: levering af et AI-system eller en AI-model til almen brug med henblik på distribution eller anvendelse på EU-markedet som led i erhvervsvirksomhed mod eller uden vederlag
11)
»ibrugtagning«: levering af et AI-system til anvendelse for første gang enten direkte til idriftsætteren eller til egen brug i Unionen i overensstemmelse med dets tilsigtede formål
12)
»tilsigtet formål«: den anvendelse, som et AI-system af udbyderen er tilsigtet, herunder den specifikke sammenhæng og de specifikke betingelser for anvendelse som angivet i de oplysninger, udbyderen giver i brugsanvisningen, reklame- eller salgsmaterialet og reklame- og salgserklæringerne samt i den tekniske dokumentation
13)
»fejlanvendelse, der med rimelighed kan forudses«: anvendelse af et AI-system på en måde, der ikke er i overensstemmelse med systemets tilsigtede formål, men som kan skyldes menneskelig adfærd eller interaktion med andre systemer, herunder andre AI-systemer, der med rimelighed kan forudses
14)
»sikkerhedskomponent«: en komponent i et produkt eller et AI-system, som har en sikkerhedsfunktion for det pågældende produkt eller AI-system eller i tilfælde af svigt eller funktionsfejl, som bringer personers sundhed og sikkerhed eller ejendom i fare, i produktet eller systemet
15)
»brugsanvisning«: oplysninger fra udbyderen med henblik på at informere idriftsætteren om navnlig et AI-systems tilsigtede formål og korrekte anvendelse
16)
»tilbagekaldelse af et AI-system«: enhver foranstaltning, der har til formål at opnå, at et AI-system, der allerede er gjort tilgængeligt for idriftsætterne, returneres til udbyderen eller tages ud af drift eller deaktiveres
17)
»tilbagetrækning af et AI-system«: enhver foranstaltning, der har til formål at forhindre, at et AI-system i forsyningskæden gøres tilgængeligt på markedet
18)
»et AI-systems ydeevne«: et AI-systems evne til at opfylde det tilsigtede formål
19)
»bemyndigende myndighed«: den nationale myndighed, der er ansvarlig for at indføre og gennemføre de nødvendige procedurer for vurdering, udpegelse og notifikation af overensstemmelsesvurderingsorganer og for overvågning heraf
20)
»overensstemmelsesvurdering«: processen til påvisning af, om de i kapitel III, afdeling 2, fastsatte krav vedrørende et højrisiko-AI-system er opfyldt
21)
»overensstemmelsesvurderingsorgan«: et organ, der som tredjepart udfører overensstemmelsesvurderingsaktiviteter, herunder afprøvning, certificering og inspektion
22)
»bemyndiget organ«: et overensstemmelsesvurderingsorgan, der er notificeret i overensstemmelse med denne forordning og anden relevant EU-harmoniseringslovgivning
23)
»væsentlig ændring«: en ændring af et AI-system efter dets omsætning eller ibrugtagning, som ikke er forudset eller planlagt i udbyderens indledende overensstemmelsesvurdering, og som følge af hvilken AI-systemets overholdelse af de i kapitel III, afdeling 2, fastsatte krav påvirkes eller medfører en ændring af det tilsigtede formål, med henblik på hvilket AI-systemet er vurderet
24)
»CE-mærkning«: en mærkning, hvormed en udbyder angiver, at et AI-system er i overensstemmelse med de krav, der er fastsat i kapitel III, afdeling 2, og anden gældende EU-harmoniseringslovgivning, og om anbringelse af denne mærkning
25)
»system til overvågning efter omsætningen«: alle aktiviteter, som udbydere af AI-systemer udfører for at samle og gennemgå erfaringer med anvendelse af de AI-systemer, de bringer i omsætning eller ibrugtager, med henblik på at afdække eventuelle behov for omgående at foretage nødvendige, korrigerende eller forebyggende tiltag
26)
»markedsovervågningsmyndighed«: den nationale myndighed, der udfører aktiviteterne og træffer foranstaltningerne i henhold til forordning (EU) 2019/1020
27)
»harmoniseret standard«: en harmoniseret standard som defineret i artikel 2, nr. 1), litra c), i forordning (EU) nr. 1025/2012
28)
»fælles specifikation«: et sæt af tekniske specifikationer som defineret i artikel 2, nr. 4), i forordning (EU) nr. 1025/2012, der giver mulighed for at overholde visse krav, der er fastsat i nærværende forordning
29)
»træningsdata«: data, der anvendes til træning af et AI-system ved hjælp af tilpasning af dets lærbare parametre
30)
»valideringsdata«: data, der anvendes til at foretage en evaluering af det trænede AI-system og til at justere systemets ikkelærbare parametre og dets læringsproces med henblik på bl.a. at forhindre undertilpasning eller overtilpasning
31)
»valideringsdatasæt«: et separat datasæt eller en del af træningsdatasættet, enten som et fast eller variabelt split
32)
»afprøvningsdata«: data, der anvendes til en uafhængig evaluering af AI-systemet for at bekræfte systemets forventede ydeevne, inden det bringes i omsætning eller ibrugtages
33)
»inputdata«: data, der leveres til eller hentes direkte af et AI-system, og på grundlag af hvilke systemet leverer et output
34)
»biometriske data«: personoplysninger som følge af specifik teknisk behandling vedrørende en fysisk persons fysiske, fysiologiske eller adfærdsmæssige karakteristika som f.eks. ansigtsbilleder eller fingeraftryksoplysninger
35)
»biometrisk identifikation«: automatiseret genkendelse af fysiske, fysiologiske, adfærdsmæssige eller psykologiske menneskelige træk med henblik på at fastslå en fysisk persons identitet ved at sammenligne den pågældende persons biometriske data med biometriske data om enkeltpersoner lagret i en database
36)
»biometrisk verifikation«: automatiseret, en-til-en-verifikation, herunder autentificering, af fysiske personers identitet ved at sammenligne deres biometriske data med tidligere afgivne biometriske data
37)
»særlige kategorier af personoplysninger«: de kategorier af personoplysninger, der er omhandlet i artikel 9, stk. 1, i forordning (EU) 2016/679, artikel 10 i direktiv (EU) 2016/680 og artikel 10, stk. 1, i forordning (EU) 2018/1725
38)
»følsomme operationelle data«: operationelle data vedrørende aktiviteter med henblik på forebyggelse, afsløring, efterforskning eller retsforfølgning af strafbare handlinger, hvis videregivelse kan bringe straffesagens integritet i fare
39)
»system til følelsesgenkendelse«: et AI-system, der har til formål at genkende eller udlede fysiske personers følelser eller hensigter på grundlag af deres biometriske data
40)
»system til biometrisk kategorisering«: et AI-system, der har til formål at placere fysiske personer i bestemte kategorier på grundlag af deres biometriske data, medmindre de understøtter en anden kommerciel tjeneste og er strengt nødvendige af objektive tekniske årsager
41)
»system til biometrisk fjernidentifikation«: et AI-system, der har til formål at identificere fysiske personer uden deres aktive deltagelse, typisk på afstand, ved at sammenligne en persons biometriske data med de biometriske data i en referencedatabase
42)
»system til biometrisk fjernidentifikation i realtid«: et system til biometrisk fjernidentifikation, hvor optagelse af biometriske data, sammenligning og identifikation alle finder sted uden væsentlig forsinkelse, omfattende ikke blot øjeblikkelig identifikation, men også begrænsede, korte forsinkelser for at undgå omgåelse
43)
»system til efterfølgende biometrisk fjernidentifikation«: et system til biometrisk fjernidentifikation, som ikke er et system til biometrisk fjernidentifikation i realtid
44)
»offentligt sted«: ethvert offentligt eller privatejet fysisk sted, der er tilgængeligt for et ubestemt antal fysiske personer, uanset om der kan gælde visse adgangsbetingelser, og uanset de potentielle kapacitetsbegrænsninger
45)
»retshåndhævende myndigheder«:
a)
enhver offentlig myndighed, der er kompetent med hensyn til at forebygge, efterforske, afsløre eller retsforfølge strafbare handlinger eller fuldbyrde strafferetlige sanktioner, herunder beskytte mod og forebygge trusler mod den offentlige sikkerhed, eller
b)
ethvert andet organ eller enhver anden enhed, som i henhold til medlemsstaternes nationale ret udøver offentlig myndighed og offentlige beføjelser med henblik på at forebygge, efterforske, afsløre eller retsforfølge strafbare handlinger eller fuldbyrde strafferetlige sanktioner, herunder beskytte mod og forebygge trusler mod den offentlige sikkerhed
46)
»retshåndhævelse«: aktiviteter, som udføres af retshåndhævende myndigheder eller på deres vegne, med hensyn til at forebygge, efterforske, afsløre eller retsforfølge strafbare handlinger eller fuldbyrde strafferetlige sanktioner, herunder beskytte mod og forebygge trusler mod den offentlige sikkerhed
47)
»AI-kontoret«: Kommissionens funktion med at bidrage til gennemførelsen og overvågningen af og tilsynet med AI-systemer og AI-modeller til almen brug og AI-forvaltning, der er fastsat i Kommissionens afgørelse af 24. januar 2024; henvisninger i denne forordning til AI-kontoret forstås som henvisninger til Kommissionen
48)
»national kompetent myndighed«: en bemyndigende myndighed eller en markedsovervågningsmyndighed; for så vidt angår AI-systemer, der tages i brug eller anvendes af EU-institutioner, -agenturer, -kontorer og -organer, forstås henvisninger til nationale kompetente myndigheder eller markedsovervågningsmyndigheder i denne forordning som henvisninger til Den Europæiske Tilsynsførende for Databeskyttelse
49)
»alvorlig hændelse«: en hændelse eller funktionsfejl i et AI-system, som direkte eller indirekte fører til et af følgende udfald:
a)
et menneskes død eller alvorlig skade på et menneskes helbred
b)
en alvorlig og uoprettelig forstyrrelse i forvaltningen eller driften af kritisk infrastruktur
c)
overtrædelse af forpligtelser i henhold til den del af EU-retten, der har til formål at beskytte de grundlæggende rettigheder
d)
alvorlig skade på ejendom eller miljøet
50)
»personoplysninger«: personoplysninger som defineret i artikel 4, nr. 1), i forordning (EU) 2016/679
51)
»andre data end personoplysninger«: andre data end personoplysninger som defineret i artikel 4, nr. 1), i forordning (EU) 2016/679
52)
»profilering«: profilering som defineret artikel 4, nr. 4), i forordning (EU) 2016/679
53)
»plan for afprøvning under faktiske forhold«: et dokument, der beskriver mål, metode, geografisk, befolkningsmæssig og tidsmæssig rækkevidde, overvågning, tilrettelæggelse og gennemførelse af afprøvning under faktiske forhold
54)
»sandkasseplan«: et dokument, der er opnået enighed om mellem den deltagende udbyder og den kompetente myndighed, og som beskriver mål, betingelser, tidsramme, metode og kravene for de aktiviteter, der udføres inden for sandkassen
55)
»reguleringsmæssig AI-sandkasse«: en kontrolleret ramme, som er oprettet af en kompetent myndighed, og som giver udbydere eller potentielle udbydere af AI-systemer mulighed for, hvis det er relevant, under faktiske forhold at udvikle, træne, validere og afprøve et innovativt AI-system i henhold til en sandkasseplan i en begrænset periode under reguleringsmæssigt tilsyn
56)
»AI-færdigheder«: færdigheder, viden og forståelse, der giver udbydere, idriftsættere og berørte personer mulighed for under hensyntagen til deres respektive rettigheder og forpligtelser i forbindelse med denne forordning at idriftsætte AI-systemer på et informeret grundlag samt at øge bevidstheden om muligheder og risici ved AI og den mulige skade, som den kan forvolde
57)
»afprøvning under faktiske forhold«: midlertidig afprøvning af et AI-system med henblik på dets tilsigtede formål under faktiske forhold uden for et laboratorium eller på anden måde simuleret miljø med henblik på at indsamle pålidelige og solide data og vurdere og verificere AI-systemets overensstemmelse med kravene i denne forordning, og det er ikke ensbetydende med at bringe AI-systemet i omsætning eller ibrugtage det som omhandlet i denne forordning, forudsat at alle betingelserne i henhold til artikel 57 eller 60 er opfyldt
58)
»forsøgsperson« med henblik på afprøvning under faktiske forhold: en fysisk person, der deltager i afprøvning under faktiske forhold
59)
»informeret samtykke«: en forsøgspersons frie, specifikke, utvetydige og frivillige tilkendegivelse af sin vilje til at deltage i en bestemt afprøvning under faktiske forhold efter at være blevet informeret om alle aspekter af afprøvningen, der er relevante for forsøgspersonens beslutning om at deltage
60)
»deepfake«: et ved hjælp af AI genereret eller manipuleret billed-, lyd- eller videoindhold, der i væsentlig grad ligner faktiske personer, genstande, steder, enheder eller begivenheder, og som fejlagtigt vil fremstå ægte eller sandfærdigt
61)
»udbredt overtrædelse«: enhver handling eller undladelse, der er i strid med EU-retten, som beskytter enkeltpersoners interesser, og som:
a)
har skadet eller må antages at kunne skade de kollektive interesser for enkeltpersoner med bopæl i mindst to medlemsstater ud over den medlemsstat, hvor:
i)
handlingen eller undladelsen har sin oprindelse eller har fundet sted
ii)
den pågældende udbyder eller, hvis det er relevant, dennes bemyndigede repræsentant befinder sig eller er etableret, eller
iii)
idriftsætteren er etableret, når overtrædelsen bliver begået af idriftsætteren
b)
har skadet, skader eller må antages at kunne skade enkeltpersoners kollektive interesser og har fælles træk, herunder samme ulovlige praksis og tilsidesættelse af den samme interesse, og begås samtidigt af den samme operatør i mindst tre medlemsstater
62)
»kritisk infrastruktur«: kritisk infrastruktur som defineret i artikel 2, nr. 4), i direktiv (EU) 2022/2557
63)
»AI-model til almen brug«: en AI-model, herunder når en sådan AI-model er trænet med en stor mængde data ved hjælp af selvovervågning i stor skala, som udviser betydelig generalitet og har kompetence til at udføre en lang række forskellige opgaver, uanset hvordan modellen bringes i omsætning, og som kan integreres i en række downstreamsystemer eller -applikationer, bortset fra AI-modeller, der anvendes til forsknings-, udviklings- og prototypeaktiviteter, inden de bringes i omsætning
64)
»kapaciteter med stor virkning«: kapaciteter, som svarer til eller overstiger de kapaciteter, der er registreret i de mest avancerede AI-modeller til almen brug
65)
»systemisk risiko«: en risiko, der er specifik for kapaciteter med stor virkning i AI-modeller til almen brug, og som har betydelig indvirkning på EU-markedet på grund af deres omfang eller på grund af faktiske negative virkninger, der med rimelighed kan forudses, for folkesundheden, sikkerheden, den offentlige sikkerhed, de grundlæggende rettigheder eller samfundet som helhed, som kan opformeres i stor skala i hele værdikæden
66)
»AI-system til almen brug«: et AI-system, som er baseret på en AI-model til almen brug, og som har kapacitet til at opfylde en række forskellige formål, både til direkte anvendelse og til integration i andre AI-systemer
67)
»flydende kommatalsberegning«: enhver matematisk beregning eller ligning, der omfatter flydende kommatal, som er en delmængde af de reelle tal, der typisk vises på computere i form af et heltal med fast præcision, som justeres med en heltalseksponent med fastlagt basis
68)
»downstreamudbyder«: en udbyder af et AI-system, herunder et AI-system til almen brug, som integrerer en AI-model, uanset om AI-modellen leveres af udbyderen selv og integreres vertikalt eller leveres af en anden enhed på grundlag af kontraktforhold.
Artikel 4
AI-færdigheder
Udbydere og idriftsættere af AI-systemer træffer foranstaltninger til i videst muligt omfang at sikre et tilstrækkeligt niveau af AI-færdigheder hos deres personale og andre personer, der er involveret i drift og anvendelse af AI-systemer på deres vegne, og tager herved hensyn til disse personers tekniske viden, erfaring og uddannelse og den kontekst, hvori AI-systemerne skal anvendes, og de personer eller grupper af personer, som AI-systemerne skal anvendes på.
KAPITEL II
FORBUDTE FORMER FOR AI-PRAKSIS
Artikel 5
Forbudte former for AI-praksis
1.   Følgende former for AI-praksis er forbudt:
a)
omsætning, ibrugtagning eller anvendelse af et AI-system, der anvender subliminale teknikker, der rækker ud over den menneskelige bevidsthed, eller bevidst manipulerende eller vildledende teknikker med henblik på eller med det resultat i væsentlig grad at fordreje en persons eller en gruppe af personers adfærd ved betydeligt at hæmme dennes evne til at træffe informerede beslutninger, hvilket får dem til at træffe en beslutning, som de ellers ikke ville have truffet, på en måde, der forvolder eller med rimelig sandsynlighed vil forvolde den pågældende person, en anden person eller en gruppe af personer betydelig skade
b)
omsætning, ibrugtagning eller anvendelse af et AI-system, der hos en fysisk person eller en specifik gruppe af personer udnytter sårbarheder på grundlag af alder, handicap eller en særlig social eller økonomisk situation med henblik på eller med det resultat i væsentlig grad at fordreje den pågældende persons eller en til gruppen hørende persons adfærd på en måde, der forvolder eller med rimelig sandsynlighed vil forvolde den pågældende person eller en anden person betydelig skade
c)
omsætning, ibrugtagning eller anvendelse af AI-systemer til evaluering eller klassificering af fysiske personer eller grupper af personer over en given periode på grundlag af deres sociale adfærd eller kendte, udledte eller forudsagte personlige egenskaber eller personlighedstræk, således at den sociale bedømmelse fører til et af eller begge følgende udfald:
i)
skadelig eller ugunstig behandling af visse fysiske personer eller grupper af personer i sociale sammenhænge, som ikke har noget at gøre med de sammenhænge, i hvilke dataene oprindeligt blev genereret eller indsamlet
ii)
skadelig eller ugunstig behandling af visse fysiske personer eller grupper af personer, som er uberettiget eller uforholdsmæssig i forhold til deres sociale adfærd eller betydningen heraf
d)
omsætning, ibrugtagning til dette specifikke formål eller anvendelse af et AI-system til at foretage risikovurderinger af fysiske personer for at vurdere eller forudsige risikoen for, at en fysisk person begår en strafbar handling, hvilket alene er baseret på profilering af en fysisk person eller en vurdering af deres personlighedstræk og personlige egenskaber; dette forbud finder ikke anvendelse på AI-systemer, der anvendes til at understøtte den menneskelige vurdering af en persons involvering i en kriminel aktivitet, som allerede er baseret på objektive og verificerbare kendsgerninger, der er direkte knyttet til en kriminel aktivitet
e)
omsætning, ibrugtagning til dette specifikke formål eller anvendelse af AI-systemer, der opretter eller udvider ansigtsgenkendelsesdatabaser gennem ikkemålrettet indsamling af ansigtsbilleder fra internettet eller kameraovervågning
f)
omsætning, ibrugtagning til dette specifikke formål eller anvendelse af AI-systemer til at udlede følelser hos en fysisk person på arbejdspladser og uddannelsesinstitutioner, undtagen hvis anvendelsen af AI-systemet er tilsigtet at blive bragt i omsætning af medicinske eller sikkerhedsmæssige årsager
g)
omsætning, ibrugtagning til dette specifikke formål eller anvendelse af systemer til biometrisk kategorisering, som kategoriserer fysiske personer individuelt på grundlag af deres biometriske data med henblik på at udlede deres race, politiske anskuelser, fagforeningsmedlemskab, religiøse eller filosofiske overbevisning, seksuelle forhold eller seksuelle orientering; dette forbud omfatter ikke mærkning eller filtrering af lovligt indhentede biometriske datasæt såsom billeder på grundlag af biometriske data eller kategorisering af biometriske data på retshåndhævelsesområdet
h)
anvendelse af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse, medmindre og i det omfang en sådan anvendelse er strengt nødvendig til et af følgende formål:
i)
målrettet eftersøgning af specifikke ofre for bortførelse, menneskehandel eller seksuel udnyttelse af mennesker samt eftersøgning af forsvundne personer
ii)
forebyggelse af en specifik, væsentlig og overhængende trussel mod fysiske personers liv eller fysiske sikkerhed eller en reel og aktuel eller reel og forudsigelig trussel om et terrorangreb
iii)
lokalisering eller identifikation af en person, der mistænkes for at have begået en strafbar handling, med henblik på en strafferetlig efterforskning af eller retsforfølgning eller fuldbyrdelse af en strafferetlig sanktion for overtrædelser, der er omhandlet i bilag II, og som i den pågældende medlemsstat kan straffes med frihedsstraf eller en anden frihedsberøvende foranstaltning af en maksimal varighed på mindst fire år.
Første afsnit, litra h), berører ikke artikel 9 i forordning (EU) 2016/679 med hensyn til behandling af biometriske data til andre formål end retshåndhævelse.
2.   Anvendelsen af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse til et af de i stk. 1, første afsnit, litra h), omhandlede formål må kun idriftsættes til de formål, der er fastsat i nævnte litra, for at bekræfte den specifikt målrettede persons identitet og skal tage hensyn til følgende elementer:
a)
karakteren af den situation, der giver anledning til den mulige anvendelse, navnlig alvorligheden, sandsynligheden og omfanget af den skade, der ville blive forvoldt, hvis systemet ikke blev anvendt
b)
konsekvenserne for alle de berørte personers rettigheder og friheder, navnlig alvorligheden, sandsynligheden og omfanget af disse konsekvenser, hvis systemet anvendes.
Ved anvendelse af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse til et af de i denne artikels stk. 1, første afsnit, litra h), omhandlede formål overholdes desuden nødvendige og forholdsmæssige sikkerhedsforanstaltninger og betingelser vedrørende anvendelsen i overensstemmelse med den nationale ret, der tillader anvendelse heraf, navnlig for så vidt angår tidsmæssige, geografiske og personmæssige begrænsninger. Anvendelsen af systemet til biometrisk fjernidentifikation i realtid på offentlige steder tillades kun, hvis den retshåndhævende myndighed har gennemført en konsekvensanalyse vedrørende grundlæggende rettigheder som fastsat i artikel 27 og har registreret systemet i EU-databasen i overensstemmelse med artikel 49. I behørigt begrundede hastende tilfælde kan anvendelsen af sådanne systemer dog påbegyndes uden registrering i EU-databasen, forudsat at registreringen afsluttes uden unødigt ophold.
3.   Med henblik på stk. 1, første afsnit, litra h), og stk. 2, er hver anvendelse af et system til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse betinget af en forudgående tilladelse, der er udstedt af en judiciel myndighed eller en uafhængig administrativ myndighed, hvis afgørelse er bindende i den medlemsstat, hvor anvendelsen skal finde sted, på grundlag af en begrundet anmodning og i overensstemmelse med de nærmere regler i national ret, jf. stk. 5. I behørigt begrundede hastende tilfælde kan anvendelsen af et sådant system dog påbegyndes uden tilladelse, på betingelse af at der anmodes om en sådan tilladelse uden unødigt ophold og senest inden for 24 timer. Hvis en sådan tilladelse afvises, bringes anvendelsen straks til ophør, og alle data såvel som resultater og output af denne anvendelse kasseres og slettes omgående.
Den kompetente judicielle myndighed eller en uafhængig administrativ myndighed, hvis afgørelse er bindende, udsteder kun tilladelsen, hvis den på grundlag af objektive beviser eller klare indikationer, den får forelagt, finder det godtgjort, at anvendelsen af det pågældende system til biometrisk fjernidentifikation i realtid er nødvendig og forholdsmæssig for at opfylde et af de i stk. 1, første afsnit, litra h), anførte formål som anført i anmodningen og navnlig fortsat begrænses til, hvad der er strengt nødvendigt for så vidt angår tidsperioden samt det geografiske og personmæssige anvendelsesområde. Når den pågældende myndighed træffer afgørelse om anmodningen, tager den hensyn til de i stk. 2 omhandlede elementer. Der må ikke træffes nogen afgørelse, der har negative retsvirkninger for en person, udelukkende baseret på outputtet af systemet til efterfølgende biometrisk fjernidentifikation i realtid.
4.   Uden at det berører stk. 3, skal hver anvendelse af et system til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse meddeles den relevante markedsovervågningsmyndighed og den nationale databeskyttelsesmyndighed i overensstemmelse med de nationale regler, jf. stk. 5. Meddelelsen skal som minimum indeholde de oplysninger, der er anført i stk. 6, og må ikke indeholde følsomme operationelle data.
5.   En medlemsstat kan beslutte at give mulighed for helt eller delvist at tillade anvendelse af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse inden for de begrænsninger og på de betingelser, der er nævnt i stk. 1, første afsnit, litra h), og stk. 2 og 3. De pågældende medlemsstater fastsætter i deres nationale ret de nødvendige nærmere regler for anmodning om, udstedelse af og benyttelse af samt tilsyn og indberetning i forbindelse med de i stk. 3 omhandlede tilladelser. Disse regler præciserer også, til hvilke af de i stk. 1, første afsnit, litra h), anførte formål, herunder for hvilke af de i litra h), nr. iii), nævnte strafbare handlinger, de kompetente myndigheder kan få tilladelse til at anvende disse systemer med henblik på retshåndhævelse. Medlemsstaterne meddeler Kommissionen disse regler senest 30 dage efter vedtagelsen heraf. Medlemsstaterne kan i overensstemmelse med EU-retten indføre mere restriktiv lovgivning om anvendelsen af systemer til biometrisk fjernidentifikation.
6.   De nationale markedsovervågningsmyndigheder og de nationale databeskyttelsesmyndigheder i de medlemsstater, der er blevet underrettet om anvendelsen af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse i henhold til stk. 4, forelægger Kommissionen årlige rapporter om en sådan anvendelse. Med henblik herpå stiller Kommissionen efter anmodning om tilladelser i overensstemmelse med stk. 3 og resultatet heraf en skabelon til rådighed for medlemsstaterne og de nationale markedsovervågnings- og databeskyttelsesmyndigheder, herunder oplysninger om antallet af afgørelser, der er truffet af de kompetente judicielle myndigheder eller en uafhængig administrativ myndighed, hvis afgørelse er bindende.
7.   Kommissionen offentliggør årlige rapporter om anvendelsen af systemer til biometrisk fjernidentifikation i realtid på offentlige steder med henblik på retshåndhævelse på grundlag af aggregerede data i medlemsstaterne, der bygger på de i stk. 6 omhandlede årlige rapporter. Disse rapporter må ikke indeholde følsomme operationelle data om de tilknyttede retshåndhævelsesaktiviteter.
8.   Denne artikel berører ikke de forbud, der gælder, hvis en form for AI-praksis overtræder anden EU-ret.
KAPITEL III
HØJRISIKO-AI-SYSTEMER
AFDELING 1
Klassificering af AI-systemer som højrisiko
Artikel 6
Klassificeringsregler for højrisiko-AI-systemer
1.   Uanset om et AI-system bringes i omsætning eller ibrugtages uafhængigt af de i litra a) og b) omhandlede produkter, betragtes AI-systemet som højrisiko, hvis begge følgende betingelser er opfyldt:
a)
AI-systemet tilsigtes anvendt som en sikkerhedskomponent i et produkt, eller AI-systemet er i sig selv et produkt, der er omfattet af den EU-harmoniseringslovgivning, der er anført i bilag I.
b)
Det produkt, hvis sikkerhedskomponent i henhold til litra a) er AI-systemet, eller AI-systemet selv som et produkt skal underkastes en overensstemmelsesvurdering foretaget af en tredjepart med henblik på omsætning eller ibrugtagning af produktet i henhold til den EU-harmoniseringslovgivning, der er anført i bilag I.
2.   Ud over de højrisiko-AI-systemer, der er omhandlet i stk. 1, betragtes de AI-systemer, der er omhandlet i bilag III, også som højrisiko.
3.   Uanset stk. 2 betragtes et AI-system, der er omhandlet i bilag III, ikke som højrisiko, hvis det ikke udgør en væsentlig risiko for skade på sundheden, sikkerheden eller fysiske personers grundlæggende rettigheder, herunder ved ikke i væsentlig grad at påvirke resultatet af beslutningstagning.
Første afsnit finder anvendelse, hvis enhver af følgende betingelser er opfyldt:
a)
AI-systemet tilsigtes at udføre en snæver proceduremæssig opgave
b)
AI-systemet tilsigtes at forbedre resultatet af en tidligere afsluttet menneskelig aktivitet
c)
AI-systemet tilsigtes at påvise beslutningsmønstre eller afvigelser fra tidligere beslutningsmønstre og er ikke tiltænkt at skulle erstatte eller påvirke en tidligere afsluttet menneskelig vurdering uden en ordentlig menneskelig gennemgang, eller
d)
AI-systemet tilsigtes at udføre en forberedende opgave inden en vurdering, der er relevant for de anvendelsestilfælde, der er anført i bilag III.
Uanset første afsnit betragtes et AI-system, der er omhandlet i bilag III, altid som højrisiko, hvis AI-systemet udfører profilering af fysiske personer.
4.   En udbyder, som finder, at et AI-system, der er omhandlet i bilag III, ikke er højrisiko, skal dokumentere sin vurdering, inden det pågældende system bringes i omsætning eller ibrugtages. En sådan udbyder er underlagt registreringsforpligtelsen i artikel 49, stk. 2. Efter anmodning fra de nationale kompetente myndigheder fremlægger udbyderen dokumentation for vurderingen.
5.   Kommissionen udarbejder efter høring af Det Europæiske Udvalg for Kunstig Intelligens (»AI-udvalget«) og senest den 2. februar 2026 retningslinjer, der præciserer den praktiske gennemførelse af denne artikel i overensstemmelse med artikel 96, sammen med en omfattende liste over praktiske eksempler på anvendelsestilfælde af AI-systemer, der er højrisiko og ikke højrisiko.
6.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre nærværende artikels stk. 3, andet afsnit, ved at tilføje nye betingelser til dem, der er fastsat i nævnte stykke, eller ved at ændre dem, hvis der foreligger konkret og pålidelig dokumentation for, at der findes AI-systemer, som hører under anvendelsesområdet i bilag III, men som ikke udgør en væsentlig risiko for skade på fysiske personers sundhed, sikkerhed eller grundlæggende rettigheder.
7.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 97 for at ændre nærværende artikels stk. 3, andet afsnit, ved at lade enhver af de i nævnte stykke fastsatte betingelser udgå, hvis der foreligger konkret og pålidelig dokumentation for, at dette er nødvendigt for at opretholde det beskyttelsesniveauet for sundheden, sikkerheden og de grundlæggende rettigheder, der er fastsat ved denne forordning.
8.   Enhver ændring af betingelserne i stk. 3, andet afsnit, vedtaget i overensstemmelse med denne artikels stk. 6 og 7, må ikke reducere det overordnede beskyttelsesniveau for sundheden, sikkerheden og de grundlæggende rettigheder, der er fastsat ved denne forordning, og sikrer overensstemmelse med de delegerede retsakter, der er vedtaget i henhold til artikel 7, stk. 1, og tager hensyn til den markedsmæssige og teknologiske udvikling.
Artikel 7
Ændring af bilag III
1.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre bilag III ved at tilføje eller ændre anvendelsestilfælde af højrisiko-AI-systemer, hvis begge følgende betingelser er opfyldt:
a)
AI-systemerne tilsigtes anvendt på et af de områder, der er anført i bilag III
b)
AI-systemerne udgør en risiko for skade på sundheden og sikkerheden eller for negativ indvirkning på de grundlæggende rettigheder, og denne risiko svarer til eller er større end risikoen for skade eller negativ indvirkning ved de højrisiko-AI-systemer, der allerede er omhandlet i bilag III.
2.   Ved vurderingen af betingelsen i henhold til stk. 1, litra b), tager Kommissionen hensyn til følgende kriterier:
a)
det tilsigtede formål med AI-systemet
b)
i hvilket omfang et AI-system er blevet anvendt eller sandsynligvis vil blive anvendt
c)
arten og omfanget af de data, der behandles og anvendes af AI-systemet, navnlig om der behandles særlige kategorier af personoplysninger
d)
i hvilket omfang AI-systemet handler autonomt, og muligheden for at et menneske kan underkende en afgørelse eller anbefalinger, som kan føre til potentiel skade
e)
i hvilket omfang anvendelsen af et AI-system allerede har forvoldt skade på sundheden og sikkerheden, har haft negativ indvirkning på de grundlæggende rettigheder eller har skabt betydelig bekymring med hensyn til sandsynligheden for en sådan skade eller negativ indvirkning som påvist i f.eks. rapporter eller dokumenterede påstande, der er forelagt for de nationale kompetente myndigheder, eller i andre rapporter, alt efter hvad der er relevant
f)
det potentielle omfang af en sådan skade eller negativ indvirkning, navnlig med hensyn til dens størrelse og dens mulighed for påvirkning af flere personer eller for uforholdsmæssig påvirkning af en særlig gruppe af personer
g)
i hvilket omfang personer, der er potentielt skadede eller er ofre for en negativ indvirkning, er afhængige af det resultat, et AI-system giver, navnlig hvis det af praktiske eller juridiske grunde ikke med rimelighed er muligt at fravælge resultatet
h)
i hvilket omfang der er magtmæssig ubalance, eller de personer, der er potentielt skadede eller er ofre for en negativ indvirkning, befinder sig i en sårbar situation i forhold til idriftsætteren af et AI-system, navnlig som følge af status, autoritet, viden, økonomiske eller sociale omstændigheder eller alder
i)
i hvilket omfang det resultat, der fremkommer ved inddragelse af et AI-system, let kan korrigeres eller ændres under hensyntagen til de tilgængelige tekniske løsninger til at korrigere eller ændre det, idet resultater, der har en negativ indvirkning på sundheden, sikkerheden eller de grundlæggende rettigheder, ikke anses for let at kunne korrigeres eller ændres
j)
omfanget af og sandsynligheden for fordele ved idriftsættelsen af AI-systemet for enkeltpersoner, grupper eller samfundet som helhed, herunder mulige forbedringer af produktsikkerheden
k)
i hvilket omfang gældende EU-ret indeholder bestemmelser om:
i)
effektive retsmidler med hensyn til de risici, der er forbundet med et AI-system, med undtagelse af erstatningskrav
ii)
effektive foranstaltninger til at forebygge eller i væsentlig grad minimere disse risici.
3.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre listen i bilag III ved at fjerne højrisiko-AI-systemer, hvis begge følgende betingelser er opfyldt:
a)
det pågældende højrisiko-AI-system udgør ikke længere nogen væsentlig risiko for de grundlæggende rettigheder, sundheden eller sikkerheden under hensyntagen til kriterierne i stk. 2
b)
fjernelsen reducerer ikke det generelle beskyttelsesniveau for sundhed, sikkerhed og grundlæggende rettigheder i henhold til EU-retten.
AFDELING 2
Krav til højrisiko-AI-systemer
Artikel 8
Overholdelse af krav
1.   Højrisiko-AI-systemer skal overholde de krav, der er fastsat i denne afdeling, under hensyntagen til deres tilsigtede formål og det generelt anerkendte aktuelle teknologiske niveau for AI og AI-relaterede teknologier. Ved sikringen af, at disse krav overholdes, tages det risikostyringssystem, der er omhandlet i artikel 9, i betragtning.
2.   Hvis et produkt indeholder et AI-system, som kravene i denne forordning samt kravene i den EU-harmoniseringslovgivning, der er anført i bilag I, afsnit A, finder anvendelse på, er producenterne ansvarlige for at sikre, at deres produkt fuldt ud overholder alle gældende krav i den gældende EU-harmoniseringslovgivning. For at sikre at de højrisiko-AI-systemer, der er omhandlet i stk. 1, overholder kravene i denne afdeling, og for at sikre sammenhæng, undgå overlap og minimere yderligere byrder skal udbyderne have mulighed for i relevant omfang at integrere de nødvendige afprøvnings- og rapporteringsprocesser, oplysninger og den nødvendige dokumentation, som de stiller til rådighed vedrørende deres produkt, i dokumentation og procedurer, der allerede eksisterer og kræves i henhold til den EU-harmoniseringslovgivning, der er anført i bilag I, afsnit A.
Artikel 9
Risikostyringssystem
1.   Hvad angår højrisiko-AI-systemer oprettes og gennemføres der et risikostyringssystem, som dokumenteres og vedligeholdes.
2.   Risikostyringssystemet skal forstås som en kontinuerlig iterativ proces, der er planlagt og løber i hele højrisiko-AI-systemets livscyklus, og som kræver regelmæssig systematisk gennemgang og opdatering. Det omfatter følgende trin:
a)
kortlægning og analyse af kendte og med rimelighed forudsigelige risici, som højrisiko-AI-systemet kan udgøre for sundheden, sikkerheden eller de grundlæggende rettigheder, når højrisiko-AI-systemet anvendes i overensstemmelse med dets tilsigtede formål
b)
vurdering og evaluering af de risici, der kan opstå, når højrisiko-AI-systemet anvendes i overensstemmelse med dets tilsigtede formål og ved fejlanvendelse, der med rimelighed kan forudses
c)
evaluering af andre risici, der kan opstå, på grundlag af analyse af data indsamlet fra systemet til overvågning efter omsætningen, jf. artikel 72
d)
vedtagelse af passende og målrettede risikostyringsforanstaltninger, der har til formål at imødegå de risici, der er identificeret i henhold til litra a).
3.   De i denne artikel omhandlede risici vedrører kun dem, der med rimelighed kan afbødes eller fjernes gennem udviklingen eller udformningen af højrisiko-AI-systemet eller tilvejebringelsen af tilstrækkelige tekniske oplysninger.
4.   De i stk. 2, litra d), omhandlede risikostyringsforanstaltninger tager behørigt hensyn til virkningerne og eventuelle interaktioner som følge af den kombinerede anvendelse af kravene i denne afdeling med henblik på at minimere risiciene mere effektivt og samtidig opnå en passende balance i gennemførelsen af foranstaltningerne til opfyldelse af disse krav.
5.   De i stk. 2, litra d), omhandlede risikostyringsforanstaltninger er af en sådan art, at de relevante resterende risici, der er forbundet med hver fare, samt den samlede resterende risiko ved højrisiko-AI-systemerne vurderes at være acceptabel.
I fastlæggelsen af de mest hensigtsmæssige risikostyringsforanstaltninger sikres følgende:
a)
fjernelse eller begrænsning af de risici, der er identificeret og evalueret i henhold til stk. 2, i det omfang det er teknisk muligt, gennem passende udformning og udvikling af højrisiko-AI-systemet
b)
om nødvendigt gennemførelse af passende foranstaltninger til afbødning og kontrol, som imødegår risici, der ikke kan fjernes
c)
tilvejebringelse af de oplysninger, der kræves i henhold til artikel 13, og, hvis det er relevant, træning af idriftsætterne.
Med henblik på fjernelse eller begrænsning af risici i forbindelse med anvendelsen af et højrisiko-AI-system tages der behørigt hensyn til den tekniske viden, erfaring, uddannelse og træning, som kan forventes af idriftsætteren, og den formodentlige kontekst, i hvilken systemet tilsigtes anvendt.
6.   Højrisiko-AI-systemer afprøves med henblik på at identificere de mest hensigtsmæssige og målrettede risikostyringsforanstaltninger. Afprøvning sikrer, at højrisiko-AI-systemer yder konsistent i overensstemmelse med deres tilsigtede formål og overholder de krav, der er fastsat i denne afdeling.
7.   Afprøvningsprocedurerne kan omfatte afprøvning under faktiske forhold i overensstemmelse med artikel 60.
8.   Afprøvning af højrisiko-AI-systemer foretages på et hvilket som helst tidspunkt under hele udviklingsprocessen, alt efter hvad der er relevant, og under alle omstændigheder inden de bringes i omsætning eller ibrugtages. Afprøvningen foretages på grundlag af på forhånd definerede parametre og probabilistiske tærskler, der er passende i forhold til det tilsigtede formål med højrisiko-AI-systemet.
9.   Ved gennemførelsen af det risikostyringssystem, der er fastsat i stk. 1-7, tager udbyderne hensyn til, om der i betragtning af det tilsigtede formål med højrisiko-AI-systemet er sandsynlighed for, at det har en negativ indvirkning på personer under 18 år og i relevant omfang på andre sårbare grupper.
10.   For udbydere af højrisiko-AI-systemer, der er underlagt krav vedrørende interne risikostyringsprocesser i henhold til andre relevante bestemmelser i EU-retten, kan de aspekter, der er fastsat i stk. 1-9, være en del af eller kombineres med de risikostyringsprocedurer, der er fastlagt i henhold til den pågældende ret.
Artikel 10
Data og datastyring
1.   De højrisiko-AI-systemer, der gør brug af teknikker, som omfatter træning af AI-modeller med data, udvikles på grundlag af trænings-, validerings- og afprøvningsdatasæt, der opfylder de kvalitetskriterier, der er omhandlet i stk. 2-5, når sådanne datasæt anvendes.
2.   Trænings-, validerings- og afprøvningsdatasæt skal være underlagt former for datastyrings- og dataforvaltningspraksis, som er tilpasset højrisiko-AI-systemets tilsigtede formål. Disse former for praksis vedrører navnlig:
a)
de relevante valg med hensyn til udformning
b)
dataindsamlingsprocesser og dataenes oprindelse og, hvis der er tale om personoplysninger, det oprindelige formål med dataindsamlingen
c)
relevant dataforberedelsesbehandling såsom annotation, mærkning, rensning, opdatering, berigelse og aggregering
d)
formuleringen af antagelser, navnlig med hensyn til de oplysninger, som dataene skal måle og repræsentere
e)
en vurdering af tilgængeligheden, mængden og egnetheden af de datasæt, der er nødvendige
f)
undersøgelse med hensyn til mulige bias, der sandsynligvis vil påvirke personers sundhed og sikkerhed, have negativ indvirkning på de grundlæggende rettigheder eller føre til forskelsbehandling, som er forbudt i henhold til EU-retten, navnlig hvis dataoutput påvirker input til fremtidige operationer
g)
passende foranstaltninger til at påvise, forebygge og afbøde de mulige bias, der er identificeret i henhold til litra f)
h)
kortlægning af relevante datamangler eller datautilstrækkeligheder, som forhindrer overholdelse af denne forordning, og hvordan de kan afhjælpes.
3.   Trænings-, validerings- og afprøvningsdatasæt skal i betragtning af det tilsigtede formål være relevante, tilstrækkeligt repræsentative og i videst muligt omfang fejlfrie og fuldstændige. De skal have de tilstrækkelige statistiske egenskaber, herunder, hvis det er relevant, med hensyn til de personer eller grupper af personer, på hvilke højrisiko-AI-systemet tilsigtes anvendt. Disse egenskaber kan opfyldes for de enkelte datasæt eller for en kombination heraf.
4.   I datasæt tages der, i det omfang det er nødvendigt i lyset af deres tilsigtede formål, hensyn til de egenskaber eller elementer, der er særlige for den specifikke geografiske, kontekstuelle, adfærdsmæssige eller funktionelle ramme, inden for hvilken højrisiko-AI-systemet tilsigtes anvendt.
5.   I det omfang det er strengt nødvendigt for at sikre, at bias i forbindelse med højrisiko-AI-systemer påvises og korrigeres i overensstemmelse med denne artikels stk. 2, litra f) og g), kan udbydere af sådanne systemer undtagelsesvis behandle særlige kategorier af personoplysninger, med forbehold af passende sikkerhedsforanstaltninger med hensyn til fysiske personers grundlæggende rettigheder og friheder. Ud over bestemmelserne i forordning (EU) 2016/679 og (EU) 2018/1725 samt direktiv (EU) 2016/680 skal følgende betingelser overholdes for at udføre en sådan behandling:
a)
påvisning og korrektion af bias kan ikke opnås effektivt ved behandling af andre data, herunder syntetiske eller anonymiserede data
b)
de særlige kategorier af personoplysninger er underlagt tekniske begrænsninger for videreanvendelse af personoplysninger og de mest avancerede sikkerhedsforanstaltninger og foranstaltninger til beskyttelse af privatlivet fred, herunder pseudonymisering
c)
de særlige kategorier af personoplysninger er underlagt foranstaltninger, der skal sikre, at de behandlede personoplysninger er sikrede, beskyttede og omfattet af passende sikkerhedsforanstaltninger, herunder streng kontrol og dokumentation af adgangen, for at undgå misbrug og sikre, at kun autoriserede personer har adgang til disse personoplysninger med passende fortrolighedsforpligtelser
d)
de særlige kategorier af personoplysninger må ikke transmitteres til, overføres til eller på anden måde tilgås af andre parter
e)
de særlige kategorier af personoplysninger slettes, når bias er blevet korrigeret, eller når opbevaringsperioden for personoplysningerne udløber, alt efter hvad der indtræffer først
f)
fortegnelserne over behandlingsaktiviteter i henhold til forordning (EU) 2016/679 og (EU) 2018/1725 samt direktiv (EU) 2016/680 indeholder en begrundelse for, hvorfor behandlingen af særlige kategorier af personoplysninger var strengt nødvendig for at opdage og korrigere bias, og hvorfor dette mål ikke kunne nås ved behandling af andre data.
6.   Ved udvikling af højrisiko-AI-systemer, der ikke gør brug af teknikker, der omfatter træning af AI-modeller, finder stk. 2-5 kun anvendelse på afprøvningsdatasættene.
Artikel 11
Teknisk dokumentation
1.   Den tekniske dokumentation for et højrisiko-AI-system udarbejdes, inden systemet bringes i omsætning eller ibrugtages, og holdes ajour.
Den tekniske dokumentation udarbejdes således, at den påviser, at højrisiko-AI-systemet overholder de krav, der er fastsat i denne afdeling, og at de oplysninger, der er nødvendige for at vurdere AI-systemets overholdelse af disse krav, gives på en klar og forståelig måde til de nationale kompetente myndigheder og bemyndigede organer. Den skal som minimum indeholde de i bilag IV fastsatte elementer. SMV'er, herunder iværksættervirksomheder, kan fremlægge de elementer i den tekniske dokumentation, der er anført i bilag IV, på en forenklet måde. Med henblik herpå udarbejder Kommissionen en forenklet formular for teknisk dokumentation, der er målrettet små virksomheders og mikrovirksomheders behov. Hvis en SMV, herunder en iværksættervirksomhed, vælger at fremlægge de oplysninger, der kræves i bilag IV, på en forenklet måde, anvender den formularen, der er omhandlet i dette stykke. Bemyndigede organer skal acceptere formularen med henblik på overensstemmelsesvurderingen.
2.   Hvis et højrisiko-AI-system tilknyttet et produkt, der er omfattet af den i bilag I, afsnit A, anførte EU-harmoniseringslovgivning, bringes i omsætning eller ibrugtages, udarbejdes der et enkelt sæt teknisk dokumentation, der indeholder alle de oplysninger, der er fastsat i stk. 1, samt de oplysninger, der kræves i henhold til disse retsakter.
3.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre bilag IV, hvis det i lyset af den tekniske udvikling er nødvendigt for, at den tekniske dokumentation giver alle de oplysninger, der er nødvendige for at vurdere, om systemet overholder de krav, der er fastsat i denne afdeling.
Artikel 12
Registrering
1.   Højrisiko-AI-systemer skal teknisk muliggøre automatisk registrering af hændelser (»logfiler«) under systemets levetid.
2.   For at sikre en passende grad af sporbarhed i højrisiko-AI-systemets funktion i forhold til systemets tilsigtede formål skal logningskapaciteten muliggøre registrering af hændelser, der er relevante for:
a)
identifikation af situationer, der kan medføre, at højrisiko-AI-systemet udgør en risiko som omhandlet i artikel 79, stk. 1, eller en væsentlig ændring
b)
lettelse af overvågningen efter omsætningen, jf. artikel 72, og
c)
overvågning af driften af højrisiko-AI-systemer, jf. artikel 26, stk. 5.
3.   For så vidt angår de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 1, litra a), omfatter logningskapaciteten som minimum:
a)
registrering af tidsperioden for hver anvendelse af systemet (startdato og -klokkeslæt samt slutdato og -klokkeslæt for hver anvendelse)
b)
den referencedatabase, med hvilken systemet har sammenholdt inputdata
c)
de inputdata, som i søgningen har givet et match
d)
identifikation af de fysiske personer, der er involveret i verifikationen af resultaterne, jf. artikel 14, stk. 5.
Artikel 13
Gennemsigtighed og formidling af oplysninger til idriftsætterne
1.   Højrisiko-AI-systemer udformes og udvikles på en sådan måde, at deres drift er tilstrækkelig gennemsigtig til, at idriftsætterne kan fortolke et systems output og anvende det korrekt. Der sikres en passende type og grad af gennemsigtighed med henblik på at opnå overholdelse af de relevante udbyder- og idriftsætterforpligtelser, der er fastsat i afdeling 3.
2.   Højrisiko-AI-systemer ledsages af en brugsanvisning i et passende digitalt format eller på anden vis, som indeholder kortfattede, fuldstændige, korrekte og klare oplysninger, som er relevante, tilgængelige og forståelige for idriftsætterne.
3.   Brugsanvisningen skal som minimum indeholde følgende oplysninger:
a)
identitet på og kontaktoplysninger for udbyderen og dennes eventuelle bemyndigede repræsentant
b)
højrisiko-AI-systemets egenskaber, kapacitet og begrænsninger for dets ydeevne, herunder:
i)
det tilsigtede formål
ii)
det niveau af nøjagtighed, herunder systemets parametre, robusthed og cybersikkerhed, jf. artikel 15, i forhold til hvilket højrisiko-AI-systemet er afprøvet og valideret, og som kan forventes, samt alle kendte og forudsigelige omstændigheder, der kan have indvirkning på det forventede niveau af nøjagtighed, robusthed og cybersikkerhed
iii)
alle kendte eller forudsigelige omstændigheder i forbindelse med anvendelse af højrisiko-AI-systemet i overensstemmelse med dets tilsigtede formål eller ved fejlanvendelse, der med rimelighed kan forudses, der kan medføre risici for sundhed og sikkerhed eller grundlæggende rettigheder, jf. artikel 9, stk. 2
iv)
hvis det er relevant, højrisiko-AI-systemets tekniske kapacitet og egenskaber til at give oplysninger, som er relevante for at forklare dets output
v)
hvis det er relevant, dets ydeevne for så vidt angår de specifikke personer eller grupper af personer, på hvilke systemet tilsigtes anvendt
vi)
hvis det er relevant, specifikationer for inputdataene eller andre relevante oplysninger med hensyn til de anvendte trænings-, validerings- og afprøvningsdatasæt under hensyntagen til højrisiko-AI-systemets tilsigtede formål
vii)
hvis det er relevant, oplysninger, der sætter idriftsætterne i stand til at fortolke højrisiko-AI-systemets output og anvende det korrekt
c)
eventuelle ændringer af højrisiko-AI-systemet og dets ydeevne, som udbyderen på forhånd har fastsat på tidspunktet for den indledende overensstemmelsesvurdering
d)
foranstaltninger til menneskeligt tilsyn, jf. artikel 14, herunder de tekniske foranstaltninger, der er indført for at lette idriftsætternes fortolkning af højrisiko-AI-systemers output
e)
de nødvendige beregningskrafts- og hardwareressourcer, højrisiko-AI-systemets forventede levetid og eventuelle nødvendige vedligeholdelses- og plejeforanstaltninger, herunder deres hyppighed, for at sikre, at AI-systemet fungerer korrekt, herunder med hensyn til softwareopdateringer
f)
hvis det er relevant, en beskrivelse af de mekanismer, der er medtaget i højrisiko-AI-systemet, og som giver idriftsætterne mulighed for på korrekt vis at indsamle, lagre og fortolke logfilerne i overensstemmelse med artikel 12.
Artikel 14
Menneskeligt tilsyn
1.   Højrisiko-AI-systemer udformes og udvikles på en sådan måde, herunder med passende menneske-maskine-grænsefladeværktøjer, at fysiske personer effektivt kan overvåge dem i den periode, hvor de er i brug.
2.   Menneskeligt tilsyn har til formål at forebygge eller minimere de risici for sundhed, sikkerhed eller grundlæggende rettigheder, der kan opstå, når et højrisiko-AI-system anvendes i overensstemmelse med dets tilsigtede formål eller under forhold med fejlanvendelse, der med rimelighed kan forudses, navnlig hvis sådanne risici fortsat består trods anvendelsen af andre krav, der er fastsat i denne afdeling.
3.   Tilsynsforanstaltningerne skal stå i et rimeligt forhold til risiciene, graden af autonomi og den kontekst, som højrisiko-AI-systemet anvendes i, og sikres ved hjælp af en af eller samtlige følgende typer foranstaltninger:
a)
foranstaltninger, der er fastlagt og, hvis det er teknisk muligt, indbygget i højrisiko-AI-systemet fra udbyderens side, inden systemet bringes i omsætning eller ibrugtages
b)
foranstaltninger, der er fastlagt af udbyderen, inden højrisiko-AI-systemet bringes i omsætning eller ibrugtages, og som er egnede til at blive gennemført af idriftsætteren.
4.   Med henblik på gennemførelsen af stk. 1, 2 og 3 leveres højrisiko-AI-systemet til idriftsætteren på en sådan måde, at det er muligt for fysiske personer, der har fået til opgave at varetage menneskeligt tilsyn, alt efter hvad der er relevant og forholdsmæssigt, at:
a)
forstå højrisiko-AI-systemets relevante kapacitet og begrænsninger korrekt og være i stand til at overvåge dets drift på behørig vis, herunder med henblik på at opdage og håndtere uregelmæssigheder, funktionsforstyrrelser og uventet ydeevne
b)
være opmærksomme på den mulige tendens til automatisk eller i overdreven grad af forlade sig på output frembragt af et højrisiko-AI-system (automatiseringsbias), navnlig for så vidt angår højrisiko-AI-systemer, der anvendes til at give oplysninger eller anbefalinger til afgørelser, der skal træffes af fysiske personer
c)
fortolke højrisiko-AI-systemets output korrekt under hensyntagen til f.eks. de tilgængelige fortolkningsværktøjer og -metoder
d)
beslutte i en særlig situation ikke at anvende højrisiko-AI-systemet eller på anden måde se bort fra, tilsidesætte eller omgøre outputtet fra højrisiko-AI-systemet
e)
gribe ind i højrisiko-AI-systemets drift eller afbryde systemet ved hjælp af en »stopknap« eller en lignende procedure, som gør det muligt at afbryde systemet i en sikker tilstand.
5.   For så vidt angår de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 1, litra a), sikrer de foranstaltninger, der er omhandlet i denne artikels stk. 3, desuden, at idriftsætteren ikke foretager noget tiltag eller træffer nogen beslutninger på grundlag af en identifikation, der følger af systemet, medmindre denne identifikation er blevet verificeret og bekræftet særskilt af mindst to fysiske personer med den nødvendige kompetence, uddannelse og myndighed.
Kravet om særskilt verifikation foretaget af mindst to fysiske personer finder ikke anvendelse på højrisiko-AI-systemer, der anvendes med henblik på retshåndhævelse, migrationsstyring, grænsekontrol og asylforvaltning, hvis anvendelsen af dette krav efter EU-retten eller national ret skønnes uforholdsmæssig.
Artikel 15
Nøjagtighed, robusthed og cybersikkerhed
1.   Højrisiko-AI-systemer udformes og udvikles på en sådan måde, at de opnår et passende niveau af nøjagtighed, robusthed og cybersikkerhed, og at de i disse henseender yder konsistent i hele deres livscyklus.
2.   For at håndtere de tekniske aspekter af, hvordan de passende niveauer af nøjagtighed og robusthed, der er fastsat i stk. 1, og andre relevante ydeevneparametre måles, tilskynder Kommissionen, alt efter hvad der er relevant, i samarbejde med relevante interessenter og organisationer såsom metrologi- og benchmarkingmyndigheder til udvikling af benchmarks og målemetoder.
3.   Højrisiko-AI-systemers niveau og relevante parametre med hensyn til nøjagtighed angives i den ledsagende brugsanvisning.
4.   Højrisiko-AI-systemer skal være så modstandsdygtige som muligt over for fejl, svigt og uoverensstemmelser, der kan forekomme i systemet eller i det miljø, som systemet fungerer i, navnlig på grund af systemets interaktion med fysiske personer eller andre systemer. I denne henseende træffes der tekniske og organisatoriske foranstaltninger.
Højrisiko-AI-systemers robusthed kan opnås ved hjælp af tekniske redundansløsninger, som kan omfatte backupplaner eller »fail-safe plans«.
De højrisiko-AI-systemer, der fortsætter med at lære efter at være bragt i omsætning eller ibrugtaget, udvikles på en sådan måde med henblik på i videst muligt omfang at fjerne eller reducere risikoen for, at eventuelt output behæftet med bias påvirker input i fremtidige operationer (feedbacksløjfer), og sikre, at sådanne feedbacksløjfer behørigt imødegås ved hjælp af passende afbødende foranstaltninger.
5.   Højrisiko-AI-systemer skal være modstandsdygtige over for uautoriserede tredjeparters forsøg på at ændre deres anvendelse, output eller ydeevne ved at udnytte systemsårbarheder.
De tekniske løsninger, der har til formål at sikre cybersikkerhed i forbindelse med højrisiko-AI-systemer, skal stå i et passende forhold til de relevante omstændigheder og risiciene.
De tekniske løsninger til afhjælpning af AI-specifikke sårbarheder omfatter, alt efter hvad der er relevant, foranstaltninger til at forebygge, opdage, reagere på, afværge og kontrollere angreb, der søger at manipulere træningsdatasættet (dataforgiftning), eller forhåndstrænede komponenter, der anvendes i træning (modelforgiftning), input, der er udformet til at få AI-modellen til at begå fejl (ondsindede eksempler eller modelunddragelse), fortrolighedsangreb eller modelfejl.
AFDELING 3
Forpligtelser for udbydere og idriftsættere af højrisiko-AI-systemer og andre parter
Artikel 16
Forpligtelser for udbydere af højrisiko-AI-systemer
Udbydere af højrisiko-AI-systemer skal:
a)
sørge for, at deres højrisiko-AI-systemer overholder de krav, der er fastsat i afdeling 2
b)
angive deres navn, registrerede firmanavn eller registrerede varemærke og kontaktadresse på højrisiko-AI-systemet, eller, hvis dette ikke er muligt, på dets emballage eller i den medfølgende dokumentation, alt efter hvad der er relevant
c)
have indført et kvalitetsstyringssystem, der er i overensstemmelse med artikel 17
d)
opbevare den dokumentation, der er omhandlet i artikel 18
e)
opbevare de logfiler, der automatisk genereres af deres højrisiko-AI-systemer, når logfilerne er under deres kontrol, som omhandlet i artikel 19
f)
sørge for, at højrisiko-AI-systemet underkastes den relevante overensstemmelsesvurderingsprocedure som omhandlet i artikel 43, inden systemet bringes i omsætning eller ibrugtages
g)
udarbejde en EU-overensstemmelseserklæring i overensstemmelse med artikel 47
h)
anbringe CE-mærkningen på højrisiko-AI-systemet eller, hvis dette ikke er muligt, på dets emballage eller i den medfølgende dokumentation, for at angive overensstemmelse med denne forordning i overensstemmelse med artikel 48
i)
overholde de registreringsforpligtelser, der er omhandlet i artikel 49, stk. 1
j)
foretage de nødvendige korrigerende tiltag og fremlægge oplysningerne som krævet i henhold til artikel 20
k)
efter begrundet anmodning fra en national kompetent myndighed påvise, at højrisiko-AI-systemet er i overensstemmelse med de krav, der er fastsat i afdeling 2
l)
sikre, at højrisiko-AI-systemet overholder tilgængelighedskravene i overensstemmelse med direktiv (EU) 2016/2102 og (EU) 2019/882.
Artikel 17
Kvalitetsstyringssystem
1.   Udbydere af højrisiko-AI-systemer indfører et kvalitetsstyringssystem, der sikrer overensstemmelse med denne forordning. Systemet dokumenteres på en systematisk og velordnet måde i form af skriftlige politikker, procedurer og anvisninger og skal som minimum omfatte følgende aspekter:
a)
en strategi for overholdelse af lovgivningen, herunder overholdelse af overensstemmelsesvurderingsprocedurer og procedurer for forvaltning af ændringer af højrisiko-AI-systemet
b)
teknikker, procedurer og systematiske tiltag, der skal anvendes til udformningen, kontrollen af udformningen og verifikationen af udformningen af højrisiko-AI-systemet
c)
teknikker, procedurer og systematiske tiltag, der skal anvendes til udvikling, kvalitetskontrol og kvalitetssikring af højrisiko-AI-systemet
d)
undersøgelses-, afprøvnings- og valideringsprocedurer, der gennemføres før, under og efter udviklingen af højrisiko-AI-systemet, samt den hyppighed, hvormed de gennemføres
e)
tekniske specifikationer, herunder standarder, der anvendes, og, hvis de relevante harmoniserede standarder ikke anvendes fuldt ud eller ikke omfatter alle de relevante krav, der er fastsat i afdeling 2, de midler, der skal anvendes for at sikre, at højrisiko-AI-systemet overholder disse krav
f)
systemer til og procedurer for dataforvaltning, herunder dataopsamling, dataindsamling, dataanalyse, datamærkning, datalagring, datafiltrering, datamining, dataaggregering, dataopbevaring og enhver anden handling vedrørende data, som udføres forud for og med henblik på omsætning eller ibrugtagning af højrisiko-AI-systemer
g)
det risikoforvaltningssystem, der er omhandlet i artikel 9
h)
oprettelse, implementering og vedligeholdelse af et system til overvågning efter omsætningen i overensstemmelse med artikel 72
i)
procedurer for indberetning af en alvorlig hændelse i overensstemmelse med artikel 73
j)
håndtering af kommunikation med nationale kompetente myndigheder, andre relevante myndigheder, herunder dem, der giver eller understøtter adgang til data, bemyndigede organer, andre operatører, kunder eller andre interesserede parter
k)
systemer til og procedurer for registrering af al relevant dokumentation og alle relevante oplysninger
l)
ressourceforvaltning, herunder foranstaltninger vedrørende forsyningssikkerhed
m)
en ansvarlighedsramme, der fastlægger ledelsens og det øvrige personales ansvar med hensyn til alle de aspekter, der er anført i dette stykke.
2.   Gennemførelsen af de aspekter, der er omhandlet i stk. 1, skal stå i et rimeligt forhold til størrelsen af udbyderens organisation. Udbyderne skal under alle omstændigheder respektere den grad af strenghed og det beskyttelsesniveau, der kræves for at sikre, at deres højrisiko-AI-systemer er i overensstemmelse med denne forordning.
3.   Udbydere af højrisiko-AI-systemer, der er underlagt forpligtelser vedrørende kvalitetssikringssystemer eller en tilsvarende funktion i henhold til relevant sektorspecifik EU-ret, kan medtage de aspekter, der er anført i stk. 1, som en del af kvalitetsstyringssystemerne i henhold til denne ret.
4.   For de udbydere, der er finansielle institutioner, som er underlagt krav vedrørende deres interne ledelse, ordninger eller processer i henhold til EU-retten om finansielle tjenesteydelser, anses forpligtelsen til at indføre et kvalitetsstyringssystem med undtagelse af denne artikels stk. 1, litra g), h) og i), for at være opfyldt ved overholdelse af reglerne om ordninger eller processer for intern ledelse i henhold til den relevante EU-ret om finansielle tjenesteydelser. Med henblik herpå tages der hensyn til alle de harmoniserede standarder, der er omhandlet i artikel 40.
Artikel 18
Opbevaring af dokumentation
1.   Udbyderen skal i ti år, efter at højrisiko-AI-systemet er blevet bragt i omsætning eller ibrugtaget, kunne forelægge de nationale kompetente myndigheder:
a)
den i artikel 11 omhandlede tekniske dokumentation
b)
dokumentationen vedrørende det i artikel 17 omhandlede kvalitetsstyringssystem
c)
dokumentationen vedrørende ændringer, der er godkendt af bemyndigede organer, hvis det er relevant
d)
de afgørelser og andre dokumenter, der er udstedt af de bemyndigede organer, hvis det er relevant
e)
den i artikel 47 omhandlede EU-overensstemmelseserklæring.
2.   Hver medlemsstat fastsætter, på hvilke betingelser den i stk. 1 omhandlede dokumentation fortsat er til rådighed for de nationale kompetente myndigheder i den periode, der er anført i nævnte stykke, i de tilfælde, hvor en udbyder eller dennes bemyndigede repræsentant, der er etableret på dens område, går konkurs eller indstiller sine aktiviteter inden udløbet af denne periode.
3.   De udbydere, der er finansielle institutioner, som er underlagt krav vedrørende deres interne ledelse, ordninger eller processer i henhold til EU-retten om finansielle tjenesteydelser, beholder den tekniske dokumentation som en del af den dokumentation, der opbevares i henhold til den relevante EU-ret om finansielle tjenesteydelser.
Artikel 19
Automatisk genererede logfiler
1.   Udbydere af højrisiko-AI-systemer opbevarer de i artikel 12, stk. 1, omhandlede logfiler, der genereres automatisk af deres højrisiko-AI-systemer, i det omfang sådanne logfiler er under deres kontrol. Uden at det berører gældende EU-ret eller national ret, opbevares logfilerne i en periode, der er passende i forhold til det tilsigtede formål med højrisiko-AI-systemet, på mindst seks måneder, medmindre andet er fastsat i gældende EU-ret eller national ret, navnlig EU-retten om beskyttelse af personoplysninger.
2.   De udbydere, der er finansielle institutioner, som er underlagt krav vedrørende deres interne ledelse, ordninger eller processer i henhold til EU-retten om finansielle tjenesteydelser, beholder de logfiler, der automatisk genereres af deres højrisiko-AI-systemer som en del af den dokumentation, der opbevares i henhold til den relevante ret om finansielle tjenesteydelser.
Artikel 20
Korrigerende tiltag og oplysningspligt
1.   De udbydere af højrisiko-AI-systemer, der mener eller har grund til at mene, at et højrisiko-AI-system, som de har bragt i omsætning eller ibrugtaget, ikke er i overensstemmelse med denne forordning, foretager omgående de nødvendige korrigerende tiltag til at bringe det pågældende system i overensstemmelse hermed, tilbagetrække det, tage det ud af drift eller tilbagekalde det, alt efter hvad der er relevant. De underretter distributørerne af det pågældende højrisiko-AI-system og om nødvendigt idriftsætterne, den bemyndigede repræsentant samt importører herom.
2.   Hvis et højrisiko-AI-system udgør en risiko som omhandlet i artikel 79, stk. 1, og udbyderen får kendskab til denne risiko, undersøger denne omgående årsagerne i samarbejde med den indberettende idriftsætter, hvis det er relevant, og underretter de markedsovervågningsmyndigheder, der er kompetente for det pågældende højrisiko-AI-system, og, hvis det er relevant, det bemyndigede organ, der har udstedt en attest for det pågældende højrisiko-AI-system i overensstemmelse med artikel 44, navnlig om arten af den manglende overholdelse og om eventuelle relevante korrigerende tiltag, der er foretaget.
Artikel 21
Samarbejde med kompetente myndigheder
1.   Udbydere af højrisiko-AI-systemer giver efter begrundet anmodning fra en kompetent myndighed denne myndighed alle de fornødne oplysninger og al den fornødne dokumentation for at påvise, at højrisiko-AI-systemet er i overensstemmelse med de krav, der er fastsat i afdeling 2, på et sprog, som den pågældende myndighed let kan forstå, og på et af EU-institutionernes officielle sprog som angivet af den pågældende medlemsstat.
2.   Efter begrundet anmodning fra en kompetent myndighed giver udbydere, alt efter hvad der er relevant, også den anmodende kompetente myndighed adgang til de automatisk genererede logfiler af højrisiko-AI-systemet, der er omhandlet i artikel 12, stk. 1, i det omfang sådanne logfiler er under deres kontrol.
3.   Alle de oplysninger, som en kompetent myndighed kommer i besiddelse af i henhold til denne artikel, behandles i overensstemmelse med fortrolighedsforpligtelserne fastsat i artikel 78.
Artikel 22
Bemyndigede repræsentanter for udbydere af højrisiko-AI-systemer
1.   Udbydere, der er etableret i tredjelande, udpeger, inden deres højrisiko-AI-systemer gøres tilgængelige på EU-markedet, ved skriftligt mandat en bemyndiget repræsentant, der er etableret i Unionen.
2.   Udbyderen skal gøre det muligt for sin bemyndigede repræsentant at udføre de opgaver, der er fastsat i det mandat, vedkommende har modtaget fra udbyderen.
3.   Den bemyndigede repræsentant udfører de opgaver, der er fastsat i det mandat, vedkommende har modtaget fra udbyderen. Vedkommende skal på anmodning give markedsovervågningsmyndighederne en kopi af mandatet på et af EU-institutionernes officielle sprog som angivet af den kompetente myndighed. Med henblik på denne forordning sætter mandatet den bemyndigede repræsentant i stand til at udføre følgende opgaver:
a)
at kontrollere, at den EU-overensstemmelseserklæring, der er omhandlet i artikel 47, og den tekniske dokumentation, der er omhandlet i artikel 11, er blevet udarbejdet, og at en passende overensstemmelsesvurderingsprocedure er blevet gennemført af udbyderen
b)
i en periode på ti år efter, at højrisiko-AI-systemet er blevet bragt i omsætning eller ibrugtaget, at kunne forelægge de kompetente myndigheder og nationale myndigheder eller organer, der er omhandlet i artikel 74, stk. 10, kontaktoplysningerne for den udbyder, der udpegede den bemyndigede repræsentant, en kopi af den i artikel 47 omhandlede EU-overensstemmelseserklæringen, den tekniske dokumentation og, hvis det er relevant, den attest, der er udstedt af det bemyndigede organ
c)
efter begrundet anmodning at give de kompetente myndigheder alle de fornødne oplysninger og al den fornødne dokumentation, herunder den, der er omhandlet i dette afsnits litra b), for at påvise, at et højrisiko-AI-system er i overensstemmelse med kravene fastsat i afdeling 2, herunder adgang til logfilerne som omhandlet i artikel 12, stk. 1, der genereres automatisk af højrisiko-AI-systemet, i det omfang sådanne logfiler er under udbyderens kontrol
d)
efter begrundet anmodning at samarbejde med de kompetente myndigheder om ethvert tiltag, som sidstnævnte foretager i forbindelse med højrisiko-AI-systemet, navnlig med henblik på at reducere og afhjælpe de risici, som højrisiko-AI-systemet udgør
e)
hvis det er relevant, at overholde registreringsforpligtelserne, jf. artikel 49, stk. 1, eller, hvis registreringen foretages af udbyderen selv, sikre, at de oplysninger, der er omhandlet i bilag VIII, afsnit A, punkt 3, er korrekte.
Mandatet giver beføjelse til, at den bemyndigede repræsentant, ud over eller i stedet for udbyderen, kan modtage henvendelser fra de kompetente myndigheder om alle spørgsmål relateret til at sikre overholdelse af denne forordning.
4.   Den bemyndigede repræsentant bringer mandatet til ophør, hvis vedkommende mener eller har grund til at mene, at udbyderen handler i strid med sine forpligtelser i henhold til denne forordning. I så fald underretter den omgående den relevante markedsovervågningsmyndighed samt, hvis det er relevant, det relevante bemyndigede organ om mandatets ophør og begrundelsen herfor.
Artikel 23
Forpligtelser for importører
1.   Importører sikrer, før de bringer et højrisiko-AI-system i omsætning, at systemet er i overensstemmelse med denne forordning, ved at kontrollere, at:
a)
udbyderen af dette højrisiko-AI-system har gennemført den relevante overensstemmelsesvurderingsprocedure, jf. artikel 43
b)
udbyderen har udarbejdet den tekniske dokumentation i overensstemmelse med artikel 11 og bilag IV
c)
systemet er forsynet med den krævede CE-mærkning og ledsages af den i artikel 47 omhandlede EU-overensstemmelseserklæring og brugsanvisning
d)
udbyderen har udpeget en bemyndiget repræsentant i overensstemmelse med artikel 22, stk. 1.
2.   Hvis en importør har tilstrækkelig grund til at mene, at et højrisiko-AI-system ikke er i overensstemmelse med denne forordning eller er forfalsket eller ledsaget af forfalsket dokumentation, må vedkommende ikke bringe systemet i omsætning, før det er blevet bragt i overensstemmelse hermed. Hvis højrisiko-AI-systemet udgør en risiko som omhandlet i artikel 79, stk. 1, underretter importøren udbyderen af systemet, den bemyndigede repræsentant og markedsovervågningsmyndighederne herom.
3.   Importører angiver deres navn, registrerede firmanavn eller registrerede varemærke og kontaktadresse på højrisiko-AI-systemet og på dets emballage eller i den medfølgende dokumentation, hvis det er relevant.
4.   Importører sikrer, at opbevarings- og transportbetingelserne, hvis det er relevant, for højrisiko-AI-systemer, som de har ansvaret for, ikke bringer dets overholdelse af kravene fastsat i afdeling 2 i fare.
5.   Importører opbevarer i ti år efter, at højrisiko-AI-systemet er blevet bragt i omsætning eller ibrugtaget, en kopi af den attest, der er udstedt af det bemyndigede organ, hvis det er relevant, af brugsanvisningen og af den i artikel 47 omhandlede EU-overensstemmelseserklæring.
6.   Importører giver efter begrundet anmodning og på et sprog, som de relevante myndigheder let kan forstå, disse myndigheder alle de fornødne oplysninger og al den fornødne dokumentation, herunder den, der er omhandlet i stk. 5, for at påvise, at et højrisiko-AI-system er i overensstemmelse med kravene i afdeling 2. Med henblik herpå skal de også sikre, at den tekniske dokumentation kan stilles til rådighed for disse myndigheder.
7.   Importører samarbejder med de relevante kompetente myndigheder om ethvert tiltag, som disse myndigheder foretager vedrørende et højrisiko-AI-system, som importørerne har bragt i omsætning, navnlig med henblik på at reducere eller afbøde de risici, som det udgør.
Artikel 24
Forpligtelser for distributører
1.   Distributører kontrollerer, før de gør et højrisiko-AI-system tilgængeligt på markedet, at det er forsynet med den krævede CE-mærkning, at det ledsages af en kopi af den i artikel 47 omhandlede EU-overensstemmelseserklæring og brugsanvisning, og at udbyderen og importøren af dette system, alt efter hvad der er relevant, har opfyldt deres respektive forpligtelser som fastsat i artikel 16, litra b) og c), og artikel 23, stk. 3.
2.   Hvis en distributør på grundlag af oplysningerne i dennes besiddelse mener eller har grund til at mene, at et højrisiko-AI-system ikke er i overensstemmelse med kravene i afdeling 2, må vedkommende ikke gøre højrisiko-AI-systemet tilgængeligt på markedet, før systemet er blevet bragt i overensstemmelse med de nævnte krav. Hvis højrisiko-AI-systemet ydermere udgør en risiko som omhandlet i artikel 79, stk. 1, underretter distributøren udbyderen eller importøren af systemet, alt efter hvad der er relevant, herom.
3.   Distributører sikrer, hvis det er relevant, at opbevarings- og transportbetingelserne for højrisiko-AI-systemer, som de har ansvaret for, ikke bringer systemets overholdelse af kravene i afdeling 2 i fare.
4.   Hvis en distributør på grundlag af oplysningerne i dennes besiddelse mener eller har grund til at mene, at et højrisiko-AI-system, som vedkommende har gjort tilgængeligt på markedet, ikke er i overensstemmelse med kravene i afdeling 2, foretager vedkommende de nødvendige korrigerende tiltag for at bringe systemet i overensstemmelse med disse krav, tilbagetrække det eller tilbagekalde det eller sikrer, at udbyderen, importøren eller enhver relevant operatør, alt efter hvad der er relevant, foretager disse korrigerende tiltag. Hvis højrisiko-AI-systemet udgør en risiko som omhandlet i artikel 79, stk. 1, orienterer distributøren omgående udbyderen eller importøren af systemet og de myndigheder, der er kompetente for det pågældende højrisiko-AI-system, herom og giver navnlig nærmere oplysninger om den manglende overholdelse og de foretagne korrigerende tiltag.
5.   Efter begrundet anmodning fra en relevant kompetent myndighed giver distributører af et højrisiko-AI-system denne myndighed alle fornødne oplysninger og al fornøden dokumentation vedrørende deres handlinger i henhold til stk. 1-4 for at påvise, at dette højrisiko-AI-system er i overensstemmelse med kravene i afdeling 2.
6.   Distributører samarbejder med de relevante kompetente myndigheder om ethvert tiltag, som disse myndigheder foretager vedrørende et højrisiko-AI-system, som distributørerne har bragt i omsætning, navnlig med henblik på at reducere eller afbøde de risici, som det udgør.
Artikel 25
Ansvar i hele AI-værdikæden
1.   Enhver distributør, importør, idriftsætter eller anden tredjepart anses for at være udbyder af et højrisiko-AI-system med henblik på denne forordning og er underlagt forpligtelserne for udbydere, jf. artikel 16, i følgende tilfælde:
a)
de anbringer deres navn eller varemærke på et højrisiko-AI-system, der allerede er bragt i omsætning eller ibrugtaget, uden at det berører kontraktlige ordninger om, at forpligtelserne er fordelt anderledes
b)
de foretager en væsentlig ændring af et højrisiko-AI-system, der allerede er bragt i omsætning eller allerede er ibrugtaget, på en sådan måde, at det forbliver et højrisiko-AI-system i henhold til artikel 6
c)
de ændrer det tilsigtede formål med et AI-system, herunder et AI-system til almen brug, der ikke er klassificeret som højrisiko og allerede er bragt i omsætning eller ibrugtaget, på en sådan måde, at det pågældende AI-system bliver et højrisiko-AI-system i overensstemmelse med artikel 6.
2.   Hvis de omstændigheder, der er omhandlet i stk. 1, indtræffer, anses den udbyder, der oprindeligt bragte AI-systemet i omsætning eller ibrugtog det, ikke længere for at være udbyder af dette specifikke AI-system i denne forordnings forstand. Denne oprindelige udbyder skal arbejde tæt sammen med nye udbydere og stille de nødvendige oplysninger til rådighed og give den teknisk adgang og anden bistand, som med rimelighed kan forventes, og som kræves for at opfylde forpligtelserne i denne forordning, navnlig hvad angår overholdelse af overensstemmelsesvurderingen af højrisiko-AI-systemer. Dette stykke finder ikke anvendelse i de tilfælde, hvor den oprindelige udbyder klart har præciseret, at dennes AI-system ikke skal ændres til et højrisiko-AI-system og dermed ikke er omfattet af forpligtelsen til at udlevere dokumentationen.
3.   Hvad angår højrisiko-AI-systemer, der er sikkerhedskomponenter i produkter, der er omfattet af EU-harmoniseringslovgivningen opført i bilag I, afsnit A, anses producenten for at være udbyderen af højrisiko-AI-systemet og underlægges forpligtelserne i henhold til artikel 16 i følgende tilfælde:
a)
Højrisiko-AI-systemet bringes i omsætning sammen med produktet under producentens navn eller varemærke.
b)
Højrisiko-AI-systemet ibrugtages under producentens navn eller varemærke, efter at produktet er bragt i omsætning.
4.   Udbyderen af et højrisiko-AI-system og den tredjepart, der leverer et AI-system, værktøjer, tjenester, komponenter eller processer, der anvendes eller integreres i et højrisiko-AI-system, skal ved skriftlig aftale præcisere de nødvendige oplysninger, kapacitet, teknisk adgang og anden bistand på grundlag af det generelt anerkendte aktuelle teknologiske niveau, så udbydere af højrisiko-AI-systemet er i stand til fuldt ud at overholde forpligtelserne i denne forordning. Dette stykke finder ikke anvendelse på tredjeparter, der gør andre værktøjer, tjenester, processer eller komponenter, der ikke er AI-modeller til almen brug, tilgængelige for offentligheden i henhold til en gratis open source-licens.
AI-kontoret kan udvikle og anbefale frivillige standardaftalevilkår mellem udbydere af højrisiko-AI-systemer og tredjeparter, der leverer værktøjer, tjenester, komponenter eller processer, som anvendes til eller integreres i højrisiko-AI-systemer. Når AI-kontoret udarbejder disse frivillige standardaftalevilkår, tager det også hensyn til eventuelle kontraktlige krav, der gælder i specifikke sektorer eller forretningsscenarier. De frivillige standardaftalevilkår offentliggøres og stilles gratis til rådighed i et letanvendeligt elektronisk format.
5.   Stk. 2 og 3 berører ikke behovet for at overholde og beskytte intellektuelle ejendomsrettigheder, fortrolige forretningsoplysninger og forretningshemmeligheder i overensstemmelse med EU-retten og national ret.
Artikel 26
Forpligtelser for idriftsættere af højrisiko-AI-systemer
1.   Idriftsættere af højrisiko-AI-systemer træffer passende tekniske og organisatoriske foranstaltninger for at sikre, at de anvender disse systemer i overensstemmelse med den brugsanvisning, der ledsager systemerne, jf. stk. 3 og 6.
2.   Idriftsættere overdrager varetagelsen af det menneskelige tilsyn til fysiske personer, der har den nødvendige kompetence, uddannelse og myndighed samt den nødvendige støtte.
3.   Forpligtelserne i stk. 1 og 2 berører ikke andre idriftsætterforpligtelser i henhold til EU-retten eller national ret eller idriftsætterens frihed til at tilrettelægge sine egne ressourcer og aktiviteter med henblik på at gennemføre de af udbyderen angivne foranstaltninger til menneskeligt tilsyn.
4.   Uden at dette berører stk. 1 og 2, og i det omfang idriftsætteren udøver kontrol over inputdataene, sikrer denne idriftsætter, at inputdataene er relevante og tilstrækkeligt repræsentative med henblik på højrisiko-AI-systemets tilsigtede formål.
5.   Idriftsættere overvåger driften af højrisiko-AI-systemet på grundlag af brugsanvisningen og underretter, hvis det er relevant, udbyderne i overensstemmelse med artikel 72. Hvis idriftsættere har grund til at mene, at anvendelsen af højrisiko-AI-systemet i overensstemmelse med anvisningerne kan resultere i, at AI-systemet udgør en risiko som omhandlet i artikel 79, stk. 1, underretter de uden unødigt ophold udbyderen eller distributøren og den relevante markedsovervågningsmyndighed og stiller anvendelsen af dette system i bero. Hvis idriftsættere har konstateret en alvorlig hændelse, underretter de også omgående først udbyderen og dernæst importøren eller distributøren og de relevante markedsovervågningsmyndigheder om den pågældende hændelse. Hvis idriftsætteren ikke er i stand til at kontakte udbyderen, finder artikel 73 tilsvarende anvendelse. Denne forpligtelse omfatter ikke følsomme operationelle data fra idriftsættere af AI-systemer, som er retshåndhævende myndigheder.
For idriftsættere, der er finansielle institutioner, som er underlagt krav vedrørende deres interne ledelse, ordninger eller processer i henhold til EU-retten om finansielle tjenesteydelser, anses overvågningsforpligtelsen i første afsnit for at være opfyldt ved overholdelse af reglerne om ordninger, processer og mekanismer for intern ledelse i henhold til den relevante ret om finansielle tjenesteydelser.
6.   Idriftsættere af højrisiko-AI-systemer opbevarer de logfiler, der genereres automatisk af det pågældende højrisiko-AI-system, i det omfang sådanne logfiler er under deres kontrol, i en periode, der er passende i forhold til det tilsigtede formål med højrisiko-AI-systemet, på mindst seks måneder, medmindre andet er fastsat i gældende EU-ret eller national ret, navnlig EU-retten om beskyttelse af personoplysninger.
Idriftsættere, der er finansielle institutioner, som er underlagt krav vedrørende deres interne ledelse, ordninger eller processer i henhold til EU-retten om finansielle tjenesteydelser, beholder logfilerne som en del af den dokumentation, der opbevares i henhold til den relevante EU-ret om finansielle tjenesteydelser.
7.   Inden ibrugtagning eller anvendelse af et højrisiko-AI-system på arbejdspladsen informerer idriftsættere, som er arbejdsgivere, arbejdstagerrepræsentanter og de berørte arbejdstagere om, at de vil være omfattet af anvendelsen af højrisiko-AI-systemet. Denne information forelægges, hvis det er relevant, i overensstemmelse med de regler og procedurer, der er fastsat i EU-retten og EU-praksis og national ret og praksis om informering af arbejdstagere og deres repræsentanter.
8.   Idriftsættere af højrisiko-AI-systemer, der er offentlige myndigheder eller EU-institutioner, -organer, -kontorer eller -agenturer, overholder de registreringsforpligtelser, der er omhandlet i artikel 49. Når sådanne idriftsættere konstaterer, at det højrisiko-AI-system, de påtænker at anvende, ikke er registreret i den EU-database, der er omhandlet i artikel 71, anvender de ikke dette system og underretter leverandøren eller distributøren.
9.   Hvis det er relevant, anvender idriftsættere af højrisiko-AI-systemer de oplysninger, der er fastsat i henhold til denne forordnings artikel 13, til at overholde deres forpligtelse til at foretage en konsekvensanalyse vedrørende databeskyttelse i henhold til artikel 35 i forordning (EU) 2016/679 eller artikel 27 i direktiv (EU) 2016/680.
10.   Uden at det berører direktiv (EU) 2016/680, anmoder idriftsætteren af et højrisiko-AI-system til efterfølgende biometrisk fjernidentifikation inden for rammerne af en efterforskning med henblik på en målrettet eftersøgning af en person, der er mistænkt eller tiltalt for at have begået en strafbar handling, om tilladelse fra en judiciel myndighed eller en administrativ myndighed, hvis afgørelse er bindende og underlagt domstolskontrol, til på forhånd eller uden unødigt ophold og senest inden for 48 timer at anvende det pågældende system, medmindre det anvendes til indledende identifikation af en potentiel mistænkt på grundlag af objektive og verificerbare kendsgerninger, der er direkte knyttet til overtrædelsen. Hver anvendelse begrænses til, hvad der er strengt nødvendigt for efterforskningen af en specifik strafbar handling.
Hvis den tilladelse, der er anmodet om i henhold til første afsnit, afvises, bringes anvendelsen af systemet til efterfølgende biometrisk fjernidentifikation, der er knyttet til denne tilladelse, der anmodes om, straks til ophør, og de personoplysninger, der er knyttet til anvendelsen af det højrisiko-AI-system, som der blev anmodet om tilladelse til, slettes.
Et sådant højrisiko-AI-system til efterfølgende biometrisk fjernidentifikation må under ingen omstændigheder anvendes til retshåndhævelsesformål på en ikkemålrettet måde uden nogen forbindelse til en strafbar handling, en straffesag, en reel og aktuel eller reel og forudsigelig trussel om en strafbar handling eller eftersøgning af en specifik forsvundet person. Det sikres, at der ikke træffes nogen afgørelse, der har negative retsvirkninger for en person, af de retshåndhævende myndigheder, udelukkende baseret på outputtet af sådanne systemer til efterfølgende biometrisk fjernidentifikation.
Dette stykke berører ikke artikel 9 i forordning (EU) 2016/679 og artikel 10 i direktiv (EU) 2016/680 med hensyn til behandling af biometriske data.
Uanset formålet eller idriftsætteren skal hver anvendelse af sådanne højrisiko-AI-systemer dokumenteres i det relevante politiregister og efter anmodning stilles til rådighed for den relevante markedsovervågningsmyndighed og den nationale databeskyttelsesmyndighed, undtagen hvis det drejer sig om videregivelse af følsomme operationelle data vedrørende retshåndhævelse. Dette afsnit berører ikke de beføjelser, der tillægges tilsynsmyndighederne ved direktiv (EU) 2016/680.
Idriftsættere forelægger årlige rapporter for de relevante markedsovervågningsmyndigheder og de relevante nationale databeskyttelsesmyndigheder om deres anvendelse af systemer til efterfølgende biometrisk fjernidentifikation, undtagen hvis det drejer sig om videregivelse af følsomme operationelle data vedrørende retshåndhævelse. Rapporterne kan samles for at dække mere end én idriftsættelse.
Medlemsstaterne kan i overensstemmelse med EU-retten indføre mere restriktiv lovgivning om anvendelsen af systemer til efterfølgende biometrisk fjernidentifikation.
11.   Uden at det berører denne forordnings artikel 50, underretter idriftsættere af de i bilag III omhandlede højrisiko-AI-systemer, der træffer beslutninger eller bistår med at træffe beslutninger vedrørende fysiske personer, de fysiske personer om, at de er genstand for anvendelsen af et højrisiko-AI-system. For højrisiko-AI-systemer, der anvendes til retshåndhævelsesformål, finder artikel 13 i direktiv (EU) 2016/680 anvendelse.
12.   Idriftsættere samarbejder med de relevante kompetente myndigheder om ethvert tiltag, som disse myndigheder foretager vedrørende højrisiko-AI-systemet, med henblik på gennemførelse af denne forordning.
Artikel 27
Konsekvensanalyse vedrørende grundlæggende rettigheder for højrisiko-AI-systemer
1.   Inden idriftsættelse af et højrisiko-AI-system omhandlet i artikel 6, stk. 2, undtagen højrisiko-AI-systemer, der tilsigtes anvendt på det område, der er anført i bilag III, punkt 2, foretager idriftsættere, der er offentligretlige organer eller private enheder, der leverer offentlige tjenester, og idriftsættere af de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 5, litra b) og c), en analyse af konsekvensen for grundlæggende rettigheder, som anvendelsen af et sådant system kan medføre. Med henblik herpå foretager idriftsætterne en konsekvensanalyse bestående af:
a)
en beskrivelse af idriftsætterens processer, i hvilke højrisiko-AI-systemet vil blive anvendt i overensstemmelse med dets tilsigtede formål
b)
en beskrivelse af den periode og hyppighed, inden for hvilken hvert højrisiko-AI-system tilsigtes anvendt
c)
de kategorier af fysiske personer og grupper, som forventes at blive påvirket af dets anvendelse i den specifikke kontekst
d)
de specifikke risici for skade, der sandsynligvis vil påvirke de kategorier af fysiske personer eller grupper af personer, som er identificeret i henhold til dette stykkes litra c), under hensyntagen til oplysningerne fra udbyderen, jf. artikel 13
e)
en beskrivelse af gennemførelsen af foranstaltninger til menneskeligt tilsyn i overensstemmelse med brugsanvisningen
f)
de foranstaltninger, der skal træffes, hvis disse risici opstår, herunder ordningerne for intern ledelse og klagemekanismer.
2.   Den i stk. 1 fastsatte forpligtelse gælder for den første anvendelse af højrisiko-AI-systemet. Idriftsætteren kan i lignende tilfælde anvende tidligere gennemførte konsekvensanalyser vedrørende grundlæggende rettigheder eller eksisterende konsekvensanalyser, som udbyderen har foretaget. Hvis idriftsætteren under anvendelsen af højrisiko-AI-systemet finder, at nogle af de elementer, der er anført i stk. 1, har ændret sig eller ikke længere er ajourførte, tager idriftsætteren de nødvendige skridt til at ajourføre oplysningerne.
3.   Når den i stk. 1 omhandlede konsekvensanalyse er foretaget, meddeler idriftsætteren markedsovervågningsmyndigheden resultaterne heraf og forelægger den i denne artikels stk. 5 omhandlede udfyldte skabelon som en del af meddelelsen. I det tilfælde, som er omhandlet i artikel 46, stk. 1, kan idriftsættere undtages fra denne meddelelsespligt.
4.   Hvis nogle af de forpligtelser, der er fastsat i denne artikel, allerede er opfyldt ved den konsekvensanalyse vedrørende databeskyttelse, der foretages i henhold til artikel 35 i forordning (EU) 2016/679 eller artikel 27 i direktiv (EU) 2016/680, supplerer den i nærværende artikels stk. 1 omhandlede konsekvensanalyse vedrørende grundlæggende rettigheder den pågældende konsekvensanalyse vedrørende databeskyttelse.
5.   AI-kontoret udarbejder en skabelon til et spørgeskema, herunder gennem et automatiseret værktøj, der skal gøre det lettere for idriftsættere at overholde deres forpligtelser i henhold til denne artikel på en forenklet måde.
AFDELING 4
Bemyndigende myndigheder og bemyndigede organer
Artikel 28
Bemyndigende myndigheder
1.   Hver medlemsstat udpeger eller opretter mindst én bemyndigende myndighed med ansvar for at indføre og gennemføre de nødvendige procedurer for vurdering, udpegelse og notifikation af overensstemmelsesvurderingsorganer og for overvågning heraf. Disse procedurer udvikles i samarbejde mellem de bemyndigende myndigheder i alle medlemsstater.
2.   Medlemsstaterne kan beslutte, at den i stk. 1 omhandlede vurdering og overvågning skal foretages af et nationalt akkrediteringsorgan som omhandlet i og i overensstemmelse med forordning (EF) nr. 765/2008.
3.   Bemyndigende myndigheder oprettes, organiseres og drives på en sådan måde, at der ikke opstår interessekonflikter med overensstemmelsesvurderingsorganerne, og at der sikres objektivitet og uvildighed i deres aktiviteter.
4.   Bemyndigende myndigheder er organiseret på en sådan måde, at afgørelser om notifikation af overensstemmelsesvurderingsorganer træffes af kompetente personer, der ikke er identiske med dem, der har foretaget vurderingen af disse organer.
5.   Bemyndigende myndigheder hverken tilbyder eller leverer aktiviteter, som udføres af overensstemmelsesvurderingsorganer, eller nogen form for rådgivningstjeneste på kommercielt eller konkurrencemæssigt grundlag.
6.   Bemyndigende myndigheder sikrer, at de oplysninger, de kommer i besiddelse af, behandles fortroligt i overensstemmelse med artikel 78.
7.   Bemyndigende myndigheder skal have et tilstrækkelig stort kompetent personale til, at de kan udføre deres opgaver behørigt. Det kompetente personale skal have den ekspertise, der er nødvendig for deres funktion, hvis det er relevant, på områder såsom informationsteknologier, AI og jura, herunder tilsyn med grundlæggende rettigheder.
Artikel 29
Ansøgning om notifikation af et overensstemmelsesvurderingsorgan
1.   Overensstemmelsesvurderingsorganer indgiver en ansøgning om notifikation til den bemyndigende myndighed i den medlemsstat, hvor de er etableret.
2.   Ansøgningen om notifikation ledsages af en beskrivelse af de overensstemmelsesvurderingsaktiviteter, det eller de overensstemmelsesvurderingsmoduler og de typer AI-systemer, som overensstemmelsesvurderingsorganet hævder at være kompetent til, samt af en eventuel akkrediteringsattest udstedt af et nationalt akkrediteringsorgan, hvori det bekræftes, at overensstemmelsesvurderingsorganet opfylder kravene i artikel 31.
Alle gyldige dokumenter vedrørende eksisterende udpegelser af det ansøgende bemyndigede organ i henhold til enhver anden EU-harmoniseringslovgivning tilføjes.
3.   Hvis det pågældende overensstemmelsesvurderingsorgan ikke kan forelægge en akkrediteringsattest, forelægger det den bemyndigende myndighed al den dokumentation, der er nødvendig for verifikationen, anerkendelsen og den regelmæssige overvågning af, at det overholder kravene i artikel 31.
4.   For bemyndigede organer, der er udpeget i henhold til enhver anden EU-harmoniseringslovgivning, kan alle dokumenter og attester, der er knyttet til disse udpegelser, alt efter hvad der er relevant, anvendes til at understøtte deres udpegelsesprocedure i henhold til denne forordning. Det bemyndigede organ ajourfører den i denne artikels stk. 2 og 3 omhandlede dokumentation, når der sker relevante ændringer, for at give myndigheden med ansvar for bemyndigede organer mulighed for at overvåge og verificere, at alle krav i artikel 31 løbende er opfyldt.
Artikel 30
Notifikationsprocedure
1.   De bemyndigende myndigheder må kun bemyndige overensstemmelsesvurderingsorganer, som opfylder kravene i artikel 31.
2.   De bemyndigende myndigheder underretter Kommissionen og de øvrige medlemsstater om hvert overensstemmelsesvurderingsorgan, der er omhandlet i stk. 1, ved hjælp af det elektroniske notifikationsværktøj, der er udviklet og forvaltes af Kommissionen.
3.   Den notifikationen, der er omhandlet i denne artikels stk. 2, skal indeholde fyldestgørende oplysninger om overensstemmelsesvurderingsaktiviteterne, overensstemmelsesvurderingsmodulet eller -modulerne, de pågældende typer AI-systemer og den relevante dokumentation for kompetencen. Hvis en bemyndigelse ikke er baseret på en akkrediteringsattest som omhandlet i artikel 29, stk. 2, skal den bemyndigende myndighed forelægge Kommissionen og de øvrige medlemsstater dokumentation, der bekræfter overensstemmelsesvurderingsorganets kompetence og de ordninger, der er indført for at sikre, at der regelmæssigt føres tilsyn med organet, og at organet også fremover vil opfylde de i artikel 31 fastsatte krav.
4.   Det pågældende overensstemmelsesvurderingsorgan må kun udføre aktiviteter som bemyndiget organ, hvis Kommissionen og de øvrige medlemsstater ikke har gjort indsigelse inden for to uger efter en bemyndigende myndigheds notifikation, hvis den indeholder en akkrediteringsattest, jf. artikel 29, stk. 2, eller senest to måneder efter den bemyndigende myndigheds notifikation, hvis den indeholder den dokumentation, der er omhandlet i artikel 29, stk. 3.
5.   Hvis der gøres indsigelse, hører Kommissionen straks de relevante medlemsstater og overensstemmelsesvurderingsorganet. Med henblik herpå træffer Kommissionen afgørelse om, hvorvidt tilladelsen er berettiget. Kommissionen retter sin afgørelse til den pågældende medlemsstat og det relevante overensstemmelsesvurderingsorgan.
Artikel 31
Krav vedrørende bemyndigede organer
1.   Et bemyndiget organ skal oprettes i henhold til national ret i en medlemsstat og være en juridisk person.
2.   Bemyndigede organer skal opfylde de organisatoriske krav samt de kvalitetsstyrings-, ressource- og procedurekrav, der er nødvendige for at kunne udføre deres opgaver, samt passende cybersikkerhedskrav.
3.   Bemyndigede organers organisationsstruktur, ansvarsfordeling, rapporteringsveje og drift skal sikre, at der er tillid til deres arbejde og til resultaterne af de bemyndigede organers overensstemmelsesvurderingsaktiviteter.
4.   Bemyndigede organer skal være uafhængige af udbyderen af højrisiko-AI-systemet, i forbindelse med hvilket de udfører overensstemmelsesvurderingsaktiviteter. Bemyndigede organer skal også være uafhængige af alle andre operatører, der har en økonomisk interesse i højrisiko-AI-systemer, der vurderes, og af enhver konkurrent til udbyderen. Dette er ikke til hinder for at anvende vurderede højrisiko-AI-systemer, som er nødvendige for overensstemmelsesvurderingsorganets drift, eller for at anvende sådanne højrisiko-AI-systemer til personlige formål.
5.   Hverken overensstemmelsesvurderingsorganet, dets øverste ledelse eller det personale, der er ansvarligt for at udføre dets overensstemmelsesvurderingsopgaver, må være direkte involveret i udformningen, udviklingen, markedsføringen eller anvendelsen af højrisiko-AI-systemer eller repræsentere parter, der deltager i disse aktiviteter. De må ikke deltage i aktiviteter, som kan være i strid med deres objektivitet eller integritet, når de udfører de aktiviteter i forbindelse med overensstemmelsesvurdering, som de er bemyndiget til at udføre. Dette gælder navnlig rådgivningstjenester.
6.   Bemyndigede organer skal være organiseret og arbejde på en sådan måde, at der i deres aktiviteter sikres uafhængighed, objektivitet og uvildighed. Bemyndigede organer skal dokumentere og gennemføre en struktur og procedurer til sikring af uvildighed og til fremme og anvendelse af principperne om uvildighed i hele deres organisation, hos alt deres personale og i alle deres vurderingsaktiviteter.
7.   Bemyndigede organer skal have indført dokumenterede procedurer, der sikrer, at deres personale, udvalg, dattervirksomheder, underentreprenører og eventuelle tilknyttede organer eller personale i eksterne organer i overensstemmelse med artikel 78 opretholder fortroligheden af de oplysninger, som de kommer i besiddelse af under udførelsen af overensstemmelsesvurderingsaktiviteterne, undtagen når videregivelse heraf er påbudt ved lov. Bemyndigede organers personale har tavshedspligt med hensyn til alle oplysninger, det kommer i besiddelse af under udførelsen af sine opgaver i henhold til denne forordning, undtagen over for de bemyndigende myndigheder i den medlemsstat, hvor aktiviteterne udføres.
8.   Bemyndigede organer skal have procedurer for udførelsen af aktiviteterne, der tager behørigt hensyn til en udbyders størrelse, til den sektor, som den opererer inden for, til dens struktur og til, hvor kompleks det pågældende AI-system er.
9.   Bemyndigede organer skal tegne en passende ansvarsforsikring for deres overensstemmelsesvurderingsaktiviteter, medmindre ansvaret i overensstemmelse med national ret ligger hos den medlemsstat, i hvilken de er etableret, eller medlemsstaten selv er direkte ansvarlig for overensstemmelsesvurderingen.
10.   Bemyndigede organer skal være i stand til at udføre alle deres opgaver i henhold til denne forordning med den størst mulige faglige integritet og den nødvendige kompetence på det specifikke område, uanset om disse opgaver udføres af bemyndigede organer selv eller på deres vegne og på deres ansvar.
11.   Bemyndigede organer skal have tilstrækkelige interne kompetencer til at kunne evaluere de opgaver, der udføres af eksterne parter på deres vegne, effektivt. Det bemyndigede organ skal have permanent adgang til tilstrækkeligt administrativt, teknisk, juridisk og videnskabeligt personale med erfaring og viden vedrørende de relevante typer af AI-systemer, de relevante data og den relevante databehandling og vedrørende kravene i afdeling 2.
12.   Bemyndigede organer skal deltage i det koordinerende arbejde, jf. artikel 38. De skal også deltage direkte eller være repræsenteret i de europæiske standardiseringsorganisationer eller sikre, at de har et ajourført kendskab til relevante standarder.
Artikel 32
Formodning om overensstemmelse med krav vedrørende bemyndigede organer
Hvis et overensstemmelsesvurderingsorgan påviser, at det er i overensstemmelse med kriterierne i de relevante harmoniserede standarder eller dele heraf, hvortil der er offentliggjort referencer i 
Den Europæiske Unions Tidende
, formodes det at overholde kravene i artikel 31, for så vidt de gældende harmoniserede standarder dækker disse krav.
Artikel 33
Dattervirksomheder i tilknytning til bemyndigede organer og underentreprise
1.   Hvis et bemyndiget organ giver bestemte opgaver i forbindelse med overensstemmelsesvurderingen i underentreprise eller anvender en dattervirksomhed, skal det sikre, at underentreprenøren eller dattervirksomheden opfylder kravene i artikel 31, og underrette den bemyndigende myndighed herom.
2.   Bemyndigede organer har det fulde ansvar for de opgaver, som udføres af en underentreprenør eller dattervirksomhed.
3.   Aktiviteter kan kun gives i underentreprise eller udføres af en dattervirksomhed, hvis udbyderen har givet sit samtykke hertil. Bemyndigede organer skal gøre en liste over deres dattervirksomheder offentligt tilgængelig.
4.   De relevante dokumenter vedrørende vurderingen af underentreprenørens eller dattervirksomhedens kvalifikationer og det arbejde, som de har udført i henhold til denne forordning, stilles til rådighed for den bemyndigende myndighed i en periode på fem år fra datoen for afslutningen af underentreprisen.
Artikel 34
Bemyndigede organers operationelle forpligtelser
1.   Bemyndigede organer skal verificere, at højrisiko-AI-systemer er i overensstemmelse med overensstemmelsesvurderingsprocedurerne i artikel 43.
2.   Bemyndigede organer skal under udførelsen af deres aktiviteter undgå unødvendige byrder for udbyderne og tage behørigt hensyn til udbyderens størrelse, den sektor, som den opererer inden for, dens struktur og til, hvor kompleks det pågældende højrisiko-AI-system er, navnlig med henblik på at minimere administrative byrder og overholdelsesomkostninger for mikrovirksomheder og små virksomheder som omhandlet i henstilling 2003/361/EF. Det bemyndigede organ skal dog respektere den grad af strenghed og det beskyttelsesniveau, der kræves for, at højrisiko-AI-systemet overholder kravene i denne forordning.
3.   Bemyndigede organer skal stille al relevant dokumentation til rådighed og efter anmodning forelægge denne, herunder udbyderens dokumentation, for den bemyndigende myndighed, der er omhandlet i artikel 28, så denne myndighed kan udføre sine vurderings-, udpegelses-, notifikations- og overvågningsaktiviteter og lette vurderingen anført i denne afdeling.
Artikel 35
Identifikationsnumre for og lister over bemyndigede organer
1.   Kommissionen tildeler hvert bemyndiget organ ét identifikationsnummer, også selv om organet er notificeret i henhold til mere end én EU-retsakt.
2.   Kommissionen offentliggør listen over organer, der er notificeret i henhold til denne forordning, herunder deres identifikationsnumre og de aktiviteter, med henblik på hvilke de er notificeret. Kommissionen sikrer, at listen ajourføres.
Artikel 36
Ændringer af notifikationer
1.   Den bemyndigende myndighed meddeler Kommissionen og de øvrige medlemsstater alle relevante ændringer i notifikationen af et bemyndiget organ via det elektroniske notifikationsværktøj, der er omhandlet i artikel 30, stk. 2.
2.   Procedurerne i artikel 29 og 30 finder anvendelse på udvidelser af rammerne for notifikationen.
Med hensyn til andre ændringer af notifikationen end udvidelser af rammerne for den, finder procedurerne i stk. 3-9 anvendelse.
3.   Hvis et bemyndiget organ beslutter at indstille sine overensstemmelsesvurderingsaktiviteter, underretter det den bemyndigende myndighed og udbyderne hurtigst muligt og i tilfælde af planlagt indstilling mindst ét år, inden dets aktiviteter indstilles. Det bemyndigede organs attester kan forblive gyldige i en periode på ni måneder, efter at det bemyndigede organs aktiviteter er indstillet, forudsat at et andet bemyndiget organ skriftligt har bekræftet, at det vil påtage sig ansvaret for de højrisiko-AI-systemer, der er omfattet af disse attester. Sidstnævnte bemyndigede organ foretager en fuld vurdering af de berørte højrisiko-AI-systemer inden udgangen af denne periode på ni måneder, før det udsteder nye attester for disse systemer. Hvis det bemyndigede organ har indstillet sine aktiviteter, trækker den bemyndigende myndighed udpegelsen tilbage.
4.   Hvis en bemyndigende myndighed har tilstrækkelig grund til at mene, at et bemyndiget organ ikke længere opfylder kravene i artikel 31, eller at det ikke opfylder sine forpligtelser, skal den bemyndigende myndighed hurtigst muligt undersøge sagen med den størst mulige omhu. I den forbindelse skal den underrette det berørte bemyndigede organ om sine indvendinger og giver det mulighed for at tilkendegive sine synspunkter. Hvis en bemyndigende myndighed konkluderer, at det bemyndigede organ ikke længere opfylder kravene i artikel 31, eller at det ikke opfylder sine forpligtelser, skal den begrænse, suspendere eller tilbagetrække udpegelsen, alt efter hvad der er relevant, afhængigt af hvor alvorlig den manglende opfyldelse af kravene eller forpligtelserne er. Den underretter omgående Kommissionen og de øvrige medlemsstater herom.
5.   Hvis et bemyndiget organs udpegelse er blevet suspenderet, begrænset eller helt eller delvist tilbagetrukket, underretter dette organ de pågældende udbydere inden for ti dage.
6.   Hvis en udpegelse begrænses, suspenderes eller tilbagetrækkes, træffer den bemyndigende myndighed de nødvendige foranstaltninger for at sikre, at det pågældende bemyndigede organs sager opbevares, og for at stille dem til rådighed for bemyndigende myndigheder i andre medlemsstater og for markedsovervågningsmyndighederne efter disses anmodning.
7.   Hvis en udpegelse begrænses, suspenderes eller tilbagetrækkes, skal den bemyndigende myndighed:
a)
vurdere indvirkningen på attester, der er udstedt af det bemyndigede organ
b)
forelægge en rapport om sine resultater til Kommissionen og de øvrige medlemsstater senest tre måneder efter, at den har givet meddelelse om ændringerne af udpegelsen
c)
pålægge det bemyndigede organ at suspendere eller tilbagetrække alle de attester, der uretmæssigt er blevet udstedt, inden for en rimelig tidsfrist, der fastsættes af myndigheden, for at sikre, at højrisiko-AI-systemer fortsat er i overensstemmelse hermed på markedet
d)
underrette Kommissionen og medlemsstaterne om attester, som den har kræves suspenderet eller tilbagetrukket
e)
give de nationale kompetente myndigheder i den medlemsstat, hvor udbyderen har sit registrerede forretningssted, alle relevante oplysninger om de attester, for hvilke den har krævet suspension eller tilbagetrækning. Den pågældende myndighed træffer de fornødne foranstaltninger, hvis det er nødvendigt, for at undgå en potentiel risiko for sundhed, sikkerhed eller grundlæggende rettigheder.
8.   Med undtagelse af uretmæssigt udstedte attester og i tilfælde, hvor en udpegelse er blevet inddraget eller begrænset, vedbliver attesterne med at være gyldige i et af følgende tilfælde:
a)
den bemyndigende myndighed har senest én måned efter suspensionen eller begrænsningen bekræftet, at der ikke er nogen risiko for sundhed, sikkerhed eller grundlæggende rettigheder vedrørende attester, der er berørt af suspensionen eller begrænsningen, og den bemyndigende myndighed har anført en frist for tiltag til at afhjælpe suspensionen eller begrænsningen, eller
b)
den bemyndigende myndighed har bekræftet, at ingen attester af relevans for suspensionen vil blive udstedt, ændret eller genudstedt under suspensionen eller begrænsningen, og anfører, hvorvidt det bemyndigede organ har kapacitet til at fortsætte overvågningen og fortsat være ansvarligt for eksisterende udstedte attester i suspensions- eller begrænsningsperioden; hvis den bemyndigende myndighed fastslår, at det bemyndigede organ ikke er i stand til at støtte eksisterende udstedte attester, bekræfter udbyderen af det system, der er omfattet af attesten, senest tre måneder efter suspensionen eller begrænsningen skriftligt over for de nationale kompetente myndigheder i den medlemsstat, hvor vedkommende har sit registrerede forretningssted, at et andet kvalificeret bemyndiget organ midlertidigt varetager det bemyndigede organs funktioner med hensyn til at overvåge og forblive ansvarligt for attesterne i suspensions- eller begrænsningsperioden.
9.   Med undtagelse af uretmæssigt udstedte attester og i tilfælde, hvor en udpegelse er blevet tilbagetrukket, vedbliver attesterne med at være gyldige i en periode på ni måneder i følgende tilfælde:
a)
den nationale kompetente myndighed i den medlemsstat, hvor udbyderen af det højrisiko-AI-system, der er omfattet af attesten, har sit registrerede forretningssted, har bekræftet, at der ikke er nogen risiko for sundhed, sikkerhed eller grundlæggende rettigheder i forbindelse med de pågældende højrisiko-AI-systemer, og
b)
et andet bemyndiget organ har skriftligt bekræftet, at det straks varetager ansvaret for disse AI-systemer, og færdiggør sin vurdering inden 12 måneder efter tilbagetrækning af udpegelsen.
Under de omstændigheder, der er omhandlet i første afsnit, kan den kompetente nationale myndighed i den medlemsstat, hvor udbyderen af det system, der er omfattet af attesten, har sit forretningssted, forlænge attesternes foreløbige gyldighed i yderligere perioder på tre måneder, dog i alt højst 12 måneder.
Den kompetente nationale myndighed eller det bemyndigede organ, der varetager funktionerne for det bemyndigede organ, der er berørt af ændringen af udpegelsen, underretter omgående Kommissionen, de øvrige medlemsstater og de øvrige bemyndigede organer herom.
Artikel 37
Anfægtelse af bemyndigede organers kompetence
1.   Kommissionen undersøger om nødvendigt alle tilfælde, hvor der er grund til at betvivle et bemyndiget organs kompetence eller et bemyndiget organs fortsatte opfyldelse af kravene i artikel 31 og dets gældende ansvarsområder.
2.   Den bemyndigende myndighed forelægger efter anmodning Kommissionen alle relevante oplysninger vedrørende notifikationen af det pågældende bemyndigede organ eller opretholdelsen af dets kompetence.
3.   Kommissionen sikrer, at alle de følsomme oplysninger, som den kommer i besiddelse af som led i sine undersøgelser i henhold til denne artikel, behandles fortroligt i overensstemmelse med artikel 78.
4.   Hvis Kommissionen konstaterer, at et bemyndiget organ ikke eller ikke længere opfylder kravene i forbindelse med sin notifikation, underretter den den bemyndigende medlemsstat herom og anmoder den om at træffe de nødvendige korrigerende foranstaltninger, herunder om nødvendigt suspension eller tilbagetrækning af notifikationen. Hvis den bemyndigende myndighed ikke træffer de nødvendige foranstaltninger, kan Kommissionen ved hjælp af en gennemførelsesretsakt suspendere, begrænse eller tilbagetrække udpegelsen. Denne gennemførelsesretsakt vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
Artikel 38
Koordinering af bemyndigede organer
1.   Kommissionen sikrer, at der med hensyn til højrisiko-AI-systemer etableres passende koordinering og samarbejde mellem de bemyndigede organer, der er aktive inden for overensstemmelsesvurderingsprocedurer i henhold til denne forordning, i form af en sektorspecifik gruppe af bemyndigede organer, og at det styres på forsvarlig måde.
2.   Hver bemyndigende myndighed sørger for, at de organer, den har bemyndiget, deltager i arbejdet i en gruppe, jf. stk. 1, enten direkte eller gennem udpegede repræsentanter.
3.   Kommissionen sørger for udveksling af viden og bedste praksis mellem de bemyndigede myndigheder.
Artikel 39
Tredjelandes overensstemmelsesvurderingsorganer
Overensstemmelsesvurderingsorganer, der er oprettet i henhold til retten i et tredjeland, med hvilket Unionen har indgået en aftale, kan godkendes til at udføre bemyndigede organers aktiviteter i henhold til denne forordning, forudsat at de opfylder kravene i artikel 31, eller at de sikrer et tilsvarende overensstemmelsesniveau.
AFDELING 5
Standarder, overensstemmelsesvurdering, attester, registrering
Artikel 40
Harmoniserede standarder og standardiseringsdokumentation
1.   Højrisiko-AI-systemer eller AI-modeller til almen brug, som er i overensstemmelse med harmoniserede standarder eller dele heraf, hvis referencer er offentliggjort i 
Den Europæiske Unions Tidende
 i overensstemmelse med forordning (EU) nr. 1025/2012, formodes at være i overensstemmelse med kravene i dette kapitels afdeling 2 eller, alt efter hvad der er relevant, med forpligtelserne i nærværende forordnings kapitel V, afdeling 2 og 3, for så vidt de nævnte standarder omfatter disse krav eller forpligtelser.
2.   I overensstemmelse med artikel 10 i forordning (EU) nr. 1025/2012 fremsætter Kommissionen uden unødigt ophold standardiseringsanmodninger, der dækker alle kravene i dette kapitels afdeling 2, og, alt efter hvad der er relevant, standardiseringsanmodninger, der dækker forpligtelserne i nærværende forordnings kapitel V, afdeling 2 og 3. I standardiseringsanmodningen anmodes der også om dokumentation vedrørende rapporterings- og dokumentationsprocesser med henblik på at forbedre AI-systemernes ressourceydeevne såsom reduktion af højrisiko-AI-systemets forbrug af energi og af andre ressourcer i løbet af dets livscyklus og vedrørende energieffektiv udvikling af AI-modeller til almen brug. I forbindelse med udarbejdelsen af en standardiseringsanmodning hører Kommissionen AI-udvalget og relevante interessenter, herunder det rådgivende forum.
Når Kommissionen fremsætter en standardiseringsanmodning til de europæiske standardiseringsorganisationer, præciserer den, at standarderne skal være klare, overensstemmende, herunder med de standarder, der er udviklet i de forskellige sektorer for produkter, der er omfattet af den gældende EU-harmoniseringslovgivning, som er opført i bilag I, og søge at sikre, at højrisiko-AI-systemer eller AI-modeller til almen brug, som bringes i omsætning eller tages i brug i Unionen, opfylder de relevante krav eller forpligtelser i nærværende forordning.
Kommissionen anmoder de europæiske standardiseringsorganisationer om at dokumentere deres bedste indsats for at nå de mål, der er omhandlet i dette stykkes første og andet afsnit, i overensstemmelse med artikel 24 i forordning (EU) nr. 1025/2012.
3.   Deltagerne i standardiseringsprocessen skal søge at fremme investering og innovation inden for AI, herunder gennem øget retssikkerhed, samt EU-markedets konkurrenceevne og vækst, at bidrage til at styrke globalt samarbejde om standardisering og tage højde for eksisterende internationale standarder inden for kunstig intelligens, som stemmer overens med Unionens værdier, grundlæggende rettigheder og interesser, og at styrke multiinteressentforvaltning, der sikrer en afbalanceret repræsentation af interesser og effektiv deltagelse af alle relevante interessenter i overensstemmelse med artikel 5, 6 og 7 i forordning (EU) nr. 1025/2012.
Artikel 41
Fælles specifikationer
1.   Kommissionen kan vedtage gennemførelsesretsakter om fastlæggelse af fælles specifikationer for kravene i dette kapitels afdeling 2 eller, alt efter hvad der er relevant, for forpligtelserne i kapitel V, afdeling 2 og 3, hvis følgende betingelser er opfyldt:
a)
Kommissionen har i henhold til artikel 10, stk. 1, i forordning (EU) nr. 1025/2012 anmodet en eller flere europæiske standardiseringsorganisationer om at udarbejde en harmoniseret standard for kravene i dette kapitels afdeling 2 eller, hvis det er relevant, for forpligtelserne i kapitel V, afdeling 2 og 3, og:
i)
anmodningen er ikke blevet imødekommet af nogen af de europæiske standardiseringsorganisationer, eller
ii)
de harmoniserede standarder, der behandler den pågældende anmodning, er ikke blevet leveret inden for den frist, der er fastsat i overensstemmelse med artikel 10, stk. 1, i forordning (EU) nr. 1025/2012, eller
iii)
de relevante harmoniserede standarder tager ikke i tilstrækkelig grad hensyn til de grundlæggende rettigheder, eller
iv)
de harmoniserede standarder er ikke i overensstemmelse med anmodningen, og
b)
ingen reference til harmoniserede standarder, der dækker de krav, der er omhandlet i dette kapitels afdeling 2, eller, hvis det er relevant, forpligtelserne i kapitel V, afdeling 2 og 3, er offentliggjort i 
Den Europæiske Unions Tidende
 i overensstemmelse med forordning (EU) nr. 1025/2012, og ingen reference af denne art forventes at blive offentliggjort inden for et rimeligt tidsrum.
Når Kommissionen udarbejder de fælles specifikationer, skal den høre det rådgivende forum, der er omhandlet i artikel 67.
De gennemførelsesretsakter, der er omhandlet i dette stykkes første afsnit, vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
2.   Inden Kommissionen udarbejder et udkast til gennemførelsesretsakt, underretter den det udvalg, der er omhandlet i artikel 22 i forordning (EU) nr. 1025/2012, om, at den anser betingelserne i nærværende artikels stk. 1 for opfyldt.
3.   Højrisiko-AI-systemer eller AI-modeller til almen brug, som er i overensstemmelse med de fælles specifikationer, der er omhandlet i stk. 1, eller dele af disse specifikationer, formodes at være i overensstemmelse med kravene fastsat i dette kapitels afdeling 2 eller, alt efter hvad der er relevant, at overholde forpligtelserne omhandlet i kapital V, afdeling 2 og 3, for så vidt de nævnte fælles specifikationer omfatter disse forpligtelser.
4.   Hvis en europæisk standardiseringsorganisation vedtager en harmoniseret standard og fremlægger denne for Kommissionen med henblik på offentliggørelse af referencen hertil i 
Den Europæiske Unions Tidende
, skal Kommissionen foretage en vurdering af den harmoniserede standard i overensstemmelse med forordning (EU) nr. 1025/2012. Når referencen til en harmoniseret standard offentliggøres i 
Den Europæiske Unions Tidende
, ophæver Kommissionen de gennemførelsesretsakter, der er omhandlet i stk. 1, eller dele deraf, der omfatter de samme krav, der er fastsat i dette kapitels afdeling 2 eller, hvis det er relevant, at de samme forpligtelser, der er fastsat i kapital V, afdeling 2 og 3.
5.   Hvis udbydere af højrisiko-AI-systemer eller AI-modeller til almen brug ikke overholder de fælles specifikationer, der er omhandlet i stk. 1, skal de behørigt begrunde, at de har indført tekniske løsninger, der opfylder de krav, der er omhandlet i dette kapitels afdeling 2 eller, alt efter hvad der er relevant, overholder de forpligtelser, der er fastsat i kapital V, afdeling 2 og 3, i et omfang, som mindst svarer hertil.
6.   Hvis en medlemsstat finder, at en fælles specifikation ikke fuldt ud opfylder kravene fastsat i afdeling 2 eller, alt efter hvad der er relevant, overholder forpligtelserne fastsat i kapital V, afdeling 2 og 3, underretter den Kommissionen herom med en detaljeret redegørelse. Kommissionen vurderer disse oplysninger og ændrer, hvis det er relevant, gennemførelsesretsakten om fastlæggelse af den pågældende fælles specifikation.
Artikel 42
Formodning om overensstemmelse med visse krav
1.   Højrisiko-AI-systemer, der er blevet trænet og afprøvet på data, som afspejler de specifikke geografiske, adfærdsmæssige, kontekstuelle eller funktionelle rammer, som de tilsigtes anvendt inden for, formodes at overholde de relevante krav i artikel 10, stk. 4.
2.   Højrisiko-AI-systemer, der er certificeret, eller for hvilke der er udstedt en overensstemmelseserklæring i henhold til en cybersikkerhedsordning i henhold til forordning (EU) 2019/881, og hvis referencer er offentliggjort i 
Den Europæiske Unions Tidende
, formodes at overholde cybersikkerhedskravene i nærværende forordnings artikel 15, såfremt cybersikkerhedsattesten eller overensstemmelseserklæringen eller dele heraf dækker disse krav.
Artikel 43
Overensstemmelsesvurdering
1.   Hvad angår højrisiko-AI-systemer, der er opført i bilag III, punkt 1, skal udbyderen, såfremt denne ved påvisningen af, at et højrisiko-AI-system overholder kravene i afdeling 2, har anvendt harmoniserede standarder omhandlet i artikel 40 eller, hvis det er relevant, fælles specifikationer omhandlet i artikel 41, vælge en af følgende overensstemmelsesvurderingsprocedurer på grundlag af:
a)
intern kontrol omhandlet i bilag VI, eller
b)
vurdering af kvalitetsstyringssystemet og vurdering af den tekniske dokumentation med inddragelse af et bemyndiget organ omhandlet i bilag VII.
Ved påvisning af et højrisiko-AI-systems overensstemmelse med kravene i afdeling 2 følger udbyderen overensstemmelsesvurderingsproceduren i bilag VII, hvis:
a)
der ikke findes harmoniserede standarder omhandlet i artikel 40, og der ikke findes fælles specifikationer omhandlet i artikel 41
b)
udbyderen ikke har anvendt eller kun har anvendt en del af den harmoniserede standard
c)
de i litra a) omhandlede fælles specifikationer findes, men udbyderen ikke har anvendt dem
d)
én eller flere af de i litra a) omhandlede harmoniserede standarder er blevet offentliggjort med en begrænsning og kun med hensyn til den del af standarden, som er genstand for begrænsning.
Med henblik på den overensstemmelsesvurderingsprocedure, der er omhandlet i bilag VII, kan udbyderen vælge hvilket som helst af de bemyndigede organer. Hvis højrisiko-AI-systemet tilsigtes ibrugtaget af retshåndhævende myndigheder, indvandringsmyndigheder, asylmyndigheder eller EU-institutioner, -organer, -kontorer eller -agenturer, fungerer den markedsovervågningsmyndighed, der er omhandlet i artikel 74, stk. 8 eller 9, alt efter hvad der er relevant, imidlertid som bemyndiget organ.
2.   Hvad angår de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 2-8, skal udbyderne følge overensstemmelsesvurderingsproceduren på grundlag af intern kontrol som omhandlet i bilag VI, som ikke foreskriver inddragelse af et bemyndiget organ.
3.   For højrisiko-AI-systemer, som er omfattet af EU-harmoniseringslovgivningen, der er opført i bilag I, afsnit A, skal udbyderen følge den relevante overensstemmelsesvurderingsprocedure som krævet i henhold til disse retsakter. Kravene i dette kapitels afdeling 2 finder anvendelse på disse højrisiko-AI-systemer og skal indgå i den nævnte vurdering. Punkt 4.3, 4.4 og 4.5 samt bilag VII, punkt 4.6, femte afsnit, finder også anvendelse.
Med henblik på denne vurdering har bemyndigede organer, der er blevet notificeret i henhold til disse retsakter, ret til at kontrollere højrisiko-AI-systemernes overensstemmelse med kravene i afdeling 2, forudsat at disse bemyndigede organers overholdelse af kravene i artikel 31, stk. 4, 5, 10 og 11, er blevet vurderet i forbindelse med notifikationsproceduren i henhold til disse retsakter.
Hvis en retsakt, der er opført i bilag I, afsnit A, giver producenten mulighed for at fravælge en af tredjepart udført overensstemmelsesvurdering, forudsat at producenten har anvendt alle de harmoniserede standarder, der omfatter alle de relevante krav, kan producenten kun anvende denne mulighed, hvis vedkommende også har anvendt harmoniserede standarder eller, hvis det er relevant, fælles specifikationer omhandlet i artikel 41, der omfatter alle kravene i dette kapitels afdeling 2.
4.   Højrisiko-AI-systemer, der allerede har været genstand for en overensstemmelsesvurderingsprocedure, skal underkastes en ny overensstemmelsesvurderingsprocedure i tilfælde af væsentlige ændringer, uanset om det ændrede system tilsigtes videredistribueret eller fortsat anvendes af den nuværende idriftsætter.
For højrisiko-AI-systemer, der bliver ved med at lære efter at være bragt i omsætning eller ibrugtaget, udgør ændringer af højrisiko-AI-systemet og dets ydeevne, som udbyderen har fastlagt på forhånd på tidspunktet for den indledende overensstemmelsesvurdering, og som er en del af oplysningerne i den tekniske dokumentation, der er omhandlet i bilag IV, punkt 2, litra f), ikke en væsentlig ændring.
5.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre bilag VI og VII ved at ajourføre dem i lyset af den tekniske udvikling.
6.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre nærværende artikels stk. 1 og 2 for at underkaste de i bilag III, punkt 2-8, omhandlede højrisiko-AI-systemer overensstemmelsesvurderingsproceduren i bilag VII eller dele heraf. Kommissionen vedtager sådanne delegerede retsakter under hensyntagen til effektiviteten af overensstemmelsesvurderingsproceduren på grundlag af intern kontrol omhandlet i bilag VI med hensyn til at forebygge eller minimere de risici for sundhed, sikkerhed og beskyttelsen af de grundlæggende rettigheder, som sådanne systemer medfører, samt hvorvidt der er tilstrækkelig kapacitet og ressourcer i de bemyndigede organer.
Artikel 44
Attester
1.   Attester, der udstedes af bemyndigede organer i overensstemmelse med bilag VII, udfærdiges på et sprog, som er letforståeligt for de relevante myndigheder i den medlemsstat, hvor det bemyndigede organ er etableret.
2.   Attester er gyldige i den periode, de angiver, og som ikke må overstige fem år for AI-systemer, der er omfattet af bilag I, og fire år for AI-systemer, der er omfattet af bilag III. På udbyderens anmodning kan en attests gyldighedsperiode forlænges med yderligere perioder på hver højst fem år for AI-systemer, der er omfattet af bilag I, og fire år for AI-systemer, der er omfattet af bilag III, på grundlag af en fornyet vurdering i overensstemmelse med gældende overensstemmelsesvurderingsprocedurer. Et eventuelt tillæg til en attest forbliver gyldigt, forudsat at den attest, det supplerer, er gyldig.
3.   Hvis et bemyndiget organ fastslår, at et AI-system ikke længere opfylder kravene i afdeling 2, skal det under iagttagelse af proportionalitetsprincippet suspendere eller tilbagetrække den udstedte attest eller begrænse den, medmindre udbyderen af systemet gennem passende korrigerende tiltag og inden for en passende frist fastsat af det bemyndigede organ sikrer overholdelse af de pågældende krav. Det bemyndigede organ skal begrunde sin afgørelse.
De bemyndigede organers afgørelser, herunder om udstedte overensstemmelsesattester, skal kunne appelleres.
Artikel 45
Oplysningsforpligtelser for bemyndigede organer
1.   Bemyndigede organer skal oplyse den bemyndigende myndighed om følgende:
a)
alle EU-vurderingsattester for teknisk dokumentation, eventuelle tillæg til disse attester og eventuelle godkendelser af kvalitetsstyringssystemer, der er udstedt i overensstemmelse med kravene i bilag VII
b)
alle afslag på, begrænsninger af, suspensioner af eller tilbagetrækninger af EU-vurderingsattester for teknisk dokumentation eller godkendelser af kvalitetsstyringssystemer udstedt i overensstemmelse med kravene i bilag VII
c)
alle forhold, der har indflydelse på omfanget af eller betingelserne for notifikationen
d)
alle anmodninger om oplysninger om overensstemmelsesvurderingsaktiviteter, som de har modtaget fra markedsovervågningsmyndighederne
e)
efter anmodning, overensstemmelsesvurderingsaktiviteter, der er udført inden anvendelsesområdet for deres notifikation, og enhver anden aktivitet, der er udført, herunder grænseoverskridende aktiviteter og underentreprise.
2.   Hvert bemyndiget organ skal underrette de øvrige bemyndigede organer om:
a)
afviste, suspenderede eller tilbagetrukne godkendelser af kvalitetsstyringssystemer samt, efter anmodning, udstedte godkendelser af kvalitetsstyringssystemer
b)
EU-vurderingsattester for teknisk dokumentation eller tillæg hertil, som det har afvist, tilbagetrukket, suspenderet eller på anden måde begrænset, og, efter anmodning, de attester og/eller tillæg hertil, som det har udstedt.
3.   Hvert bemyndiget organ skal give de øvrige bemyndigede organer, som udfører lignende overensstemmelsesvurderingsaktiviteter vedrørende de samme typer AI-systemer, relevante oplysninger om spørgsmål vedrørende negative og, efter anmodning, positive overensstemmelsesvurderingsresultater.
4.   Bemyndigende myndigheder sikrer, at de oplysninger, de kommer i besiddelse af, behandles fortroligt i overensstemmelse med artikel 78.
Artikel 46
Undtagelse fra overensstemmelsesvurderingsprocedure
1.   Uanset artikel 43 og efter behørigt begrundet anmodning kan enhver markedsovervågningsmyndighed tillade, at specifikke højrisiko-AI-systemer bringes i omsætning eller ibrugtages på den pågældende medlemsstats område af ekstraordinære hensyn til den offentlige sikkerhed eller beskyttelse af menneskers liv og sundhed, miljøbeskyttelse eller beskyttelse af centrale industrielle og infrastrukturmæssige aktiver. Tilladelsen gælder kun for en begrænset periode, mens de nødvendige overensstemmelsesvurderingsprocedurer gennemføres, under hensyntagen til de ekstraordinære hensyn, der begrunder undtagelsen. Gennemførelsen af disse procedurer skal ske uden unødigt ophold.
2.   I behørigt begrundede hastende tilfælde af ekstraordinære hensyn til den offentlige sikkerhed eller i tilfælde af en specifik, væsentlig og overhængende fare for fysiske personers liv eller fysiske sikkerhed kan de retshåndhævende myndigheder eller civilbeskyttelsesmyndighederne ibrugtage et specifikt højrisiko-AI-system uden den tilladelse, der er omhandlet i stk. 1, forudsat at der anmodes om en sådan tilladelse under eller efter anvendelsen uden unødigt ophold. Hvis den i stk. 1 omhandlede tilladelse afvises, skal anvendelsen af højrisiko-AI-systemet indstilles med øjeblikkelig virkning, og alle resultater og output af en sådan anvendelse skal omgående kasseres.
3.   Den i stk. 1 omhandlede tilladelse udstedes kun, hvis markedsovervågningsmyndigheden konkluderer, at højrisiko-AI-systemet overholder kravene i afdeling 2. Markedsovervågningsmyndigheden underretter Kommissionen og de øvrige medlemsstater om enhver tilladelse, der udstedes i henhold til stk. 1 og 2. Denne forpligtelse omfatter ikke følsomme operationelle oplysninger i forbindelse med de retshåndhævende myndigheders aktiviteter.
4.   Hvis der ikke inden for 15 kalenderdage efter modtagelsen af de i stk. 3 omhandlede oplysninger er blevet gjort indsigelse af en medlemsstat eller Kommissionen mod en tilladelse udstedt af en markedsovervågningsmyndighed i en medlemsstat i overensstemmelse med stk. 1, anses denne tilladelse for at være berettiget.
5.   Hvis en medlemsstat inden for 15 kalenderdage efter modtagelsen af den i stk. 3 omhandlede underretning gør indsigelse mod en tilladelse, der er udstedt af en markedsovervågningsmyndighed i en anden medlemsstat, eller hvis Kommissionen finder, at tilladelsen er i strid med EU-retten, eller at medlemsstaternes konklusion vedrørende systemets overholdelse af kravene som omhandlet i stk. 3 er ubegrundet, hører Kommissionen straks den relevante medlemsstat. Operatørerne skal høres og have mulighed for at fremsætte deres synspunkter. På denne baggrund træffer Kommissionen afgørelse om, hvorvidt tilladelsen er berettiget. Kommissionen retter sin afgørelse til den pågældende medlemsstat og til de relevante operatører.
6.   Hvis Kommissionen finder, at tilladelsen er uberettiget, tilbagetrækkes den af markedsovervågningsmyndigheden i den pågældende medlemsstat.
7.   For højrisiko-AI-systemer vedrørende produkter, der er omfattet af EU-harmoniseringslovgivningen, som er opført i bilag I, afsnit A, finder kun undtagelserne fra overensstemmelsesvurderingen, der er fastsat i den pågældende EU-harmoniseringslovgivning, anvendelse.
Artikel 47
EU-overensstemmelseserklæring
1.   Udbyderen udarbejder en skriftlig, maskinlæsbar, fysisk eller elektronisk undertegnet EU-overensstemmelseserklæring for hvert højrisiko-AI-system og opbevarer den, så den i ti år efter, at højrisiko-AI-systemet er blevet bragt i omsætning eller ibrugtaget, står til rådighed for de nationale kompetente myndigheder. Det skal af EU-overensstemmelseserklæringen fremgå, hvilket højrisiko-AI-system den vedrører. Et eksemplar af EU-overensstemmelseserklæringen indgives til de relevante nationale kompetente myndigheder.
2.   Det skal af EU-overensstemmelseserklæringen fremgå, at det pågældende højrisiko-AI-system opfylder kravene i afdeling 2. EU-overensstemmelseserklæringen skal indeholde de oplysninger, der er fastsat i bilag V, og skal oversættes til et sprog, der let kan forstås af de nationale kompetente myndigheder i de medlemsstater, hvor højrisiko-AI-systemet bringes i omsætning eller gøres tilgængeligt.
3.   For højrisiko-AI-systemer, der er omfattet af anden EU-harmoniseringslovgivning, i henhold til hvilken der også kræves en EU-overensstemmelseserklæring, udarbejdes der en enkelt EU-overensstemmelseserklæring for al EU-ret, der finder anvendelse på højrisiko-AI-systemet. Erklæringen skal indeholde alle de oplysninger, der er påkrævet for at identificere, hvilken EU-harmoniseringslovgivning erklæringen vedrører.
4.   Ved at udarbejde EU-overensstemmelseserklæringen står udbyderen inde for, at kravene i afdeling 2 overholdes. Udbyderen skal sørge for at holde EU-overensstemmelseserklæringen ajour, alt efter hvad der er relevant.
5.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre bilag V ved at ajourføre indholdet af EU-overensstemmelseserklæringen, der er fastsat i nævnte bilag, for at indføre elementer, der bliver nødvendige i lyset af den tekniske udvikling.
Artikel 48
CE-mærkning
1.   CE-mærkningen er underlagt de generelle principper fastsat i artikel 30 i forordning (EF) nr. 765/2008.
2.   For højrisiko-AI-systemer, som leveres digitalt, anvendes der kun en digital CE-mærkning, hvis den er let at tilgå via den grænseflade, hvorfra det pågældende system tilgås, eller via en lettilgængelig maskinlæsbar kode eller andre elektroniske midler.
3.   CE-mærkningen skal i tilknytning til højrisiko-AI-systemer anbringes synligt, letlæseligt og således, at den ikke kan slettes. Hvis højrisiko-AI-systemet er af en sådan art, at dette ikke er muligt eller berettiget, anbringes mærkningen på emballagen eller i den medfølgende dokumentation, alt efter hvad der relevant.
4.   Hvis det er relevant, skal CE-mærkningen følges af identifikationsnummeret for det bemyndigede organ, der er ansvarligt for overensstemmelsesvurderingsprocedurerne i artikel 43. Det bemyndigede organs identifikationsnummer anbringes af organet selv eller efter dettes anvisninger af udbyderen eller af udbyderens bemyndigede repræsentant. Identifikationsnummeret skal også fremgå af salgsfremmende materiale, som nævner, at højrisiko-AI-systemet opfylder kravene til CE-mærkning.
5.   Hvis højrisiko-AI-systemet er omfattet af anden EU-ret, som også indeholder bestemmelser om anbringelsen af CE-mærkning, skal CE-mærkningen angive, at højrisiko-AI-systemet ligeledes opfylder kravene i denne anden ret.
Artikel 49
Registrering
1.   Inden et højrisiko-AI-system, der er opført i bilag III, med undtagelse af de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 2, bringes i omsætning eller ibrugtages, skal udbyderen eller, hvis det er relevant, den bemyndigede repræsentant registrere sig selv og deres system i den EU-database, der er omhandlet i artikel 71.
2.   Inden et AI-system, for hvilket udbyderen har konkluderet, at det ikke udgør en høj risiko i overensstemmelse med artikel 6, stk. 3, bringes i omsætning eller tages i brug, registrerer den pågældende udbyder eller, hvis det er relevant, den bemyndigede repræsentant sig selv og dette system i den EU-database, der er omhandlet i artikel 71.
3.   Inden et højrisiko-AI-system, der er opført i bilag III, med undtagelse af de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 2, ibrugtages eller anvendes, skal idriftsættere, som er offentlige myndigheder, EU-institutioner, -organer, -kontorer eller -agenturer eller personer, der handler på deres vegne, lade sig registrere, vælge systemet og registrere dets anvendelse i den EU-database, der er omhandlet i artikel 71.
4.   For de højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 1, 6 og 7, inden for retshåndhævelse og migrationsstyring, asylforvaltning og grænsekontrol, foretages den registrering, der er omhandlet i denne artikels stk. 1, 2 og 3, i en sikker ikkeoffentlig del af den EU-database, der er omhandlet i artikel 71, og omfatter kun følgende oplysninger, alt efter hvad der er relevant, der er omhandlet i:
a)
bilag VIII, afsnit A, punkt 1-10, med undtagelse af punkt 6, 8 og 9
b)
bilag VIII, afsnit B, punkt 1-5 og 8 og 9
c)
bilag VIII, afsnit C, punkt 1-3
d)
bilag IX, punkt 1, 2, 3 og 5.
Kun Kommissionen og de nationale myndigheder, der er omhandlet i artikel 74, stk. 8, har adgang til de respektive begrænsede afsnit i den EU-database, der er opført i nærværende stykkes første afsnit.
5.   Højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 2, registreres på nationalt plan.
KAPITEL IV
GENNEMSIGTIGHEDSFORPLIGTELSER FOR UDBYDERE OG IDRIFTSÆTTERE AF VISSE AI-SYSTEMER
Artikel 50
Gennemsigtighedsforpligtelser for udbydere og idriftsættere af visse AI-systemer
1.   Udbydere skal sikre, at AI-systemer, der er tilsigtet at interagere direkte med fysiske personer, udformes og udvikles på en sådan måde, at de pågældende fysiske personer oplyses om, at de interagerer med et AI-system, medmindre dette er indlysende ud fra en rimeligt velinformeret, opmærksom og forsigtig fysisk persons synspunkt ud fra omstændighederne og anvendelsessammenhængen. Denne forpligtelse finder ikke anvendelse på AI-systemer, der ved lov er godkendt til at afsløre, forebygge, efterforske eller retsforfølge strafbare handlinger, med forbehold af passende sikkerhedsforanstaltninger for tredjemands rettigheder og friheder, medmindre disse systemer er tilgængelige for offentligheden med henblik på at anmelde en strafbar handling.
2.   Udbydere af AI-systemer, herunder AI-systemer til almen brug, der genererer syntetisk lyd-, billed-, video- eller tekstindhold, sikrer, at AI-systemets output er mærket i et maskinlæsbart format og kan spores som kunstigt genereret eller manipuleret. Udbyderne sikrer, at deres tekniske løsninger er effektive, interoperable, robuste og pålidelige, i det omfang dette er teknisk muligt, under hensyntagen til de særlige forhold og begrænsninger for forskellige typer indhold, gennemførelsesomkostningerne og det generelt anerkendte aktuelle tekniske niveau, som kan være afspejlet i relevante tekniske standarder. Denne forpligtelse finder ikke anvendelse, i det omfang AI-systemerne udfører en hjælpefunktion med henblik på standardredigering eller ikke i væsentlig grad ændrer de inputdata, der leveres af idriftsætteren eller semantikken heraf, eller, hvis det ved lov er tilladt for at afsløre, forebygge, efterforske eller retsforfølge strafbare handlinger.
3.   Idriftsættere af et system til følelsesgenkendelse eller et system til biometrisk kategorisering underretter de fysiske personer, der udsættes herfor, om driften af systemet og behandler personoplysningerne i overensstemmelse med forordning (EU) 2016/679 og (EU) 2018/1725 og direktiv (EU) 2016/680, alt efter hvad der er relevant. Denne forpligtelse finder ikke anvendelse på AI-systemer, der anvendes til biometrisk kategorisering og følelsesgenkendelse, og som i ved lov er godkendt til at afsløre, forebygge eller efterforske strafbare handlinger, med forbehold af passende sikkerhedsforanstaltninger for tredjemands rettigheder og frihedsrettigheder og i overensstemmelse med EU-retten.
4.   Idriftsættere af et AI-system, der genererer eller manipulerer billed-, lyd- eller videoindhold, der udgør en deepfake, skal oplyse, at indholdet er blevet genereret kunstigt eller manipuleret. Denne forpligtelse gælder ikke, hvis anvendelsen ved lov er tilladt for at afsløre, forebygge, efterforske eller retsforfølge strafbare handlinger. Hvis indholdet er en del af et oplagt kunstnerisk, kreativt, satirisk, fiktivt eller tilsvarende arbejde eller program, er gennemsigtighedsforpligtelserne i dette stykke begrænset til oplysning om eksistensen af sådant genereret eller manipuleret indhold på en passende måde, der ikke er til gene for visningen eller nydelsen af værket.
Idriftsættere af et AI-system, der genererer eller manipulerer tekst, der offentliggøres med det formål at informere offentligheden om spørgsmål af offentlig interesse, skal oplyse, at teksten er blevet kunstigt genereret eller manipuleret. Denne forpligtelse finder ikke anvendelse, hvis anvendelsen ved lov er tilladt for at afsløre, forebygge, efterforske eller retsforfølge strafbare handlinger, eller hvis det AI-genererede indhold har gennemgået en proces med menneskelig gennemgang eller redaktionel kontrol, og hvis en fysisk eller juridisk person har det redaktionelle ansvar for offentliggørelsen af indholdet.
5.   De oplysninger, der er omhandlet i stk. 1-4, gives til de pågældende fysiske personer på en klar og synlig måde senest på tidspunktet for den første interaktion eller eksponering. Oplysningerne skal være i overensstemmelse med gældende tilgængelighedskrav.
6.   Stk. 1-4 berører ikke kravene og forpligtelserne i kapitel III og berører ikke andre gennemsigtighedsforpligtelser, der er fastsat i EU-retten eller national ret, for idriftsættere af AI-systemer.
7.   AI-kontoret tilskynder til og letter udarbejdelsen af praksiskodekser på EU-plan for at lette en effektiv gennemførelse af forpligtelserne vedrørende påvisning og mærkning af kunstigt genereret eller manipuleret indhold. Kommissionen kan vedtage gennemførelsesretsakter for at godkende disse praksiskodekser efter proceduren i artikel 56, stk. 6. Hvis Kommissionen finder, at kodeksen ikke er tilstrækkelig, kan den vedtage en gennemførelsesretsakt, der præciserer de fælles regler for gennemførelsen af disse forpligtelser efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
KAPITEL V
AI-MODELLER TIL ALMEN BRUG
AFDELING 1
Klassificeringsregler
Artikel 51
Klassificering af AI-modeller til almen brug som AI-modeller til almen brug med systemisk risiko
1.   En AI-model til almen brug klassificeres som en AI-model til almen brug med systemisk risiko, hvis den opfylder et eller flere af følgende betingelser:
a)
den har kapaciteter med stor virkning evalueret på grundlag af passende tekniske værktøjer og metoder, herunder indikatorer og benchmarks
b)
på grundlag af en afgørelse truffet af Kommissionen på eget initiativ eller efter en kvalificeret varsling fra det videnskabelige panel har den kapaciteter eller virkning, der svarer til dem, der er fastsat i litra a), under hensyntagen til kriterierne i bilag XIII.
2.   En AI-model til almen brug antages at have kapaciteter med stor virkning i henhold til stk. 1, litra a), når den kumulerede mængde beregningskraft, der anvendes til dens træning, målt i flydende kommatalsberegninger, er større end 10
25
.
3.   Kommissionen vedtager delegerede retsakter i overensstemmelse med artikel 97 for at ændre de tærskler, der er anført i nærværende artikels stk. 1 og 2, samt for at supplere benchmarks og indikatorer i lyset af den teknologiske udvikling såsom algoritmiske forbedringer eller øget hardwareeffektivitet, når det er nødvendigt, således at disse tærskler afspejler det aktuelle tekniske niveau.
Artikel 52
Fremgangsmåde
1.   Hvis en AI-model til almen brug opfylder betingelsen i artikel 51, stk. 1, litra a), giver den relevante udbyder Kommissionen meddelelse så hurtigt som muligt og under alle omstændigheder senest to uger efter, at dette krav er opfyldt, eller det bliver kendt, at det vil blive opfyldt. Meddelelsen skal indeholde de oplysninger, der er nødvendige for at påvise, at det relevante krav er opfyldt. Hvis Kommissionen får kendskab til en AI-model til almen brug, der frembyder systemiske risici, som den ikke har fået meddelelse om, kan den beslutte at udpege den som en model med systemisk risiko.
2.   Udbyderen af en AI-model til almen brug, der opfylder betingelsen omhandlet i artikel 51, stk. 1, litra a), kan sammen med dens meddelelse fremlægge tilstrækkeligt underbyggede argumenter til at påvise, at AI-modellen til almen brug, selv om den opfylder det pågældende krav, undtagelsesvis ikke frembyder systemiske risici på grund af dens specifikke karakteristika og derfor ikke bør klassificeres som en AI-model til almen brug med systemisk risiko.
3.   Hvis Kommissionen konkluderer, at de argumenter, der er fremsat i henhold til stk. 2, ikke er tilstrækkeligt underbyggede, og den relevante udbyder ikke har været i stand til at påvise, at AI-modellen til almen brug på grund af sine specifikke karakteristika ikke frembyder systemiske risici, afviser den disse argumenter, og AI-modellen til almen brug betragtes som en AI-model til almen brug med systemisk risiko.
4.   Kommissionen kan udpege en AI-model til almen brug som frembydende systemiske risici på eget initiativ eller efter en kvalificeret varsling fra det videnskabelige panel i henhold til artikel 90, stk. 1, litra a) på grundlag af kriterierne i bilag XIII.
Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at ændre bilag XIII ved at præcisere og ajourføre kriterierne i nævnte bilag.
5.   Efter en begrundet anmodning fra en udbyder, hvis model er blevet udpeget som en AI-model til almen brug med systemisk risiko i henhold til stk. 4, tager Kommissionen hensyn til anmodningen og kan beslutte på ny at vurdere, om AI-modellen til almen brug stadig kan anses for at frembyde systemiske risici på grundlag af kriterierne i bilag XIII. En sådan anmodning skal indeholde objektive, detaljerede og nye grunde, der er kommet frem siden udpegelsesafgørelsen. Udbydere kan tidligst seks måneder efter udpegelsesafgørelsen anmode om en fornyet vurdering. Hvis Kommissionen efter sin fornyede vurdering beslutter at opretholde udpegelsen som en AI-model til almen brug med systemisk risiko, kan udbyderne tidligst seks måneder efter denne afgørelse anmode om en fornyet vurdering.
6.   Kommissionen sikrer, at der offentliggøres en liste over AI-modeller til almen brug med systemisk risiko, og ajourfører løbende denne liste, uden at det berører behovet for at overholde og beskytte intellektuelle ejendomsrettigheder og fortrolige forretningsoplysninger eller forretningshemmeligheder i overensstemmelse med EU-retten og national ret.
AFDELING 2
Forpligtelser for udbydere af AI-modeller til almen brug
Artikel 53
Forpligtelser for udbydere af AI-modeller til almen brug
1.   Udbydere af AI-modeller til almen brug skal:
a)
udarbejde og løbende ajourføre den tekniske dokumentation til modellen, herunder dens trænings- og afprøvningsproces og resultaterne af evalueringen af den, som mindst skal indeholde de oplysninger, der er fastsat i bilag XI, med henblik på efter anmodning at forelægge den for AI-kontoret og de nationale kompetente myndigheder
b)
udarbejde og løbende ajourføre oplysninger og dokumentation og stille disse til rådighed for udbydere af AI-systemer, som har til hensigt at integrere AI-modellen til almen brug i deres AI-systemer. Uden at det berører behovet for at respektere og beskytte intellektuelle ejendomsrettigheder og fortrolige forretningsoplysninger eller forretningshemmeligheder i overensstemmelse med EU-retten og national ret, skal oplysningerne og dokumentationen:
i)
give udbydere af AI-systemer mulighed for at få en god forståelse af kapaciteterne og begrænsningerne i AI-modellen til almen brug og overholde deres forpligtelser i henhold til denne forordning, og
ii)
som minimum indeholde de i bilag XII fastsatte elementer
c)
indføre en politik, der overholder EU-retten om ophavsret og beslægtede rettigheder, navnlig med henblik på at identificere og overholde, herunder ved hjælp af de nyeste teknologier, et forbehold vedrørende rettigheder, der udtrykkes i henhold til artikel 4, stk. 3, i direktiv (EU) 2019/790
d)
udarbejde og offentliggøre en tilstrækkeligt detaljeret sammenfatning om det indhold, der anvendes til træning af AI-modellen til almen brug, i overensstemmelse med en skabelon, der leveres af AI-kontoret.
2.   Forpligtelserne i stk. 1, litra a) og b), finder ikke anvendelse på udbydere af AI-modeller, der frigives i henhold til en gratis open source-licens, der giver mulighed for adgang til, anvendelse, ændring og distribution af modellen, og hvis parametre, herunder vægtene, oplysningerne om modelarkitekturen og oplysningerne om modelanvendelsen, gøres offentligt tilgængelige. Denne undtagelse finder ikke anvendelse på AI-modeller til almen brug med systemiske risici.
3.   Udbydere af AI-modeller til almen brug samarbejder om nødvendigt med Kommissionen og de nationale kompetente myndigheder i forbindelse med udøvelsen af deres kompetencer og beføjelser i henhold til denne forordning.
4.   Udbydere af AI-modeller til almen brug kan basere sig på praksiskodekser som omhandlet i artikel 56 for at påvise overholdelse af forpligtelserne i nærværende artikels stk. 1, indtil der er offentliggjort en harmoniseret standard. Overholdelse af europæiske harmoniserede standarder giver udbydere formodning om overensstemmelse, i det omfang disse standarder dækker disse forpligtelser. Udbydere af AI-modeller til almen brug, som ikke overholder en godkendt praksiskodeks, eller som ikke overholder en europæisk harmoniseret standard, skal påvise alternative passende måder for overensstemmelse med henblik på Kommissionens vurdering.
5.   For at lette overholdelsen af bilag XI, navnlig punkt 2, litra d) og e), i nævnte bilag, tillægges Kommissionen beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97 for at præcisere måle- og beregningsmetoder med henblik på at muliggøre sammenlignelig og verificerbar dokumentation.
6.   Kommissionen tillægges beføjelser til at vedtage delegerede retsakter i overensstemmelse med artikel 97, stk. 2, for at ændre bilag XI og XII i lyset af den teknologiske udvikling.
7.   Alle de oplysninger eller al den dokumentation, der indhentes i henhold til denne artikel, herunder forretningshemmeligheder, behandles i overensstemmelse med fortrolighedsforpligtelserne fastsat i artikel 78.
Artikel 54
Bemyndigede repræsentanter for udbydere af AI-modeller til almen brug
1.   Før en AI-model til almen brug bringes i omsætning på EU-markedet, udnævner udbydere, der er etableret i tredjelande, ved skriftligt mandat en bemyndiget repræsentant, der er etableret i Unionen.
2.   Udbyderen skal gøre det muligt for sin bemyndigede repræsentant at udføre de opgaver, der er fastsat i det mandat, vedkommende har modtaget fra udbyderen.
3.   Den bemyndigede repræsentant udfører de opgaver, der er fastsat i det mandat, vedkommende har modtaget fra udbyderen. Vedkommende skal på anmodning give AI-kontoret en kopi af mandatet på et af EU-institutionernes officielle sprog. Med henblik på denne forordning sætter mandatet den bemyndigede repræsentant i stand til at udføre følgende opgaver:
a)
kontrollere, at den tekniske dokumentation, der er omhandlet i bilag XI, er udarbejdet, og at alle de forpligtelser, der er omhandlet i artikel 53 og, hvis det er relevant, artikel 55, er blevet opfyldt af udbyderen
b)
opbevare en kopi af den tekniske dokumentation, der er omhandlet i bilag XI, så den står til rådighed for AI-kontoret og de nationale kompetente myndigheder, i en periode på ti år, efter at AI-modellen til almen brug er bragt i omsætning, og kontaktoplysningerne på den udbyder, der har udnævnt den bemyndigede repræsentant
c)
efter en begrundet anmodning give AI-kontoret alle de oplysninger og al den dokumentation, herunder den, der er omhandlet i litra b), som kræves for at påvise overholdelse af forpligtelserne i dette kapitel
d)
efter en begrundet anmodning samarbejde med AI-kontoret og de kompetente myndigheder om ethvert tiltag, som de foretager i forbindelse med AI-modellen til almen brug, herunder når modellen er integreret i AI-systemer, der bringes i omsætning eller ibrugtages i Unionen.
4.   Mandatet giver den bemyndigede repræsentant, ud over eller i stedet for udbyderen, beføjelse til at modtage henvendelser fra AI-kontoret eller de kompetente myndigheder om alle spørgsmål relateret til at sikre overholdelse af denne forordning.
5.   Den bemyndigede repræsentant bringer mandatet til ophør, hvis vedkommende mener eller har grund til at mene, at udbyderen handler i strid med sine forpligtelser i henhold til denne forordning. I så fald underretter vedkommende også omgående AI-kontoret om ophøret af mandatet og årsagerne hertil.
6.   Forpligtelsen i denne artikel finder ikke anvendelse på udbydere af AI-modeller til almen brug, der frigives i henhold til en gratis open source-licens, der giver mulighed for adgang til, anvendelse, ændring og distribution af modellen, og hvis parametre, herunder vægtene, oplysningerne om modelarkitekturen og oplysningerne om modelanvendelsen, gøres offentligt tilgængelige, medmindre AI-modellen til almen brug frembyder systemiske risici.
AFDELING 3
Forpligtelser for udbydere af AI-modeller til almen brug med systemisk risiko
Artikel 55
Forpligtelser for udbydere af AI-modeller til almen brug med systemisk risiko
1.   Ud over de forpligtelser, der er opført i artikel 53 og 54, skal udbydere af AI-modeller til almen brug med systemisk risiko:
a)
foretage modelevaluering i overensstemmelse med standardiserede protokoller og værktøjer, der afspejler det aktuelle tekniske niveau, herunder gennemførelse og dokumentation af kontradiktorisk afprøvning af modellen med henblik på at identificere og afbøde systemiske risici
b)
vurdere og afbøde mulige systemiske risici på EU-plan, herunder deres kilder, der kan skyldes udvikling, omsætning eller anvendelse af AI-modeller til almen brug med systemisk risiko
c)
uden unødigt ophold følge, dokumentere og indberette relevante oplysninger om alvorlige hændelser og mulige korrigerende foranstaltninger til håndtering heraf til AI-kontoret og, alt efter hvad der er relevant, til de nationale kompetente myndigheder
d)
sikre et tilstrækkeligt niveau af cybersikkerhedsbeskyttelse for AI-modellen til almen brug med systemisk risiko og modellens fysiske infrastruktur.
2.   Udbydere af AI-modeller til almen brug med systemisk risiko kan basere sig på praksiskodekser som omhandlet i artikel 56 for at påvise overholdelse af forpligtelserne i nærværende artikels stk. 1, indtil der er offentliggjort en harmoniseret standard. Overholdelse af europæiske harmoniserede standarder giver udbydere formodning om overensstemmelse, i det omfang disse standarder dækker disse forpligtelser. Udbydere af AI-modeller til almen brug med systemiske risici, som ikke overholder en godkendt praksiskodeks, eller som ikke overholder en europæisk harmoniseret standard, skal påvise alternative passende måder for overensstemmelse med henblik på Kommissionens vurdering.
3.   Alle de oplysninger eller al den dokumentation, der indhentes i henhold til denne artikel, herunder forretningshemmeligheder, behandles i overensstemmelse med fortrolighedsforpligtelserne fastsat i artikel 78.
AFDELING 4
Praksiskodekser
Artikel 56
Praksiskodekser
1.   AI-kontoret tilskynder til og letter udarbejdelsen af praksiskodekser på EU-plan for at bidrage til en korrekt anvendelse af denne forordning under hensyntagen til internationale tilgange.
2.   AI-kontoret og AI-udvalget tilstræber at sikre, at praksiskodekserne som minimum omfatter de forpligtelser, der er fastsat i artikel 53 og 55, herunder følgende spørgsmål:
a)
midlerne til at sikre, at de oplysninger, der er omhandlet i artikel 53, stk. 1, litra a) og b), holdes ajour i lyset af den markedsmæssige og teknologiske udvikling
b)
resuméet af det indhold, der anvendes til uddannelse, er tilstrækkeligt detaljeret
c)
identifikationen af typen og arten af de systemiske risici på EU-plan, herunder deres kilder, hvis det er relevant
d)
foranstaltningerne, procedurerne og de nærmere bestemmelser for vurdering og styring af de systemiske risici på EU-plan, herunder dokumentation herfor, som skal stå i et rimeligt forhold til risiciene, tage hensyn til, hvor alvorlige og sandsynlige de er, og tage hensyn til de specifikke udfordringer i forbindelse med styringen af disse risici i lyset af de mulige måder, hvorpå sådanne risici kan opstå og vise sig i AI-værdikæden.
3.   AI-kontoret kan opfordre alle udbydere af AI-modeller til almen brug samt relevante nationale kompetente myndigheder til at deltage i udarbejdelsen af praksiskodekser. Civilsamfundsorganisationer, industrien, den akademiske verden og andre relevante interessenter såsom downstreamudbydere og uafhængige eksperter kan støtte processen.
4.   AI-kontoret og AI-udvalget tilstræber at sikre, at praksiskodekserne klart fastsætter deres specifikke mål og indeholder forpligtelser eller foranstaltninger, herunder i relevant omfang centrale resultatindikatorer, for at sikre realiseringen af disse mål, og at de tager behørigt hensyn til alle interesserede parters, herunder berørte personers, behov og interesser på EU-plan.
5.   AI-kontoret tilstræber at sikre, at deltagerne i praksiskodekserne regelmæssigt aflægger rapport til AI-kontoret om gennemførelsen af forpligtelserne og de trufne foranstaltninger og deres resultater, herunder i relevant omfang målt i forhold til de centrale resultatindikatorer. De centrale resultatindikatorer og rapporteringsforpligtelserne skal afspejle forskelle i størrelse og kapacitet mellem de forskellige deltagere.
6.   AI-kontoret og AI-udvalget overvåger og evaluerer regelmæssigt deltagernes realisering af praksiskodeksernes mål og deres bidrag til en korrekt anvendelse af denne forordning. AI-kontoret og AI-udvalget vurderer, om praksiskodekserne dækker de forpligtelser, der er fastsat i artikel 53 og 55, og overvåger og evaluerer regelmæssigt realiseringen af deres mål. De offentliggør deres vurdering af, om praksiskodekserne er fyldestgørende.
Kommissionen kan ved en gennemførelsesretsakt godkende en praksiskodeks og give den generel gyldighed i Unionen. Denne gennemførelsesretsakt vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
7.   AI-kontoret kan opfordre samtlige udbydere af AI-modeller til almen brug til at overholde praksiskodekser. For udbydere af AI-modeller til almen brug, der ikke frembyder systemiske risici, kan denne overholdelse begrænses til de forpligtelser, der er fastsat i artikel 53, medmindre de udtrykkeligt tilkendegiver deres interesse i at tilslutte sig den fulde kodeks.
8.   AI-kontoret skal, alt efter hvad der er relevant, også tilskynde til og lette gennemgangen og tilpasningen af praksiskodekserne, navnlig i lyset af nye standarder. AI-kontoret bistår ved vurderingen af tilgængelige standarder.
9.   Praksiskodekser skal være klar senest den 2. maj 2025. AI-kontoret tager de nødvendige skridt, herunder indbyder udbydere i henhold til stk. 7.
Hvis en praksiskodeks ikke kan færdiggøres senest den 2. august 2025, eller hvis AI-kontoret efter sin vurdering i henhold til denne artikels stk. 6 finder, at den ikke er fyldestgørende, kan Kommissionen ved hjælp af gennemførelsesretsakter fastsætte fælles regler for gennemførelsen af de forpligtelser, der er fastsat i artikel 53 og 55, herunder spørgsmålene i nærværende artikels stk. 2. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
KAPITEL VI
FORANSTALTNINGER TIL STØTTE FOR INNOVATION
Artikel 57
Reguleringsmæssige AI-sandkasser
1.   Medlemsstaterne sikrer, at deres kompetente myndigheder opretter mindst én reguleringsmæssig AI-sandkasse på nationalt plan, som skal være operationel senest den 2. august 2026. Denne sandkasse kan også oprettes i fællesskab med andre medlemsstaters kompetente myndigheder. Kommissionen kan yde teknisk støtte, rådgivning og værktøjer til oprettelse og drift af reguleringsmæssige AI-sandkasser.
Forpligtelsen i henhold til første afsnit kan også opfyldes ved deltagelse i en eksisterende sandkasse, for så vidt som denne deltagelse giver de deltagende medlemsstater et tilsvarende nationalt dækningsniveau.
2.   Der kan også oprettes yderligere reguleringsmæssige AI-sandkasser på regionalt eller lokalt plan eller i fællesskab med andre medlemsstaters kompetente myndigheder.
3.   Den Europæiske Tilsynsførende for Databeskyttelse kan også oprette en reguleringsmæssig AI-sandkasse for EU-institutioner, -organer, -kontorer og -agenturer og varetage de nationale kompetente myndigheders roller og opgaver i overensstemmelse med dette kapitel.
4.   Medlemsstaterne sikrer, at de kompetente myndigheder, der er omhandlet i stk. 1 og 2, tildeler tilstrækkelige ressourcer til, at denne artikel overholdes effektivt og rettidigt. Hvis det er relevant, samarbejder de nationale kompetente myndigheder med andre relevante myndigheder og kan gøre det muligt at inddrage andre aktører i AI-økosystemet. Denne artikel berører ikke andre reguleringsmæssige sandkasser, der er oprettet i henhold til EU-retten eller national ret. Medlemsstaterne sikrer et passende samarbejde mellem de myndigheder, der fører tilsyn med disse andre sandkasser, og de nationale kompetente myndigheder.
5.   Reguleringsmæssig AI-sandkasser, der oprettes i henhold til stk. 1, skal tilvejebringe et kontrolleret miljø, der fremmer innovation og letter udvikling, træning, afprøvning og validering af innovative AI-systemer i et begrænset tidsrum, inden de bringes i omsætning eller tages i brug i henhold til en specifik sandkasseplan, som aftales mellem udbyderne eller de potentielle udbydere og den kompetente myndighed. Sådanne sandkasser kan omfatte afprøvning under faktiske forhold under tilsyn i sandkasserne.
6.   De kompetente myndigheder yder, alt efter hvad der er relevant, vejledning, tilsyn og støtte inden for den reguleringsmæssige AI-sandkasse med henblik på at identificere risici, navnlig for grundlæggende rettigheder, sundhed og sikkerhed, afprøvning, afbødende foranstaltninger og deres effektivitet i forbindelse med forpligtelserne og kravene i denne forordning og, hvis det er relevant, anden EU-ret og national ret, der føres tilsyn med inden for sandkassen.
7.   De kompetente myndigheder giver udbydere og potentielle udbydere, der deltager i den reguleringsmæssige AI-sandkasse, vejledning om reguleringsmæssige forventninger og om, hvordan de opfylder de krav og forpligtelser, der er fastsat i denne forordning.
Efter anmodning fra udbyderen eller den potentielle udbyder af AI-systemet forelægger den kompetente myndighed en skriftlig dokumentation for de aktiviteter, der er udført med succes i sandkassen. Den kompetente myndighed forelægger også en slutrapport med en detaljeret beskrivelse af de aktiviteter, der er gennemført i sandkassen, og de dermed forbundne resultater og læringsresultater. Udbydere kan anvende sådan dokumentation til at påvise, at de overholder denne forordning gennem overensstemmelsesvurderingsprocessen eller relevante markedsovervågningsaktiviteter. I denne forbindelse tager markedsovervågningsmyndighederne og de bemyndigede organer positivt hensyn til slutrapporterne og den skriftlige dokumentation fra den nationale kompetente myndighed med henblik på at fremskynde overensstemmelsesvurderingsprocedurerne i rimeligt omfang.
8.   Med forbehold af fortrolighedsbestemmelserne i artikel 78 og med samtykke fra udbyderen eller den potentielle udbyder har Kommissionen og AI-udvalget tilladelse til at få adgang til slutrapporterne og tager, alt efter hvad der er relevant, hensyn til disse, når de udfører deres opgaver i henhold til denne forordning. Hvis både udbyderen eller den potentielle udbyder og den nationale kompetente myndighed når til udtrykkelig enighed, kan slutrapporten gøres offentligt tilgængelig via den centrale informationsplatform, der er omhandlet i nærværende artikel.
9.   Oprettelsen af reguleringsmæssige AI-sandkasser har til formål at bidrage til følgende mål:
a)
at forbedre retssikkerheden med henblik på at opnå overholdelse af bestemmelserne i denne forordning eller, hvis det er relevant, anden gældende EU-ret og national ret
b)
at støtte udvekslingen af bedste praksis gennem samarbejde med de myndigheder, der er involveret i den reguleringsmæssige AI-sandkasse
c)
at fremme innovation og konkurrenceevne og lette udviklingen af et AI-økosystem
d)
at bidrage til evidensbaseret lovgivningsmæssig læring
e)
at lette og fremskynde adgangen til EU-markedet for AI-systemer, navnlig når de leveres af SMV'er, herunder iværksættervirksomheder.
10.   I det omfang de innovative AI-systemer omfatter behandling af personoplysninger eller på anden måde henhører under tilsynsområdet for andre nationale myndigheder eller kompetente myndigheder, der giver eller understøtter adgang til data, sikrer de nationale kompetente myndigheder, at de nationale databeskyttelsesmyndigheder og disse andre nationale eller kompetente myndigheder er tilknyttet driften af den reguleringsmæssige AI-sandkasse og involveret i tilsynet med disse aspekter i henhold til deres respektive opgaver og beføjelser.
11.   De reguleringsmæssige AI-sandkasser berører ikke de tilsynsbeføjelser eller korrigerende beføjelser, som de kompetente myndigheder, der fører tilsyn med sandkasserne, har, herunder på regionalt eller lokalt plan. Enhver væsentlig risiko for sundhed og sikkerhed og grundlæggende rettigheder, der konstateres under udviklingen og afprøvningen af sådanne AI-systemer, fører til passende afbødning. De nationale kompetente myndigheder har beføjelse til midlertidigt eller permanent at suspendere afprøvningsprocessen eller deltagelse i sandkassen, hvis der ikke er mulighed for effektiv afbødning, og meddeler AI-kontoret denne afgørelse. De nationale kompetente myndigheder udøver deres tilsynsbeføjelser inden for rammerne af den relevante ret, idet de anvender deres skønsbeføjelser, når de gennemfører retlige bestemmelser for et specifikt projekt vedrørende reguleringsmæssige AI-sandkasser, med det formål at støtte innovation inden for AI i Unionen.
12.   Udbydere og potentielle udbydere, der deltager i den reguleringsmæssige AI-sandkasse, forbliver ansvarlige i henhold til gældende EU-ansvarsret og gældende national ansvarsret for enhver skade, der påføres tredjeparter som følge af de forsøg, der finder sted i sandkassen. Såfremt de potentielle udbydere overholder den specifikke plan og vilkårene og betingelserne for deres deltagelse og i god tro følger den nationale kompetente myndigheds vejledning, pålægger myndighederne dog ingen administrative bøder for overtrædelse af denne forordning. I tilfælde af at andre kompetente myndigheder med ansvar for anden EU-ret og national ret har været aktivt involveret i tilsynet med AI-systemet i sandkassen og givet vejledning om overholdelse, pålægges der ingen administrative bøder i forbindelse med den pågældende ret.
13.   De reguleringsmæssige AI-sandkasser udformes og gennemføres på en sådan måde, at de letter det grænseoverskridende samarbejde mellem de nationale kompetente myndigheder, hvis det er relevant.
14.   De nationale kompetente myndigheder koordinerer deres aktiviteter og samarbejder inden for AI-udvalgets rammer.
15.   De nationale kompetente myndigheder underretter AI-kontoret og AI-udvalget om oprettelsen af en sandkasse og kan anmode dem om støtte og vejledning. AI-kontoret offentliggør en liste over planlagte og eksisterende sandkasser og ajourfører den for at tilskynde til større interaktion i de reguleringsmæssige AI-sandkasser og tværnationalt samarbejde.
16.   De nationale kompetente myndigheder forelægger AI-kontoret og AI-udvalget årlige rapporter, fra og med ét år efter oprettelsen af den reguleringsmæssige AI-sandkasse og derefter hvert år indtil dens ophør, og en slutrapport. Disse rapporter skal indeholde oplysninger om fremskridt med og resultater af gennemførelsen af de pågældende sandkasser, herunder bedste praksis, hændelser, indhøstede erfaringer og anbefalinger vedrørende deres udformning og, hvis det er relevant, anvendelsen og den eventuelle revision af denne forordning, herunder tilhørende delegerede retsakter og gennemførelsesretsakter, og anvendelsen af anden EU-ret, som de kompetente myndigheder fører tilsyn med inden for sandkassen. De nationale kompetente myndigheder gør disse årlige rapporter eller sammendrag heraf offentligt tilgængelige online. Kommissionen tager, hvis det er relevant, hensyn til de årlige rapporter, når den udfører sine opgaver i henhold til denne forordning.
17.   Kommissionen udvikler en fælles og særlig grænseflade, der indeholder alle relevante oplysninger vedrørende reguleringsmæssige AI-sandkasser, for at give interessenter mulighed for at interagere med reguleringsmæssige AI-sandkasser og rette forespørgsler til de kompetente myndigheder og søge ikkebindende vejledning om overensstemmelsen af innovative produkter, tjenester og forretningsmodeller, der integrerer AI-teknologier, i overensstemmelse med artikel 62, stk. 1, litra c). Kommissionen koordinerer proaktivt med nationale kompetente myndigheder, hvis det er relevant.
Artikel 58
Nærmere ordninger for og funktionsmåden af reguleringsmæssige AI-sandkasser
1.   For at undgå fragmentering i Unionen vedtager Kommissionen gennemførelsesretsakter, der fastsætter de nærmere ordninger for oprettelse, udvikling, gennemførelse, drift af og tilsyn med de reguleringsmæssige AI-sandkasser. Gennemførelsesretsakterne skal omfatte fælles principper vedrørende følgende punkter:
a)
støtteberettigelse og udvælgelseskriterier med henblik på deltagelse i den reguleringsmæssige AI-sandkasse
b)
procedurer for anvendelse, deltagelse, overvågning, udtræden fra og afslutning af den reguleringsmæssige AI-sandkasse, herunder sandkasseplanen og slutrapporten
c)
hvilke vilkår og betingelser der gælder for deltagerne.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
2.   De i stk. 1 omhandlede gennemførelsesretsakter skal sikre:
a)
at reguleringsmæssige AI-sandkasser er åbne for enhver ansøgende udbyder eller potentiel udbyder af et AI-system, som opfylder støtteberettigelses- og udvælgelseskriterierne, som skal være gennemsigtige og fair, og at de nationale kompetente myndigheder underretter ansøgerne om deres afgørelse senest tre måneder efter ansøgningen
b)
at reguleringsmæssige AI-sandkasser giver bred og lige adgang og holder trit med efterspørgslen efter deltagelse; udbydere og potentielle udbydere kan også indgive ansøgninger i partnerskab med idriftsættere eller andre relevante tredjeparter
c)
at de nærmere ordninger for og betingelser vedrørende reguleringsmæssige AI-sandkasser i videst mulig udstrækning støtter fleksibilitet for nationale kompetente myndigheder til at oprette og drive deres reguleringsmæssige AI-sandkasser
d)
at adgang til de reguleringsmæssige AI-sandkasser er gratis for SMV'er, herunder iværksættervirksomheder, uden at det berører ekstraordinære omkostninger, som de nationale kompetente myndigheder kan få dækket på fair og forholdsmæssig vis
e)
at de ved hjælp af læringsresultaterne fra de reguleringsmæssige AI-sandkasser gør det lettere for udbydere og potentielle udbydere at overholde overensstemmelsesvurderingsforpligtelserne i henhold til denne forordning og frivilligt at anvende adfærdskodekserne, som er omhandlet i artikel 95
f)
at de reguleringsmæssige AI-sandkasser letter inddragelsen af andre relevante aktører inden for AI-økosystemet såsom bemyndigede organer og standardiseringsorganisationer, SMV'er, herunder iværksættervirksomheder, virksomheder, innovatorer, afprøvnings- og forsøgsfaciliteter, forsknings- og forsøgslaboratorier og europæiske digitale innovationsknudepunkter, ekspertisecentre, individuelle forskere, med henblik på at muliggøre og lette samarbejdet med den offentlige og private sektor
g)
at procedurer, processer og administrative krav vedrørende ansøgning om, udvælgelse af, deltagelse i og udtræden af den reguleringsmæssige AI-sandkasse er enkle, letforståelige og klart kommunikeret, så det bliver lettere for SMV'er, herunder iværksættervirksomheder, med begrænset juridisk og administrativ kapacitet at deltage, og strømlines i hele Unionen for at undgå fragmentering, samt at deltagelse i en reguleringsmæssig AI-sandkasse oprettet af en medlemsstat eller af Den Europæiske Tilsynsførende for Databeskyttelse anerkendes gensidigt og ensartet og har samme retsvirkning i hele Unionen
h)
at deltagelse i den reguleringsmæssige AI-sandkasse begrænses til en periode, der er passende til projektets kompleksitet og omfang, og som kan forlænges af den nationale kompetente myndighed
i)
at reguleringsmæssige AI-sandkasser letter udviklingen af værktøjer og infrastruktur til afprøvning, benchmarking, vurdering og forklaring af dimensioner af AI-systemer, der er relevante for reguleringsmæssig læring såsom nøjagtighed, robusthed og cybersikkerhed, samt foranstaltninger til at mindske risici for de grundlæggende rettigheder og samfundet som helhed.
3.   Potentielle udbydere i de reguleringsmæssige AI-sandkasser, navnlig SMV'er og iværksættervirksomheder, henvises, hvis det er relevant, til føridriftsættelsestjenester såsom vejledning om gennemførelsen af denne forordning, til andre værdiforøgende tjenester såsom hjælp med standardiseringsdokumenter og certificering, afprøvnings- og forsøgsfaciliteter, europæiske digitale innovationsknudepunkter og ekspertisecentre.
4.   Hvis de nationale kompetente myndigheder overvejer at tillade afprøvning under faktiske forhold under tilsyn inden for rammerne af en reguleringsmæssig AI-sandkasse, der skal oprettes i henhold til denne artikel, aftaler de specifikt vilkårene og betingelserne for en sådan afprøvning og navnlig de fornødne sikkerhedsforanstaltninger med deltagerne med henblik på at beskytte de grundlæggende rettigheder, sundheden og sikkerheden. Hvis det er relevant, samarbejder de med andre nationale kompetente myndigheder med henblik på at sikre en ensartet praksis i hele Unionen.
Artikel 59
Viderebehandling af personoplysninger med henblik på udvikling af visse samfundsnyttige AI-systemer i den reguleringsmæssige AI-sandkasse
1.   I den reguleringsmæssige AI-sandkasse må personoplysninger, der er lovligt indsamlet til andre formål, kun behandles med henblik på udvikling, træning og afprøvning af visse AI-systemer i sandkassen, når alle følgende betingelser er opfyldt:
a)
AI-systemer skal udvikles med henblik på beskyttelse af væsentlige samfundsinteresser, der varetages af en offentlig myndighed eller anden fysisk eller juridisk person, og på et eller flere af følgende områder:
i)
den offentlige sikkerhed og folkesundheden, herunder opsporing af sygdomme, diagnoser, forebyggelse, overvågning og behandling samt forbedring af sundhedssystemerne
ii)
et højt beskyttelsesniveau og forbedring af miljøkvaliteten, beskyttelse af biodiversiteten, beskyttelse mod forurening, foranstaltninger vedrørende den grønne omstilling, foranstaltninger vedrørende modvirkning af og tilpasning til klimaændringer
iii)
energibæredygtighed
iv)
sikkerhed og modstandsdygtighed i transportsystemerne og mobilitet, kritisk infrastruktur og netværk
v)
effektivitet og kvalitet i den offentlige forvaltning og offentlige tjenester
b)
de behandlede oplysninger skal være nødvendige for at overholde et eller flere af de krav, der er omhandlet i kapitel III, afdeling 2, såfremt disse krav ikke praktisk kan opfyldes ved behandling af anonymiserede eller syntetiske oplysninger eller andre oplysninger end personoplysninger
c)
der skal foreligge effektive overvågningsmekanismer til at konstatere, om der kan opstå høje risici for de registreredes rettigheder og frihedsrettigheder, som omhandlet i artikel 35 i forordning (EU) 2016/679 og artikel 39 i forordning (EU) 2018/1725, i forbindelse med forsøgene i sandkassen, samt beredskabsmekanismer til straks at afbøde disse risici og om nødvendigt standse behandlingen
d)
alle personoplysninger, der skal behandles i forbindelse med sandkassen, skal befinde sig i et funktionelt adskilt, isoleret og beskyttet databehandlingsmiljø under den potentielle udbyders kontrol, og kun autoriserede personer har adgang til disse data
e)
udbyderne kan kun dele de oprindeligt indsamlede data yderligere i overensstemmelse med EU-databeskyttelsesretten; personoplysninger, der er skabt i sandkassen, kan ikke deles uden for sandkassen
f)
enhver behandling af personoplysninger i forbindelse med sandkassen fører hverken til foranstaltninger eller afgørelser, der berører de registrerede, eller påvirker anvendelsen af deres rettigheder fastsat i EU-retten om beskyttelse af personoplysninger
g)
alle personoplysninger, der skal behandles i forbindelse med sandkassen, skal beskyttes gennem passende tekniske og organisatoriske foranstaltninger og slettes, når deltagelsen i sandkassen afsluttes, eller når opbevaringsperioden for personoplysningerne udløber
h)
logfilerne over behandlingen af personoplysninger i forbindelse med sandkassen opbevares, så længe de deltager i sandkassen, medmindre andet er fastsat i EU-retten eller national ret
i)
en fuldstændig og detaljeret beskrivelse af processen og begrundelsen for træningen, afprøvningen og valideringen af AI-systemet opbevares sammen med afprøvningsresultaterne som en del af den tekniske dokumentation omhandlet i bilag IV
j)
der offentliggøres på de kompetente myndigheders websted et kort resumé af det AI-projekt, der er udviklet i sandkassen, dets mål og dets forventede resultater; denne forpligtelse omfatter ikke følsomme operationelle oplysninger i forbindelse med aktiviteter, der udføres af retshåndhævende myndigheder, grænsekontrolmyndigheder, indvandringsmyndigheder eller asylmyndigheder.
2.   Med henblik på at forebygge, efterforske, opdage eller retsforfølge strafbare handlinger eller fuldbyrde strafferetlige sanktioner, herunder beskytte mod og forebygge trusler mod den offentlige sikkerhed, under de retshåndhævende myndigheders kontrol og ansvar baseres behandlingen af personoplysninger i reguleringsmæssige AI-sandkasser på særlig EU-ret eller national ret og på de samme kumulative betingelser som omhandlet i stk. 1.
3.   Stk. 1 berører ikke EU-ret eller national ret, der udelukker behandling til andre formål end dem, der udtrykkeligt er nævnt i den pågældende ret, og heller ikke EU-ret eller national ret, der fastsætter grundlaget for behandling af personoplysninger, som er nødvendig med henblik på udvikling, afprøvning eller træning af innovative AI-systemer, eller noget andet retsgrundlag, der overholder EU-retten om beskyttelse af personoplysninger.
Artikel 60
Afprøvning af højrisiko-AI-systemer under faktiske forhold uden for reguleringsmæssige AI-sandkasser
1.   Afprøvning af højrisiko-AI-systemer under faktiske forhold uden for reguleringsmæssige AI-sandkasser kan udføres af udbydere eller potentielle udbydere af højrisiko-AI-systemer, der er opført i bilag III, i overensstemmelse med denne artikel og den plan for afprøvning under faktiske forhold, der er omhandlet i denne artikel, uden at det berører forbuddene i henhold til artikel 5.
Kommissionen præciserer ved hjælp af gennemførelsesretsakter de nærmere elementer i planen for afprøvning under faktiske forhold. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
Nærværende stykke berører ikke EU-ret eller national ret om afprøvning under faktiske forhold af højrisiko-AI-systemer i forbindelse med produkter, der er omfattet af EU-harmoniseringslovgivningen, der er opført i bilag I.
2.   Udbydere eller potentielle udbydere kan selv eller i partnerskab med en eller flere idriftsættere eller potentielle idriftsættere gennemføre afprøvning af de højrisiko-AI-systemer, der er omhandlet i bilag III, under faktiske forhold på et hvilket som helst tidspunkt, inden AI-systemet bringes i omsætning eller ibrugtages.
3.   Afprøvning af højrisiko-AI-systemer under faktiske forhold i henhold til denne artikel berører ikke enhver anden etisk gennemgang, der er påkrævet i henhold til EU-retten eller national ret.
4.   Udbydere eller potentielle udbydere må kun udføre afprøvningen under faktiske forhold, hvis alle følgende betingelser er opfyldt:
a)
udbyderen eller den potentielle udbyder har udarbejdet en plan for afprøvning under faktiske forhold og forelagt den for markedsovervågningsmyndigheden i den medlemsstat, hvor afprøvningen skal udføres under faktiske forhold
b)
markedsovervågningsmyndigheden i den medlemsstat, hvor afprøvningen under faktiske forhold skal udføres, har godkendt afprøvningen under faktiske forhold og planen for afprøvning under faktiske forhold; hvis markedsovervågningsmyndigheden ikke har givet et svar inden for 30 dage, betragtes afprøvningen under faktiske forhold og planen for afprøvning under faktiske forhold som godkendt; hvis national ret ikke indeholder bestemmelser om stiltiende godkendelse, skal der fortsat foreligge en tilladelse til afprøvning under faktiske forhold
c)
udbyderen eller den potentielle udbyder med undtagelse af udbydere eller potentielle udbydere af højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 1, 6 og 7, inden for retshåndhævelse, migrationsstyring, asylforvaltning og grænsekontrol, og af højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 2, har registreret afprøvningen under faktiske forhold i overensstemmelse med artikel 71, stk. 4, med et EU-dækkende unikt individuelt identifikationsnummer og de oplysninger, der er angivet i bilag IX; udbyderen eller den potentielle udbyder af højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 1, 6 og 7, inden for retshåndhævelse, migrationsstyring, asylforvaltning og grænsekontrol, har registreret afprøvningen under faktiske forhold i den sikre ikkeoffentlige del af EU-databasen, jf. artikel 49, stk. 4, litra d), med et EU-dækkende unikt individuelt identifikationsnummer og de oplysninger, der er angivet i nævnte litra; udbyderen eller den potentielle udbyder af højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 2, har registreret afprøvningen under faktiske forhold i overensstemmelse med artikel 49, stk. 5
d)
den udbyder eller potentielle udbyder, der udfører afprøvningen under faktiske forhold, er etableret i Unionen eller har udpeget en retlig repræsentant, der er etableret i Unionen
e)
data, der indsamles og behandles med henblik på afprøvning under faktiske forhold, må kun overføres til tredjelande, forudsat at der er gennemført passende og gældende sikkerhedsforanstaltninger i henhold til EU-retten
f)
afprøvningen under faktiske forhold varer ikke længere end nødvendigt for at nå målene herfor og under ingen omstændigheder længere end seks måneder, som kan forlænges i en yderligere periode på seks måneder, forudsat at udbyderen eller den potentielle udbyder på forhånd har underrettet markedsovervågningsmyndigheden ledsaget af en redegørelse for behovet for en sådan forlængelse
g)
de personer, der er genstand for afprøvningen under faktiske forhold, og som er personer, der tilhører sårbare grupper på grund af deres alder eller handicap, beskyttes på passende vis
h)
hvis en udbyder eller potentiel udbyder organiserer afprøvningen under faktiske forhold i samarbejde med en eller flere idriftsættere eller potentielle idriftsættere, er sidstnævnte blevet informeret om alle de aspekter af afprøvningen, der er relevante for deres beslutning om at deltage, og har modtaget den relevante brugsanvisning til AI-systemet, jf. artikel 13; udbyderen eller den potentielle udbyder og idriftsætteren eller den potentielle idriftsætter skal indgå en aftale, der præciserer deres roller og ansvar med henblik på at sikre overholdelse af bestemmelserne om afprøvning under faktiske forhold i henhold til denne forordning og i henhold til anden gældende EU-ret og national ret
i)
de personer, der er genstand for afprøvningen under faktiske forhold, har givet informeret samtykke i overensstemmelse med artikel 61 eller i tilfælde af retshåndhævelse, hvis indhentning af informeret samtykke ville forhindre, at AI-systemet afprøves, og selve afprøvningen og resultatet af afprøvningen under faktiske forhold må ikke have nogen negativ indvirkning på forsøgspersonerne, og deres personoplysninger slettes, efter at afprøvningen er udført
j)
afprøvningen under faktiske forhold overvåges effektivt af udbyderen eller den potentielle udbyder samt af idriftsættere eller potentielle idriftsættere gennem personer, der er tilstrækkeligt kvalificerede på det relevante område og har den nødvendige kapacitet, uddannelse og myndighed til at udføre deres opgaver
k)
AI-systemets forudsigelser, anbefalinger eller beslutninger kan effektivt omgøres og tilsidesættes.
5.   Enhver forsøgsperson, der medvirker i afprøvningen under faktiske forhold, eller vedkommendes retligt udpegede repræsentant, alt efter hvad der er relevant, kan, uden at det medfører ulemper og uden at skulle give nogen begrundelse, når som helst trække sig tilbage fra afprøvningen ved at trække sit informerede samtykke tilbage og anmode om øjeblikkeligt og permanent at få sine personoplysninger slettet. Tilbagetrækningen af det informerede samtykke berører ikke de allerede udførte aktiviteter.
6.   I overensstemmelse med artikel 75 tillægger medlemsstaterne deres markedsovervågningsmyndigheder beføjelser til at kræve oplysninger, som udbydere og potentielle udbydere skal indgive, til at foretage uanmeldte fjerninspektioner eller inspektioner på stedet og til at foretage kontrol af, hvordan afprøvningen udføres under faktiske forhold, og de relaterede højrisiko-AI-systemer. Markedsovervågningsmyndighederne anvender disse beføjelser til at sørge for, at afprøvningen under faktiske forhold forløber sikkert.
7.   Enhver alvorlig hændelse, der konstateres under afprøvningen under faktiske forhold, indberettes til den nationale markedsovervågningsmyndighed i overensstemmelse med artikel 73. Udbyderen eller den potentielle udbyder træffer straks afbødende foranstaltninger eller, hvis dette ikke er muligt, suspenderer afprøvningen under faktiske forhold, indtil en sådan afhjælpning finder sted, eller, hvis dette ikke sker, bringer den til ophør. Udbyderen eller den potentielle udbyder indfører en procedure for øjeblikkelig tilbagekaldelse af AI-systemet efter en sådan afslutning af afprøvningen under faktiske forhold.
8.   Udbydere eller potentielle udbydere giver den nationale markedsovervågningsmyndighed i den medlemsstat, hvor afprøvningen under faktiske forhold udføres, meddelelse om suspensionen eller afslutningen af afprøvningen under faktiske forhold og om de endelige resultater.
9.   Udbyderen eller den potentielle udbyder er ansvarlige i henhold til gældende EU-ansvarsret og gældende national ansvarsret for enhver skade, der forvoldes i forbindelse med deres afprøvning under faktiske forhold.
Artikel 61
Informeret samtykke til at deltage i afprøvning under faktiske forhold uden for reguleringsmæssige AI-sandkasser
1.   Med henblik på afprøvning under faktiske forhold i henhold til artikel 60 indhentes der frit informeret samtykke fra forsøgspersoner, inden de deltager i sådanne forsøg, og efter at de er blevet behørigt informeret med præcise, klare, relevante og forståelige oplysninger om:
a)
afprøvningens art og formål under faktiske forhold, og hvilke mulige ulemper der kan være forbundet med deres deltagelse
b)
de betingelser, hvorunder afprøvningen under faktiske forhold skal udføres, herunder den forventede varighed af forsøgspersonens eller forsøgspersonernes deltagelse
c)
deres rettigheder og garantier for så vidt angår deres deltagelse, navnlig deres ret til at nægte at deltage i og retten til når som helst at trække sig tilbage fra afprøvningen under faktiske forhold, uden at det medfører ulemper, og uden at der skal gives nogen begrundelse herfor
d)
ordninger for anmodning om omgørelse eller tilsidesættelse af AI-systemets forudsigelser, anbefalinger eller beslutninger
e)
det EU-dækkende unikke individuelle identifikationsnummer for afprøvningen under faktiske forhold i overensstemmelse med artikel 60, stk. 4, litra c), og kontaktoplysninger på den udbyder eller dennes retlige repræsentant, hos hvem der kan indhentes yderligere oplysninger.
2.   Det informerede samtykke dateres og dokumenteres, og der gives en kopi til forsøgspersonerne eller deres retlige repræsentant.
Artikel 62
Foranstaltninger for udbydere og idriftsættere, navnlig SMV'er, herunder iværksættervirksomheder
1.   Medlemsstaterne skal foretage følgende tiltag:
a)
give SMV'er, herunder iværksættervirksomheder, der har vedtægtsmæssigt hjemsted eller en filial i Unionen, prioriteret adgang til de reguleringsmæssige AI-sandkasser, i det omfang de opfylder deltagelsesbetingelserne og udvælgelseskriterierne; den prioriterede adgang afskærer ikke andre SMV'er, herunder iværksættervirksomheder, end dem, der er omhandlet i dette stykke, fra at få adgang til den reguleringsmæssige AI-sandkasse, forudsat at de også opfylder deltagelsesbetingelserne og udvælgelseskriterierne
b)
organisere specifikke oplysnings- og uddannelsesaktiviteter om anvendelsen af denne forordning, der er skræddersyet til behovene hos SMV'er, herunder iværksættervirksomheder, idriftsættere og, alt efter hvad der er relevant, lokale offentlige myndigheder
c)
benytte eksisterende særlige kanaler og, hvis det er relevant, etablere nye kanaler til kommunikation med SMV'er, herunder iværksættervirksomheder, idriftsættere, andre innovatorer og, alt efter hvad der er relevant, lokale offentlige myndigheder for at yde rådgivning og besvare forespørgsler om gennemførelsen af denne forordning, herunder for så vidt angår deltagelse i reguleringsmæssige AI-sandkasser
d)
lette SMV'ers og andre relevante interessenters deltagelse i standardiseringsudviklingsprocessen.
2.   Der tages hensyn til SMV-udbyderes, herunder iværksættervirksomheder, særlige interesser og behov ved fastsættelsen af gebyrerne for overensstemmelsesvurdering i henhold til artikel 43, idet gebyrerne nedsættes i forhold til deres størrelse, markedsstørrelse og andre relevante indikatorer.
3.   AI-kontoret skal foretage følgende tiltag:
a)
tilvejebringe standardiserede skabeloner for de områder, der er omfattet af denne forordning, som angivet af AI-udvalget i dets anmodning
b)
udvikle og vedligeholde en fælles informationsplatform, der giver alle operatører i hele Unionen letanvendelige oplysninger i forbindelse med denne forordning
c)
tilrettelægge passende kommunikationskampagner for at øge bevidstheden om de forpligtelser, der følger af denne forordning
d)
evaluere og fremme konvergensen af bedste praksis i offentlige udbudsprocedurer i forbindelse med AI-systemer.
Artikel 63
Undtagelser for særlige operatører
1.   Mikrovirksomheder som omhandlet i henstilling 2003/361/EF kan overholde visse elementer i det kvalitetsstyringssystem, der kræves i henhold til denne forordnings artikel 17, på en forenklet måde, forudsat at de ikke har partnervirksomheder eller tilknyttede virksomheder som omhandlet i nævnte henstilling. Med henblik herpå udvikler Kommissionen retningslinjer for de elementer i kvalitetsstyringssystemet, der kan overholdes på en forenklet måde under hensyntagen til mikrovirksomhedernes behov uden at påvirke beskyttelsesniveauet eller behovet for overholdelse af kravene til højrisiko-AI-systemer.
2.   Denne artikels stk. 1 skal ikke fortolkes således, at det fritager disse operatører for at opfylde andre krav eller forpligtelser, der er fastsat i denne forordning, herunder dem, der er fastsat i artikel 9, 10, 11, 12, 13, 14, 15, 72 og 73.
KAPITEL VII
FORVALTNING
AFDELING 1
Forvaltning på EU-plan
Artikel 64
AI-kontoret
1.   Kommissionen udvikler EU-ekspertise og -kapacitet inden for AI gennem AI-kontoret.
2.   Medlemsstaterne letter de opgaver, der overdrages til AI-kontoret, som afspejlet i denne forordning.
Artikel 65
Oprettelse af Det Europæiske Udvalg for Kunstig Intelligens og dets struktur
1.   Der oprettes herved et Europæisk Udvalg for Kunstig Intelligens (»AI-udvalget«).
2.   AI-udvalget består af én repræsentant pr. medlemsstat. Den Europæiske Tilsynsførende for Databeskyttelse deltager som observatør. AI-kontoret deltager også i AI-udvalgets møder uden at deltage i afstemningerne. AI-udvalget kan indbyde andre nationale myndigheder, organer eller eksperter og EU-myndigheder, -organer eller -eksperter til møderne fra sag til sag, hvis de spørgsmål, der drøftes, er relevante for dem.
3.   Hver repræsentant udpeges af deres medlemsstat for en periode på tre år, der kan forlænges én gang.
4.   Medlemsstaterne sikrer, at deres repræsentanter i AI-udvalget:
a)
har de relevante kompetencer og beføjelser i deres medlemsstat til at kunne bidrage aktivt til udførelsen af AI-udvalgets opgaver, der er omhandlet i artikel 66
b)
udpeges som eneste kontaktpunkt for AI-udvalget og, hvis det er relevant, idet der tages hensyn til medlemsstaternes behov, som eneste kontaktpunkt for interessenter
c)
har beføjelse til at lette sammenhæng og koordinering mellem de nationale kompetente myndigheder i deres medlemsstat for så vidt angår gennemførelsen af denne forordning, herunder gennem indsamling af relevante data og oplysninger med henblik på udførelse af deres opgaver i AI-udvalget.
5.   De udpegede repræsentanter for medlemsstaterne vedtager AI-udvalgets forretningsorden med to tredjedeles flertal. Forretningsordenen fastlægger navnlig procedurer for udvælgelsesprocessen, varigheden af mandatet for og en beskrivelse af formandskabets opgaver, de nærmere afstemningsordninger og tilrettelæggelsen af AI-udvalgets og dets undergruppers aktiviteter.
6.   AI-udvalget opretter to stående undergrupper for at tilvejebringe en platform for samarbejde og udveksling mellem markedsovervågningsmyndighederne og underretning af myndigheder om spørgsmål vedrørende henholdsvis markedsovervågning og bemyndigede organer.
Den stående undergruppe for markedsovervågning bør fungere som den administrative samarbejdsgruppe (ADCO) i forbindelse med denne forordning som omhandlet i artikel 30 i forordning (EU) 2019/1020.
AI-udvalget kan i relevant omfang nedsætte andre stående eller midlertidige undergrupper med henblik på at behandle specifikke spørgsmål. Hvis det er relevant, kan repræsentanter for det rådgivende forum omhandlet i artikel 67 indbydes til sådanne undergrupper eller til specifikke møder i disse undergrupper som observatører.
7.   AI-udvalget skal være organiseret og arbejde på en sådan måde, at der i dets arbejde sikres objektivitet og uvildighed.
8.   AI-udvalgets formandskab varetages af en af repræsentanterne for medlemsstaterne. AI-kontoret varetager sekretariatsfunktionen for AI-udvalget, indkalder til møderne efter anmodning fra formanden og udarbejder dagsordenen i overensstemmelse med AI-udvalgets opgaver i henhold til denne forordning og dens forretningsorden.
Artikel 66
AI-udvalgets opgaver
AI-udvalget rådgiver og bistår Kommissionen og medlemsstaterne med henblik på at lette en ensartet og effektiv anvendelse af denne forordning. Med henblik herpå kan AI-udvalget navnlig:
a)
bidrage til koordineringen mellem de nationale kompetente myndigheder, der er ansvarlige for anvendelsen af denne forordning, og i samarbejde og efter aftale med de pågældende markedsovervågningsmyndigheder støtte markedsovervågningsmyndigheders fælles aktiviteter, der er omhandlet i artikel 74, stk. 11
b)
indsamle og udveksle teknisk og reguleringsmæssig ekspertise og bedste praksis blandt medlemsstaterne
c)
yde rådgivning om gennemførelsen af denne forordning, navnlig med hensyn til håndhævelsen af reglerne om AI-modeller til almen brug
d)
bidrage til harmonisering af administrative former for praksis i medlemsstaterne, herunder i forbindelse med undtagelsen fra de overensstemmelsesvurderingsprocedurer, der er omhandlet i artikel 46, reguleringsmæssige AI-sandkassers funktion og afprøvning under faktiske forhold, der er omhandlet i artikel 57, 59 og 60
e)
på anmodning af Kommissionen eller på eget initiativ fremsætte henstillinger og afgive skriftlige udtalelser om alle relevante spørgsmål vedrørende gennemførelsen af denne forordning og dens ensartede og effektive anvendelse, herunder:
i)
om udarbejdelse og anvendelse af adfærdskodekser og praksiskodekser i henhold til denne forordning samt af Kommissionens retningslinjer
ii)
evalueringen og revisionen af denne forordning i medfør af artikel 112, herunder for så vidt angår de indberetninger af alvorlige hændelser, der er omhandlet i artikel 73, og funktionen af den EU-database, der er omhandlet i artikel 71, udarbejdelsen af delegerede retsakter eller gennemførelsesretsakter og for så vidt angår eventuelle tilpasninger af denne forordning til den EU-harmoniseringslovgivning, der er opført i bilag I
iii)
om tekniske specifikationer eller eksisterende standarder vedrørende de i kapitel III, afdeling 2, fastsatte krav
iv)
om anvendelsen af harmoniserede standarder eller fælles specifikationer, der er omhandlet i artikel 40 og 41
v)
tendenser såsom europæisk global konkurrenceevne inden for AI, udbredelsen af AI i Unionen og udviklingen af digitale færdigheder
vi)
tendenser vedrørende udviklingen i typologien af AI-værdikæder, navnlig vedrørende de deraf følgende konsekvenser med hensyn til ansvarlighed
vii)
om det potentielle behov for ændring af bilag III i overensstemmelse med artikel 7 og om det potentielle behov for en eventuel revision af artikel 5 i medfør af artikel 112 under hensyntagen til relevant tilgængelig dokumentation og den seneste teknologiske udvikling
f)
støtte Kommissionen i at fremme AI-færdigheder, offentlighedens kendskab til og forståelse af fordele, risici, sikkerhedsforanstaltninger og rettigheder og forpligtelser i forbindelse med anvendelsen af AI-systemer
g)
lette udarbejdelsen af fælles kriterier og en fælles forståelse blandt markedsoperatører og kompetente myndigheder af de relevante begreber i denne forordning, herunder ved at bidrage til udarbejdelse af benchmarks
h)
samarbejde, alt efter hvad der er relevant, med andre EU-institutioner, -organer, -kontorer og -agenturer samt relevante EU-ekspertgrupper og -netværk, navnlig inden for produktsikkerhed, cybersikkerhed, konkurrence, digitale tjenester og medietjenester, finansielle tjenesteydelser, forbrugerbeskyttelse, databeskyttelse og beskyttelse af grundlæggende rettigheder
i)
bidrage til et effektivt samarbejde med de kompetente myndigheder i tredjelande og med internationale organisationer
j)
bistå de nationale kompetente myndigheder og Kommissionen med udviklingen af den organisatoriske og tekniske ekspertise, der er nødvendig for gennemførelsen af denne forordning, herunder ved at bidrage til vurderingen af uddannelsesbehovene for personale i de medlemsstater, der er involveret i gennemførelsen af denne forordning
k)
bistå AI-kontoret med at støtte de nationale kompetente myndigheder i etableringen og udviklingen af reguleringsmæssige AI-sandkasser og lette samarbejdet og informationsudvekslingen mellem reguleringsmæssige AI-sandkasser
l)
bidrage til og yde relevant rådgivning om udarbejdelsen af vejledningsdokumenter
m)
rådgive Kommissionen i forbindelse med internationale spørgsmål om AI
n)
afgive udtalelser til Kommissionen om de kvalificerede varslinger vedrørende AI-modeller til almen brug
o)
modtage udtalelser fra medlemsstaterne om kvalificerede varslinger vedrørende AI-modeller til almen brug og om nationale erfaringer og praksis vedrørende overvågning og håndhævelse af AI-systemer, navnlig de systemer, der integrerer AI-modeller til almen brug.
Artikel 67
Det rådgivende forum
1.   Der oprettes et rådgivende forum til at yde teknisk ekspertise til og rådgive AI-udvalget og Kommissionen og bidrage til deres opgaver i henhold til denne forordning.
2.   Det rådgivende forums medlemmer skal repræsentere et afbalanceret udvalg af interessenter, herunder industrien, iværksættervirksomheder, SMV'er, civilsamfundet og den akademiske verden. Der skal være balance mellem det rådgivende forums medlemmer med hensyn til kommercielle og ikkekommercielle interesser og inden for kategorien af kommercielle interesser med hensyn til SMV'er og andre virksomheder.
3.   Kommissionen udpeger medlemmerne af det rådgivende forum i overensstemmelse med kriterierne i stk. 2 blandt interessenter med anerkendt ekspertise inden for AI.
4.   Mandatperioden for medlemmerne af det rådgivende forum er to år, som kan forlænges med højst fire år.
5.   Agenturet for Grundlæggende Rettigheder, ENISA, Den Europæiske Standardiseringsorganisation (CEN), Den Europæiske Komité for Elektroteknisk Standardisering (Cenelec) og Det Europæiske Standardiseringsinstitut for Telekommunikation (ETSI) er permanente medlemmer af det rådgivende forum.
6.   Det rådgivende forum fastsætter selv sin forretningsorden. Det vælger to medformænd blandt sine medlemmer i overensstemmelse med kriterierne i stk. 2. Medformændenes mandatperiode er på to år og kan forlænges én gang.
7.   Det rådgivende forum afholder møder mindst to gange om året. Det rådgivende forum kan indbyde eksperter og andre interessenter til sine møder.
8.   Det rådgivende forum kan udarbejde udtalelser, anbefalinger og skriftlige bidrag på anmodning af AI-udvalget eller Kommissionen.
9.   Det rådgivende forum kan oprette stående eller midlertidige underudvalg, alt efter hvad der er relevant med henblik på undersøgelse af specifikke spørgsmål vedrørende denne forordnings formål.
10.   Det rådgivende forum udarbejder en årlig rapport om sine aktiviteter. Denne rapport offentliggøres.
Artikel 68
Videnskabeligt panel af uafhængige eksperter
1.   Kommissionen fastsætter ved hjælp af en gennemførelsesretsakt bestemmelser om oprettelse af et videnskabeligt panel af uafhængige eksperter (»det videnskabelige panel«), der skal støtte håndhævelsesaktiviteterne i henhold til denne forordning. Denne gennemførelsesretsakt vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
2.   Det videnskabelige panel skal bestå af eksperter, der udvælges af Kommissionen på grundlag af den ajourførte videnskabelige eller tekniske ekspertise inden for AI, der er nødvendig med henblik på de opgaver, der er fastsat i stk. 3, og skal kunne påvise, at alle følgende betingelser er opfyldt:
a)
særlig ekspertise og kompetence og videnskabelig eller teknisk ekspertise inden for AI
b)
uafhængighed af udbydere af AI-systemer eller AI-modeller til almen brug
c)
evne til at udføre aktiviteter omhyggeligt, nøjagtigt og objektivt.
Kommissionen fastsætter i samråd med AI-udvalget antallet af eksperter i panelet i overensstemmelse med de nødvendige behov og sikrer en fair kønsmæssig og geografisk repræsentation.
3.   Det videnskabelige panel rådgiver og støtter AI-kontoret, navnlig med hensyn til følgende opgaver:
a)
støtte gennemførelsen og håndhævelsen af denne forordning for så vidt angår AI-modeller og -systemer til almen brug, navnlig ved at:
i)
varsle AI-kontoret om mulige systemiske risici på EU-plan ved AI-modeller til almen brug i overensstemmelse med artikel 90
ii)
bidrage til udvikling af værktøjer og metoder til at evaluere kapaciteterne i AI-modeller og -systemer til almen brug, herunder gennem benchmarks
iii)
yde rådgivning om klassificering af AI-modeller til almen brug med systemisk risiko
iv)
yde rådgivning om klassificering af forskellige AI-modeller og -systemer til almen brug
v)
bidrage til udviklingen af værktøjer og skabeloner
b)
støtte markedsovervågningsmyndighederne arbejde efter disses anmodning
c)
støtte grænseoverskridende markedsovervågningsaktiviteter som omhandlet i artikel 74, stk. 11, uden at dette berører markedsovervågningsmyndighedernes beføjelser
d)
støtte AI-kontoret i udførelsen af dets opgaver inden for rammerne af EU-beskyttelsesproceduren i henhold til artikel 81.
4.   Eksperterne i det videnskabelige panel udfører deres opgaver uvildigt og objektivt og sikrer fortroligheden af de oplysninger og data, der er indhentet under udførelsen af deres opgaver og aktiviteter. De må hverken søge eller modtage instrukser fra nogen, når de udfører deres opgaver i henhold til stk. 3. Hver ekspert udfærdiger en interesseerklæring, der gøres offentligt tilgængelig. AI-kontoret etablerer systemer og procedurer til aktivt at håndtere og forebygge potentielle interessekonflikter.
5.   Den gennemførelsesretsakt, der er omhandlet i stk. 1, skal indeholde bestemmelser om betingelserne, procedurerne og de nærmere ordninger for, hvordan det videnskabelige panel og dets medlemmer kan sende varslinger og anmode AI-kontoret om bistand til udførelsen af det videnskabelige panels opgaver.
Artikel 69
Medlemsstaternes adgang til puljen af eksperter
1.   Medlemsstaterne kan anmode eksperter i det videnskabelige panel om at støtte deres håndhævelsesaktiviteter i henhold til denne forordning.
2.   Medlemsstaterne kan pålægges at betale gebyrer for den rådgivning og støtte, som eksperterne yder. Gebyrernes struktur og størrelse samt størrelsen og strukturen af de omkostninger, der kan kræves erstattet, fastsættes i den gennemførelsesretsakt, der er omhandlet i artikel 68, stk. 1, under hensyntagen til målene om en passende gennemførelse af denne forordning, omkostningseffektivitet og nødvendigheden af at sikre, at alle medlemsstater har effektiv adgang til eksperter.
3.   Kommissionen letter medlemsstaternes rettidige adgang til eksperterne efter behov og sikrer, at kombinationen af støtteaktiviteter, som udføres af EU-AI-afprøvningsstøtte i henhold til artikel 84, og eksperter i henhold til nærværende artikel tilrettelægges effektivt og giver den bedst mulige merværdi.
AFDELING 2
Nationale kompetente myndigheder
Artikel 70
Udpegelse af nationale kompetente myndigheder og centrale kontaktpunkter
1.   Hver medlemsstat opretter eller udpeger som nationale kompetente myndigheder mindst én bemyndigende myndighed og mindst én markedsovervågningsmyndighed med henblik på denne forordning. Disse nationale kompetente myndigheder udøver deres beføjelser uafhængigt, upartisk og uden bias for derved at beskytte objektiviteten i deres aktiviteter og opgaver og for at sikre anvendelsen og gennemførelsen af denne forordning. Medlemmerne af disse myndigheder afholder sig fra ethvert tiltag, som er uforenelig med deres hverv. Forudsat at disse principper overholdes, kan sådanne aktiviteter og opgaver udføres af en eller flere udpegede myndigheder i overensstemmelse med medlemsstatens organisatoriske behov.
2.   Medlemsstaterne meddeler Kommissionen identiteten af de bemyndigende myndigheder og markedsovervågningsmyndighederne og disse myndigheders opgaver samt eventuelle efterfølgende ændringer heraf. Medlemsstaterne offentliggør senest den 2. august 2025 oplysninger om, hvordan de kompetente myndigheder og de centrale kontaktpunkter kan kontaktes ved hjælp af elektroniske kommunikationsmidler. Medlemsstaterne udpeger en markedsovervågningsmyndighed til at fungere som centralt kontaktpunkt for denne forordning og underretter Kommissionen om identiteten af det centrale kontaktpunkt. Kommissionen offentliggør en liste over de centrale kontaktpunkter.
3.   Medlemsstaterne sikrer, at deres nationale kompetente myndigheder tilføres tilstrækkelige tekniske, finansielle og menneskelige ressourcer og infrastruktur, til at de kan udføre deres opgaver effektivt i henhold til denne forordning. De nationale kompetente myndigheder skal navnlig råde over et tilstrækkeligt antal medarbejdere på fast basis, hvis kompetencer og ekspertise spænder over en indgående forståelse af AI-teknologier, data og databehandling, beskyttelse af personoplysninger, cybersikkerhed, grundlæggende rettigheder, sundheds- og sikkerhedsrisici og viden om gældende standarder og retlige krav. Medlemsstaterne skal årligt vurdere og om nødvendigt ajourføre de kompetence- og ressourcebehov, der er omhandlet i dette stykke.
4.   De nationale kompetente myndigheder skal træffe passende foranstaltninger for at sikre et tilstrækkeligt niveau af cybersikkerhed.
5.   De nationale kompetente myndigheder handler i forbindelse med udførelsen af deres opgaver i overensstemmelse med fortrolighedsforpligtelserne fastsat i artikel 78.
6.   Senest den 2. august 2025 og én gang hvert andet år derefter aflægger medlemsstaterne rapport til Kommissionen om status for de nationale kompetente myndigheders finansielle og menneskelige ressourcer med en vurdering af deres tilstrækkelighed. Kommissionen videresender disse oplysninger til AI-udvalget med henblik på drøftelse og eventuelle henstillinger.
7.   Kommissionen letter udvekslingen af erfaringer mellem de nationale kompetente myndigheder.
8.   De nationale kompetente myndigheder kan yde vejledning og rådgivning om gennemførelsen af denne forordning, navnlig til SMV'er, herunder iværksættervirksomheder, under hensyntagen til AI-udvalgets og Kommissionens vejledning og rådgivning, alt efter hvad der er relevant. Når de nationale kompetente myndigheder agter at yde vejledning og rådgivning i forbindelse med et AI-system på områder, der er omfattet af anden EU-ret, skal de nationale kompetente myndigheder i henhold til denne EU-ret høres, alt efter hvad der er relevant.
9.   Hvis EU-institutioner, -organer, -kontorer eller -agenturer er omfattet af denne forordnings anvendelsesområde, fungerer Den Europæiske Tilsynsførende for Databeskyttelse som den kompetente myndighed for tilsynet med dem.
KAPITEL VIII
EU-DATABASE FOR HØJRISIKO-AI-SYSTEMER
Artikel 71
EU-database for højrisiko-AI-systemer opført i bilag III
1.   Kommissionen opretter og vedligeholder i samarbejde med medlemsstaterne en EU-database med de i denne artikels stk. 2 og 3 omhandlede oplysninger vedrørende højrisiko-AI-systemer, jf. artikel 6, stk. 2, som er registreret i overensstemmelse med artikel 49 og 60, og AI-systemer, der ikke anses som højrisiko-AI-systemer i henhold til artikel 6, stk. 3, og som er registeret i overensstemmelse med artikel 6, stk. 4, og artikel 49. Ved fastsættelsen af funktionsspecifikationerne for en sådan database hører Kommissionen de relevante eksperter og, når den ajourfører funktionsspecifikationerne for en sådan database, hører Kommissionen AI-udvalget.
2.   De data, der er anført i bilag VIII, afsnit A og B, indlæses i EU-databasen af udbyderen eller, hvis det er relevant, af den bemyndigede repræsentant.
3.   De data, der er anført i bilag VIII, afsnit C, indlæses i EU-databasen af den idriftsætter, som er eller handler på vegne af en offentlig myndighed eller et offentligt agentur eller organ i overensstemmelse med artikel 49, stk. 3 og 4.
4.   Med undtagelse af det afsnit, der er omhandlet i artikel 49, stk. 4, og artikel 60, stk. 4, litra c), skal oplysningerne i EU-databasen, der er registreret i overensstemmelse med artikel 49, kunne tilgås og være offentligt tilgængelige på en brugervenlig måde. Oplysningerne bør være lette at finde rundt i og maskinlæsbare. De oplysninger, der registreres i overensstemmelse med artikel 60, må kun være tilgængelige for markedsovervågningsmyndighederne og Kommissionen, medmindre den potentielle udbyder eller udbyderen har givet sit samtykke til, at oplysningerne også gøres tilgængelige for offentligheden.
5.   EU-databasen må kun indeholde personoplysninger, i det omfang det er nødvendigt for at indsamle og behandle oplysninger i overensstemmelse med denne forordning. Disse oplysninger omfatter navne og kontaktoplysninger på de fysiske personer, der er ansvarlige for registrering af systemet og har retlig beføjelse til at repræsentere udbyderen eller idriftsætteren, alt efter hvad der er relevant.
6.   Kommissionen er dataansvarlig for EU-databasen. Den stiller tilstrækkelig teknisk og administrativ støtte til rådighed for udbydere, potentielle udbydere og idriftsættere. EU-databasen skal overholde gældende tilgængelighedskrav.
KAPITEL IX
OVERVÅGNING EFTER OMSÆTNINGEN, UDVEKSLING AF OPLYSNINGER OG MARKEDSOVERVÅGNING
AFDELING 1
Overvågning efter omsætningen
Artikel 72
Udbydernes overvågning efter omsætningen og plan for overvågning efter omsætningen for højrisiko-AI-systemer
1.   Udbyderne skal oprette og dokumentere et system til overvågning efter omsætningen på en måde, der står i et rimeligt forhold til arten af AI-teknologierne og risiciene ved højrisiko-AI-systemet.
2.   Systemet til overvågning efter omsætningen indsamler, dokumenterer og analyserer relevante data, som idriftsætterne kan afgive, eller som kan indsamles via andre kilder, om højrisiko-AI-systemers ydeevne i hele deres levetid, og som giver udbyderen mulighed for at evaluere, at AI-systemerne løbende overholder de i kapitel III, afdeling 2, fastsatte krav. Hvis det er relevant, skal overvågning efter omsætningen omfatte en analyse af interaktionen med andre AI-systemer. Denne forpligtelse omfatter ikke følsomme operationelle data om idriftsættere, som er retshåndhævende myndigheder.
3.   Systemet til overvågning efter omsætningen skal baseres på en plan for overvågning efter omsætningen. Planen for overvågning efter omsætningen skal være en del af den tekniske dokumentation, der er omhandlet i bilag IV. Kommissionen vedtager senest den 2. februar 2026 en gennemførelsesretsakt om detaljerede bestemmelser om en model for planen for overvågning efter omsætningen og listen over elementer, der skal indgå i planen. Denne gennemførelsesretsakt vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
4.   For højrisiko-AI-systemer, der er omfattet af EU-harmoniseringslovgivningen, som er opført i bilag I, afsnit A, hvor der allerede er etableret et system til og en plan for overvågning efter omsætningen i henhold til nævnte lovgivning, skal udbyderne med henblik på at sikre sammenhæng, undgå overlap og minimere yderligere byrder have mulighed for, alt efter hvad der er relevant, at integrere de nødvendige elementer, der er beskrevet i stk. 1, 2 og 3, ved hjælp af den model, der er omhandlet i stk. 3, i allerede eksisterende systemer og planer i henhold til nævnte lovgivning, forudsat at dette opnår et tilsvarende beskyttelsesniveau.
Dette stykkes første afsnit finder også anvendelse på de i bilag III, punkt 5, omhandlede højrisiko-AI-systemer, der bringes i omsætning eller ibrugtages af finansielle institutioner, som er underlagt krav i henhold til EU-retten om finansielle tjenesteydelser for så vidt angår deres interne ledelse, ordninger eller processer.
AFDELING 2
Udveksling af oplysninger om alvorlige hændelser
Artikel 73
Indberetning af alvorlige hændelser
1.   Udbydere af højrisiko-AI-systemer, der bringes i omsætning på EU-markedet, indberetter enhver alvorlig hændelse til markedsovervågningsmyndighederne i de medlemsstater, hvor denne hændelse fandt sted.
2.   Den i stk. 1 omhandlede indberetning foretages umiddelbart efter, at udbyderen har fastslået en årsagssammenhæng mellem AI-systemet og den alvorlige hændelse eller en rimelig sandsynlighed for en sådan sammenhæng, og under alle omstændigheder senest 15 dage efter, at udbyderen eller, hvor det er relevant, idriftsætteren har fået kendskab til den alvorlige hændelse.
I den i først afsnit omhandlede frist for indberetning tages der hensyn til den alvorlige hændelses alvor.
3.   Uanset denne artikels stk. 2 forelægges den i denne artikels stk. 1 omhandlede rapport i tilfælde af en udbredt overtrædelse eller en alvorlig hændelse som defineret i artikel 3, nr. 49), litra b), omgående og senest to dage efter, at udbyderen eller, hvis det er relevant, idriftsætteren har fået kendskab til den pågældende hændelse.
4.   Uanset stk. 2 forelægges rapporten i tilfælde af en persons dødsfald umiddelbart efter, at udbyderen eller idriftsætteren har fastslået, eller så snart vedkommende har mistanke om en årsagssammenhæng mellem højrisiko-AI-systemet og den alvorlige hændelse, og senest ti dage efter den dato, hvor udbyderen eller, hvis det er relevant, idriftsætteren har fået kendskab til den alvorlige hændelse.
5.   Udbyderen eller, hvis det er relevant, idriftsætteren kan om nødvendigt for at sikre rettidig indberetning forelægge en indledende rapport, som ikke er fyldestgørende, efterfulgt af en fyldestgørende rapport.
6.   Efter indberetning af en alvorlig hændelse i henhold til stk. 1 skal udbyderen straks foretage de nødvendige undersøgelser vedrørende den alvorlige hændelse og det pågældende AI-system. Dette omfatter en risikovurdering af hændelsen og korrigerende tiltag.
Udbyderen samarbejder med de kompetente myndigheder og, hvis det er relevant, med det berørte bemyndigede organ under de undersøgelser, der er omhandlet i første afsnit, og må ikke foretage nogen undersøgelse, der medfører ændringer af det pågældende AI-system på en sådan måde, at det kan påvirke en efterfølgende evaluering af årsagerne til hændelsen, uden først at orientere de kompetente myndigheder om et sådant tiltag.
7.   Når den relevante markedsovervågningsmyndighed modtager en indberetning vedrørende en alvorlig hændelse omhandlet i artikel 3, nr. 49), litra c), underretter den de nationale offentlige myndigheder eller organer, der er omhandlet i artikel 77, stk. 1. Kommissionen udarbejder særlig vejledning for at lette overholdelsen af forpligtelserne i nærværende artikels stk. 1. Denne vejledning udstedes senest den 2. august 2025 og vurderes regelmæssigt.
8.   Markedsovervågningsmyndigheden træffer passende foranstaltninger, jf. artikel 19 i forordning (EU) 2019/1020, senest syv dage fra den dato, hvor den modtog den i nærværende artikels stk. 1 omhandlede indberetning, og følger indberetningsprocedurerne som fastsat i nævnte forordning.
9.   I forbindelse med de i bilag III omhandlede højrisiko-AI-systemer, der bringes i omsætning eller ibrugtages af udbydere, som er underlagt Unionens lovgivningsmæssige instrumenter om indberetningsforpligtelser svarende til dem, der er fastsat i denne forordning, begrænses indberetningen af alvorlige hændelser til dem, der er omhandlet i artikel 3, nr. 49), litra c).
10.   For højrisiko-AI-systemer, som er sikkerhedskomponenter i udstyr, eller som selv er udstyr, der er omfattet af forordning (EU) 2017/745 og (EU) 2017/746, begrænses indberetningen af alvorlige hændelser til dem, der er omhandlet i nærværende forordnings artikel 3, nr. 49), litra c), og foretages til den nationale kompetente myndighed, som er valgt til dette formål af den medlemsstat, hvor hændelsen fandt sted.
11.   De nationale kompetente myndigheder underretter omgående Kommissionen om enhver alvorlig hændelse, uanset om de har foretaget tiltag desangående, i overensstemmelse med artikel 20 i forordning (EU) 2019/1020.
AFDELING 3
Håndhævelse
Artikel 74
Markedsovervågning og kontrol af AI-systemer på EU-markedet
1.   Forordning (EU) 2019/1020 finder anvendelse på AI-systemer, der er omfattet af nærværende forordning. Med henblik på effektiv håndhævelse af nærværende forordning gælder følgende:
a)
enhver henvisning til en erhvervsdrivende i henhold til forordning (EU) 2019/1020 skal forstås således, at den omfatter alle operatører, der er omfattet af nærværende forordnings artikel 2, stk. 1
b)
enhver henvisning til et produkt i henhold til forordning (EU) 2019/1020 skal forstås således, at den omfatter alle AI-systemer, der henhører under nærværende forordnings anvendelsesområde.
2.   Som led i deres rapporteringsforpligtelser i henhold til artikel 34, stk. 4, i forordning (EU) 2019/1020 aflægger markedsovervågningsmyndighederne årligt rapport til Kommissionen og de relevante nationale konkurrencemyndigheder i forbindelse med markedsovervågningsaktiviteter, som kan være af potentiel interesse for anvendelsen af EU-retten om konkurrenceregler. De aflægger også årligt rapport til Kommissionen om anvendelsen af forbudt praksis, der har fundet sted i løbet af det pågældende år, og om de foranstaltninger, der er truffet.
3.   For så vidt angår højrisiko-AI-systemer, som er knyttet til produkter, der er omfattet af EU-harmoniseringslovgivningen, som er opført i bilag I, afsnit A, er markedsovervågningsmyndigheden med henblik på denne forordning den myndighed, der i henhold til disse retsakter er ansvarlig for markedsovervågningsaktiviteter.
Uanset første afsnit og under behørige omstændigheder kan medlemsstaterne udpege en anden relevant myndighed til at fungere som markedsovervågningsmyndighed, forudsat at de sikrer koordinering med de relevante sektorspecifikke markedsovervågningsmyndigheder, der er ansvarlige for håndhævelsen af den EU-harmoniseringslovgivning, der er opført i bilag I.
4.   De procedurer, der er omhandlet i denne forordnings artikel 79-83, finder ikke anvendelse på AI-systemer, som er knyttet til produkter, der er omfattet af EU-harmoniseringslovgivningen, som er opført i bilag I, afsnit A, hvis sådanne retsakter allerede indeholder bestemmelser om procedurer, der sikrer et tilsvarende beskyttelsesniveau og har det samme formål. I sådanne tilfælde finder de relevante sektorprocedurer anvendelse i stedet.
5.   Uden at det berører markedsovervågningsmyndighedernes beføjelser i henhold til artikel 14 i forordning (EU) 2019/1020, kan markedsovervågningsmyndighederne med henblik på at sikre en effektiv håndhævelse af nærværende forordning udøve de beføjelser, der er omhandlet i nævnte forordnings artikel 14, stk. 4, litra d) og j), på afstand, alt efter hvad der er relevant.
6.   For så vidt angår højrisiko-AI-systemer, der bringes i omsætning, ibrugtages eller anvendes af finansielle institutioner, der er omfattet af EU-retten om finansielle tjenesteydelser, er markedsovervågningsmyndigheden med henblik på denne forordning den relevante nationale myndighed, der i henhold til nævnte lovgivning er ansvarlig for det finansielle tilsyn med disse institutioner, såfremt omsætningen, ibrugtagningen eller anvendelsen af AI-systemet er i direkte forbindelse med leveringen af disse finansielle tjenesteydelser.
7.   Uanset stk. 6 kan medlemsstaten under behørige omstændigheder, og forudsat at der sikres koordinering, udpege en anden relevant myndighed som markedsovervågningsmyndighed med henblik på denne forordning.
Nationale markedsovervågningsmyndigheder, som fører tilsyn med kreditinstitutter, der er reguleret i henhold til direktiv 2013/36/EU, og som deltager i den fælles tilsynsmekanisme, der er oprettet ved forordning (EU) nr. 1024/2013, bør straks indberette alle de oplysninger identificeret i forbindelse med deres markedsovervågningsaktiviteter, som kan være af potentiel interesse for Den Europæiske Centralbanks tilsynsopgaver som fastsat i nævnte forordning, til Den Europæiske Centralbank.
8.   For så vidt angår de højrisiko-AI-systemer, der er anført i bilag III, punkt 1, til denne forordning for så vidt systemerne anvendes til retshåndhævelsesformål, grænseforvaltning og retsvæsen og demokrati, og de højrisiko-AI-systemer, der er anført i bilag III, punkt 6, 7 og 8, til denne forordning, udpeger medlemsstaterne med henblik på denne forordning som markedsovervågningsmyndigheder enten de kompetente datatilsynsmyndigheder i henhold til forordning (EU) 2016/679 eller direktiv (EU) 2016/680 eller enhver anden myndighed, der er udpeget på de samme betingelser, der er fastsat i artikel 41-44 i direktiv (EU) 2016/680. Markedsovervågningsaktiviteter må på ingen måde påvirke de judicielle myndigheders uafhængighed eller på anden måde gribe ind i deres aktiviteter, når de handler i deres egenskab af domstol.
9.   I tilfælde, hvor EU-institutioner, -organer, -kontorer eller -agenturer er omfattet af denne forordning, fungerer Den Europæiske Tilsynsførende for Databeskyttelse som deres markedsovervågningsmyndighed, undtagen i forbindelse med EU-Domstolen, som handler i sin egenskab af domstol.
10.   Medlemsstaterne skal lette koordinering mellem markedsovervågningsmyndigheder, der er udpeget i henhold til denne forordning, og andre relevante nationale myndigheder eller organer, der fører tilsyn med anvendelsen af den EU-harmoniseringslovgivning, der er opført i bilag I, eller anden EU-ret, der kan være relevant for de i bilag III omhandlede højrisiko-AI-systemer.
11.   Markedsovervågningsmyndighederne og Kommissionen kan foreslå fælles aktiviteter, herunder fælles undersøgelser, som skal gennemføres af enten markedsovervågningsmyndigheder eller af markedsovervågningsmyndigheder sammen med Kommissionen, og som har til formål at fremme overholdelse, identificere manglende overholdelse, øge bevidstheden eller yde vejledning for så vidt angår denne forordning med hensyn til specifikke kategorier af højrisiko-AI-systemer, der anses for at udgøre en alvorlig risiko i to eller flere medlemsstater i overensstemmelse med artikel 9 i forordning (EU) 2019/1020. AI-kontoret sørger for koordinerende støtte til de fælles undersøgelser.
12.   Uden at det berører de beføjelser, der er fastsat i forordning (EU) 2019/1020, og hvis det er relevant og begrænset til, hvad der er nødvendigt for, at markedsovervågningsmyndighederne kan udføre deres opgaver, gives de af udbydere fuld adgang til den dokumentation samt til de trænings-, validerings- og afprøvningsdatasæt, der anvendes til udvikling af højrisiko-AI-systemer, herunder, hvis det er relevant og med forbehold af sikkerhedsforanstaltninger, via programmeringsgrænseflader for applikationer (API'er) eller andre relevante tekniske midler og værktøjer, der muliggør fjernadgang.
13.   Markedsovervågningsmyndighederne gives efter begrundet anmodning adgang til kildekoden for højrisiko-AI-systemet, og kun når begge følgende betingelser er opfyldt:
a)
adgang til kildekode er nødvendig for at vurdere, om et højrisiko-AI-system er i overensstemmelse med kravene i kapitel III, afdeling 2, og
b)
afprøvnings- eller revisionsprocedurer og -verifikationer på grundlag af data og dokumentation fra udbyderen er udtømt eller har vist sig at være utilstrækkelige.
14.   Alle de oplysninger eller al den dokumentation, som markedsovervågningsmyndighederne kommer i besiddelse af, behandles i overensstemmelse med fortrolighedsforpligtelserne fastsat i artikel 78.
Artikel 75
Gensidig bistand, markedsovervågning og kontrol med AI-systemer til almen brug
1.   Hvis et AI-system er baseret på en AI-model til almen brug, og modellen og systemet er udviklet af den samme udbyder, har AI-kontoret beføjelser til at overvåge og føre tilsyn med, om det pågældende AI-system overholder kravene i denne forordning. For at varetage sine overvågnings- og tilsynsopgaver skal AI-kontoret have alle beføjelser som markedsovervågningsmyndighed, der er fastsat i denne afdeling og forordning (EU) 2019/1020.
2.   Hvis de relevante markedsovervågningsmyndigheder har tilstrækkelig grund til at mene, at AI-systemer til almen brug, som kan anvendes direkte af idriftsættere til mindst ét formål, der er klassificeret som højrisiko i henhold til denne forordning, ikke overholder kravene i denne forordning, samarbejder de med AI-kontoret om at foretage evalueringer af overholdelsen og underretter AI-udvalget og andre markedsovervågningsmyndigheder i overensstemmelse hermed.
3.   Hvis en markedsovervågningsmyndighed ikke er i stand til at afslutte sin undersøgelse af højrisiko-AI-systemet som følge af manglende adgang til visse oplysninger vedrørende AI-modellen til almen brug, selv om den har udfoldet alle de nødvendige bestræbelser på at indhente disse oplysninger, kan den fremsætte en begrundet anmodning til AI-kontoret, hvorved adgangen til disse oplysninger skal håndhæves. I dette tilfælde skal AI-kontoret straks og under alle omstændigheder inden for 30 dage give den anmodende myndighed alle oplysninger, som AI-kontoret anser for at være relevante for at fastslå, om et højrisiko-AI-system overholder gældende regler eller ej. Markedsovervågningsmyndighederne sikrer, at de oplysninger, som de kommer i besiddelse af, behandles fortroligt i overensstemmelse med denne forordnings artikel 78. Proceduren i kapitel VI i forordning (EU) 2019/1020 finder tilsvarende anvendelse.
Artikel 76
Markedsovervågningsmyndighedernes tilsyn med afprøvning under faktiske forhold
1.   Markedsovervågningsmyndighederne har kompetencer og beføjelser til at sikre, at afprøvning under faktiske forhold er i overensstemmelse med denne forordning.
2.   Hvis der udføres afprøvning under faktiske forhold for AI-systemer, som der føres tilsyn med i den reguleringsmæssige AI-sandkasse i henhold til artikel 58, kontrollerer markedsovervågningsmyndighederne overholdelsen af artikel 60 som led i deres tilsynsrolle for den reguleringsmæssige AI-sandkasse. Disse myndigheder kan, alt efter hvad der er relevant, tillade, at afprøvningen under faktiske forhold udføres af udbyderen eller den potentielle udbyder som en undtagelse fra betingelserne i artikel 60, stk. 4, litra f) og g).
3.   Hvis en markedsovervågningsmyndighed er blevet underrettet af den potentielle udbyder, udbyderen eller enhver tredjepart om en alvorlig hændelse eller har andre grunde til at mene, at betingelserne i artikel 60 og 61 ikke er opfyldt, kan den træffe en af følgende afgørelser på sit område, alt efter hvad der er relevant:
a)
suspendere eller afslutte afprøvningen under faktiske forhold
b)
kræve, at udbyderen eller den potentielle udbyder og idriftsætteren eller den potentielle idriftsætter ændrer et hvilket som helst aspekt af afprøvningen under faktiske forhold.
4.   Hvis en markedsovervågningsmyndighed har truffet en afgørelse omhandlet i denne artikels stk. 3 eller har gjort indsigelse som omhandlet i artikel 60, stk. 4, litra b), skal afgørelsen eller indsigelsen indeholde en begrundelse herfor og angive, hvordan udbyderen eller den potentielle udbyder kan anfægte afgørelsen eller indsigelsen.
5.   Hvis en markedsovervågningsmyndighed har truffet en afgørelse omhandlet i stk. 3, meddeler den, hvis det er relevant, begrundelsen herfor til markedsovervågningsmyndighederne i de andre medlemsstater, hvor AI-systemet er blevet afprøvet i overensstemmelse med planen for afprøvning.
Artikel 77
Beføjelser tillagt myndigheder, der beskytter de grundlæggende rettigheder
1.   Nationale offentlige myndigheder eller organer, der fører tilsyn med eller håndhæver overholdelsen af forpligtelser i henhold til EU-retten om beskyttelse af de grundlæggende rettigheder, herunder retten til beskyttelse mod forskelsbehandling, i forbindelse med anvendelsen af højrisiko-AI-systemer omhandlet i. bilag III har beføjelse til at anmode om og få adgang til al dokumentation, der er udarbejdet eller opretholdt i henhold til denne forordning, på et tilgængeligt sprog og i et tilgængeligt format, hvis adgang til denne dokumentation er nødvendig for effektivt at kunne udøve deres mandater inden for rammerne af deres jurisdiktion. Den relevante offentlige myndighed eller det relevante offentlige organ underretter markedsovervågningsmyndigheden i den pågældende medlemsstat om enhver sådan anmodning.
2.   Senest den 2. november 2024 identificerer hver medlemsstat de offentlige myndigheder eller organer, der er omhandlet i stk. 1, og offentliggør en liste. Medlemsstaterne meddeler listen til Kommissionen og de øvrige medlemsstater og holder listen ajour.
3.   Hvis den i stk. 1 omhandlede dokumentation er utilstrækkelig til at fastslå, om der er sket en tilsidesættelse af forpligtelser i henhold til den del af EU-retten, der beskytter de grundlæggende rettigheder, kan den offentlige myndighed eller det offentlige organ, der er omhandlet i stk. 1, fremsætte en begrundet anmodning til markedsovervågningsmyndigheden om at tilrettelægge afprøvning af højrisiko-AI-systemet ved hjælp af tekniske midler. Markedsovervågningsmyndigheden tilrettelægger afprøvningen med tæt inddragelse af den anmodende offentlige myndighed eller det anmodende offentlige organ inden for rimelig tid efter anmodningen.
4.   Alle de oplysninger eller al den dokumentation, som de i denne artikels stk. 1 omhandlede nationale offentlige myndigheder eller organer kommer i besiddelse af i henhold til denne artikel, behandles i overensstemmelse med fortrolighedsforpligtelserne fastsat i artikel 78.
Artikel 78
Fortrolighed
1.   Kommissionen, markedsovervågningsmyndighederne og bemyndigede organer og enhver anden fysisk eller juridisk person, der er involveret i anvendelsen af denne forordning, respekterer i overensstemmelse med EU-retten eller national ret fortroligheden af oplysninger og data, som de kommer i besiddelse af under udførelsen af deres opgaver og aktiviteter, på en sådan måde, at de navnlig beskytter:
a)
intellektuelle ejendomsrettigheder og fysiske eller juridiske personers fortrolige forretningsoplysninger eller forretningshemmeligheder, herunder kildekode, med undtagelse af de tilfælde, der er omhandlet i artikel 5 i Europa-Parlamentets og Rådets direktiv (EU) 2016/943 
(
57
)
b)
den effektive gennemførelse af denne forordning, navnlig for så vidt angår inspektioner, undersøgelser eller revisioner
c)
offentlige og nationale sikkerhedsinteresser
d)
strafferetlige eller administrative procedurers gennemførelse
e)
informationer, der er klassificeret i henhold til EU-retten eller national ret.
2.   De myndigheder, der er involveret i anvendelsen af denne forordning i henhold til stk. 1, må kun anmode om data, der er strengt nødvendige for at vurdere den risiko, som AI-systemer udgør, og for at udøve deres beføjelser i overensstemmelse med denne forordning og med forordning (EU) 2019/1020. De skal indføre passende og effektive cybersikkerhedsforanstaltninger for at beskytte sikkerheden og fortroligheden af de indsamlede oplysninger og data og slette de indsamlede data, så snart de ikke længere er nødvendige til det formål, som de blev indsamlet til, i overensstemmelse med gældende EU-ret eller national ret.
3.   Uden at det berører stk. 1 og 2 må oplysninger, der udveksles fortroligt mellem de nationale kompetente myndigheder eller mellem de nationale kompetente myndigheder og Kommissionen, ikke videregives uden forudgående høring af den oprindelige nationale kompetente myndighed og idriftsætteren i tilfælde, hvor højrisiko-AI-systemer omhandlet i bilag III, punkt 1, 6 eller 7, anvendes af retshåndhævende myndigheder, grænsekontrolmyndigheder, indvandringsmyndigheder eller asylmyndigheder, og hvis en sådan videregivelse ville bringe offentlige og nationale sikkerhedsinteresser i fare. Denne udveksling af oplysninger omfatter ikke følsomme operationelle oplysninger i forbindelse med aktiviteter, der udføres af retshåndhævende myndigheder, grænsekontrolmyndigheder, indvandringsmyndigheder eller asylmyndigheder.
I tilfælde, hvor de retshåndhævende myndigheder, indvandringsmyndighederne eller asylmyndighederne er udbydere af højrisiko-AI-systemer, der er omhandlet i bilag III, punkt 1, 6 eller 7, skal den tekniske dokumentation, der er omhandlet i bilag IV, forblive hos disse myndigheder. Disse myndigheder sikrer, at de markedsovervågningsmyndigheder, der er omhandlet i artikel 74, stk. 8 og 9, alt efter hvad der er relevant, efter anmodning omgående kan få adgang til dokumentationen eller få en kopi heraf. Kun det af markedsovervågningsmyndighedens personale, der har et passende sikkerhedsgodkendelsesniveau, må få adgang til dokumentationen eller en kopi heraf.
4.   Stk. 1, 2 og 3 berører ikke Kommissionens, medlemsstaternes og deres relevante myndigheders samt de bemyndigede organers rettigheder eller forpligtelser med hensyn til udveksling af oplysninger og udsendelse af advarsler, herunder i forbindelse med grænseoverskridende samarbejde, eller de berørte parters forpligtelse til at afgive oplysninger inden for rammerne af medlemsstaternes strafferet.
5.   Kommissionen og medlemsstaterne kan om nødvendigt og i overensstemmelse med relevante bestemmelser i internationale aftaler og handelsaftaler udveksle fortrolige oplysninger med reguleringsmyndigheder i tredjelande, med hvilke de har indgået bilaterale eller multilaterale fortrolighedsordninger, der sikrer en tilstrækkelig grad af fortrolighed.
Artikel 79
Procedure på nationalt plan i tilfælde af AI-systemer, der udgør en risiko
1.   AI-systemer, der udgør en risiko, skal forstås som et »produkt, der udgør en risiko« som defineret i artikel 3, nr. 19), i forordning (EU) 2019/1020, for så vidt de udgør risici for sundhed eller sikkerhed eller for personers grundlæggende rettigheder.
2.   Hvis en medlemsstats markedsovervågningsmyndighed har tilstrækkelig grund til at mene, at et AI-system udgør en risiko som omhandlet i denne artikels stk. 1, foretager den en evaluering af det pågældende AI-system for så vidt angår dets overholdelse af alle de krav og forpligtelser, der er fastsat i denne forordning. Der lægges særlig vægt på AI-systemer, der udgør en risiko for sårbare grupper. Hvis der identificeres risici for grundlæggende rettigheder, underretter markedsovervågningsmyndigheden også de relevante nationale offentlige myndigheder eller organer, der er omhandlet i artikel 77, stk. 1, og samarbejder fuldt ud med dem. De relevante operatører samarbejder om nødvendigt med markedsovervågningsmyndigheden og med de andre nationale offentlige myndigheder eller organer, der er omhandlet i artikel 77, stk. 1.
Hvis markedsovervågningsmyndigheden i forbindelse med evalueringen eller i givet fald i samarbejde med den nationale offentlige myndighed, der er omhandlet i artikel 77, stk. 1, konstaterer, at AI-systemet ikke overholder kravene og forpligtelserne i denne forordning, anmoder den uden unødigt ophold den pågældende operatør om at foretage alle fornødne korrigerende tiltag til at sørge for, at AI-systemet overholder kravene og forpligtelserne, tilbagetrække AI-systemet fra markedet eller tilbagekalde det inden for en tidsfrist, som markedsovervågningsmyndigheden kan fastsætte, og under alle omstændigheder inden for 15 arbejdsdage eller som fastsat i den relevante EU-harmoniseringslovgivning.
Markedsovervågningsmyndigheden skal underrette det relevante bemyndigede organ herom. Artikel 18 i forordning (EU) 2019/1020 finder anvendelse på de i dette stykkes andet afsnit omhandlede foranstaltninger.
3.   Hvis markedsovervågningsmyndigheden konstaterer, at den manglende overholdelse ikke er begrænset til medlemsstatens område, underretter den uden unødigt ophold Kommissionen og de øvrige medlemsstater om resultaterne af evalueringen og om de tiltag, den har pålagt operatøren at foretage.
4.   Operatøren sikrer, at der foretages alle fornødne korrigerende tiltag over for alle de pågældende AI-systemer, som denne har gjort tilgængelige EU-markedet.
5.   Hvis AI-systemets operatør ikke foretager tilstrækkelige korrigerende tiltag inden for den frist, der er omhandlet i stk. 2, træffer markedsovervågningsmyndigheden de nødvendige foreløbige foranstaltninger til at forbyde eller begrænse, at AI-systemet gøres tilgængeligt på dens nationale marked eller ibrugtages, tilbagetrække produktet eller det selvstændige AI-system fra dette marked eller tilbagekalde det. Den pågældende myndighed giver uden unødigt ophold Kommissionen og de øvrige medlemsstater meddelelse om disse foranstaltninger.
6.   Den i stk. 5 omhandlede underretning skal indeholde alle tilgængelige oplysninger, navnlig de nødvendige oplysninger til identifikation af det AI-system, der ikke overholder kravene, AI-systemets og forsyningskædens oprindelse, arten af den påståede manglende overholdelse og af den pågældende risiko, arten og varigheden af de trufne nationale foranstaltninger samt de synspunkter, som den pågældende operatør har fremsat. Markedsovervågningsmyndighederne oplyser navnlig, om den manglende overholdelse af kravene skyldes et eller flere af følgende:
a)
manglende overholdelse af forbuddet mod de i artikel 5 omhandlede former for AI-praksis
b)
et højrisiko-AI-systems manglende opfyldelse af kravene i kapitel III, afdeling 2
c)
mangler i de harmoniserede standarder eller fælles specifikationer, der er omhandlet i artikel 40 og 41, og som danner grundlag for overensstemmelsesformodningen
d)
manglende overholdelse af artikel 50.
7.   Andre markedsovervågningsmyndigheder end markedsovervågningsmyndigheden i den medlemsstat, der har indledt proceduren, underretter uden unødigt ophold Kommissionen og de øvrige medlemsstater om de trufne foranstaltninger og om yderligere oplysninger, som de måtte råde over, om det pågældende AI-systems manglende overholdelse og om deres indsigelser, hvis de ikke er indforstået med den meddelte nationale foranstaltning.
8.   Hvis der ikke inden for tre måneder efter modtagelsen af den i denne artikels stk. 5 omhandlede underretning er blevet gjort indsigelse af enten en markedsovervågningsmyndighed i en medlemsstat eller af Kommissionen mod en foreløbig foranstaltning truffet af en markedsovervågningsmyndighed i en anden medlemsstat, anses denne foranstaltning for at være berettiget. Dette berører ikke den pågældende operatørs procedurerettigheder i overensstemmelse med artikel 18 i forordning (EU) 2019/1020. Den periode på tre måneder, der er omhandlet i nærværende stykke, nedsættes til 30 dage i tilfælde af manglende overholdelse af forbuddet mod de i nærværende forordnings artikel 5 anførte former for AI-praksis.
9.   Markedsovervågningsmyndighederne sikrer, at der uden unødigt ophold træffes de fornødne restriktive foranstaltninger med hensyn til det pågældende produkt eller AI-system såsom tilbagetrækning af produktet eller AI-systemet fra deres marked.
Artikel 80
Procedure i tilfælde af AI-systemer, der af udbyderen er klassificeret som ikkehøjrisiko, i forbindelse med anvendelsen af bilag III
1.   Hvis en markedsovervågningsmyndighed har tilstrækkelig grund til at mene, at et AI-system, der af udbyderen er klassificeret som ikkehøjrisiko i henhold til artikel 6, stk. 3, faktisk er højrisiko, foretager markedsovervågningsmyndigheden en evaluering af det pågældende AI-system med hensyn til dets klassificering som et højrisiko-AI-system på grundlag af de betingelser, der er fastsat i artikel 6, stk. 3, og Kommissionens retningslinjer.
2.   Hvis markedsovervågningsmyndigheden som led i denne evaluering konstaterer, at det pågældende AI-system er højrisiko, pålægger den uden unødigt ophold den relevante udbyder at foretage alle fornødne tiltag til at bringe AI-systemet i overensstemmelse med de krav og forpligtelser, der er fastsat i denne forordning, samt foretage fornødne korrigerende tiltag inden for en tidsfrist, som markedsovervågningsmyndigheden kan fastsætte.
3.   Hvis markedsovervågningsmyndigheden konstaterer, at anvendelsen af det pågældende AI-system ikke er begrænset til medlemsstatens område, underretter den uden unødigt ophold Kommissionen og de øvrige medlemsstater om resultaterne af evalueringen og om de tiltag, den har pålagt udbyderen at foretage.
4.   Udbyderen sikrer, at der foretages alle de nødvendige tiltag til at bringe AI-systemet i overensstemmelse med kravene og forpligtelserne i denne forordning. Hvis den pågældende udbyder af et AI-system ikke bringer AI-systemet i overensstemmelse med disse krav og forpligtelser inden for den tidsfrist, der er omhandlet i denne artikels stk. 2, straffes udbyderen med bøder i overensstemmelse med artikel 99.
5.   Udbyderen sikrer, at der foretages alle fornødne korrigerende tiltag over for alle de pågældende AI-systemer, som denne har gjort tilgængelige EU-markedet.
6.   Hvis udbyderen af det pågældende AI-system ikke foretager tilstrækkelige korrigerende tiltag inden for den tidsfrist, der er omhandlet i denne artikels stk. 2, finder artikel 79, stk. 5-9, anvendelse.
7.   Hvis markedsovervågningsmyndigheden som led i evalueringen i henhold til denne artikels stk. 1 konstaterer, at AI-systemet er blevet fejlklassificeret af udbyderen som ikkehøjrisiko for at omgå anvendelsen af kravene i kapitel III, afdeling 2, straffes udbyderen med bøder i overensstemmelse med artikel 99.
8.   Ved udøvelsen af deres beføjelse til at overvåge anvendelsen af denne artikel og i overensstemmelse med artikel 11 i forordning (EU) 2019/1020 kan markedsovervågningsmyndighederne foretage passende kontroller under særlig hensyntagen til oplysninger, der er lagret i den EU-database, der er omhandlet i nærværende forordnings artikel 71.
Artikel 81
Beskyttelsesprocedure på EU-plan
1.   Hvis markedsovervågningsmyndigheden i en medlemsstat inden for tre måneder efter modtagelsen af den i artikel 79, stk. 5, omhandlede underretning eller inden for 30 dage i tilfælde af manglende overholdelse af forbuddet mod de i artikel 5 anførte former for AI-praksis har gjort indsigelse mod en foranstaltning truffet af en anden markedsovervågningsmyndighed, eller hvis Kommissionen finder, at foranstaltningen er i strid med EU-retten, hører Kommissionen uden unødigt ophold den relevante medlemsstats markedsovervågningsmyndighed og den eller de relevante operatører og evaluerer den nationale foranstaltning. På grundlag af resultaterne af denne evaluering træffer Kommissionen senest seks måneder efter den i artikel 79, stk. 5, omhandlede underretning afgørelse om, hvorvidt den nationale foranstaltning er berettiget, eller inden for 60 dage i tilfælde af manglende overholdelse af forbuddet mod de i artikel 5 anførte former for AI-praksis og meddeler sin afgørelse til markedsovervågningsmyndigheden i den pågældende medlemsstat. Kommissionen underretter også alle andre markedsovervågningsmyndigheder om sin afgørelse.
2.   Hvis Kommissionen anser den foranstaltning, der er truffet af den relevante medlemsstat, for at være berettiget, sikrer alle medlemsstater, at de træffer de fornødne restriktive foranstaltninger med hensyn til det pågældende AI-system, f.eks. krav om tilbagetrækning af AI-systemet fra deres marked uden unødigt ophold, og underretter Kommissionen herom. Hvis Kommissionen anser den nationale foranstaltning for ikke at være berettiget, trækker den pågældende medlemsstat foranstaltningen tilbage og underretter Kommissionen herom.
3.   Hvis den nationale foranstaltning anses for at være berettiget, og hvis AI-systemets manglende overholdelse tilskrives mangler ved de harmoniserede standarder eller fælles specifikationer, der er omhandlet i denne forordnings artikel 40 og 41, anvender Kommissionen proceduren i artikel 11 i forordning (EU) nr. 1025/2012.
Artikel 82
AI-systemer, som overholder kravene, men som udgør en risiko
1.   Hvis en medlemsstats markedsovervågningsmyndighed efter at have foretaget en vurdering i henhold til artikel 79 og efter høring af den relevante nationale offentlige myndighed, der er omhandlet i artikel 77, stk. 1, finder, at et højrisiko-AI-system, selv om det overholder kravene i denne forordning, alligevel udgør en risiko for personers sundhed eller sikkerhed, for grundlæggende rettigheder eller for andre aspekter vedrørende beskyttelse af samfundsinteresser, skal den pålægge den relevante operatør uden unødigt ophold at træffe alle nødvendige foranstaltninger for at sikre, at det pågældende AI-system, når det bringes i omsætning eller ibrugtages, ikke længere udgør en sådan risiko, inden for en tidsfrist, som den kan fastsætte.
2.   Udbyderen eller en anden relevant operatør sikrer, at der foretages korrigerende tiltag med hensyn til alle de pågældende AI-systemer, som vedkommende har gjort tilgængelige på EU-markedet, inden for den tidsfrist, der er fastsat af medlemsstatens markedsovervågningsmyndighed, der er omhandlet stk. 1.
3.   Medlemsstaterne underretter omgående Kommissionen og de øvrige medlemsstater om resultaterne i henhold til stk. 1. Denne underretning skal indeholde alle tilgængelige oplysninger, især de nødvendige data til identifikation af de pågældende AI-systemer, AI-systemets oprindelse og forsyningskæde, arten af den pågældende risiko og arten og varigheden af de trufne nationale foranstaltninger.
4.   Kommissionen hører uden unødigt ophold de berørte medlemsstater og de relevante operatører og vurderer de trufne nationale foranstaltninger. På grundlag af resultaterne af denne vurdering træffer Kommissionen afgørelse om, hvorvidt foranstaltningen er berettiget, og foreslår om nødvendigt andre passende foranstaltninger.
5.   Kommissionen meddeler omgående sin afgørelse til de pågældende medlemsstater og til de relevante operatører. Den underretter også de øvrige medlemsstater.
Artikel 83
Formel manglende overholdelse
1.   Hvis en medlemsstats markedsovervågningsmyndighed konstaterer et af følgende forhold, pålægger den den pågældende udbyder at bringe den manglende overholdelse til ophør inden for en tidsfrist, som den kan fastsætte:
a)
CE-mærkningen er anbragt i modstrid med artikel 48
b)
CE-mærkningen er ikke anbragt
c)
den i artikel 47 omhandlede EU-overensstemmelseserklæring er ikke udarbejdet
d)
den i artikel 47 omhandlede EU-overensstemmelseserklæring er ikke udarbejdet korrekt
e)
den i artikel 71 omhandlede registrering i EU-databasen er ikke foretaget
f)
der er, hvor det er relevant, ikke udpeget nogen bemyndiget repræsentant
g)
den tekniske dokumentation er ikke tilgængelig.
2.   Hvis der fortsat er tale om manglende overholdelse omhandlet i stk. 1, skal markedsovervågningsmyndigheden i den pågældende medlemsstat træffe nødvendige og forholdsmæssige foranstaltninger for at begrænse eller forbyde, at højrisiko-AI-systemet gøres tilgængeligt på markedet, eller for at sikre, at det straks tilbagekaldes eller tilbagetrækkes fra markedet.
Artikel 84
EU-støttestrukturer for afprøvning af AI
1.   Kommissionen udpeger en eller flere EU-støttestrukturer for afprøvning af AI til at udføre de opgaver, der er anført i artikel 21, stk. 6, i forordning (EU) 2019/1020 inden for AI.
2.   Uden at det berører de opgaver, der er omhandlet i stk. 1, skal EU-støttestrukturer for afprøvning af AI også yde uafhængig teknisk eller videnskabelig rådgivning på anmodning af AI-udvalget, Kommissionen eller markedsovervågningsmyndighederne.
AFDELING 4
Retsmidler
Artikel 85
Ret til at indgive klage til en markedsovervågningsmyndighed
Uden at det berører andre administrative klageadgange eller adgang til retsmidler, kan enhver fysisk eller juridisk person, der har grund til at mene, at der er sket en overtrædelse af bestemmelserne i denne forordning, indgive klager til den relevante markedsovervågningsmyndighed.
I overensstemmelse med forordning (EU) 2019/1020 tages sådanne klager i betragtning med henblik på at udføre markedsovervågningsaktiviteterne og behandles i overensstemmelse med de særlige procedurer, som markedsovervågningsmyndighederne har fastlagt dertil.
Artikel 86
Ret til at få en forklaring om individuel beslutningstagning
1.   Enhver berørt person, der er omfattet af en afgørelse truffet af idriftsætteren på grundlag af output fra et højrisiko-AI-system opført i bilag III, med undtagelse af systemerne opført i nævnte bilags punkt 2, og som har retsvirkninger eller på tilsvarende måde i væsentlig grad påvirker den pågældende person på en måde, som de anser for at have negativ indvirkning på vedkommendes sundhed, sikkerhed eller grundlæggende rettigheder, har ret til at få en klar og meningsfuld forklaring fra idriftsætteren om AI-systemets rolle i beslutningsprocessen og hovedelementerne i den trufne afgørelse.
2.   Stk. 1 finder ikke anvendelse på anvendelsen af AI-systemer, for hvilke undtagelser fra eller begrænsninger af forpligtelsen i henhold til nævnte stykke følger af EU-retten eller national ret, der overholder EU-retten.
3.   Denne artikel finder kun anvendelse, for så vidt den i stk. 1 omhandlede ret ikke på anden vis er fastsat i EU-retten.
Artikel 87
Indberetning af overtrædelser og beskyttelse af indberettende personer
Direktiv (EU) 2019/1937 finder anvendelse på indberetning af overtrædelser af denne forordning og på beskyttelsen af personer, der indberetter sådanne overtrædelser.
AFDELING 5
Tilsyn, undersøgelser, håndhævelse og overvågning i forbindelse med udbydere af AI-modeller til almen brug
Artikel 88
Håndhævelse af forpligtelser for udbydere af AI-modeller til almen brug
1.   Kommissionen har enekompetence til at føre tilsyn med og håndhæve kapitel V under hensyntagen til de proceduremæssige garantier i henhold til artikel 94. Kommissionen overdrager gennemførelsen af disse opgaver til AI-kontoret, uden at dette berører Kommissionens organisationsbeføjelser og kompetencefordelingen mellem medlemsstaterne og Unionen på grundlag af traktaterne.
2.   Uden at det berører artikel 75, stk. 3, kan markedsovervågningsmyndighederne anmode Kommissionen om at udøve de beføjelser, der er fastsat i denne afdeling, hvis dette er nødvendigt og forholdsmæssigt for at bistå med udførelsen af deres opgaver i henhold til denne forordning.
Artikel 89
Overvågningstiltag
1.   AI-kontoret kan for at kunne udføre de opgaver, der tildeles det i henhold til denne afdeling, foretage de nødvendige tiltag for at overvåge, at udbydere af AI-modeller til almen brug gennemfører og overholder denne forordning effektivt, herunder overholder godkendte praksiskodekser.
2.   Downstreamudbydere har ret til at indgive en klage over en overtrædelse af denne forordning. En klage skal være behørigt begrundet og som minimum indeholde:
a)
kontaktpunktet for udbyderen af den pågældende AI-model til almen brug
b)
en beskrivelse af de relevante kendsgerninger, de pågældende bestemmelser i denne forordning og årsagen til, at downstreamudbyderen mener, at udbyderen af den pågældende AI-model til almen brug har overtrådt denne forordning
c)
alle andre oplysninger, som downstreamudbyderen, som sendte anmodningen, anser for relevante, herunder i givet fald oplysninger indsamlet på eget initiativ.
Artikel 90
Varslinger om systemiske risici fra det videnskabelige panel
1.   Det videnskabelige panel kan sende en kvalificeret varsling til AI-kontoret, hvis det har begrundet mistanke om, at:
a)
en AI-model til almen brug udgør en konkret identificerbar risiko på EU-plan, eller
b)
en AI-model til almen brug opfylder betingelserne omhandlet i artikel 51.
2.   Efter en sådan kvalificeret varsling kan Kommissionen gennem AI-kontoret og efter at have underrettet AI-udvalget udøve de beføjelser, der er fastsat i denne afdeling, med henblik på at vurdere sagen. AI-kontoret underretter AI-udvalget om enhver foranstaltning i henhold til artikel 91-94.
3.   En kvalificeret varsling skal være behørigt begrundet og som minimum indeholde:
a)
kontaktpunktet for udbyderen af den pågældende AI-model til almen brug med systemisk risiko
b)
en beskrivelse af de relevante kendsgerninger og årsager til varslingen fra det videnskabelige panel
c)
alle andre oplysninger, som det videnskabelige panel anser for relevante, herunder i givet fald oplysninger indsamlet på eget initiativ.
Artikel 91
Beføjelse til at anmode om dokumentation og oplysninger
1.   Kommissionen kan anmode udbyderen af den pågældende AI-model til almen brug om at stille den dokumentation til rådighed, som udbyderen har udarbejdet i overensstemmelse med artikel 53 og 55, eller eventuelle yderligere oplysninger, som er nødvendige for at vurdere, om udbyderen overholder denne forordning.
2.   Inden anmodningen om oplysninger sendes, kan AI-kontoret indlede en struktureret dialog med udbyderen af AI-modellen til almen brug.
3.   Efter en behørigt begrundet anmodning fra det videnskabelige panel kan Kommissionen fremsætte en anmodning om oplysninger til en udbyder af en AI-model til almen brug, hvis adgangen til oplysninger er nødvendig og forholdsmæssig for udførelsen af det videnskabelige panels opgaver i henhold til artikel 68, stk. 2.
4.   Anmodningen om oplysninger skal angive retsgrundlaget og formålet med anmodningen, præcisere, hvilke oplysninger der anmodes om, fastsætte tidsfristen, inden for hvilken oplysningerne skal fremlægges, og angive de bøder, der er fastsat i artikel 101, for at afgive ukorrekte, ufuldstændige eller vildledende oplysninger.
5.   Udbyderen af den pågældende AI-model til almen brug eller dennes repræsentant skal afgive de oplysninger, der anmodes om. Såfremt det drejer sig om juridiske personer, selskaber eller firmaer, eller hvis udbyderen ikke har status som juridisk person, skal de personer, som ved lov eller ifølge deres vedtægter har beføjelse til at repræsentere dem, afgive de oplysninger, der anmodes om på vegne af udbyderen af den pågældende AI-model til almen brug. Behørigt befuldmægtigede advokater kan afgive oplysninger på deres klienters vegne. Klienterne bærer dog det fulde ansvar, såfremt de afgivne oplysninger er ufuldstændige, ukorrekte eller vildledende.
Artikel 92
Beføjelse til at foretage evalueringer
1.   AI-kontoret kan efter høring af AI-udvalget foretage evalueringer af den pågældende AI-model til almen brug:
a)
med henblik på at vurdere, om udbyderen overholder forpligtelserne i henhold til denne forordning, hvis de indsamlede oplysninger i henhold til artikel 91 er utilstrækkelige, eller
b)
med henblik på at undersøge systemiske risici på EU-plan for AI-modeller til almen brug med systemisk risiko, navnlig efter en kvalificeret varsling fra det videnskabelige panel i overensstemmelse med artikel 90, stk. 1, litra a).
2.   Kommissionen kan beslutte at udpege uafhængige eksperter til at foretage evalueringer på dens vegne, herunder fra det videnskabelige panel, der er oprettet i henhold til artikel 68. Uafhængige eksperter, der udpeges til denne opgave, skal opfylde kriterierne anført i artikel 68, stk. 2.
3.   Med henblik på stk. 1 kan Kommissionen anmode om adgang til den pågældende AI-model til almen brug via API'er eller andre hensigtsmæssige tekniske midler og værktøjer, herunder kildekode.
4.   Anmodningen om adgang skal angive retsgrundlaget, formålet med og begrundelsen for anmodningen og fastsætte tidsfristen, inden for hvilken der skal gives adgang, samt bøder, der er fastsat i artikel 101, ved manglende adgang.
5.   Udbydere af den pågældende AI-model til almen brug eller dennes repræsentant skal afgive de oplysninger, der anmodes om. Såfremt det drejer sig om juridiske personer, selskaber eller firmaer, eller hvis udbyderen ikke har status som juridisk person, skal de personer, som ved lov eller ifølge deres vedtægter har beføjelse til at repræsentere dem, give den adgang, der anmodes om på vegne af udbyderen af den pågældende AI-model til almen brug.
6.   Kommissionen vedtager gennemførelsesretsakter, der fastsætter de nærmere ordninger og bestemmelser og betingelser for evalueringerne, herunder de nærmere ordninger for inddragelse af uafhængige eksperter, og proceduren for udvælgelse heraf. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
7.   Inden der anmodes om adgang til den pågældende AI-model til almen brug, kan AI-kontoret indlede en struktureret dialog med udbyderen af AI-modellen til almen brug for at indsamle flere oplysninger om den interne afprøvning af modellen, interne sikkerhedsforanstaltninger til forebyggelse af systemiske risici og andre interne procedurer og foranstaltninger, som udbyderen har truffet for at afbøde sådanne risici.
Artikel 93
Beføjelse til at anmode om foranstaltninger
1.   Hvis det er nødvendigt og hensigtsmæssigt, kan Kommissionen anmode udbyderne om at:
a)
træffe passende foranstaltninger til at overholde forpligtelserne i artikel 53 og 54
b)
gennemføre afbødende foranstaltninger, hvis den evaluering, der foretages i overensstemmelse med artikel 92, har givet anledning til alvorlig og begrundet mistanke om en systemisk risiko på EU-plan
c)
begrænse tilgængeliggørelsen på markedet, tilbagetrække eller tilbagekalde modellen.
2.   Inden der anmodes om foranstaltninger, kan AI-kontoret indlede en struktureret dialog med udbyderen af AI-modellen til almen brug.
3.   Hvis udbyderen af AI-modellen til almen brug med systemisk risiko under den strukturerede dialog, der er omhandlet i stk. 2, afgiver tilsagn om at gennemføre afbødende foranstaltninger for at afhjælpe en systemisk risiko på EU-plan, kan Kommissionen ved en afgørelse gøre disse tilsagn bindende og erklære, at der ikke er yderligere grundlag for handling.
Artikel 94
Erhvervsdrivendes procedurerettigheder i forbindelse med AI-modellen til almen brug
Artikel 18 i forordning (EU) 2019/1020 finder tilsvarende anvendelse på udbydere af AI-modellen til almen brug, uden at dette berører de mere specifikke procedurerettigheder, som er fastsat i nærværende forordning.
KAPITEL X
ADFÆRDSKODEKSER OG RETNINGSLINJER
Artikel 95
Adfærdskodekser for frivillig anvendelse af specifikke krav
1.   AI-kontoret og medlemsstaterne tilskynder til og letter udarbejdelsen af adfærdskodekser, herunder tilhørende forvaltningsmekanismer, der har til formål at fremme frivillig anvendelse af visse af eller alle de i kapitel III, afdeling 2, fastsatte krav på AI-systemer, der ikke er højrisiko-AI-systemer, under hensyntagen til de tilgængelige tekniske løsninger og industriens bedste praksis, der gør det muligt at anvende sådanne krav.
2.   AI-kontoret og medlemsstaterne letter udarbejdelsen af adfærdskodekser vedrørende frivillig anvendelse, herunder fra idriftsætternes side, af specifikke krav til alle AI-systemer på grundlag af klare mål og centrale resultatindikatorer til måling af realiseringen af disse mål, herunder elementer såsom, men ikke begrænset til:
a)
relevante elementer fastsat i Unionens etiske retningslinjer for troværdig AI
b)
vurdering og minimering af AI-systemers indvirkning på miljømæssig bæredygtighed, herunder med hensyn til energieffektiv programmering og teknikker til effektiv udformning, træning og anvendelse af AI
c)
fremme af AI-færdigheder, navnlig hos personer, der beskæftiger sig med udvikling, drift og anvendelse af AI
d)
fremme af en inklusiv og mangfoldig udformning af AI-systemer, herunder gennem oprettelse af inklusive og mangfoldige udviklingsteams og fremme af interessenters inddragelse i denne proces
e)
vurdering og forebyggelse af, at AI-systemer har negativ indvirkning på sårbare personer eller grupper af sårbare personer, herunder for så vidt angår tilgængelighed for personer med handicap, samt på ligestilling mellem kønnene.
3.   Adfærdskodekser kan udarbejdes af individuelle udbydere eller idriftsættere af AI-systemer, af organisationer, der repræsenterer dem, eller af begge, herunder med inddragelse af eventuelle interesserede parter og deres repræsentative organisationer, herunder civilsamfundsorganisationer og den akademiske verden. Adfærdskodekser kan omfatte et eller flere AI-systemer under hensyntagen til ligheden mellem de relevante systemers tilsigtede formål.
4.   Når AI-kontoret og medlemsstaterne tilskynder til og letter udarbejdelsen af adfærdskodekser, tager de hensyn til SMV'ers, herunder iværksættervirksomheders, særlige interesser og behov.
Artikel 96
Retningslinjer fra Kommissionen om gennemførelsen af denne forordning
1.   Kommissionen udarbejder retningslinjer for den praktiske gennemførelse af denne forordning, navnlig for:
a)
anvendelsen af de krav og forpligtelser, der er omhandlet i artikel 8-15 og artikel 25
b)
de forbudte former for praksis, der er omhandlet i artikel 5
c)
den praktiske gennemførelse af bestemmelserne om væsentlig ændring
d)
den praktiske gennemførelse af gennemsigtighedsforpligtelserne i artikel 50
e)
detaljerede oplysninger om forholdet mellem denne forordning og EU-harmoniseringslovgivningen, der er opført i bilag I, samt anden relevant EU-ret, herunder for så vidt angår konsekvens i håndhævelsen deraf
f)
anvendelsen af definitionen af et AI-system som fastsat i artikel 3, nr. 1).
Når Kommissionen udsteder sådanne retningslinjer, skal den være særlig opmærksom på behovene hos SMV'er, herunder iværksættervirksomheder, hos lokale offentlige myndigheder og i sektorer, der med størst sandsynlighed vil blive berørt af denne forordning.
Der skal med de retningslinjer, der er omhandlet i dette stykkes første afsnit, tages behørigt hensyn til det generelt anerkendte aktuelle teknologiske niveau inden for AI samt til relevante harmoniserede standarder og fælles specifikationer, der er omhandlet i artikel 40 og 41, eller til de harmoniserede standarder eller tekniske specifikationer, der er fastsat i henhold til EU-harmoniseringsretten.
2.   På anmodning af medlemsstaterne eller AI-kontoret eller på eget initiativ ajourfører Kommissionen tidligere vedtagne retningslinjer, når det skønnes nødvendigt.
KAPITEL XI
DELEGATION AF BEFØJELSER OG UDVALGSPROCEDURE
Artikel 97
Udøvelse af de delegerede beføjelser
1.   Beføjelsen til at vedtage delegerede retsakter tillægges Kommissionen på de i denne artikel fastlagte betingelser.
2.   Beføjelsen til at vedtage delegerede retsakter, jf. artikel 6, stk. 6 og 7, artikel 7, stk. 1 og 3, artikel 11, stk. 3, artikel 43, stk. 5 og 6, artikel 47, stk. 5, artikel 51, stk. 3, artikel 52, stk. 4, og artikel 53, stk. 5 og 6, tillægges Kommissionen for en periode på fem år fra den 1. august 2024. Kommissionen udarbejder en rapport vedrørende delegationen af beføjelser senest ni måneder inden udløbet af femårsperioden. Delegationen af beføjelser forlænges stiltiende for perioder af samme varighed, medmindre Europa-Parlamentet eller Rådet modsætter sig en sådan forlængelse senest tre måneder inden udløbet af hver periode.
3.   Den i artikel 6, stk. 6 og 7, artikel 7, stk. 1 og 3, artikel 11, stk. 3, artikel 43, stk. 5 og 6, artikel 47, stk. 5, artikel 51, stk. 3, artikel 52, stk. 4, og artikel 53, stk. 5 og 6, omhandlede delegation af beføjelser kan til enhver tid tilbagekaldes af Europa-Parlamentet eller Rådet. En afgørelse om tilbagekaldelse bringer delegationen af de beføjelser, der er angivet i den pågældende afgørelse, til ophør. Den får virkning dagen efter offentliggørelsen af afgørelsen i 
Den Europæiske Unions Tidende
 eller på et senere tidspunkt, der angives i afgørelsen. Den berører ikke gyldigheden af delegerede retsakter, der allerede er i kraft.
4.   Inden vedtagelsen af en delegeret retsakt hører Kommissionen eksperter, som er udpeget af hver enkelt medlemsstat, i overensstemmelse med principperne i den interinstitutionelle aftale af 13. april 2016 om bedre lovgivning.
5.   Så snart Kommissionen vedtager en delegeret retsakt, giver den samtidigt Europa-Parlamentet og Rådet meddelelse herom.
6.   Enhver delegeret retsakt vedtaget i henhold til artikel 6, stk. 6 eller 7, artikel 7, stk. 1 eller 3, artikel 11, stk. 3, artikel 43, stk. 5 eller 6, artikel 47, stk. 5, artikel 51, stk. 3, artikel 52, stk. 4, eller artikel 53, stk. 5 eller 6, træder kun i kraft, hvis hverken Europa-Parlamentet eller Rådet har gjort indsigelse inden for en frist på tre måneder fra meddelelsen af den pågældende retsakt til Europa-Parlamentet og Rådet, eller hvis Europa-Parlamentet og Rådet inden udløbet af denne frist begge har underrettet Kommissionen om, at de ikke agter at gøre indsigelse. Fristen forlænges med tre måneder på Europa-Parlamentets eller Rådets initiativ.
Artikel 98
Udvalgsprocedure
1.   Kommissionen bistås af et udvalg. Dette udvalg er et udvalg som omhandlet i forordning (EU) nr. 182/2011.
2.   Når der henvises til dette stykke, finder artikel 5 i forordning (EU) nr. 182/2011 anvendelse.
KAPITEL XII
SANKTIONER
Artikel 99
Sanktioner
1.   I overensstemmelse med de vilkår og betingelser, der er fastsat i denne forordning, fastsætter medlemsstaterne regler om sanktioner og andre håndhævelsesforanstaltninger, som også kan omfatte advarsler og ikkeøkonomiske foranstaltninger, for operatørers overtrædelse af denne forordning og træffer alle nødvendige foranstaltninger for at sikre, at de gennemføres korrekt og effektivt, og dermed tage hensyn til de retningslinjer, som Kommissionen har udstedt i henhold til artikel 96. Sanktionerne skal være effektive, stå i et rimeligt forhold til overtrædelsen og have afskrækkende virkning. Der tages hensyn til SMV'ers, herunder iværksættervirksomheders, interesser og deres økonomiske levedygtighed.
2.   Medlemsstaterne giver straks og senest på anvendelsesdatoen Kommissionen meddelelse om reglerne om sanktioner og andre håndhævelsesforanstaltninger, der er omhandlet i stk. 1, og meddeler den straks enhver efterfølgende ændring heraf.
3.   Manglende overholdelse af forbud mod de i artikel 5 anførte former for AI-praksis straffes med administrative bøder på op til 35 000 000 EUR eller, hvis lovovertræderen er en virksomhed, op til 7 % af dens samlede globale årlige omsætning i det foregående regnskabsår, alt efter hvilket beløb der er størst.
4.   Manglende overholdelse af en af følgende bestemmelser vedrørende operatører eller bemyndigede organer, bortset fra de bestemmelser, der er fastsat i artikel 5, straffes med administrative bøder på op til 15 000 000 EUR eller, hvis lovovertræderen er en virksomhed, op til 3 % af dens samlede globale årlige omsætning i det foregående regnskabsår, alt efter hvilket beløb der er størst:
a)
forpligtelser for udbydere i henhold til artikel 16
b)
forpligtelser for bemyndigede repræsentanter i henhold til artikel 22
c)
forpligtelser for importører i henhold til artikel 23
d)
forpligtelser for distributører i henhold til artikel 24
e)
forpligtelser for idriftsættere i henhold til artikel 26
f)
krav til og forpligtelser for bemyndigede organer i henhold til artikel 31, artikel 33, stk. 1, 3 og 4, eller artikel 34
g)
gennemsigtighedsforpligtelser for udbydere og idriftsættere i henhold til artikel 50.
5.   Afgivelse af ukorrekte, ufuldstændige eller vildledende oplysninger til bemyndigede organer eller nationale kompetente myndigheder som svar på en anmodning straffes med administrative bøder på op til 7 500 000 EUR eller, hvis lovovertræderen er en virksomhed, op til 1 % af dens samlede globale årlige omsætning i det foregående regnskabsår, alt efter hvilket beløb der er størst.
6.   For SMV'er, herunder iværksættervirksomheder, skal hver bøde, der er omhandlet i denne artikel, være op til den procentsats eller det beløb, der er omhandlet i stk. 3, 4 og 5, alt efter hvilken af dem der er lavest.
7.   Når der træffes afgørelse om, hvorvidt der skal pålægges en administrativ bøde, og ved fastsættelsen af den administrative bødes størrelse tages der i hvert enkelt tilfælde hensyn til alle relevante omstændigheder i den specifikke situation, og der tages i relevant omfang hensyn til følgende:
a)
overtrædelsens art, grovhed og varighed samt dens konsekvenser under hensyntagen til formålet med AI-systemet samt, hvis det er relevant, antallet af berørte personer og omfanget af den skade, de har lidt
b)
hvorvidt andre markedsovervågningsmyndigheder allerede har pålagt den samme operatør administrative bøder for samme overtrædelse
c)
hvorvidt andre myndigheder allerede har pålagt den samme operatør administrative bøder for overtrædelser af anden EU-ret eller national ret, når sådanne overtrædelser skyldes den samme aktivitet eller undladelse, der udgør en relevant overtrædelse af denne forordning
d)
størrelsen på den operatør, der har begået overtrædelsen, og dennes årlige omsætning og markedsandel
e)
om der er andre skærpende eller formildende faktorer ved sagens omstændigheder såsom opnåede økonomiske fordele eller undgåede tab som direkte eller indirekte følge af overtrædelsen
f)
graden af samarbejde med de nationale kompetente myndigheder for at afhjælpe overtrædelsen og begrænse de negative konsekvenser, som overtrædelsen måtte have givet anledning til
g)
graden af ansvar hos operatøren under hensyntagen til de tekniske og organisatoriske foranstaltninger, som vedkommende har gennemført
h)
den måde, hvorpå de nationale kompetente myndigheder fik kendskab til overtrædelsen, navnlig om operatøren har underrettet om overtrædelsen, og i givet fald i hvilket omfang
i)
hvorvidt overtrædelsen blev begået forsætligt eller uagtsomt
j)
ethvert tiltag fra operatørens side for at afbøde skaden på de pågældende personer.
8.   Hver medlemsstat fastsætter regler om, i hvilket omfang administrative bøder kan pålægges offentlige myndigheder og organer, der er etableret i den pågældende medlemsstat.
9.   Afhængigt af medlemsstaternes retssystem kan reglerne om administrative bøder anvendes på en sådan måde, at bøderne pålægges af kompetente nationale domstole eller af andre organer, alt efter hvad der er relevant i disse medlemsstater. Anvendelsen af disse regler i disse medlemsstater har tilsvarende virkning.
10.   Udøvelse af beføjelser i henhold til denne artikel skal være underlagt fornødne proceduremæssige sikkerhedsforanstaltninger i overensstemmelse med EU-retten og national ret, herunder effektive retsmidler og retfærdig procedure.
11.   Medlemsstaterne aflægger årligt rapport til Kommissionen om de administrative bøder, de har udstedt i løbet af det pågældende år, i overensstemmelse med denne artikel, og om eventuelle dermed forbundne tvister eller retssager.
Artikel 100
Administrative bøder til EU-institutioner, -organer, -kontorer og -agenturer
1.   Den Europæiske Tilsynsførende for Databeskyttelse kan pålægge de EU-institutioner, -organer, -kontorer og -agenturer, der er omfattet af denne forordnings anvendelsesområde, administrative bøder. Når der træffes afgørelse om, hvorvidt der skal pålægges en administrativ bøde, og ved fastsættelsen af den administrative bødes størrelse tages der i hvert enkelt tilfælde hensyn til alle relevante omstændigheder i den specifikke situation, og der tages behørigt hensyn til følgende:
a)
overtrædelsens art, grovhed og varighed samt dens konsekvenser, under hensyntagen til formålet med det pågældende AI-system, samt, hvis det er relevant, antallet af berørte personer og omfanget af den skade, de har lidt
b)
graden af ansvar hos EU-institutionen, -organet, -kontoret eller -agenturet under hensyntagen til de tekniske og organisatoriske foranstaltninger, som de har gennemført
c)
ethvert tiltag, der foretages af EU-institutionen, -organet, -kontoret eller -agenturet for at afhjælpe den skade, som de berørte personer har lidt
d)
graden af samarbejde med Den Europæiske Tilsynsførende for Databeskyttelse med henblik på at afhjælpe overtrædelsen og afbøde de mulige negative virkninger af overtrædelsen, herunder overholdelse af enhver af de foranstaltninger, som Den Europæiske Tilsynsførende for Databeskyttelse tidligere har pålagt den pågældende EU-institution eller det pågældende EU-organ, -kontor eller -agentur med hensyn til samme genstand
e)
eventuelle lignende overtrædelser, som den pågældende EU-institution eller det pågældende EU-organ, EU-kontor eller EU-agentur tidligere har begået
f)
den måde, hvorpå Den Europæiske Tilsynsførende for Databeskyttelse fik kendskab til overtrædelsen, navnlig om den pågældende EU-institution eller det pågældende EU-organ, -kontor eller -agentur gav underretning om overtrædelsen, og i givet fald i hvilket omfang
g)
EU-institutionens, -organets, -kontorets eller -agenturets årlige budget.
2.   Manglende overholdelse af forbuddet mod de i artikel 5 anførte former for AI-praksis straffes med administrative bøder på op til 1 500 000 EUR.
3.   AI-systemets manglende overholdelse af ethvert krav eller enhver forpligtelse i henhold til denne forordning, bortset fra kravene i artikel 5, straffes med administrative bøder på op til 750 000 EUR.
4.   Inden der træffes afgørelse i henhold til denne artikel, giver Den Europæiske Tilsynsførende for Databeskyttelse den pågældende EU-institution eller det pågældende EU-organ, -kontor eller -agentur, der er genstand for de procedurer, som gennemføres af Den Europæiske Tilsynsførende for Databeskyttelse, mulighed for at blive hørt om genstanden for den mulige overtrædelse. Den Europæiske Tilsynsførende for Databeskyttelse baserer udelukkende sine afgørelser på elementer og forhold, som de berørte parter har haft mulighed for at fremsætte bemærkninger til. Eventuelle klagere inddrages i vid udstrækning i proceduren.
5.   De deltagende parters ret til forsvar skal sikres fuldt ud i procedureforløbet. De har ret til aktindsigt i Den Europæiske Tilsynsførende for Databeskyttelses sagsakter med forbehold af fysiske personers eller virksomheders berettigede interesse i at beskytte deres personoplysninger eller forretningshemmeligheder.
6.   Midler, der er indsamlet ved pålæg af bøder i henhold til denne artikel, bidrager til Unionens almindelige budget. Bøderne berører ikke den effektive funktion af den EU-institution eller det EU-organ, -kontor eller -agentur, der er blevet pålagt bøden.
7.   Den Europæiske Tilsynsførende for Databeskyttelse underretter hvert år Kommissionen om de administrative bøder, den har pålagt i henhold til denne artikel, og om eventuelle tvister eller retssager, den har indledt.
Artikel 101
Bøder til udbydere af AI-modeller til almen brug
1.   Kommissionen kan pålægge udbydere af AI-modeller til almen brug bøder på op til 3 % af deres årlige samlede globale omsætning i det foregående regnskabsår eller 15 000 000 EUR, alt efter hvilket beløb der er størst, når Kommissionen finder, at udbyderen forsætligt eller uagtsomt:
a)
har overtrådt de relevante bestemmelser i denne forordning
b)
har undladt at efterkomme en anmodning om et dokument eller om oplysninger i henhold til artikel 91 eller har afgivet ukorrekte, ufuldstændige eller vildledende oplysninger
c)
har undladt at efterkomme en foranstaltning, der er anmodet om i henhold til artikel 93
d)
har undladt at give Kommissionen adgang til AI-modellen til almen brug eller AI-modellen til almen brug med systemisk risiko med henblik på at foretage en evaluering i henhold til artikel 92.
Ved fastsættelse af bødens eller tvangsbødens størrelse tages overtrædelsens karakter, alvor og varighed i betragtning under behørig hensyntagen til proportionalitets- og rimelighedsprincippet. Kommissionen tager også hensyn til forpligtelser, der er indgået i overensstemmelse med artikel 93, stk. 3, eller i de relevante praksiskodekser i overensstemmelse med artikel 56.
2.   Inden Kommissionen vedtager afgørelsen i henhold til stk. 1, meddeler den sine foreløbige resultater til udbyderen af AI-modellen til almen brug og giver vedkommende mulighed for at blive hørt.
3.   Bøder, der pålægges i overensstemmelse med denne artikel, skal være effektive, stå i et rimeligt forhold til overtrædelsen og have afskrækkende virkning.
4.   Information om de bøder, der pålægges i henhold til denne artikel, meddeles også AI-udvalget, alt efter hvad der er relevant.
5.   EU-Domstolen har fuld prøvelsesret med hensyn til Kommissionens afgørelser om fastsættelse af bøder i henhold til denne artikel. Den kan annullere, nedsætte eller forhøje den pålagte bøde.
6.   Kommissionen vedtager gennemførelsesretsakter med de nærmere ordninger og proceduremæssige sikkerhedsforanstaltninger for procedurerne med henblik på eventuel vedtagelse af afgørelser i henhold til denne artikels stk. 1. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren, jf. artikel 98, stk. 2.
KAPITEL XIII
AFSLUTTENDE BESTEMMELSER
Artikel 102
Ændring af forordning (EF) nr. 300/2008
I artikel 4, stk. 3, i forordning (EF) nr. 300/2008, tilføjes følgende afsnit:
»Når der vedtages detaljerede foranstaltninger vedrørende tekniske specifikationer og procedurer for godkendelse og brug af sikkerhedsudstyr vedrørende kunstig intelligens-systemer som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordnings kapital III, afdeling 2.
Artikel 103
Ændring af forordning (EU) nr. 167/2013
I artikel 17, stk. 5, i forordning (EU) nr. 167/2013 tilføjes følgende afsnit:
»Når der i henhold til første afsnit vedtages delegerede retsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.
Artikel 104
Ændring af forordning (EU) nr. 168/2013
I artikel 22, stk. 5, i forordning (EU) nr. 168/2013 tilføjes følgende afsnit:
»Når der i henhold til første afsnit vedtages delegerede retsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.
Artikel 105
Ændring af direktiv 2014/90/EU
I artikel 8 i direktiv 2014/90/EU tilføjes følgende stykke:
»5.   For så vidt angår kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, tager Kommissionen, når den udfører sine aktiviteter i henhold til stk. 1, og når den vedtager tekniske specifikationer og afprøvningsstandarder i overensstemmelse med stk. 2 og 3, hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.
Artikel 106
Ændring af direktiv (EU) 2016/797
I artikel 5 i direktiv (EU) 2016/797 tilføjes følgende stykke:
»12.   Når der i henhold til stk. 1 vedtages delegerede retsakter eller i henhold til stk. 11 vedtages gennemførelsesretsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.
Artikel 107
Ændring af forordning (EU) 2018/858
I artikel 5 i forordning (EU) 2018/858 tilføjes følgende stykke:
»4.   Når der i henhold til stk. 3 vedtages delegerede retsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.
Artikel 108
Ændring af forordning (EU) 2018/1139
I forordning (EU) 2018/1139 foretages følgende ændringer:
1)
I artikel 17 tilføjes følgende stykke:
»3.   Uden at det berører stk. 2, når der i henhold til stk. 1 vedtages gennemførelsesretsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.
(
*
)
  Europa-Parlamentets og Rådets forordning (EU) 2024/1689 af 13. juni 2024 om harmoniserede regler for kunstig intelligens og om ændring af forordning (EF) nr. 300/2008, (EU) nr. 167/2013, (EU) nr. 168/2013, (EU) 2018/858, (EU) 2018/1139 og (EU) 2019/2144 samt direktiv 2014/90/EU, (EU) 2016/797 og (EU) 2020/1828 (forordningen om kunstig intelligens) (
EUT L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj
).«
                                       "
2)
I artikel 19 tilføjes følgende stykke:
»4.   Når der i henhold til stk. 1 og 2 vedtages delegerede retsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i forordning (EU) 2024/1689, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.«
3)
I artikel 43 tilføjes følgende stykke:
»4.   Når der i henhold til stk. 1 vedtages gennemførelsesretsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i forordning (EU) 2024/1689, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.«
4)
I artikel 47 tilføjes følgende stykke:
»3.   Når der i henhold til stk. 1 og 2 vedtages delegerede retsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i forordning (EU) 2024/1689, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.«
5)
I artikel 57 tilføjes følgende afsnit:
»Når der vedtages sådanne gennemførelsesretsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i forordning (EU) 2024/1689, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.«
6)
I artikel 58 tilføjes følgende stykke:
»3.   Når der i henhold til stk. 1 og 2 vedtages delegerede retsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i forordning (EU) 2024/1689, skal der tages hensyn til kravene i nævnte forordnings kapitel III, afdeling 2.«
Artikel 109
Ændring af forordning (EU) 2019/2144
I artikel 11 i forordning (EU) 2019/2144 tilføjes følgende stykke:
»3.   Når der i henhold til stk. 2 vedtages gennemførelsesretsakter vedrørende kunstig intelligens-systemer, som er sikkerhedskomponenter som omhandlet i Europa-Parlamentets og Rådets forordning (EU) 2024/1689
 (
*
)
, skal der tages hensyn til kravene i nævnte forordning kapitel III, afdeling 2.
Artikel 110
Ændring af direktiv (EU) 2020/1828
I bilag I til Europa-Parlamentets og Rådets direktiv (EU) 2020/1828 
(
58
)
 tilføjes følgende punkt:
»68)
Europa-Parlamentets og Rådets forordning (EU) 2024/1689 af 13. juni 2024 om harmoniserede regler for kunstig intelligens og om ændring af forordning (EF) nr. 300/2008, (EU) nr. 167/2013, (EU) nr. 168/2013, (EU) 2018/858, (EU) 2018/1139 og (EU) 2019/2144 samt direktiv 2014/90/EU, (EU) 2016/797 og (EU) 2020/1828 (forordningen om kunstig intelligens) (
EUT L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj
).«
Artikel 111
AI-systemer, der allerede er bragt i omsætning eller ibrugtaget, og AI-modeller til almen brug, der allerede er bragt i omsætning
1.   Uden at det berører anvendelsen af artikel 5 som omhandlet i artikel 113, stk. 3, litra a), skal AI-systemer, som er komponenter i de store IT-systemer, der er oprettet ved de retsakter, der er opført i bilag X, og som er blevet bragt i omsætning eller ibrugtaget inden den 2. august 2027, bringes i overensstemmelse med denne forordning senest den 31. december 2030.
De krav, der er fastsat i denne forordning, skal tages i betragtning ved den evaluering, som skal foretages i henhold til de retsakter, der er opført i bilag X, af hvert af de store IT-systemer, der er oprettet ved disse retsakter, og hvis disse retsakter erstattes eller ændres.
2.   Uden at det berører anvendelsen af artikel 5 som omhandlet i artikel 113, stk. 3, litra a), finder denne forordning kun anvendelse på operatører af andre højrisiko-AI-systemer end de systemer, der er omhandlet i nærværende artikels stk. 1, og som er bragt i omsætning eller ibrugtaget inden den 2. august 2026, hvis disse systemer fra denne dato er genstand for betydelige ændringer af deres udformning. I alle tilfælde skal udbydere og idriftsættere af højrisiko-AI-systemer, der tilsigtes anvendt af offentlige myndigheder, tage de nødvendige skridt til at overholde kravene og forpligtelserne i denne forordning senest den 2. august 2030.
3.   Udbydere af AI-modeller til almen brug, der er bragt i omsætning før den 2. august 2025, tager de nødvendige skridt til at overholde de forpligtelser, der er fastsat i denne forordning, senest den 2. august 2027.
Artikel 112
Evaluering og revision
1.   Kommissionen vurderer behovet for at ændre listen i bilag III og listen over forbudte former for AI-praksis i artikel 5 én gang om året efter denne forordnings ikrafttræden og indtil slutningen af perioden med delegation af beføjelser, der er fastsat i artikel 97. Kommissionen forelægger resultaterne af denne vurdering for Europa-Parlamentet og Rådet.
2.   Senest den 2. august 2028 og hvert fjerde år derefter evaluerer Kommissionen og aflægger rapport til Europa-Parlamentet og Rådet om følgende:
a)
behovet for ændringer om udvidelse af eksisterende områdeoverskrifter eller tilføjelse af nye områdeoverskrifter i bilag III
b)
ændringer af listen over de AI-systemer, der kræver yderligere gennemsigtighedsforanstaltninger i henhold til artikel 50
c)
ændringer om styrkelse af effektiviteten af tilsyns- og forvaltningssystemet.
3.   Senest den 2. august 2029 og hvert fjerde år derefter forelægger Kommissionen Europa-Parlamentet og Rådet en rapport om evaluering og revision af denne forordning. Rapporten skal indeholde en vurdering af håndhævelsesstrukturen og det eventuelle behov for, at et EU-agentur løser eventuelle konstaterede mangler. På grundlag af resultaterne ledsages rapporten i givet fald af et forslag til ændring af denne forordning. Rapporterne offentliggøres.
4.   I de i stk. 2 omhandlede rapporter lægges der særlig vægt på følgende:
a)
status over de nationale kompetente myndigheders finansielle, tekniske og menneskelige ressourcer med henblik på effektivt at udføre de opgaver, de pålægges i henhold til denne forordning
b)
status over de sanktioner, navnlig de administrative bøder, der er omhandlet i artikel 99, stk. 1, som medlemsstaterne har pålagt som følge af overtrædelser af denne forordning
c)
vedtagne harmoniserede standarder og fælles specifikationer, der er udarbejdet til støtte for denne forordning
d)
antallet af virksomheder, der kommer ind på markedet efter anvendelsen af denne forordning, og hvor mange af dem der er SMV'er.
5.   Senest den 2. august 2028 evaluerer Kommissionen AI-kontorets funktion, og om det har fået tilstrækkelige beføjelser og kompetencer til at udføre sine opgaver, samt om det vil være relevant og nødvendigt for en korrekt gennemførelse og håndhævelse af denne forordning at opgradere AI-Kontoret og dets håndhævelsesbeføjelser og øge dets ressourcer. Kommissionen forelægger en rapport om sin evaluering for Europa-Parlamentet og Rådet.
6.   Senest den 2. august 2028 og hvert fjerde år derefter forelægger Kommissionen en rapport om revisionen af fremskridt med udviklingen af standardiseringsdokumentation om en energieffektiv udvikling af AI-modeller til almen brug og vurderer behovet for yderligere foranstaltninger eller tiltag, herunder bindende foranstaltninger eller tiltag. Rapporten forelægges Europa-Parlamentet og Rådet og offentliggøres.
7.   Senest den 2. august 2028 og hvert tredje år derefter evaluerer Kommissionen virkningen og effektiviteten af frivillige adfærdskodekser med henblik på at fremme anvendelsen af kravene i kapitel III, afdeling 2, på andre AI-systemer end højrisiko-AI-systemer og eventuelt andre yderligere krav til andre AI-systemer end højrisiko-AI-systemer, herunder vedrørende miljømæssig bæredygtighed.
8.   Med henblik på stk. 1-7 indgiver AI-udvalget, medlemsstaterne og de nationale kompetente myndigheder oplysninger til Kommissionen på dennes anmodning og uden unødigt ophold.
9.   Når Kommissionen foretager de evalueringer og revisioner, der er omhandlet i stk. 1-7, tager den hensyn til holdninger og resultater fra AI-udvalget, fra Europa-Parlamentet, fra Rådet og fra andre relevante organer eller kilder.
10.   Kommissionen forelægger om nødvendigt relevante forslag til ændring af denne forordning, navnlig under hensyntagen til den teknologiske udvikling, AI-systemernes indvirkning på sundhed og sikkerhed og de grundlæggende rettigheder og i lyset af fremskridtene i informationssamfundet.
11.   Som grundlag for de evalueringer og revisioner, der er omhandlet i denne artikels stk. 1-7, påtager AI-kontoret sig at udvikle en objektiv og inddragende metode til evaluering af risikoniveauerne baseret på de kriterier, der er anført i de relevante artikler, og medtagelse af nye systemer i:
(a)
listen i bilag III, herunder udvidelse af eksisterende områdeoverskrifter eller tilføjelse af nye områdeoverskrifter i nævnte bilag
(b)
listen over de forbudte former for praksis, der er omhandlet i artikel 5, og
(c)
listen over de AI-systemer, der kræver yderligere gennemsigtighedsforanstaltninger i henhold til artikel 50.
12.   Alle ændringer til denne forordning i medfør af stk. 10 eller relevante delegerede retsakter eller gennemførelsesretsakter, som vedrører den sektorspecifikke EU-harmoniseringslovgivning, der er opført i bilag 1, afsnit B, skal tage hensyn til de enkelte sektorers reguleringsmæssige forhold og eksisterende forvaltning, overensstemmelsesvurdering og håndhævelsesmekanismer og de deri fastsatte myndigheder.
13.   Senest den 2. august 2031 foretager Kommissionen en evaluering af håndhævelsen af denne forordning og aflægger rapport herom til Europa-Parlamentet, Rådet og Det Europæiske Økonomiske og Sociale Udvalg under hensyntagen til denne forordnings første anvendelsesår. På grundlag af resultaterne ledsages rapporten, hvor det er relevant, af et forslag om ændring af denne forordning med hensyn til håndhævelsesstrukturen og behovet for, at et EU-agentur løser eventuelle konstaterede mangler.
Artikel 113
Ikrafttræden og anvendelse
Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i 
Den Europæiske Unions Tidende
.
Den finder anvendelse fra den 2. august 2026.
Dog finder:
a)
kapitel I og II anvendelse fra den 2. februar 2025
b)
kapitel III, afdeling 4, kapitel V, VII og XII og artikel 78 anvendelse fra den 2. august 2025, med undtagelse af artikel 101
c)
artikel 6, stk. 1, og de tilsvarende forpligtelser i denne forordning anvendelse fra den 2. august 2027.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat.
Udfærdiget i Bruxelles, den 13. juni 2024.
På Europa-Parlamentets vegne
Formand
R. METSOLA
På Rådets vegne
Formand
M. MICHEL
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53
)
  Europa-Parlamentets og Rådets forordning (EU) 2023/988 af 10. maj 2023 om produktsikkerhed i almindelighed, om ændring af Europa-Parlamentets og Rådets forordning (EU) nr. 1025/2012 og Europa-Parlamentets og Rådets direktiv (EU) 2020/1828 og om ophævelse af Europa-Parlamentets og Rådets direktiv 2001/95/EF og Rådets direktiv 87/357/EØF (
EUT L 135 af 23.5.2023, s. 1
).
(
54
)
  Europa-Parlamentets og Rådets direktiv (EU) 2019/1937 af 23. oktober 2019 om beskyttelse af personer, der indberetter overtrædelser af EU-retten (
EUT L 305 af 26.11.2019, s. 17
).
(
55
)
  
            
EUT L 123 af 12.5.2016, s. 1
.
(
56
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 af 16. februar 2011 om de generelle regler og principper for, hvordan medlemsstaterne skal kontrollere Kommissionens udøvelse af gennemførelsesbeføjelser (
EUT L 55 af 28.2.2011, s. 13
).
(
57
)
  Europa-Parlamentets og Rådets direktiv (EU) 2016/943 af 8. juni 2016 om beskyttelse af fortrolig knowhow og fortrolige forretningsoplysninger (forretningshemmeligheder) mod ulovlig erhvervelse, brug og videregivelse (
EUT L 157 af 15.6.2016, s. 1
).
(
58
)
  Europa-Parlamentets og Rådets direktiv (EU) 2020/1828 af 25. november 2020 om adgang til anlæggelse af gruppesøgsmål til beskyttelse af forbrugernes kollektive interesser og om ophævelse af direktiv 2009/22/EF (
EUT L 409 af 4.12.2020, s. 1
).
BILAG I
Liste over EU-harmoniseringslovgivning
Afsnit A. Liste over EU-harmoniseringslovgivning baseret på den nye lovgivningsmæssige ramme
1.
Europa-Parlamentets og Rådets direktiv 2006/42/EF af 17. maj 2006 om maskiner og om ændring af direktiv 95/16/EF (
EUT L 157 af 9.6.2006, s. 24
)
2.
Europa-Parlamentets og Rådets direktiv 2009/48/EF af 18. juni 2009 om sikkerhedskrav til legetøj (
EUT L 170 af 30.6.2009, s. 1
)
3.
Europa-Parlamentets og Rådets direktiv 2013/53/EU af 20. november 2013 om fritidsfartøjer og personlige fartøjer og om ophævelse af direktiv 94/25/EF (
EUT L 354 af 28.12.2013, s. 90
)
4.
Europa-Parlamentets og Rådets direktiv 2014/33/EU af. 26. februar 2014 om harmonisering af medlemsstaternes love om elevatorer og sikkerhedskomponenter til elevatorer (
EUT L 96 af 29.3.2014, s. 251
)
5.
Europa-Parlamentets og Rådets direktiv 2014/34/EU af 26. februar 2014 om harmonisering af medlemsstaternes love om materiel og sikringssystemer til anvendelse i en potentielt eksplosiv atmosfære (
EUT L 96 af 29.3.2014, s. 309
)
6.
Europa-Parlamentets og Rådets direktiv 2014/53/EU af 16. april 2014 om harmonisering af medlemsstaternes love om tilgængeliggørelse af radioudstyr på markedet og om ophævelse af direktiv 1999/5/EF (
EUT L 153 af 22.5.2014, s. 62
)
7.
Europa-Parlamentets og Rådets direktiv 2014/68/EU af 15. maj 2014 om harmonisering af medlemsstaternes lovgivning om tilgængeliggørelse på markedet af trykbærende udstyr (
EUT L 189 af 27.6.2014, s. 164
)
8.
Europa-Parlamentets og Rådets forordning (EU) 2016/424 af 9. marts 2016 om tovbaneanlæg og om ophævelse af direktiv 2000/9/EF (
EUT L 81 af 31.3.2016, s. 1
)
9.
Europa-Parlamentets og Rådets forordning (EU) 2016/425 af 9. marts 2016 om personlige værnemidler og om ophævelse af Rådets direktiv 89/686/EØF (
EUT L 81 af 31.3.2016, s. 51
)
10.
Europa-Parlamentets og Rådets forordning (EU) 2016/426 af 9. marts 2016 om apparater, der forbrænder gasformigt brændstof, og om ophævelse af direktiv 2009/142/EF (
EUT L 81 af 31.3.2016, s. 99
)
11.
Europa-Parlamentets og Rådets forordning (EU) 2017/745 af 5. april 2017 om medicinsk udstyr, om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009 og om ophævelse af Rådets direktiv 90/385/EØF og 93/42/EØF (
EUT L 117 af 5.5.2017, s. 1
)
12.
Europa-Parlamentets og Rådets forordning (EU) 2017/746 af 5. april 2017 om medicinsk udstyr til in vitro-diagnostik og om ophævelse af direktiv 98/79/EF og Kommissionens afgørelse 2010/227/EU (
EUT L 117 af 5.5.2017, s. 176
).
Afsnit B. Liste over anden EU-harmoniseringslovgivning
13.
Europa-Parlamentets og Rådets forordning (EF) nr. 300/2008 af 11. marts 2008 om fælles bestemmelser om sikkerhed inden for civil luftfart og om ophævelse af forordning (EF) nr. 2320/2002 (
EUT L 97 af 9.4.2008, s. 72
)
14.
Europa-Parlamentets og Rådets forordning (EU) nr. 168/2013 af 15. januar 2013 om godkendelse og markedsovervågning af to- og trehjulede køretøjer samt quadricykler (
EUT L 60 af 2.3.2013, s. 52
)
15.
Europa-Parlamentets og Rådets forordning (EU) nr. 167/2013 af 5. februar 2013 om godkendelse og markedsovervågning af landbrugs- og skovbrugstraktorer (
EUT L 60 af 2.3.2013, s. 1
)
16.
Europa-Parlamentets og Rådets direktiv 2014/90/EU af 23. juli 2014 om skibsudstyr og om ophævelse af Rådets direktiv 96/98/EF (
EUT L 257 af 28.8.2014, s. 146
)
17.
Europa-Parlamentets og Rådets direktiv (EU) 2016/797 af 11. maj 2016 om interoperabilitet i jernbanesystemet i Den Europæiske Union (
EUT L 138 af 26.5.2016, s. 44
)
18.
Europa-Parlamentets og Rådets forordning (EU) 2018/858 af 30. maj 2018 om godkendelse og markedsovervågning af motorkøretøjer og påhængskøretøjer dertil samt af systemer, komponenter og separate tekniske enheder til sådanne køretøjer, om ændring af forordning (EF) nr. 715/2007 og (EF) nr. 595/2009 og om ophævelse af direktiv 2007/46/EF (
EUT L 151 af 14.6.2018, s. 1
)
19.
Europa-Parlamentets og Rådets forordning (EU) 2019/2144 af 27. november 2019 om krav til typegodkendelse af motorkøretøjer og påhængskøretøjer dertil samt systemer, komponenter og separate tekniske enheder til sådanne køretøjer for så vidt angår deres generelle sikkerhed og beskyttelsen af køretøjspassagerer og bløde trafikanter og om ændring af Europa-Parlamentets og Rådets forordning (EU) 2018/858 og ophævelse af Europa-Parlamentets og Rådets forordning (EF) nr. 78/2009, forordning (EF) nr. 79/2009 og forordning (EF) nr. 661/2009 og Kommissionens forordning (EF) nr. 631/2009, (EU) nr. 406/2010, (EU) nr. 672/2010, (EU) nr. 1003/2010, (EU) nr. 1005/2010, (EU) nr. 1008/2010, (EU) nr. 1009/2010, (EU) nr. 19/2011, (EU) nr. 109/2011, (EU) nr. 458/2011, (EU) nr. 65/2012, (EU) nr. 130/2012, (EU) nr. 347/2012, (EU) nr. 351/2012, (EU) nr. 1230/2012 og (EU) 2015/166 (
EUT L 325 af 16.12.2019, s. 1
)
20.
Europa-Parlamentets og Rådets forordning (EU) 2018/1139 af 4. juli 2018 om fælles regler for civil luftfart og oprettelse af Den Europæiske Unions Luftfartssikkerhedsagentur og om ændring af Europa-Parlamentets og Rådets forordning (EF) nr. 2111/2005, (EF) nr. 1008/2008, (EU) nr. 996/2010, (EU) nr. 376/2014 og direktiv 2014/30/EU og 2014/53/EU og om ophævelse af Europa-Parlamentets og Rådets forordning (EF) nr. 552/2004 og (EF) nr. 216/2008 og Rådets forordning (EØF) nr. 3922/91 (
EUT L 212 af 22.8.2018, s. 1
) for så vidt angår konstruktion, fremstilling og omsætning af luftfartøjer, som er omhandlet i nævnte forordnings artikel 2, stk. 1, litra a) og b), hvis det drejer sig om ubemandede luftfartøjer og tilhørende motorer, propeller, dele og udstyr til fjernkontrol af disse luftfartøjer.
BILAG II
Liste over strafbare handlinger omhandlet i artikel 5, stk. 1, første afsnit, litra h), nr. iii)
Strafbare handlinger omhandlet i artikel 5, stk. 1, første afsnit, litra h), nr. iii):
—
terrorisme
—
menneskehandel
—
seksuel udnyttelse af børn og børnepornografi
—
ulovlig handel med narkotika eller psykotrope stoffer
—
ulovlig handel med våben, ammunition eller sprængstoffer
—
forsætligt manddrab og grov legemsbeskadigelse
—
ulovlig handel med menneskeorganer eller -væv
—
ulovlig handel med nukleare eller radioaktive materialer
—
bortførelse, frihedsberøvelse eller gidseltagning
—
forbrydelser, der er omfattet af Den Internationale Straffedomstols kompetence
—
skibs- eller flykapring
—
voldtægt
—
miljøkriminalitet
—
organiseret eller væbnet røveri
—
sabotage
—
deltagelse i en kriminel organisation, der er involveret i en eller flere af ovennævnte strafbare handlinger.
BILAG III
Højrisiko-AI-systemer omhandlet i artikel 6, stk. 2
Højrisiko-AI-systemer i henhold til artikel 6, stk. 2, er de AI-systemer, der er opført under et af følgende områder:
1.
Biometri, for så vidt som dets anvendelse er tilladt i henhold til relevant EU-ret eller national ret:
a)
systemer til biometrisk fjernidentifikation.
Dette omfatter ikke AI-systemer, der er tilsigtet biometrisk verifikation, og hvis eneste formål er at bekræfte, at en bestemt fysisk person er den person, vedkommende hævder at være
b)
AI-systemer, der er tilsigtet biometrisk kategorisering i henhold til følsomme eller beskyttede egenskaber eller karakteristika på grundlag af udledning af disse egenskaber eller karakteristika
c)
AI-systemer, der er tilsigtet følelsesgenkendelse.
2.
Kritisk infrastruktur: AI-systemer, der tilsigtes anvendt som sikkerhedskomponenter i forvaltningen og driften af kritisk digital infrastruktur, vejtrafik eller forsyning af vand, gas, varme og elektricitet.
3.
Uddannelse og erhvervsuddannelse:
a)
AI-systemer, der tilsigtes anvendt til at bestemme fysiske personers adgang til eller optagelse eller deres fordeling på uddannelsesinstitutioner på alle niveauer
b)
AI-systemer, der tilsigtes anvendt til at evaluere læringsresultater, herunder når disse resultater anvendes til at styre fysiske personers læringsproces på uddannelsesinstitutioner på alle niveauer
c)
AI-systemer, der tilsigtes anvendt til at bedømme det nødvendige uddannelsesniveau, som den enkelte vil få eller vil kunne få adgang til, i forbindelse med eller inden for uddannelsesinstitutioner på alle niveauer
d)
AI-systemer, der tilsigtes anvendt til at overvåge og opdage forbudt adfærd blandt studerende under prøver i forbindelse med eller inden for uddannelsesinstitutioner på alle niveauer.
4.
Beskæftigelse, forvaltning af arbejdstagere og adgang til selvstændig virksomhed:
a)
AI-systemer, der tilsigtes anvendt til rekruttering eller udvælgelse af fysiske personer, navnlig til at indrykke målrettede jobannoncer, analysere og filtrere jobansøgninger og evaluere kandidater
b)
AI-systemer, der tilsigtes anvendt til at træffe beslutninger, der påvirker vilkårene for arbejdsrelaterede forhold, forfremmelse eller afskedigelse i arbejdsrelaterede kontraktforhold, til at fordele opgaver på grundlag af individuel adfærd eller personlighedstræk eller personlige egenskaber eller til at overvåge og evaluere personers præstationer og adfærd i sådanne forhold.
5.
Adgang til og benyttelse af væsentlige private tjenester og væsentlige offentlige tjenester og ydelser:
a)
AI-systemer, der tilsigtes anvendt af offentlige myndigheder eller på vegne af offentlige myndigheder til at vurdere fysiske personers berettigelse til væsentlige offentlige bistandsydelser og -tjenester, herunder sundhedstjenester, samt til at tildele, nedsætte, tilbagekalde eller kræve tilbagebetaling af sådanne ydelser og tjenester
b)
AI-systemer, der tilsigtes anvendt til at evaluere fysiske personers kreditværdighed eller fastslå deres kreditvurdering, med undtagelse af AI-systemer, der anvendes til at afsløre økonomisk svig
c)
AI-systemer, der tilsigtes anvendt til at foretage risikovurdering og prisfastsættelse for så vidt angår fysiske personer i forbindelse med livs- og sygeforsikring
d)
AI-systemer, der er tilsigtet at evaluere og klassificere nødopkald fra fysiske personer eller til at blive anvendt til at sende beredskabstjenester i nødsituationer eller til at tildele prioriteter i forbindelse hermed, herunder udrykning af politi, brandslukning og lægehjælp samt patientsorteringssystemer for førstehjælp
6.
Retshåndhævelse, for så vidt som deres anvendelse er tilladt i henhold til relevant EU-ret eller national ret:
a)
AI-systemer, der tilsigtes anvendt af eller på vegne af retshåndhævende myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til støtte for retshåndhævende myndigheder eller på deres vegne til at vurdere risikoen for, at en fysisk person bliver offer for strafbare handlinger
b)
AI-systemer, der tilsigtes anvendt af eller på vegne af retshåndhævende myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til støtte for retshåndhævende myndigheder som polygrafer eller lignende værktøjer
c)
AI-systemer, der tilsigtes anvendt af eller på vegne af retshåndhævende myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til støtte for retshåndhævende myndigheder til at vurdere pålideligheden af bevismateriale i forbindelse med efterforskning eller retsforfølgning af strafbare handlinger
d)
AI-systemer, der tilsigtes anvendt af retshåndhævende myndigheder eller på deres vegne eller af EU-institutioner, -organer, -kontorer eller -agenturer til støtte for retshåndhævende myndigheder til at vurdere risikoen for, at en fysisk person begår eller på ny begår lovovertrædelser, der ikke udelukkende er baseret på profilering af fysiske personer som omhandlet i artikel 3, stk. 4, i direktiv (EU) 2016/680, eller til at vurdere fysiske personers eller gruppers personlighedstræk og personlige egenskaber eller tidligere kriminelle adfærd
e)
AI-systemer, der tilsigtes anvendt af eller på vegne af retshåndhævende myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til støtte for retshåndhævende myndigheder til profilering af fysiske personer som omhandlet i artikel 3, stk. 4, i direktiv (EU) 2016/680 i forbindelse med afsløring, efterforskning eller retsforfølgning af strafbare handlinger.
7.
Migrationsstyring, asylforvaltning og grænsekontrol, for så vidt som deres anvendelse er tilladt i henhold til relevant EU-ret eller national ret:
a)
AI-systemer, der tilsigtes anvendt af eller på vegne af kompetente offentlige myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer som polygrafer eller lignende værktøjer
b)
AI-systemer, der tilsigtes anvendt af eller på vegne af kompetente offentlige myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til at vurdere en risiko, herunder en sikkerhedsrisiko, en risiko for irregulær migration eller en sundhedsrisiko, som udgøres af en fysisk person, der har til hensigt at rejse ind i eller er indrejst i en medlemsstat
c)
AI-systemer, der tilsigtes anvendt af eller på vegne af kompetente offentlige myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer til at bistå kompetente offentlige myndigheder i behandlingen af ansøgninger om asyl, visum eller opholdstilladelser og hertil relaterede klager med henblik på at fastslå, om de fysiske personer, der ansøger, er berettigede, herunder tilhørende vurdering af pålideligheden af bevismateriale
d)
AI-systemer, der tilsigtes anvendt af eller på vegne af kompetente offentlige myndigheder eller af EU-institutioner, -organer, -kontorer eller -agenturer i forbindelse med migrationsstyring, asylforvaltning eller grænsekontrol med henblik på at opdage, genkende eller identificere fysiske personer, bortset fra kontrol af rejselegitimation.
8.
Retspleje og demokratiske processer:
a)
AI-systemer, der tilsigtes anvendt af judicielle myndigheder eller på deres vegne til at bistå en judiciel myndighed med at undersøge og fortolke fakta og retten og anvende retten på konkrete sagsforhold eller til at blive anvendt på en lignende måde i forbindelse med alternativ tvistbilæggelse
b)
AI-systemer, der tilsigtes anvendt til at påvirke resultatet af et valg eller en folkeafstemning eller fysiske personers stemmeadfærd i forbindelse med udøvelsen af deres stemme ved valg eller folkeafstemninger. Dette omfatter ikke AI-systemer, hvis output fysiske personer ikke er direkte eksponeret for, såsom værktøjer, der anvendes til at organisere, optimere eller strukturere politiske kampagner ud fra et administrativt eller logistisk synspunkt.
BILAG IV
Teknisk dokumentation omhandlet i artikel 11, stk. 1
Den tekniske dokumentation, der er omhandlet i artikel 11, stk. 1, skal som minimum indeholde følgende oplysninger, alt efter hvad der er relevant for det pågældende AI-system:
1.
En generel beskrivelse af AI-systemet, herunder:
a)
det tilsigtede formål, udbyderens navn samt systemets dato og version, der afspejler sammenhængen med tidligere versioner
b)
hvis det er relevant, hvordan AI-systemet interagerer med eller kan bruges til at interagere med hardware eller software, herunder med andre AI-systemer, der ikke er en del af selve AI-systemet
c)
versionerne af relevant software eller firmware og eventuelle krav vedrørende opdateringer
d)
en beskrivelse af alle de former, hvori AI-systemet bringes i omsætning eller ibrugtages, såsom softwarepakke indlejret i hardware, downloads eller API'er
e)
en beskrivelse af den hardware, som AI-systemet tilsigtes at køre på
f)
hvis AI-systemet er komponent i produkter, fotografier eller illustrationer, der viser disse produkters eksterne karakteristika, mærkning og interne layout
g)
en grundlæggende beskrivelse af den brugergrænseflade, der stilles til rådighed for idriftsætteren
h)
brugsanvisning til idriftsætteren og en grundlæggende beskrivelse af den brugergrænseflade, der stilles til rådighed for idriftsætteren, hvis det er relevant.
2.
En detaljeret beskrivelse af elementerne i AI-systemet og af processen for dets udvikling, herunder:
a)
de metoder og trin, der er brugt i udviklingen af AI-systemet, herunder, hvis det er relevant, anvendelse af forhåndstrænede systemer eller værktøjer leveret af tredjeparter, og hvordan disse er blevet anvendt, integreret eller ændret af udbyderen
b)
systemets konstruktionsspecifikationer, dvs. AI-systemets og algoritmernes generelle logik, navnlig de vigtigste valg med hensyn til udformning, herunder begrundelser og antagelser, herunder med hensyn til personer eller grupper af personer, som systemet tilsigtes anvendt på, de overordnede klassificeringsvalg, hvad systemet er udformet til at optimere for og relevansen af de forskellige parametre, en beskrivelse af systemets forventede output og outputkvalitet samt beslutninger om eventuelle trade-offs i de tekniske løsninger, der er valgt for at overholde kravene i kapitel III, afdeling 2
c)
en beskrivelse af systemarkitekturen, der forklarer, hvordan softwarekomponenterne bygger på eller føder ind i hinanden og integreres i den samlede anvendelse; de beregningskraftsressourcer, der anvendes til at udvikle, træne, afprøve og validere AI-systemet
d)
hvis det er relevant, datakravene i form af datablade, der beskriver de anvendte træningsmetoder og -teknikker og de anvendte træningsdatasæt, herunder en generel beskrivelse af disse datasæt, oplysninger om deres oprindelse, omfang og vigtigste karakteristika, hvordan dataene er indhentet og udvalgt, mærkningsprocedurer (f.eks. for læring med tilsyn) og datarensningsmetoder (f.eks. påvisning af outliere)
e)
vurdering af de foranstaltninger til menneskeligt tilsyn, der er nødvendige i overensstemmelse med artikel 14, herunder en vurdering af de tekniske foranstaltninger, der er nødvendige for at lette idriftsætternes fortolkning af AI-systemets output, i overensstemmelse med artikel 13, stk. 3, litra d)
f)
hvis det er relevant, en detaljeret beskrivelse af på forhånd fastlagte ændringer af AI-systemet og dets ydeevne sammen med alle relevante oplysninger vedrørende de tekniske løsninger, der er valgt for at sikre, at AI-systemet til stadighed overholder de relevante krav i kapitel III, afdeling 2
g)
de anvendte validerings- og afprøvningsprocedurer, herunder oplysninger om de anvendte validerings- og afprøvningsdata og deres vigtigste karakteristika, parametre til måling af nøjagtighed, robusthed og overholdelse af andre relevante krav i kapitel III, afdeling 2, samt potentielt forskelsbehandlende virkninger samt afprøvningslogfiler og alle afprøvningsrapporter, der er dateret og underskrevet af de ansvarlige personer, herunder med hensyn til forudbestemte ændringer som omhandlet i litra f)
h)
indførte cybersikkerhedsforanstaltninger.
3.
Detaljerede oplysninger om overvågningen af AI-systemet, dets funktion og kontrollen hermed, navnlig med hensyn til dets kapacitet og begrænsninger i ydeevne, herunder nøjagtighedsgraden for specifikke personer eller grupper af personer, som systemet tilsigtes anvendt på, og det samlede forventede nøjagtighedsniveau i forhold til det tilsigtede formål, de forventede utilsigtede resultater og kilder til risici for sundhed og sikkerhed, grundlæggende rettigheder og forskelsbehandling i lyset af AI-systemets tilsigtede formål, foranstaltningerne til menneskeligt tilsyn i overensstemmelse med artikel 14, herunder de tekniske foranstaltninger, der er indført for at lette idriftsætternes fortolkning af AI-systemets output, samt specifikationer for inputdata, alt efter hvad der er relevant.
4.
En beskrivelse af ydeevneparametrenes egnethed til det specifikke AI-system.
5.
En detaljeret beskrivelse af risikostyringssystemet i overensstemmelse med artikel 9.
6.
En beskrivelse af relevante ændringer, som udbyderen foretager af systemet i løbet af dets livscyklus.
7.
En liste over de helt eller delvis anvendte harmoniserede standarder, hvis referencer er offentliggjort i 
Den Europæiske Unions Tidende
, samt, hvis disse harmoniserede standarder ikke er blevet anvendt, en detaljeret beskrivelse af de løsninger, der er anvendt for at opfylde kravene i kapitel III, afdeling 2, herunder en liste over andre relevante tekniske specifikationer, som er anvendt.
8.
En kopi af den i artikel 47 omhandlede EU-overensstemmelseserklæring.
9.
En detaljeret beskrivelse af det system, der er indført til evaluering af AI-systemets ydeevne, efter at systemet er bragt i omsætning, i overensstemmelse med artikel 72, herunder planen for overvågning efter omsætningen, der er omhandlet i artikel 72, stk. 3.
BILAG V
EU-overensstemmelseserklæring
EU-overensstemmelseserklæringen, der er omhandlet i artikel 47, skal indeholde følgende oplysninger:
1.
AI-systemets navn, type og enhver yderligere entydig reference, der gør det muligt at identificere og spore AI-systemet
2.
udbyderens navn og adresse eller, hvis det er relevant, den bemyndigede repræsentants navn og adresse
3.
en erklæring om, at den i artikel 47 omhandlede EU-overensstemmelseserklæring udstedes på udbyderens ansvar
4.
en erklæring om, at AI-systemet er i overensstemmelse med denne forordning og eventuelt med al anden relevant EU-ret, der fastsætter bestemmelser om udstedelse af den i artikel 47 omhandlede EU-overensstemmelseserklæring
5.
hvis et AI-system indbefatter behandling af personoplysninger, en erklæring om, at AI-systemet overholder forordning (EU) 2016/679 og (EU) 2018/1725 samt direktiv (EU) 2016/680
6.
referencer til de relevante anvendte harmoniserede standarder eller referencer til anden fælles specifikation, som der erklæres overensstemmelse med
7.
hvis det er relevant, navnet og identifikationsnummeret på det bemyndigede organ, en beskrivelse af den gennemførte overensstemmelsesvurderingsprocedure og identifikation af den udstedte attest
8.
udstedelsessted og -dato for erklæringen, navn og stilling på den person, der har underskrevet den, samt en angivelse af, for hvem eller på hvis vegne vedkommende har underskrevet, og underskrift.
BILAG VI
Procedurer for overensstemmelsesvurdering baseret på intern kontrol
1.
Proceduren for overensstemmelsesvurdering baseret på intern kontrol er overensstemmelsesvurderingsproceduren baseret på punkt 2, 3 og 4.
2.
Udbyderen verificerer, at det etablerede kvalitetsstyringssystem overholder kravene i artikel 17.
3.
Udbyderen undersøger oplysningerne i den tekniske dokumentation med henblik på at vurdere, hvorvidt AI-systemet overholder de relevante væsentlige krav i kapitel III, afdeling 2.
4.
Udbyderen verificerer også, at udformnings- og udviklingsprocessen for AI-systemet og dets overvågning efter omsætningen som omhandlet i artikel 72 er i overensstemmelse med den tekniske dokumentation.
BILAG VII
Overensstemmelse baseret på en vurdering af kvalitetsstyringssystemet og en vurdering af den tekniske dokumentation
1.   Indledning
Overensstemmelse baseret på en vurdering af kvalitetsstyringssystemet og en vurdering af den tekniske dokumentation er overensstemmelsesvurderingsproceduren baseret på punkt 2-5.
2.   Oversigt
Det godkendte kvalitetsstyringssystem for udformning, udvikling og afprøvning af AI-systemer i henhold til artikel 17 undersøges i overensstemmelse med punkt 3 og er underlagt den i punkt 5 omhandlede overvågning. AI-systemets tekniske dokumentation undersøges i overensstemmelse med punkt 4.
3.   Kvalitetsstyringssystem
3.1.
Udbyderens ansøgning skal omfatte:
a)
udbyderens navn og adresse samt navn og adresse på udbyderens bemyndigede repræsentant, hvis ansøgningen indgives af denne
b)
listen over AI-systemer, der er omfattet af det samme kvalitetsstyringssystem
c)
den tekniske dokumentation for hvert AI-system, der er omfattet af det samme kvalitetsstyringssystem
d)
dokumentationen vedrørende kvalitetsstyringssystemet, som skal omfatte alle de aspekter, der er anført i artikel 17
e)
en beskrivelse af de procedurer, der er indført for at sikre, at kvalitetsstyringssystemet fortsat er fyldestgørende og effektivt
f)
en skriftlig erklæring om, at samme ansøgning ikke er blevet indgivet til et andet bemyndiget organ.
3.2.
Det bemyndigede organ vurderer kvalitetsstyringssystemet for at afgøre, om det opfylder kravene omhandlet i artikel 17.
Afgørelsen meddeles udbyderen eller dennes bemyndigede repræsentant.
Meddelelsen skal indeholde konklusionerne af vurderingen af kvalitetsstyringssystemet og en begrundelse for afgørelsen.
3.3.
Det godkendte kvalitetsstyringssystem skal fortsat gennemføres og vedligeholdes af udbyderen, således at det forbliver hensigtsmæssigt og effektivt.
3.4.
Enhver tilsigtet ændring af det godkendte kvalitetsstyringssystem eller listen over AI-systemer, der er omfattet af dette, skal af udbyderen meddeles det bemyndigede organ.
Det bemyndigede organ vurderer de foreslåede ændringer og afgør, om det ændrede kvalitetsstyringssystem stadig opfylder de i punkt 3.2 omhandlede krav, eller om en fornyet vurdering er nødvendig.
Det bemyndigede organ meddeler udbyderen sin afgørelse. Meddelelsen skal indeholde konklusionerne af undersøgelsen af de foreslåede ændringer og en begrundelse for afgørelsen.
4.   Kontrol af den tekniske dokumentation
4.1.
Ud over den i punkt 3 omhandlede ansøgning, skal udbyderen til det bemyndigede organ indsende en ansøgning om vurdering af den tekniske dokumentation vedrørende det AI-system, som denne agter at bringe i omsætning eller ibrugtage, og som er omfattet af det kvalitetsstyringssystem, der er omhandlet i punkt 3.
4.2.
Ansøgningen skal indeholde:
a)
udbyderens navn og adresse
b)
en skriftlig erklæring om, at samme ansøgning ikke er blevet indgivet til et andet bemyndiget organ
c)
den i bilag IV omhandlede tekniske dokumentation.
4.3.
Den tekniske dokumentation vurderes af det bemyndigede organ. Hvis det er relevant og begrænset til, hvad der er nødvendigt for, at det bemyndigede organ kan udføre sine opgaver, gives det fuld adgang til de anvendte trænings-, validerings- og afprøvningsdatasæt, herunder, hvis det er relevant, og med forbehold af sikkerhedsforanstaltninger, via API'er eller andre relevante tekniske midler og værktøjer, der muliggør fjernadgang.
4.4.
I forbindelse med vurderingen af den tekniske dokumentation kan det bemyndigede organ kræve, at udbyderen fremlægger yderligere dokumentation eller udfører yderligere afprøvninger for at muliggøre en korrekt vurdering af AI-systemets overensstemmelse med kravene i kapitel III, afdeling 2. Hvis det bemyndigede organ ikke er tilfreds med de afprøvninger, som udbyderen har foretaget, skal det bemyndigede organ selv foretage de nødvendige afprøvninger direkte, alt efter hvad der er relevant.
4.5.
Hvis det er nødvendigt for at vurdere, om højrisiko-AI-systemet er i overensstemmelse med kravene i kapitel III, afdeling 2, skal det bemyndigede organ, efter at alle andre rimelige metoder til at verificere overensstemmelsen er udtømt eller har vist sig utilstrækkelige, og efter begrundet anmodning gives adgang til AI-systemets træningsmodeller og trænede modeller, herunder dets relevante parametre. En sådan adgang er omfattet af gældende EU-ret om beskyttelse af intellektuel ejendom og forretningshemmeligheder.
4.6.
Det bemyndigede organs afgørelse meddeles udbyderen eller dennes bemyndigede repræsentant. Meddelelsen skal indeholde konklusionerne af vurderingen af den tekniske dokumentation og en begrundelse for afgørelsen.
Hvis AI-systemet er i overensstemmelse med kravene i kapitel III, afdeling 2, udsteder det bemyndigede organ en EU-vurderingsattest for teknisk dokumentation. Attesten skal indeholde udbyderens navn og adresse, undersøgelseskonklusionerne, eventuelle betingelser for dets gyldighed og de nødvendige data til identifikation af AI-systemet.
Attesten og bilagene hertil skal indeholde alle relevante oplysninger, der gør det muligt at vurdere AI-systemets overensstemmelse med kravene, herunder, hvis det er relevant, kontrol under brug.
Hvis AI-systemet ikke er i overensstemmelse med kravene i kapitel III, afdeling 2, afviser det bemyndigede organ at udstede en EU-vurderingsattest for teknisk dokumentation og oplyser ansøgeren herom og giver en detaljeret begrundelse for afslaget.
Hvis AI-systemet ikke opfylder kravet vedrørende de data, der anvendes til at træne det, skal AI-systemet gentrænes, inden der ansøges om en ny overensstemmelsesvurdering. I dette tilfælde skal det bemyndigede organs begrundede afgørelse om afslag på udstedelse af en EU-vurderingsattest for teknisk dokumentation indeholde specifikke betragtninger om kvaliteten af de data, der er anvendt til at træne AI-systemet, navnlig om årsagerne til manglende overholdelse.
4.7.
Enhver ændring af AI-systemet, der kan påvirke AI-systemets overholdelse af kravene eller systemets tilsigtede formål, skal vurderes af det bemyndigede organ, der har udstedt EU-vurderingsattesten for teknisk dokumentation. Udbyderen skal underrette det bemyndigede organ om sin hensigt om at indføre nogen af ovennævnte ændringer, eller hvis denne på anden måde bliver opmærksom på forekomsten af sådanne ændringer. Det bemyndigede organ vurderer de tilsigtede ændringer og afgør, om disse ændringer kræver en ny overensstemmelsesvurdering i overensstemmelse med artikel 43, stk. 4, eller om de kan behandles ved hjælp af et tillæg til EU-vurderingsattesten for teknisk dokumentation. I sidstnævnte tilfælde vurderer det bemyndigede organ ændringerne, meddeler udbyderen sin afgørelse og udsteder, såfremt ændringerne godkendes, et tillæg til EU-vurderingsattesten for teknisk dokumentation til udbyderen.
5.   Overvågning af det godkendte kvalitetsstyringssystem
5.1.
Formålet med den overvågning, der udføres af det bemyndigede organ, der er omhandlet i punkt 3, er at sikre, at udbyderen behørigt overholder vilkårene og betingelserne i det godkendte kvalitetsstyringssystem.
5.2.
Med henblik på vurdering skal udbyderen give det bemyndigede organ adgang til de lokaler, hvor udformningen, udviklingen eller afprøvningen af AI-systemerne finder sted. Udbyderen skal yderligere give det bemyndigede organ alle nødvendige oplysninger.
5.3.
Det bemyndigede organ aflægger jævnligt kontrolbesøg for at sikre, at udbyderen vedligeholder og anvender kvalitetsstyringssystemet, og det udsteder en revisionsrapport til udbyderen. I forbindelse med disse kontrolbesøg kan det bemyndigede organ foretage yderligere afprøvninger af de AI-systemer, for hvilke der er udstedt en EU-vurderingsattest for teknisk dokumentation.
BILAG VIII
Oplysninger, der skal indsendes ved registrering af højrisiko-AI-systemer i overensstemmelse med artikel 49
Afsnit A — Oplysninger, der skal indsendes af udbydere af højrisiko-AI-systemer i overensstemmelse med artikel 49, stk. 1
Følgende oplysninger skal forelægges og derefter holdes ajourført med hensyn til højrisiko-AI-systemer, der skal registreres i overensstemmelse med artikel 49, stk. 1:
1.
udbyderens navn, adresse og kontaktoplysninger
2.
hvis oplysninger forelægges af en anden person på vegne af udbyderen, denne persons navn, adresse og kontaktoplysninger
3.
den bemyndigede repræsentants navn, adresse og kontaktoplysninger, hvis det er relevant
4.
AI-systemets handelsnavn og enhver yderligere entydig reference, der gør det muligt at identificere og spore AI-systemet
5.
en beskrivelse af det tilsigtede formål med AI-systemet og af de komponenter og funktioner, der understøttes af dette AI-system
6.
en grundlæggende og kortfattet beskrivelse af de oplysninger, der anvendes af systemet (data, input), og dets driftslogik
7.
AI-systemets status (i omsætning eller i drift, ikke længere i omsætning/i drift, tilbagekaldt)
8.
type, nummer og udløbsdato for den attest, der er udstedt af det bemyndigede organ, samt navn eller identifikationsnummer på det pågældende bemyndigede organ, hvis det er relevant
9.
en scannet kopi af den i punkt 8 omhandlede attest, hvis det er relevant
10.
enhver medlemsstat, hvor AI-systemet har været bragt i omsætning, ibrugtaget eller gjort tilgængeligt i Unionen
11.
en kopi af den i artikel 47 omhandlede EU-overensstemmelseserklæring
12.
brugsanvisning i elektronisk form, dog gives disse oplysninger ikke for højrisiko-AI-systemer inden for retshåndhævelse og migrationsstyring, asylforvaltning og grænsekontrol, der er omhandlet i bilag III, punkt 1, 6 og 7
13.
en URL for yderligere oplysninger (valgfrit).
Afsnit B — Oplysninger, der skal indsendes af udbydere af højrisiko-AI-systemer i overensstemmelse med artikel 49, stk. 2
Følgende oplysninger skal forelægges og derefter holdes ajourført med hensyn til højrisiko-AI-systemer, der registreres i overensstemmelse med artikel 49, stk. 2:
1.
udbyderens navn, adresse og kontaktoplysninger
2.
hvis oplysninger forelægges af en anden person på vegne af udbyderen, denne persons navn, adresse og kontaktoplysninger
3.
den bemyndigede repræsentants navn, adresse og kontaktoplysninger, hvis det er relevant
4.
AI-systemets handelsnavn og enhver yderligere entydig reference, der gør det muligt at identificere og spore AI-systemet
5.
en beskrivelse af det tilsigtede formål med AI-systemet
6.
den eller de betingelser i medfør af artikel 6, stk. 3, på grundlag af hvilke(n) AI-systemet ikke betragtes som højrisiko
7.
en kort sammenfatning af grundene at, AI-systemet ikke betragtes som højrisiko i forbindelse med anvendelse af proceduren i artikel 6, stk. 3
8.
AI-systemets status (i omsætning eller i drift, ikke længere i omsætning/i drift, tilbagekaldt)
9.
enhver medlemsstat, hvor AI-systemet har været bragt i omsætning, ibrugtaget eller gjort tilgængeligt i Unionen.
Afsnit C — Oplysninger, der skal indsendes af idriftsættere af højrisiko-AI-systemer i overensstemmelse med artikel 49, stk. 3
Følgende oplysninger skal forelægges og derefter holdes ajourført med hensyn til højrisiko-AI-systemer, der registreres i overensstemmelse med artikel 49, stk. 3:
1.
idriftsætterens navn, adresse og kontaktoplysninger
2.
navn, adresse og kontaktoplysninger på enhver person, der indsender oplysninger på vegne af idriftsætteren
3.
URL'en for indlæsningen af AI-systemet i EU-databasen for udbyderen af AI-systemet
4.
et sammendrag af resultaterne af den konsekvensanalyse vedrørende grundlæggende rettigheder, der er foretaget i overensstemmelse med artikel 27
5.
et sammendrag af konsekvensanalysen vedrørende databeskyttelse foretaget i overensstemmelse med artikel 35 i forordning (EU) 2016/679 eller artikel 27 i direktiv (EU) 2016/680 som specificeret i nærværende forordnings artikel 26, stk. 8, hvis det er relevant.
BILAG IX
Oplysninger, der skal indsendes ved registrering af højrisiko-AI-systemer anført i bilag III i forbindelse med afprøvning under faktiske forhold i overensstemmelse med artikel 60
Følgende oplysninger skal forelægges og derefter holdes ajourført med hensyn til afprøvning under faktiske forhold, der registreres i overensstemmelse med artikel 60:
1.
et EU-dækkende unikt individuelt identifikationsnummer for afprøvningen under faktiske forhold
2.
navn og kontaktoplysninger på udbyderen eller den potentielle udbyder og på de idriftsættere, der er involveret i afprøvningen under faktiske forhold
3.
en kort beskrivelse af AI-systemet, dets tilsigtede formål og andre oplysninger, der er nødvendige for at identificere systemet
4.
et sammendrag af de vigtigste karakteristika ved planen for afprøvning under faktiske forhold
5.
oplysninger om suspendering eller afslutning af afprøvningen under faktiske forhold.
BILAG X
Lovgivningsmæssige EU-retsakter om store IT-systemer inden for området med frihed, sikkerhed og retfærdighed
1.   Schengeninformationssystemet
a)
Europa-Parlamentets og Rådets forordning (EU) 2018/1860 af 28. november 2018 om brug af Schengeninformationssystemet i forbindelse med tilbagesendelse af tredjelandsstatsborgere med ulovligt ophold (
EUT L 312 af 7.12.2018, s. 1
)
b)
Europa-Parlamentets og Rådets forordning (EU) 2018/1861 af 28. november 2018 om oprettelse, drift og brug af Schengeninformationssystemet (SIS) på området ind- og udrejsekontrol, om ændring af konventionen om gennemførelse af Schengenaftalen og om ændring og ophævelse af forordning (EF) nr. 1987/2006 (
EUT L 312 af 7.12.2018, s. 14
)
c)
Europa-Parlamentets og Rådets forordning (EU) 2018/1862 af 28. november 2018 om oprettelse, drift og brug af Schengeninformationssystemet (SIS) på området politisamarbejde og strafferetligt samarbejde, om ændring og ophævelse af Rådets afgørelse 2007/533/RIA og om ophævelse af Europa-Parlamentets og Rådets forordning (EF) nr. 1986/2006 og Kommissionens afgørelse 2010/261/EU (
EUT L 312 af 7.12.2018, s. 56
).
2.   Visuminformationssystemet
a)
Europa-Parlamentets og Rådets forordning (EU) 2021/1133 af 7. juli 2021 om ændring af forordning (EU) nr. 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 og (EU) 2019/818 for så vidt angår fastsættelse af betingelserne for adgang til andre EU-informationssystemer med henblik på visuminformationssystemet (
EUT L 248 af 13.7.2021, s. 1
)
b)
Europa-Parlamentets og Rådets forordning (EU) 2021/1134 af 7. juli 2021 om ændring af Europa-Parlamentets og Rådets forordning (EF) nr. 767/2008, (EF) nr. 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861, (EU) 2019/817 og (EU) 2019/1896 og om ophævelse af Rådets beslutning 2004/512/EF og Rådets afgørelse 2008/633/RIA, med henblik på reform af visuminformationssystemet (
EUT L 248 af 13.7.2021, s. 11
).
3.   Eurodac
Europa-Parlamentets og Rådets forordning (EU) 2024/1358 af 14. maj 2024 om oprettelse af »Eurodac« til sammenligning af biometriske oplysninger med henblik på effektiv anvendelse af Europa-Parlamentets og Rådets forordning (EU) 2024/1315 og (EU) 2024/1350 og Rådets direktiv 2001/55/EF og på identificering af tredjelandsstatsborgere og statsløse med ulovligt ophold og om medlemsstaternes retshåndhævende myndigheders og Europols adgang til at indgive anmodning om sammenligning med Eurodacoplysninger med henblik på retshåndhævelse, om ændring af Europa-Parlamentets og Rådets forordning (EU) 2018/1240 og (EU) 2019/818 og om ophævelse af Europa-Parlamentets og Rådets forordning (EU) nr. 603/2013 (
EUT L, 2024/1358, 22.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1358/oj
).
4.   Ind- og udrejsesystemet
Europa-Parlamentets og Rådets forordning (EU) 2017/2226 af 30. november 2017 om oprettelse af et ind- og udrejsesystem til registrering af ind- og udrejseoplysninger og oplysninger om nægtelse af indrejse vedrørende tredjelandsstatsborgere, der passerer medlemsstaternes ydre grænser, om fastlæggelse af betingelserne for adgang til ind- og udrejsesystemet til retshåndhævelsesformål og om ændring af konventionen om gennemførelse af Schengenaftalen og forordning (EF) nr. 767/2008 og (EU) nr. 1077/2011 (
EUT L 327 af 9.12.2017, s. 20
).
5.   Det europæiske system vedrørende rejseinformation og rejsetilladelse
a)
Europa-Parlamentets og Rådets forordning (EU) 2018/1240 af 12. september 2018 om oprettelse af et europæisk system vedrørende rejseinformation og rejsetilladelse (ETIAS) og om ændring af forordning (EU) nr. 1077/2011, (EU) nr. 515/2014, (EU) 2016/399, (EU) 2016/1624 og (EU) 2017/2226 (
EUT L 236 af 19.9.2018, s. 1
)
b)
Europa-Parlamentets og Rådets forordning (EU) 2018/1241 af 12. september 2018 om ændring af forordning (EU) 2016/794 med henblik på oprettelse af et europæisk system vedrørende rejseinformation og rejsetilladelse (ETIAS) (
EUT L 236 af 19.9.2018, s. 72
).
6.   Det europæiske informationssystem vedrørende strafferegistre for statsborgere i tredjelande og statsløse
Europa-Parlamentets og Rådets forordning (EU) 2019/816 af 17. april 2019 om oprettelse af et centralt system til bestemmelse af, hvilke medlemsstater der ligger inde med oplysninger om straffedomme afsagt over tredjelandsstatsborgere og statsløse personer (ECRIS-TCN) for at supplere det europæiske informationssystem vedrørende strafferegistre, og om ændring af forordning (EU) 2018/1726 (
EUT L 135 af 22.5.2019, s. 1
).
7.   Interoperabilitet
a)
Europa-Parlamentets og Rådets forordning (EU) 2019/817 af 20. maj 2019 om fastsættelse af en ramme for interoperabilitet mellem EU-informationssystemer vedrørende grænser og visum og om ændring af Europa-Parlamentets og Rådets forordning (EF) nr. 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 og (EU) 2018/1861, Rådets beslutning 2004/512/EF og Rådets afgørelse 2008/633/RIA (
EUT L 135 af 22.5.2019, s. 27
)
b)
Europa-Parlamentets og Rådets forordning (EU) 2019/818 af 20. maj 2019 om fastsættelse af en ramme for interoperabilitet mellem EU-informationssystemer vedrørende politisamarbejde og retligt samarbejde, asyl og migration og om ændring af forordning (EU) 2018/1726, (EU) 2018/1862 og (EU) 2019/816 (
EUT L 135 af 22.5.2019, s. 85
).
BILAG XI
Teknisk dokumentation omhandlet i artikel 53, stk. 1, litra a) — teknisk dokumentation for udbydere af AI-modeller til almen brug
Afsnit 1
Oplysninger, der skal forelægges af alle udbydere af AI-modeller til almen brug
Den tekniske dokumentation omhandlet i artikel 53, stk. 1, litra a), skal som minimum indeholde følgende oplysninger, alt efter hvad der er relevant for modellens størrelse og risikoprofil:
1.
En generel beskrivelse af AI-modellen til almen brug, herunder:
a)
de opgaver, som modellen tilsigtes at udføre, og typen og arten af AI-systemer, som den kan integreres i
b)
gældende acceptable anvendelsespolitikker
c)
frigivelsesdato og distributionsmetoder
d)
parametrenes arkitektur og antal
e)
modalitet (f.eks. tekst, billede) og format af input og output
f)
licensen.
2.
En detaljeret beskrivelse af elementerne i den model, der er omhandlet i punkt 1, og relevante oplysninger om udviklingsprocessen, herunder følgende elementer:
a)
de tekniske midler (f.eks. brugsanvisning, infrastruktur, værktøjer), der er nødvendige for, at AI-modellen til almen brug kan integreres i AI-systemer
b)
modellens konstruktionsspecifikationer og træningsprocessen, herunder træningsmetoder og -teknikker, de vigtigste valg med hensyn til udformning, herunder begrundelser og antagelser, hvad modellen er udformet til at optimere for og relevansen af de forskellige parametre, alt efter hvad der er relevant
c)
oplysninger om de data, der anvendes til træning, afprøvning og validering, hvis det er relevant, herunder dataenes type og oprindelse og kurateringsmetoder (f.eks. rensning, filtrering osv.), antallet af datapunkter, deres omfang og vigtigste karakteristika, hvordan dataene er indhentet og udvalgt, samt alle andre foranstaltninger til at opdage uegnede datakilder og metoder til at opdage identificerbare bias, hvor det er relevant
d)
de beregningskraftsressourcer, der anvendes til at træne modellen (f.eks. antal flydende kommatalsberegninger), træningstid og andre relevante detaljer vedrørende træningen
e)
modellens kendte eller anslåede energiforbrug.
For så vidt angår litra e) kan energiforbruget, hvis modellens energiforbrug er ukendt, baseres på oplysninger om anvendte beregningskraftsressourcer.
Afsnit 2
Yderligere oplysninger, der skal forelægges af udbydere af AI-modeller til almen brug med systemisk risiko
1.
En detaljeret beskrivelse af evalueringsstrategierne, herunder evalueringsresultater, på grundlag af tilgængelige offentlige evalueringsprotokoller og -værktøjer eller på anden måde af andre evalueringsmetoder. Evalueringsstrategierne skal omfatte evalueringskriterier, parametre og metoder til identifikation af begrænsninger.
2.
Hvis det er relevant, en detaljeret beskrivelse af de foranstaltninger, der er truffet med henblik på at gennemføre intern og/eller ekstern kontradiktorisk afprøvning (f.eks. red teaming), modeltilpasninger, herunder tilpasning og finjustering.
3.
Hvis det er relevant, en detaljeret beskrivelse af systemarkitekturen, der forklarer, hvordan softwarekomponenterne bygger på eller føder ind i hinanden og integreres i den samlede anvendelse.
BILAG XII
Gennemsigtighedsoplysninger omhandlet i artikel 53, stk. 1, litra b) — teknisk dokumentation for udbydere af AI-modeller til almen brug til downstreamudbydere, der integrerer modellen i deres AI-system
Oplysningerne omhandlet i artikel 53, stk. 1, litra b), skal som minimum omfatte følgende:
1.
En generel beskrivelse af AI-modellen til almen brug, herunder:
a)
de opgaver, som modellen tilsigtes at udføre, og typen og arten af AI-systemer, som den kan integreres i
b)
gældende acceptable anvendelsespolitikker
c)
frigivelsesdato og distributionsmetoder
d)
hvis det er relevant, hvordan modellen interagerer eller kan bruges til at interagere med hardware eller software, der ikke er en del af selve modellen
e)
versioner af relevant software vedrørende anvendelsen af AI-modellen til almen brug, hvis det er relevant
f)
parametrenes arkitektur og antal
g)
modalitet (f.eks. tekst, billede) og format af input og output
h)
licensen til modellen.
2.
En beskrivelse af elementerne i modellen og af processen for dens udvikling, herunder:
a)
de tekniske midler (f.eks. brugsanvisning, infrastruktur, værktøjer), der er nødvendige for, at AI-modellen til almen brug kan integreres i AI-systemer
b)
modalitet (f.eks. tekst, billede osv.) og format af input og output og deres maksimale størrelse (f.eks. kontekstvinduesstørrelse osv.)
c)
oplysninger om de data, der anvendes til træning, afprøvning og validering, hvis det er relevant, herunder dataenes type og oprindelse og kurateringsmetoder.
BILAG XIII
Kriterier for udpegelse af AI-modeller til almen brug med systemisk risiko, jf. artikel 51
Med henblik på at fastslå, at en AI-model til almen brug har kapaciteter eller virkninger, der svarer til dem, der er fastsat i artikel 51, stk. 1, litra a), tager Kommissionen hensyn til følgende kriterier:
a)
antal parametre i modellen
b)
datasættets kvalitet eller størrelse, f.eks. målt ved hjælp af tokens
c)
den mængde beregningskraft, der anvendes til træning af modellen, målt i flydende kommatalsberegninger eller angivet ved en kombination af andre variabler såsom anslåede træningsomkostninger, anslået tid til træningen eller anslået energiforbrug til træningen
d)
modellens input- og outputmetoder, f.eks. tekst til tekst (store sprogmodeller), tekst til billede, multimodalitet og de nyeste tærskler til bestemmelse af kapaciteter med stor virkning for hver modalitet, samt den specifikke type input og output (f.eks. biologiske sekvenser)
e)
benchmarks og evalueringer af modellens kapaciteter, herunder hensyntagen til antal opgaver uden yderligere træning, tilpasningsevne til at lære nye, særskilte opgaver, dens grad af autonomi og skalerbarhed og de værktøjer, den har adgang til
f)
om den har stor indvirkning på det indre marked på grund af dens omfang, hvilket formodes at være tilfældet, når den er blevet gjort tilgængelig for mindst 10 000 registrerede erhvervsbrugere etableret i Unionen
g)
antal registrerede slutbrugere.
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
ISSN 1977-0634 (electronic edition)

Summary:
Regler for pålidelig kunstig intelligens i EU
RESUMÉ AF:
Forordning (EU) 2024/1689 om harmoniserede regler for kunstig intelligens (forordningen om kunstig intelligens)
HVAD ER FORMÅLET MED FORORDNINGEN?
Forordning (EU) 2024/1689 har til formål at tilskynde til udviklingen og udbredelsen af 
sikre
 og 
pålidelige
 systemer til kunstig intelligens (AI) på hele 
Den Europæiske Union
s (EU) 
indre marked
 i både den private og offentlige sektor og samtidig sikre EU-borgernes sundhed og sikkerhed samt respekt for 
grundlæggende rettigheder
. 
Forordningen
 fastsætter risikobaserede regler om:
omsætningen, ibrugtagningen og anvendelsen af visse AI-systemer
forbud mod visse former for AI-praksis
krav og forpligtelser vedrørende højrisiko-AI-systemer
gennemsigtighed for visse AI-systemer
gennemsigtighed og risikostyring for AI-modeller til almen brug (effektive AI-modeller, der understøtter AI-systemer, som kan udføre en lang række opgaver)
overvågning efter omsætningen, markedsovervågning, forvaltning og håndhævelse
støtte til innovation med særligt fokus på 
små og mellemstore virksomheder
 (SMV’er), herunder iværksættervirksomheder.
Der er visse undtagelser, f.eks. for systemer der udelukkende bruges til 
militær og forsvar
 eller til 
forskningsformål
.
HOVEDPUNKTER
Hvad er et AI-system?
Et AI-system er et maskinbaseret system, der er udviklet til at fungere med en vis grad af autonomi, og som kan:
udvise en 
tilpasningsevne
 efter idriftsættelsen
generere output
, såsom forudsigelser, indhold, anbefalinger eller beslutninger, af det input, det modtager (for at opnå eksplicitte eller implicitte mål)
En risikobaseret tilgang
Lovgivningen følger en risikobaseret tilgang, hvilket betyder, at jo højere risiko der er for at forårsage skade på samfundet, desto strengere er reglerne. Forordningen 
definerer brugen af AI på følgende områder som højrisiko
 på grund af den potentielle indvirkning på grundlæggende rettigheder, sikkerhed og trivsel:
sikkerhedskomponenter
 i produkter, der er omfattet af EU-harmoniseringslovgivningen (eller som selvstændige produkter), som skal gennemgå en tredjeparts overensstemmelsesvurdering i henhold til samme EU-harmoniseringslovgivning
biometri
, når det anvendes til fjernidentifikation, kategorisering af enkeltpersoner ifølge egenskaber (såsom race eller religion) eller følelsesgenkendelse, undtagen når disse bruges til blot at bekræfte identiteten
kritisk infrastruktur
, når AI er en sikkerhedskomponent inden for områder som digital infrastruktur, trafik, vand, gas, opvarmning og elektricitet
uddannelse og erhvervsuddannelse
, herunder adgang til uddannelsesspørgsmål, evaluering af læringsudbytte, vurdering af uddannelsesniveauer eller overvågning af adfærd under prøver
beskæftigelse
, herunder rekruttering, udvælgelse af kandidater, beslutningstagning vedrørende ansættelsesvilkår (forfremmelser, opsigelser), opgavefordeling eller overvågning af resultater
væsentlige tjenester
 — AI-systemer, der anvendes af offentlige myndigheder til at vurdere, om personer er berettigede til offentlige tjenesteydelser (sundhedspleje, ydelser), kreditvurdering, vurdering af forsikringsrisici og prioritering af nødberedskab
retshåndhævelse
 — AI-systemer til vurdering af risici i forbindelse med kriminalitet, polygrafer, vurdering af pålideligheden af bevismateriale, forudsigelse af gentagelsestilfælde eller profilering af enkeltpersoner til strafferetlig efterforskning
indvandring og grænsekontrol
 — AI-systemer, der bruges til at vurdere risici i forbindelse med 
indvandrings-, asyl-
 og visumansøgninger eller til at opdage og identificere personer i migrationssituationer
retspleje og demokratiske processer
 — AI-systemer, som anvendes af retsmyndighederne til juridisk forskning og fortolkning eller systemer, der kan påvirke valgresultaterne.
Forordningen forbyder følgende AU-praksisser med et uacceptabelt risikoniveau
Subliminale eller vildledende teknikker
 til at manipulere individuel adfærd eller gruppeadfærd, hvilket skader deres evne til at træffe informerede beslutninger og eventuelt forvolder skade.
Udnyttelse af sårbarhed
 baseret på alder, handicap eller socioøkonomiske situationer for at manipulere enkeltpersoner eller grupper, hvilket fører til mulig skade.
Social bedømmelse
 med vurdering eller klassificering af personer på grundlag af adfærd eller karakteristika, hvilket medfører urimelig behandling, der ikke er i overensstemmelse med den sammenhæng, som dataene blev indsamlet i, eller på en måde, der ikke står i et rimeligt forhold til karakteren af deres adfærd.
Strafferetlig risikovurdering
, der forudser sandsynligheden for at begå en forbrydelse udelukkende på grundlag af profilering eller personlighedstræk, med undtagelse af objektive faktuelle efterforskninger.
Indsamling til ansigtsgenkendelsesdatabaser
 fra internettet eller overvågningskameraer uden specifik målretning.
Udledelse af følelser på følsomme områder
, såsom arbejdspladser eller uddannelsesinstitutioner, medmindre de anvendes til medicinske eller sikkerhedsmæssige formål.
Biometrisk kategorisering
 baseret på data med henblik på at udlede følsomme egenskaber såsom race, religion eller politisk overbevisning, med undtagelse af lovlig anvendelse i retshåndhævelse.
Biometrisk identifikation i realtid i offentligheden gennem retshåndhævelse
 medmindre det er strengt nødvendigt i særlige situationer (f.eks. at finde forsvundne personer, forebygge overhængende trusler eller identificere mistænkte for alvorlige forbrydelser). Dette skal følge strenge juridiske procedurer, herunder forudgående godkendelse, et begrænset anvendelsesområde og beskyttelsesforanstaltninger for at beskytte rettigheder og frihedsrettigheder.
Forordningen indfører oplysningspligter, når der kan opstå en risiko som følge af manglende 
gennemsigtighed omkring brugen af AI
:
AI, der har til formål at efterligne mennesker (f.eks. en chatbot), skal oplyse det menneske, den interagerer med, om dette
outputtet af generativ AI skal mærkes som AI-genereret på en maskinlæsbar måde
i visse tilfælde skal outputtet af generativ AI mærkes synligt, navnlig deepfakes og tekst, der har til formål at informere offentligheden om emner af samfundsmæssig interesse.
Alle andre AI-systemer anses for at have 
begrænset risiko
, og forordningen indfører derfor ingen yderligere regler.
Pålidelig brug af store AI-modeller
AI-modeller til almen brug er AU-modeller, der er trænet med store mængder data og som kan udføre en lang række opgaver. De kan være komponenter i AI-systemer.
Forordningen indfører 
gennemsigtighedsforpligtelser
 for udbydere af sådanne AU-modeller til almen brug, navnlig teknisk dokumentation, levering af oplysninger til downstreamudviklere af AI-systemer og offentliggørelse af data, der anvendes til træning af modellen.
De mest effektive AI-modeller til almen brug kan udgøre 
systemiske risici
. Hvis en model opfylder en vis kapacitetsgrænse, skal udbyderen af den pågældende model opfylde yderligere forpligtelser vedrørende risikostyring og cybersikkerhed.
Forvaltning
Forordningen opretter flere forvaltningsorganer, der er aktive fra den 
2. august
 2025
:
nationale kompetente myndigheder
, der fører tilsyn med og håndhæver reglerne for AI-systemer
et 
AI-kontor
 inden for 
Europa-Kommissionen
, der skal koordinere den sammenhængende anvendelse af de fælles regler i hele EU og fungere som regulator for AI-modeller til almen brug.
EU’s 
medlemsstater
 og AI-kontoret arbejder tæt sammen om et 
AI-udvalg
, der består af repræsentanter fra medlemsstaterne, for at sikre en ensartet og effektiv anvendelse af forordningen.
Forordningen opretter to rådgivende organer for AI-kontoret og AI-udvalget:
et 
videnskabeligt panel af uafhængige eksperter
, der skal yde videnskabelig rådgivning
et 
rådgivende forum for interessenter
 med henblik på at yde teknisk ekspertise til AI-udvalget og Kommissionen.
Sanktioner
Bøderne for overtrædelser fastsættes som en procentdel af den lovovertrædende virksomheds 
årlige omsætning
 eller et forudbestemt beløb, afhængigt af, hvilket beløb der er højest. Små og mellemstore virksomheder og iværksættervirksomheder er underlagt forholdsmæssige administrative bøder.
Gennemsigtighed og beskyttelse af grundlæggende rettigheder
Udviklingen og brugen af højrisiko-AI-systemer er underlagt øget gennemsigtighed:
før et højrisiko-AI-system anvendes af enheder, der udbyder offentlige tjenester, skal der udføres en 
konsekvensanalyse vedrørende grundlæggende rettigheder
højrisiko-AI-systemer og enheder, der anvender dem, skal være registreret i en 
EU-database
.
Innovation
Forordningen fastlægger en innovationsvenlig retlig ramme og har til formål at fremme evidensbaseret lovgivningsmæssig læring. Den lægger op til 
reguleringsmæssige AI-sandkasser
, der skal muliggøre et kontrolleret miljø, hvor innovative AI-systemer kan udvikles, testes og valideres, herunder under reelle forhold. Derudover giver forordningen mulighed for at teste højrisiko-AI-systemer i praksis under visse betingelser.
Evaluering og revision
Kommissionen vurderer behovet for at ændre listen over højrisikoanvendelser af AI og forbudte former for AI-praksis hvert år. Senest den 
2. august
 2028
 og hvert fjerde år derefter vurderer og rapporterer Kommissionen om følgende:
tilføjelse til eller udvidelse af listen over 
højrisikokategorier
ændringer af listen over AI-systemer, der kræver 
yderligere gennemsigtighedsforanstaltninger
ændringer, der forbedrer 
tilsyn og forvaltning
.
HVORNÅR GÆLDER FORORDNINGEN FRA?
Forordningen træder i kraft den 
2. august
 2026
. Der er dog visse undtagelser:
forbuddene, definitionerne og forpligtelserne vedrørende AI-færdigheder trådte i kraft den 
2. februar
 2025
visse regler træder i kraft den 
2. august
 2025
, herunder regler om forvaltningsstruktur, sanktioner og forpligtelser for udbydere af AU-modeller til almen brug.
BAGGRUND
For yderligere oplysninger henvises til:
AI-forordning
 (Europa-Kommissionen)
Europæisk AI-kontor
 (Europa-Kommissionen).
HOVEDDOKUMENT
Europa-Parlamentets og Rådets forordning (EU) 
2024/1689
 af 
13. juni
 2024
 om harmoniserede regler for kunstig intelligens og om ændring af forordning (EF) nr. 300/2008, (EU) nr. 167/2013, (EU) nr. 168/2013, (EU) 2018/858, (EU) 2018/1139 og (EU) 2019/2144 samt direktiv 2014/90/EU, (EU) 2016/797 og (EU) 2020/1828 (forordningen om kunstig intelligens) (EUT 
L, 2024/1689
 af 
12.7.2024
).
TILHØRENDE DOKUMENTER
Europa-Parlamentets og Rådets forordning (EU) 
2022/2065
 af 
19. oktober
 2022
 om et indre marked for digitale tjenester og om ændring af direktiv 2000/31/EF (lov om digitale tjenester) (EUT 
L 277
 af 
27.10.2022
, 
s. 1-102
).
Europa-Parlamentets og Rådets direktiv (EU) 
2020/1828
 af 
25. november
 2020
 om adgang til anlæggelse af gruppesøgsmål til beskyttelse af forbrugernes kollektive interesser og om ophævelse af direktiv 2009/22/EF (EUT 
L 409
 af 
4.12.2020
, 
s. 1-27
).
Efterfølgende ændringer til direktiv (EU) 2020/1828 er blevet indarbejdet i grundteksten. Denne 
konsoliderede udgave
 har ingen retsvirkning.
Europa-Parlamentets og Rådets forordning (EU) 
2019/881
 af 
17. april
 2019
 om ENISA (Den Europæiske Unions Agentur for Cybersikkerhed), om cybersikkerhedscertificering af informations- og kommunikationsteknologi og om ophævelse af forordning (EU) nr. 526/2013 (forordningen om cybersikkerhed) (EØS-relevant tekst) (EUT L 
L 151
 af 
7.6.2019
, 
s. 15-69
).
Europa-Parlamentets og Rådets direktiv (EU) 
2019/882
 af 
17. april
 2019
 om tilgængelighedskrav for produkter og tjenester (EUT 
L 151
 af 
7.6.2019
, 
s. 70-115
).
Europa-Parlamentets og Rådets forordning (EU) 
2019/1020
 af 
20. juni
 2019
 om markedsovervågning og produktoverensstemmelse og om ændring af direktiv 2004/42/EF og forordning (EF) nr. 765/2008 og (EU) nr. 305/2011 (EUT 
L 169
 af 
25.6.2019
, 
s. 1-44
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) 
2019/2144
 af 
27. november
 2019
 om krav til typegodkendelse af motorkøretøjer og påhængskøretøjer dertil samt systemer, komponenter og separate tekniske enheder til sådanne køretøjer for så vidt angår deres generelle sikkerhed og beskyttelsen af køretøjspassagerer og bløde trafikanter og om ændring af Europa-Parlamentets og Rådets forordning (EU) 2018/858 og ophævelse af Europa-Parlamentets og Rådets forordning (EF) nr. 78/2009, forordning (EF) nr. 79/2009 og forordning (EF) nr. 661/2009 og Kommissionens forordning (EF) nr. 631/2009, (EU) nr. 406/2010, (EU) nr. 672/2010, (EU) nr. 1003/2010, (EU) nr. 1005/2010, (EU) nr. 1008/2010, (EU) nr. 1009/2010, (EU) nr. 19/2011, (EU) nr. 109/2011, (EU) nr. 458/2011, (EU) nr. 65/2012, (EU) nr. 130/2012, (EU) nr. 347/2012, (EU) nr. 351/2012, (EU) nr. 1230/2012 og (EU) 2015/166 (EUT 
L 325
 af 
16.12.2019
, 
s. 1-40
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) 
2018/858
 af 
30. maj
 2018
 om godkendelse og markedsovervågning af motorkøretøjer og påhængskøretøjer dertil samt af systemer, komponenter og separate tekniske enheder til sådanne køretøjer, om ændring af forordning (EF) nr. 715/2007 og (EF) nr. 595/2009 og om ophævelse af direktiv 2007/46/EF (EUT 
L 151
 af 
14.6.2018
, 
s. 1-218
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) 
2018/1139
 af 
4. juli
 2018
 om fælles regler for civil luftfart og oprettelse af Den Europæiske Unions Luftfartssikkerhedsagentur og om ændring af Europa-Parlamentets og Rådets forordning (EF) nr. 2111/2005, (EF) nr. 1008/2008, (EU) nr. 996/2010, (EU) nr. 376/2014 og direktiv 2014/30/EU og 2014/53/EU og om ophævelse af Europa-Parlamentets og Rådets forordning (EF) nr. 552/2004 og (EF) nr. 216/2008 og Rådets forordning (EØF) nr. 3922/91 (EUT 
L 212
 af 
22.8.2018
, 
s. 1-122
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) 
2018/1725
 af 
23. oktober
 2018
 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger i Unionens institutioner, organer, kontorer og agenturer og om fri udveksling af sådanne oplysninger og om ophævelse af forordning (EF) nr. 45/2001 og afgørelse nr. 1247/2002/EF (EUT 
L 295
 af 
21.11.2018
, 
s. 39-98
).
Europa-Parlamentets og Rådets forordning (EU) 
2016/679
 af 
27. april
 2016
 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger og om fri udveksling af sådanne oplysninger og om ophævelse af direktiv 95/46/EF (generel forordning om databeskyttelse) (EUT 
L 119
 af 
4.5.2016
, 
s. 1-88
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets direktiv (EU) 
2016/680
 af 
27. april
 2016
 om beskyttelse af fysiske personer i forbindelse med kompetente myndigheders behandling af personoplysninger med henblik på at forebygge, efterforske, afsløre eller retsforfølge strafbare handlinger eller fuldbyrde strafferetlige sanktioner og om fri udveksling af sådanne oplysninger og om ophævelse af Rådets rammeafgørelse 2008/977/RIA (EUT 
L 119
 af 
4.5.2016
, 
s. 89-131
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets direktiv (EU) 
2016/797
 af 
11. maj
 2016
 om interoperabilitet i jernbanesystemet i Den Europæiske Union (omarbejdning) (EUT 
L 138
 af 
26.5.2016
, 
s. 44-101
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets direktiv (EU) 
2016/2102
 af 
26. oktober
 2016
 om tilgængeligheden af offentlige organers websteder og mobilapplikationer (EUT 
L 327
 af 
2.12.2016
, 
s. 1-15
).
Europa-Parlamentets og Rådets direktiv 
2014/90/EU
 af 
23. juli
 2014
 om skibsudstyr og om ophævelse af Rådets direktiv 96/98/EF (EUT 
L 257
 af 
28.8.2014
, 
s. 146-185
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) nr. 
167/2013
 af 
5. februar
 2013
 om godkendelse og markedsovervågning af landbrugs- og skovbrugstraktorer (EUT 
L 60
 af 
2.3.2013
, 
s. 1-51
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) nr. 
168/2013
 af 
15. januar
 2013
 om godkendelse og markedsovervågning af to- og trehjulede køretøjer samt quadricykler (EUT 
L 60
 af 
2.3.2013
, 
s. 52-128
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EU) nr. 
1025/2012
 af 
25. oktober
 2012
 om europæisk standardisering, om ændring af Rådets direktiv 89/686/EØF og 93/15/EØF og Europa-Parlamentets og Rådets direktiv 94/9/EF, 94/25/EF, 95/16/EF, 97/23/EF, 98/34/EF, 2004/22/EF, 2007/23/EF, 2009/23/EF og 2009/105/EF og om ophævelse af Rådets beslutning 87/95/EØF og Europa-Parlamentets og Rådets afgørelse nr. 1673/2006/EF (EUT 
L 316
 af 
14.11.2012
, 
s. 12-33
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EF) nr. 
300/2008
 af 
11. marts
 2008
 om fælles bestemmelser om sikkerhed inden for civil luftfart og om ophævelse af forordning (EF) nr. 2320/2002 (EUT 
L 97
 af 
9.4.2008
, 
s. 72-84
).
Se den 
konsoliderede udgave
.
Europa-Parlamentets og Rådets forordning (EF) nr. 
765/2008
 af 
9. juli
 2008
 om kravene til akkreditering og markedsovervågning i forbindelse med markedsføring af produkter og om ophævelse af Rådets forordning (EØF) nr. 339/93 (EUT 
L 218
 af 
13.8.2008
, 
s. 30-47
).
Se den 
konsoliderede udgave
.
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11.3.2025