under Annex III 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 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 of the European Parliament and of the Council<fnref n="26" />. In order to ensure the full functionality of the database, when deployed, the procedure for setting the database should include the elaboration of functional specifications by the Commission and an independent audit report. The Commission should take into account cybersecurity and hazard-related risks when carrying out its tasks as data controller on the EU database. In order to maximise the availability and use of the database by the public, the database, including the information made available through it, should comply with requirements under the Directive 2019/882.

(70) 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 such obligation, the characteristics of individuals 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 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

<footnote n="26">²⁶ 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).</footnote>
origin, personal preferences and interests. Such information and notifications should be
provided in accessible formats for persons with disabilities.

(70a) 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 the 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 system or at the level of the 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.

(70b) Further to the technical solutions employed by the providers of the system, deployers, who use an AI system to generate or manipulate image, audio or video content that appreciably resembles existing persons, places or events and would falsely appear to a person to be authentic ('deep fakes'), should also clearly and distinguishably disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin. The compliance with this transparency obligation should not be interpreted as indicating that the use of the 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 of Fundamental Rights of the EU, in particular where the content
is part of an evidently creative, satirical, artistic or fictional 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.

(70c) To ensure consistent implementation, it is appropriate to empower the Commission to adopt implementing acts on the application of the provisions on the labelling and detection of artificially generated or manipulated content. Without prejudice to the mandatory nature and full applicability of these 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 in the value chain, disseminating content or checking its authenticity and provenance to enable the public to effectively distinguish AI-generated content.

(70d) 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 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 2022/2065 for providers of hosting services to process notices on illegal content received pursuant to Article 16(1) 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.

(70e) The compliance with the transparency obligations for the AI systems coved by this Regulation should not be interpreted as indicating that the use of the 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.

(71) Artificial intelligence 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 artificial intelligence 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 several Member States' competent authorities, insofar as this participation provides equivalent level of national coverage for the participating Member States. 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 regulatory sandboxes have the adequate resources for their functioning, including financial and human resources.

(72) 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 Member States legislation, 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 companies, 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 small and medium enterprises (SMEs), including start-ups. Regulatory sandboxes should be widely available throughout the Union, and particular attention should be given to their accessibility for SMEs, including startups. 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 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 legislation allowing
for the establishment of other sandboxes aiming at ensuring compliance with legislation
other that 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.

(72a) 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 line with Article 6(4) and 9(2)(g) of Regulation (EU) 2016/679, and Article 5, 6 and 10 of Regulation (EU) 2018/1725, and without prejudice to Articles 4(2) and 10 of Directive (EU) 2016/680. All other obligations of data controllers and rights of data subjects under Regulation (EU) 2016/679, Regulation (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)(b) of Regulation (EU) 2016/679 and
Article 24(2)(b) of Regulation (EU) 2018/1725. Providers and prospective providers in the 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 the sandbox.

(72b) In order to accelerate the process of development and placing on the market of high-risk AI systems listed in Annex III, 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 and 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 the Regulation for providers or prospective providers. Such guarantees should include, among others, requesting informed consent of natural persons to participate in testing in real world conditions, with the exception of law enforcement in cases 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-wide 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 EU data protection law. As regards transfer of data, it is also appropriate to envisage that data collected and processed for the purpose of the testing in real world conditions should only be transferred to third countries outside the Union provided appropriate and applicable safeguards under Union law are implemented, notably 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 the Data
Governance Act and the Data Act.

(72c) To ensure that Artificial Intelligence 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.

(73) 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 this objective, Member States should develop initiatives, which are targeted at those operators, including on, awareness raising and information communication. Member States shall provide SME's, including start-ups, having 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 shall utilise existing channels and where appropriate, establish new dedicated channels for communication with SMEs, 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 shall 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 SMEs including start-up providers 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 deployers 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, notably 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 AI 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 recently changed from the small to medium-size category
within the meaning of the Annex to Recommendation 2003/361/EC (Article 16) should
have access to these support measures, as these new medium-sized enterprises may
sometimes lack the legal resources and training necessary to ensure proper understanding
and compliance with provisions.

(73a) In order to promote and protect innovation, the AI-on demand platform, all relevant EU funding programmes and projects, such as Digital Europe Programme, Horizon Europe, implemented by the Commission and the Member States at national or Union level should, as appropriate, contribute to the achievement of the objectives of this Regulation.

(74) In particular, 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, notably 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 national or EU level should contribute to the implementation of this Regulation. Within their respective mission and fields of competence, they may provide in particular technical and scientific support to providers and notified bodies.

(74a) Moreover, in order to ensure proportionality considering the very small size of some operators 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.

(75) 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 notably the case for expert panels, expert laboratories and reference laboratories in the field of medical devices pursuant to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

(75a) 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 artificial intelligence. 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 Commission has established the AI Office by Commission decision of [...], which has as its mission to develop Union expertise and capabilities in the field of artificial intelligence and to contribute to the implementation of Union legislation on artificial intelligence. 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 European Artificial Intelligence 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, both at national and Union level, should be established. The development of Union expertise and capabilities should also include making use of existing resources and expertise, notably through synergies with structures built up in the context of the Union level enforcement of other legislation 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.

(76) In order to facilitate a smooth, effective and harmonised implementation of this Regulation a European Artificial Intelligence 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 artificial intelligence. In order to give some flexibility to Member States in the designation of their representatives in the AI 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 in the meaning of Article 30 of Regulation (EU) 2019/1020. In line with the role and tasks of the Commission pursuant to Article 33 of Regulation (EU) 2019/1020, the Commission should support the activities of the standing subgroup for market surveillance by undertaking market evaluations or studies, notably 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 EU bodies, expert groups and networks active in the context of relevant EU legislation, including in particular those active under relevant EU regulation on data, digital products and services.

(76x) With a view to ensure 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 social partners, as well as the Fundamental Rights Agency, European Union Agency for Cybersecurity, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI).

(76y) 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 artificial intelligence 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 reinforcing 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.

(76a) In order to support adequate enforcement as regards AI systems and reinforce the capacities of the Member States, EU AI testing support structures should be established and made available to the Member States.

(77) Member States hold a key role in the application and enforcement of this Regulation. In this 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 single point of contact.

(77a) 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.

(78) 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, breaches of obligations under Union law intended to protect fundamental rights or serious damage to property or the environment.

(79) 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 under this Regulation and 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.

(79a) 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.

(80) Union legislation on financial services 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 legislation, the competent authorities for the supervision and enforcement of the financial services legislation, notably competent authorities as defined in Directive 2009/138/EC, Directive (EU) 2016/97, Directive 2013/36/EU Regulation (EU) No 575/2013, Directive 2008/48/EC and Directive 2014/17/EU 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 on market surveillance to enforce the requirements and obligations of this Regulation, including powers to carry out ex post market surveillance activities that can be integrated, as appropriate, into their existing supervisory mechanisms and procedures under the relevant Union financial services legislation. 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 (SSM) established by Council Regulation No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the European Central Bank's prudential supervisory tasks as specified in that Regulation. To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated under Directive 2013/36/EU of the European Parliament and of the Council<fnref n="27" />, 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

<footnote n="27">²⁷ 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).</footnote>
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/EU (Solvency II) and the insurance intermediaries under Directive 2016/97/EU and other types of financial institutions subject to requirements regarding internal governance, arrangements or processes established pursuant to the relevant Union financial services legislation to ensure consistency and equal treatment in the financial sector.

(80-x) Each market surveillance authority for high-risk AI systems listed in point 1 of Annex III insofar as these systems are used for law enforcement purposes and for purposes listed in points 6, 7 and 8 of Annex III 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 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.

(80x) The market surveillance authorities of the Member States 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 several Member States. Joint activities to promote compliance should be carried out in accordance with Article 9 of the 2019/1020. The AI Office should provide coordination support for joint investigations.

(80y) It is necessary to clarify the responsibilities and competences on national and Union 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 report the AI system to the AI Office 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. In such cases, the market surveillance authorities should provide mutual assistance in cross-border cases in Chapter VI of Regulation (EU) 2019/1020 should apply by analogy.

(80z) 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 Commission should 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. 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.

(80z+1) With a view to complement 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 these tasks, there should be a mechanism whereby the scientific panel can request the Commission to require documentation or information from a provider.
(80z+2) 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. In the conduct of 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 case of identified systemic risks as well as restricting the making available on the market, withdrawing or recalling the model. As a safeguard in case 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 by analogy, without prejudice to more specific procedural rights provided for by this Regulation.

(81) 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 artificial intelligence in the Union. Providers of non-high-risk AI systems 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 models should also be encouraged to apply on a voluntary basis additional requirements related, for example, to the elements of the European ethic 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 and research organisations, trade unions and consumer protection organisation 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 be also developed in an inclusive way, as appropriate, with the involvement of relevant
stakeholders such as business and civil society organisations, academia and research organisations, trade unions and consumer protection organisation. The Commission may develop initiatives, including of a sectorial 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.

(82) 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<sup>28</sup> would apply as a safety net.

(83) 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 or administrative proceedings, and the integrity of classified information.

(84) 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 in respect of 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 provider's size, in particular if the provider is an SME including a start-up. The European Data Protection

<footnote n="28">28 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 (Text with EEA relevance) (OJ L 135, 23.5.2023, p. 1–51).</footnote>
Supervisor should have the power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation.

(84a) Compliance with the obligations on providers of general-purpose AI models imposed under this Regulation should be enforceable among others 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.

(84aa) Union and national law already provides 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 having grounds to consider that there has been an infringement of the provisions of this Regulation should be entitled to lodge a complaint to the relevant market surveillance authority or the AI Office where applicable.

(84b) Affected persons should have the right to request an explanation when a decision is taken by the deployer with the output from certain high-risk systems as provided for in this Regulation as the main basis and which produces legal effects or similarly significantly affects him or her in a way that they consider to adversely impact their health, safety or fundamental rights. This explanation should be a clear and meaningful and should provide a basis for affected persons to exercise their rights. This 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 legislation.

(84c) Persons acting as ‘whistle-blowers’ on the breaches of this Regulation should be afforded the protection guaranteed by Union legislation on the protection of persons who report breaches of law. Therefore, Directive (EU) 2019/1937 should apply to the reporting of breaches of this Regulation and the protection of persons reporting such breaches.

(85) 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 Union harmonisation legislation listed in Annex II, the high-risk AI systems listed in Annex III, the provisions regarding technical documentation listed in
Annex IV, the content of the EU declaration of conformity in Annex V, the provisions regarding the conformity assessment procedures in Annex VI and VII, 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 as well as to supplement benchmarks and indicators in the rules for classification of general-purpose AI models with systemic risk, the criteria for the designation of general-purpose AI models with systemic risk in Annex IXc, the technical documentation for providers of general-purpose AI models in Annex VIIIb and the transparency information for providers of general-purpose AI models in Annex VIIIc. 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-Making¹. 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.

(85a) Given the rapid technological developments and the required technical expertise in the effective application of this Regulation, the Commission should evaluate and review this Regulation by three years after the date of entry into application 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 in Annex III and the list of prohibited practices once a year. Moreover, by two years after entry into application 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 high-risk areas in Annex III, the AI systems within the scope of the transparency obligations in Title IV, 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, within two years after the entry into application and every three years thereafter, the Commission should evaluate the impact and effectiveness of voluntary codes of conducts to foster the application of the requirements set out in Title III, Chapter 2, for systems other than high-risk AI systems and possibly other additional requirements for such AI systems.
(86) 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 Council¹.

(87) Since the objective of this Regulation 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.

(87a) 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 as defined in this Regulation. By way of exception 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 Annex IX and operators of high-risk AI systems that are intended to be used by public authorities should take the necessary steps to comply with the requirements of this Regulation by end of 2030 and by four years after the entry into application respectively.

(87b) Providers of high-risk AI systems are encouraged to start to comply, on voluntary basis, with the relevant obligations foreseen under this Regulation already during the transitional period.

(88) This Regulation should apply from ... [OP – please insert the date established in Art. 85]. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions should apply already from ... [OP – please insert the date – 6 months after entry into force of this Regulation]. While the full effect of these 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 risk and has 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 [OP - please insert the date established in Art. 85], therefore the provisions on
notified bodies and governance structure should apply from ... [OP - please insert the date
- twelve months following the entry into force of this Regulation]. Given the rapid pace of
technological advancements and adoption of general-purpose AI models, obligations for
providers of general purpose AI models should apply within 12 months from the date of
entry into force. Codes of Practice should be ready at the latest 3 months before the entry
into application of the relevant provisions, to enable providers to demonstrate compliance
in 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 [OP - please insert
the date - twelve months following the entry into force of this Regulation].

(89) The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(2) of Regulation (EU) 2018/1725 and delivered an opinion on 18 June 2021.

# TITLE I GENERAL PROVISIONS

## Article 1 - Subject matter

1. The purpose of this Regulation is to improve the functioning of the internal market and promoting the uptake of human centric and trustworthy artificial intelligence, while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, rule of law and environmental protection against harmful effects of artificial intelligence 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 artificial intelligence systems ('AI systems') in the Union;

(b) prohibitions of certain artificial intelligence practices;

(c) specific requirements for high-risk AI systems and obligations for operators of such systems;

(d) harmonised transparency rules for certain AI systems;

(da) harmonised rules for the placing on the market of general-purpose AI models;

(e) rules on market monitoring, market surveillance governance and enforcement;

(ea) 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 who are located within the Union or in a third country;

(b) deployers of AI systems that have their place of establishment or who are located within the Union;

(c) providers and deployers of AI systems that have their place of establishment or who are located in a third country, where the output produced by the system is used in the Union;

(ca) importers and distributors of AI systems;

(cb) product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;

(cc) authorised representatives of providers, which are not established in the Union.

(cc) affected persons that are located in the Union.
2. For AI systems classified as high-risk AI systems in accordance with Articles 6(1) and 6(2) related to products covered by Union harmonisation legislation listed in Annex II, section B only Article 84 of this Regulation shall apply. Article 53 shall apply only insofar as the requirements for high-risk AI systems under this Regulation have been integrated under that Union harmonisation legislation.

3. This Regulation shall not apply to areas outside the scope of EU law and in any event shall not affect the competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member States to carry out the tasks in relation to those competences.

This Regulation shall not apply to AI systems if and insofar placed on the market, put into service, or used with or without modification of such systems exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities.

This Regulation shall 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 shall not apply 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, under the condition that this third country or international organisations provide 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 intermediary service providers set out in Chapter II, Section 4 of Directive 2000/31/EC of the European Parliament and of the Council<fnref n="29" /> [as to be replaced by the corresponding provisions of the Digital Services Act].

<footnote n="29">²⁹ Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') (OJ L 178, 17.7.2000, p. 1).</footnote>
5a. This Regulation shall not apply to AI systems and models, including their output, specifically developed and put into service for the sole purpose of scientific research and development.

5a. 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 Regulations (EU) 2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, without prejudice to arrangements provided for in Article 10(5) and Article 54 of this Regulation.

5b. This Regulation shall not apply to any research, testing and development activity regarding AI systems or models prior to being placed on the market or put into service; those activities shall be conducted respecting applicable Union law. The testing in real world conditions shall not be covered by this exemption.

5b. This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety.

5c. This Regulation shall not apply to obligations of deployers who are natural persons using AI systems in the course of a purely personal non-professional activity.

5e. This Regulation shall not preclude Member States or the Union 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 to encourage or allow the application of collective agreements which are more favourable to workers.

5g. The obligations laid down in this Regulation shall 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 an AI system that falls under Title II and IV.

## Article 3 - Definitions

For the purpose of this Regulation, the following definitions apply:

(1) 'AI system' is a machine-based system 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;

(1a) 'risk' means the combination of the probability of an occurrence of harm and the severity of that harm;

(2) '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 them on the market or puts the system into service under its own name or trademark, whether for payment or free of charge;

(4) 'deployer means any 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 any 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 any 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 outside the Union;

(7) 'distributor' means any 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 the provider, the product manufacturer, the deployer, the authorised representative, the importer or the 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 any 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 of a product or system' means a component of a product or of a system which fulfils a safety function for that product or 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 user of in particular an AI system's intended purpose and proper use;

(16) 'recall of an AI system' means any measure aimed at achieving the return to the provider or taking it out of service or disabling the use of an AI system made available to deployers;

(17) 'withdrawal of an AI system' means any measure aimed at preventing 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 Title III, Chapter 2 of this Regulation 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 the AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment by the provider and as a result of which the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation is affected or results in a modification to the intended purpose for which the AI system has been assessed;

(24) 'CE marking of conformity' (CE marking) means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Title III, Chapter 2 of this Regulation and other applicable Union legislation harmonising the conditions for the marketing of products ('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 European standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;

(28) 'common specification' means a set of technical specifications, as defined in point 4 of Article 2 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, among
other things, in order to prevent underfitting or overfitting; whereas the validation
dataset is a separate dataset or part of the training dataset, either as a fixed or variable
split;

(31) ‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;

(32) ‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an output;

(33) ‘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;

(33a) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, and psychological human features for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a database;

(33c) ‘biometric verification’ means the automated verification of the identity of natural persons by comparing biometric data of an individual to previously provided biometric data (one-to-one verification, including authentication);

(33d) ‘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;

(33e) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation and prosecution of criminal offences, the disclosure of which can jeopardise the integrity of criminal proceedings;

(34) ‘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;

(35) ‘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
ancillary to another commercial service and strictly necessary for objective technical reasons;

(36) ‘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;

(37) ‘‘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. This comprises not only instant identification, but also limited short delays in order to avoid circumvention;

(38) ‘‘post’ remote biometric identification system’ means a remote biometric identification system other than a ‘real-time’ remote biometric identification system;

(39) ‘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;

(40) ‘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;

(41) ‘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 the safeguarding against and the prevention of threats to public security;
(42) ‘Artificial Intelligence Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems, general purpose AI models and AI governance. References in this Regulation to the Artificial Intelligence office shall be understood as references to the Commission;

(43) ‘national competent authority’ means any of the following: the notifying authority and the market surveillance authority. As regards AI systems put into service or used by EU institutions, agencies, offices and bodies, any reference to national competent authorities or market surveillance authorities in this Regulation shall be understood as referring to the European Data Protection Supervisor;

(44) ‘serious incident’ means any 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 damage to a person’s health;

(b) a serious and irreversible disruption of the management and operation of critical infrastructure;

(ba) breach of obligations under Union law intended to protect fundamental rights;

(bb) serious damage to property or the environment.

(44a) 'personal data' means personal data as defined in Article 4, point (1) of Regulation (EU) 2016/679;

(44c) ‘non-personal data’ means data other than personal data as defined in point (1) of Article 4 of Regulation (EU) 2016/679;

(be) ‘profiling’ means any form of automated processing of personal data as defined in point (4) of Article 4 of Regulation (EU) 2016/679; or in the case of law enforcement authorities – in point 4 of Article 3 of Directive (EU) 2016/680 or, in the case of Union institutions, bodies, offices or agencies, in point 5 Article 3 of Regulation (EU) 2018/1725;

(bf) ‘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;
(44 eb) '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;

(bg) 'AI regulatory sandbox' means a concrete and 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;

(bh) 'AI literacy' refers to skills, knowledge and understanding that allows providers, users 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;

(bi) 'testing in real world conditions' means the temporary testing of an AI system for its intended purpose in real world conditions outside of 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; testing in real world conditions shall not be considered as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all conditions under Article 53 or Article 54a are fulfilled;

(bj) 'subject' for the purpose of real world testing means a natural person who participates in testing in real world conditions;

(bk) '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;

(bl) "deep fake" means AI generated or manipulated image, audio or video content that resembles existing persons, objects, places or other entities or events and would falsely appear to a person to be authentic or truthful;

(44e) 'widespread infringement' means any act or omission contrary to Union law that protects the interest of individuals:
(a) which 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 established; or

(iii) the deployer is established, when the infringement is committed by the deployer;

(b) which protects the interests of individuals, that have caused, cause or are likely to cause harm to the collective interests of individuals and that have common features, including the same unlawful practice, the same interest being infringed and that are occurring concurrently, committed by the same operator, in at least three Member States;

(44h) 'critical infrastructure' means an asset, a facility, equipment, a network or a system, or a part of thereof, which is necessary for the provision of an essential service within the meaning of Article 2(4) of Directive (EU) 2022/2557;

(44b) 'general purpose AI model' means an AI model, including when trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable to competently perform 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. This does not cover AI models that are used before release on the market for research, development and prototyping activities;

(44c) '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;

(44d) 'systemic risk at Union level' means a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the internal market due to its reach, and with 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;
(44e) 'general purpose AI system' means an AI system which is based on a general purpose AI model, that has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;

(44f) '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;

(44g) 'downstream provider' means a provider of an AI system, including a general-purpose AI system, which integrates an AI model, regardless of whether the model is provided by themselves and vertically integrated or provided by another entity based on contractual relations.

### Article 4b - 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 which the AI systems are to be used.

## TITLE II - PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES

### Article 5 - Prohibited Artificial Intelligence Practices

1. The following artificial intelligence practices shall be prohibited:

(a) the placing on the market, putting into service or use of an AI system that deploys subliminal techniques beyond a person's consciousness or purposefully manipulative
or deceptive techniques, with the objective to or the effect of materially distorting a person's or a group of persons' behaviour by appreciably impairing the person's ability to make an informed decision, thereby causing the person to take a decision that that person would not have otherwise taken in a manner that causes or is likely to cause that person, another person or group of persons significant harm;

(b) the placing on the market, putting into service or use of an AI system that exploits any of the vulnerabilities of a person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective to or the effect of materially distorting the behaviour of that person or a person pertaining to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm;

(ba) the placing on the market or putting into service for this specific purpose, or 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;

(c) the placing on the market, putting into service or use of AI systems for the evaluation or classification of natural persons or groups thereof 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 whole groups thereof 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 thereof that is unjustified or disproportionate to their social behaviour or its gravity;

(d) the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement unless and in as 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 and sexual exploitation of human beings as well as 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 purposes of conducting a criminal investigation, prosecution or executing a criminal penalty for offences, referred to in Annex IIa and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years. This paragraph is without prejudice to the provisions in Article 9 of the GDPR for the processing of biometric data for purposes other than law enforcement.

(da) the placing on the market, putting into service for this specific purpose, or use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person to commit 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;

(db) the placing on the market, putting into service for this specific purpose, or use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;

(dc) the placing on the market, putting into service for this specific purpose, or use of AI systems to infer emotions of a natural person in the areas of workplace and education institutions except in cases where the use of the AI system is intended to be put in place or into the market for medical or safety reasons.

1a. This Article shall not affect the prohibitions that apply where an artificial intelligence practice infringes other Union law.

2. The use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1
point (d) shall only be deployed for the purposes under paragraph 1, point (d) to confirm
the specifically targeted individual's identity 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 caused in the absence of the use of the system;

(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 purpose of law enforcement for any of the objectives referred to in
paragraph 1 point (d) shall comply with necessary and proportionate safeguards and
conditions in relation to the use in accordance with national legislations authorizing 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 only
be authorised if the law enforcement authority has completed a fundamental rights impact
assessment as provided for in Article 29a and has registered the system in the database
according to Article 51. However, in duly justified cases of urgency, the use of the system
may be commenced without the registration, provided that the registration is completed
without undue delay.

3. As regards paragraphs 1, point (d) and 2, each use for the purpose 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 4. However, in a duly justified situation of urgency, the use of the system may be commenced without an authorisation provided that such authorisation shall be requested without undue delay, at the latest within 24 hours. If such authorisation is rejected, its use shall be stopped with immediate effect and all the data, as well as the results and outputs of this use shall be immediately discarded and deleted.

The competent judicial authority or an independent administrative authority whose
decision is binding shall only grant the authorisation where it is satisfied, based on
objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote
biometric identification system at issue is necessary for and proportionate to achieving
one of the objectives specified in paragraph 1, point (d), as identified in the request and,
in particular, remains limited to what is strictly necessary concerning the period of time
as well as geographic and personal scope. In deciding on the request, the competent
judicial authority or an independent administrative authority whose decision is binding
shall take into account the elements referred to in paragraph 2. It shall be ensured that no
decision that produces an adverse legal effect on a person may be taken by the judicial
authority or an independent administrative authority whose decision is binding solely
based on the output of the remote biometric identification system.

3a. 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 4. The notification shall as a minimum contain the information specified under paragraph 5 and shall not include sensitive operational data.

4. 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 purpose of law enforcement within the limits and under the conditions listed in paragraphs 1, point (d), 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, point (d), including which of the criminal offences referred to in point (iii) thereof, the competent authorities may be authorised to use those systems for the purpose 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.

5. 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 3a 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.

6. 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 based on the annual reports referred to in paragraph 5, which shall not include sensitive operational data of the related law enforcement activities.

# TITLE III - HIGH-RISK AI SYSTEMS

## Chapter 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 from the products referred to in points (a) and (b), that AI system shall be considered 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 II;

(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 putting into service of that product pursuant to the Union harmonisation legislation listed in Annex II.

2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall also be considered high-risk.

2a. By derogation from paragraph 2 AI systems shall not be considered as high risk if they do 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. This
shall be the case if one or more of the following criteria are 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 purpose of the use cases listed in Annex III.

Notwithstanding first subparagraph of this paragraph, an AI system shall always be considered high-risk if the AI system performs profiling of natural persons.

2b. 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 51(1a). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.

2c. The Commission shall, after consulting the AI Board, and no later than 18 months after the entry into force of this Regulation, provide guidelines specifying the practical implementation of this article completed by a comprehensive list of practical examples of high risk and non-high risk use cases on AI systems in accordance with the conditions set out in Article 82a.

2d. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend the criteria laid down in points (a) to (d) of the first subparagraph of paragraph 2a.

The Commission may adopt delegated acts adding new criteria to those laid down in points (a) to (d) of the first subparagraph of paragraph 2a, or modifying them, only where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III but that do not pose a significant risk of harm to the health, safety and fundamental rights.
The Commission shall adopt delegated acts deleting any of the criteria laid down in the first subparagraph of paragraph 2a where there is concrete and reliable evidence that this is necessary for the purpose of maintaining the level of protection of health, safety and fundamental rights in the Union.

Any amendment to the criteria laid down in points (a) to (d) set out in the first subparagraph of paragraph 2a shall not decrease the overall level of protection of health, safety and fundamental rights in the Union.

When adopting the delegated acts, the Commission shall ensure consistency with the delegated acts adopted pursuant to Article 7(1) and shall 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 73 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 points 1 to 8 of 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 for the purposes of paragraph 1 whether an AI system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk AI systems already referred to in Annex III, 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;

(ba) the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
(bb) 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;

(c) 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;

(d) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect a plurality of persons or to disproportionately affect a particular group of persons;

(e) the extent to which potentially harmed or adversely impacted persons 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;

(f) the extent to which there is an imbalance of power, or the potentially harmed or adversely impacted persons are in a vulnerable position in relation to the user of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;

(g) 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, whereby outcomes having and adverse impact on health, safety, fundamental rights, shall not be considered as easily corrigible or reversible;

(gb) 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;

(h) the extent to which existing Union legislation 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.
2a. The Commission is empowered to adopt delegated acts in accordance with Article 73 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(s) concerned no longer pose 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.

## Chapter 2 - REQUIREMENTS FOR HIGH-RISK AI SYSTEMS

### Article 8 - Compliance with the requirements

1. High-risk AI systems shall comply with the requirements established in this Chapter, taking into account its 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.

2a. Where a product contains an artificial intelligence system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Annex II, Section A apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements required under the Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred in paragraph 1 with the requirements set out in Chapter 2 of this Title, and in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice to integrate, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into already existing documentation and procedures required under the Union harmonisation legislation listed in Annex II, Section A.
## 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) identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to the health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;

(b) 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) evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;

(d) adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point a of this paragraph in accordance with the provisions of the following paragraphs.

2a. The risks referred to in this paragraph 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.

3. 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 Chapter 2, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.

4. The risk management measures referred to in paragraph 2, point (d) shall be such that 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 identified risks and evaluated pursuant to paragraph 2 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 the required information pursuant to Article 13, referred to in paragraph 2, point (b) of this Article, 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, training to be expected by the deployer and the presumable context in which the system is intended to be used.

5. High-risk AI systems shall be tested for the purposes 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 they are in compliance with the requirements set out in this Chapter.

6. Testing procedures may include testing in real world conditions in accordance with Article 54a.

7. The testing of the high-risk AI systems shall be performed, as appropriate, at any point in time throughout the development process, and, in any event, prior to the placing on the market or the putting into service. Testing shall be made against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.

8. When implementing the risk management system described in paragraphs 1 to 6, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to adversely impact persons under the age of 18 and, as appropriate, other vulnerable groups of people.

9. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under relevant sectorial Union law, the aspects described in
paragraphs 1 to 8 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 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 datasets are used.

2. Training, validation and testing data sets shall be subject to appropriate data governance and management practices appropriate for the intended purpose of the AI system. Those practices shall concern in particular:

(a) the relevant design choices;

(aa) data collection processes and origin of data, and in the case of personal data, the original purpose of data collection;

(c) relevant data preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;

(d) the formulation of assumptions, notably 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, negatively impact fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;

(fa) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);

(g) 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 datasets 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. These characteristics of the data sets may be met at the level of individual data sets or a combination thereof.

4. Datasets 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 purposes of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with the second paragraph, point f and fa, the providers of such systems may exceptionally process special 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, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to provisions set out in the Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725, all the following conditions shall apply 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 processed for the purpose of this paragraph 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 processed for the purpose of this paragraph 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 only authorised persons have access to those personal data with appropriate confidentiality obligations;

(d) the special categories of personal data processed for the purpose of this paragraph are not to be transmitted, transferred or otherwise accessed by other parties;
(e) the special categories of personal data processed for the purpose of this paragraph are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whatever comes first;

(f) the records of processing activities pursuant to Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725 includes justification why the processing of special categories of personal data was strictly necessary to detect and correct biases and this 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 models, paragraphs 2 to 5 shall 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 to demonstrate that the high-risk AI system complies with the requirements set out in this Chapter and 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. For this purpose, the Commission shall establish a simplified technical documentation form targeted at the needs of small and micro enterprises. Where an SME, including start-ups, 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 purpose of conformity assessment.

2. Where a high-risk AI system related to a product, to which the legal acts listed in Annex II, section A apply, is placed on the market or put into service one single 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 73 to amend Annex IV where necessary to ensure that, in the light of technical progress, the
technical documentation provides all the necessary information to assess the compliance of
the system with the requirements set out in this Chapter.

Article 12 - Record-keeping

1. High-risk AI systems shall technically allow for the automatic recording of events (‘logs’) over the duration of the lifetime of the system.

2. In order to ensure a level of traceability of the AI system's functioning that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:

(i) identification of situations that may result in the AI system presenting a risk within the meaning of Article 65(1) or in a substantial modification;

(ii) facilitation of the post-market monitoring referred to in Article 61; and

(iii) monitoring of the operation of high-risk AI systems referred to in Article 29(4).

4. For high-risk AI systems referred to in paragraph 1, point (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 to ensure that their operation is sufficiently transparent to enable deployers to interpret the 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 Chapter 3 of this Title.

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 users.

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);

(iiia) where applicable, the technical capabilities and characteristics of the AI system to provide information that is relevant to explain its output;

(iv) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;

(v) 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 AI system;
(va) where applicable, information to enable deployers to interpret the system's
output 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 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;

(ea) where relevant, a description of the mechanisms included within the AI system that allows users 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 the AI system is in use.

2. Human oversight shall aim at preventing or minimising 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 when such risks persist notwithstanding the application of other requirements set out in this Chapter.

3. The oversight measures shall be commensurate to the risks, level of autonomy and context of use of the AI system and shall be ensured through either one or all 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 user.

4. For the purpose of implementing paragraphs 1 to 3, the high-risk AI system shall be provided to the user in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate to the circumstances:

(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, also 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 otherwise disregard, override or reverse the output of the high-risk AI system;

(e) to intervene on 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 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 this 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 purpose of law enforcement, migration, border control
or asylum, in cases 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 perform consistently in those respects throughout their lifecycle.

1a. To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 of this Article and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholder and organisations such as metrology and benchmarking authorities, encourage as appropriate, the development of benchmarks and measurement methodologies.

2. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.

3. 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 towards 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 to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations ('feedback loops') are duly addressed with appropriate mitigation measures.

4. High-risk AI systems shall be resilient as regards to attempts by unauthorised third parties to alter their use, outputs or performance by exploiting the system vulnerabilities.

The technical solutions aimed at ensuring 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 dataset ('data poisoning'), or pre-trained components used in training ('model poisoning'), inputs designed to cause the model to make a mistake ('adversarial examples' or 'model evasion'), confidentiality attacks or model flaws.

# Chapter 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 Chapter 2 of this Title;

(aa) indicate their name, registered trade name or registered trade mark, the address at which they can be contacted on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable;

(b) have a quality management system in place which complies with Article 17;

(c) keep the documentation referred to in Article 18;

(d) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 20;

(e) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its placing on the market or putting into service;

(ea) draw up an EU declaration of conformity in accordance with Article 48;

(eb) affix the CE marking to the high-risk AI system to indicate conformity with this Regulation, in accordance with Article 49;
(f) comply with the registration obligations referred to in Article 51(1);

(g) take the necessary corrective actions and provide information as required in Article 21;

(j) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title;

(ja) ensure that the high-risk AI system complies with accessibility requirements, in accordance with Directive 2019/882 on accessibility requirements for products and services and Directive 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies.

## 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 Chapter II of this Title, 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 purposes of the placing on the market or 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 61;

(i) procedures related to the reporting of a serious incident in accordance with Article 62;

(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 aspects listed in this paragraph.

2. The implementation of 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 compliance of their AI systems with this Regulation.

2a. For providers of high-risk AI systems that are subject to obligations regarding quality management systems or their equivalent function under relevant sectorial Union law, the aspects described in paragraph 1 may be part of the quality management systems pursuant to that law.
3. For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation, the obligation to put in place a quality management system with the exception of paragraph 1, points (g), (h) and (i) shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services legislation. In that context, any harmonised standards referred to in Article 40 of this Regulation shall be taken into account.

## Article 18 - Documentation keeping

1. The provider shall, for a period ending 10 years after the 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 48.

1a. 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.

2. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services legislation.
## Article 20 - 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 6 months, unless provided otherwise in 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 legislation shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation kept under the relevant financial service legislation.

## Article 21 - Corrective actions and duty of information

Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system which 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 in question and, where applicable, the deployers, the authorised representative and importers accordingly.

Where the high-risk AI system presents a risk within the meaning of Article 65(1) and the provider becomes aware of that risk, they shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities of the Member States in which they made the high-risk AI system available and, where applicable, the notified body that issued a certificate for the 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 23 - 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 Chapter 2 of this Title, in a language which can be easily understood by the authority in an official Union language determined by the Member State concerned.

1a. Upon a reasoned request by a national competent authority providers shall also give the requesting national competent authority, as applicable, access to the logs referred to in Article 12(1) automatically generated by the high-risk AI system to the extent such logs are under their control.

1b. Any information obtained by a national competent authority pursuant to the provisions of this Article shall be treated in compliance with the confidentiality obligations set out in Article 70.

## Article 25 - Authorised representatives

1. Prior to making their systems available on the Union market providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

1b. The provider shall enable its authorised representative to perform its tasks under this Regulation.

2. 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 institution of the Union determined by the national competent authority. For the purpose of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:
(-a) verify that the EU declaration of conformity and the technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;

(a) keep at the disposal of the national competent authorities and national authorities referred to in Article 63(7), for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider by which the authorised representative has been appointed, a copy of the EU declaration of conformity, the technical documentation and, if applicable, the certificate issued by the notified body;

(b) provide a national competent authority, upon a reasoned request, with all the information and documentation, including that kept according to point (a), necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title, including access to the logs, as referred to in Article 12(1), automatically generated by the high-risk AI system to the extent such logs are under the control of the provider;

(c) cooperate with competent authorities, upon a reasoned request, on any action the latter takes in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;

(ca) where applicable, comply with the registration obligations referred in Article 51(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in [point 3] 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.

2b. The authorised representative shall terminate the mandate if it considers or has reason to consider that the provider acts contrary to its obligations under this Regulation. In such a case, it shall also immediately inform the market surveillance authority of the Member State in which it is established, as well as, where applicable, the relevant notified body, about the termination of the mandate and the reasons thereof.
## Article 26 - Obligations of importers

1. Before placing a high-risk AI system on the market, importers of such system shall ensure that such a 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 that 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 conformity marking and is accompanied by the EU declaration of conformity and instructions of use;

(ca) the provider has appointed an authorised representative in accordance with Article 25(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 that system on the market until that AI system has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 65(1), the importer shall inform the provider of the AI system, the authorised representatives and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trademark, 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, where applicable, storage or transport conditions do not jeopardise its compliance with the requirements set out in Chapter 2 of this Title.

4a. Importers shall keep, for a period ending 10 years after the 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.

5. Importers shall provide national competent authorities, upon a reasoned request, with all the necessary information and documentation including that kept in accordance with
paragraph 4a to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title in a language which can be easily understood by them. To this purpose they shall also ensure that the technical documentation can be made available to those authorities.

5a. Importers shall cooperate with national competent authorities on any action those authorities take, in particular to reduce and mitigate the risks posed by the high-risk AI system.

## Article 27 - Obligations of distributors

1. Before making a high-risk AI system available on the market, distributors shall verify that the high-risk AI system bears the required CE conformity marking, that it is accompanied by a copy of EU declaration of conformity and instruction of use, and that the provider and the importer of the system, as applicable, have complied with their obligations set out in Article 16, point (aa) and (b) and 26(3) respectively.

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 Chapter 2 of this Title, it shall not make the high-risk AI system available on the market until that system has been brought into conformity with those requirements. Furthermore, where the system presents a risk within the meaning of Article 65(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, where applicable, storage or transport conditions do not jeopardise the compliance of the system with the requirements set out in Chapter 2 of this Title.

4. A distributor that considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system which it has made available on the market is not in conformity with the requirements set out in Chapter 2 of this Title 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 65(1), the distributor shall immediately
inform the provider or importer of the system and the national competent authorities of the Member States in which it has made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective actions taken.

5. Upon a reasoned request from a national competent authority, distributors of the high-risk AI system shall provide that authority with all the information and documentation regarding its activities as described in paragraph 1 to 4 necessary to demonstrate the conformity of a high-risk system with the requirements set out in Chapter 2 of this Title.

5a. Distributors shall cooperate with national competent authorities on any action those authorities take in relation to an AI system, of which they are the distributor, in particular to reduce or mitigate the risk posed by the high-risk AI system.

## Article 28 - Responsibilities along the AI value chain

1. Any distributor, importer, deployer or other third-party shall be considered 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 allocated otherwise;

(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 and in a way that it remains a high-risk AI system in accordance with Article 6;

(ba) 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 manner that the AI system becomes a high risk AI system in accordance with Article 6.

2. Where the circumstances referred to in paragraph 1, point (a) to (ba) occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered a provider of that specific AI system for the purposes of this Regulation. This former provider shall closely cooperate 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 the cases where the former provider has expressly excluded the change of its
system into a high-risk system and therefore the obligation to hand over the
documentation.

2a. For high-risk AI systems that are safety components of products to which the legal acts listed in Annex II, section A apply, the manufacturer of those products shall be considered the provider of the high-risk AI system and shall be subject to the obligations under Article 16 under either of the following scenarios:

(i) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;

(ii) 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.

2b. 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 obligation shall not apply to third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models under a free and open licence.

The AI Office may 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. When developing voluntary model contractual terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The model contractual terms shall be published and be available free of charge in an easily usable electronic format.

2b. Paragraphs 2 and 2a are without prejudice to the need to respect and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.
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 of use accompanying the systems, pursuant to paragraphs 2 and 5 of this Article.

1a. To the extent deployers exercise control over the high-risk AI system, they shall ensure that the natural persons assigned to ensure human oversight of the high-risk AI system shall have the necessary competence, training and authority as well as the necessary support.

2. The obligations in paragraph 1 and 1a, are without prejudice to other deployer obligations under Union or national law and to the deployer's discretion in organising its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.

3. Without prejudice to paragraph 1 and 1a, 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.

4. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions of use and when relevant, inform providers in accordance with Article 61. When they have reasons to consider that the use in accordance with the instructions of use may result in the AI system presenting a risk within the meaning of Article 65(1) they shall, without undue delay, inform the provider or distributor and relevant market surveillance authority and suspend the use of the system. They shall also immediately inform first the provider, and then the importer or distributor and relevant market surveillance authorities when they have identified any serious incident. If the deployer is not able to reach the provider, Article 62 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 legislation, 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 legislation.
5. 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 legislation shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service legislation.

(a) Prior to putting into service or use 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 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.

(b) Deployers of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies shall comply with the registration obligations referred to in Article 51. When they find that the system that they envisage to use has not been registered in the EU database referred to in Article 60 they shall not use that system and shall inform the provider or the distributor.

6. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 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.

6a. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person convicted or suspected of having committed a criminal offence, the deployer of an AI system for post-remote biometric identification shall request an authorisation, prior, 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 the system, except when the system 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 requested authorisation provided for in the first subparagraph of this paragraph is rejected, the use of the post remote biometric identification system linked to that authorisation shall be stopped with immediate effect and the personal data linked to the use of the system for which the authorisation was requested shall be deleted.

In any case, such AI system for post remote biometric identification shall not 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 solely based on the output of these post remote biometric identification systems.

This paragraph is without prejudice to the provisions of Article 10 of the Directive (EU) 2016/680 and Article 9 of the GDPR for the processing of biometric data.

Regardless of the purpose or deployer, each use of these 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 the Directive 2016/680 to supervisory authorities.

Deployers shall, in addition, submit annual reports to the relevant market surveillance and national data protection authorities on the uses of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law enforcement. The reports can be aggregated to cover several deployments in one operation.

Member States may introduce, in accordance with Union law, more restrictive laws on the use of post remote biometric identification systems.

6b. Without prejudice to Article 52, 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 2016/680 shall apply.
6c. Deployers shall cooperate with the relevant national competent authorities on any action those authorities take in relation with the high-risk system in order to implement this Regulation.

Article 29a - Fundamental rights impact assessment for high-risk AI systems

1. Prior to deploying a high-risk AI system as defined in Article 6(2), with the exception of 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 private operators providing public services and operators deploying high-risk systems referred to in Annex III, point 5, (b) and (ca) shall perform an assessment of the impact on fundamental rights that the use of the 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 and frequency in 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 impact the categories of persons or group of persons identified pursuant point (c), 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 of use;

(f) the measures to be taken in case of the materialization of these risks, including their 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 factors listed in paragraph 1
change are or no longer up to date, the deployer will take the necessary steps to update the information.

3. Once the impact assessment has been performed, the deployer shall notify the market surveillance authority of the results of the assessment, submitting the filled template referred to in paragraph 5 as a part of the notification. In the case referred to in Article 47(1), deployers may be exempted from these obligations.

4. If any of the obligations laid down in this article are 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 shall be conducted in conjunction with that data protection impact assessment.

5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers to implement the obligations of this Article in a simplified manner.

## Chapter 4 - NOTIFIYING AUTHORITIES AND NOTIFIED BODIES

### Article 30 - 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. These 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 shall 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 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 not offer or provide any activities that conformity assessment bodies perform or any consultancy services on a commercial or competitive basis.

6. Notifying authorities shall safeguard the confidentiality of the information they obtain in accordance with Article 70.

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, artificial intelligence and law, including the supervision of fundamental rights.

### Article 31 - 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 33. 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 33. 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 paragraph 2 and paragraph 3 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 33.

## Article 32 - Notification procedure

1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 33.

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 shall include full details of the conformity assessment activities, the conformity assessment module or modules and 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 31 (2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 33.

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 31(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 31(3).

4a. Where objections are raised, the Commission shall without delay enter into consultation with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified or not. The Commission
shall address its decision to the Member State concerned and the relevant conformity
assessment body.

Article 33 - Requirements relating to notified bodies

1. A notified body shall be established under national law of a Member State and 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 be such as to ensure that there is confidence in the performance by 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 it performs conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in the high-risk AI system that is assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed AI systems that are necessary for the operations of the conformity assessment body or the use of such systems for personal purposes.

4a. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, development, marketing or use of high-risk AI systems, or represent the parties engaged in those activities. They shall not engage in any activity that may 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.

5. 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.
6. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies respect the confidentiality of the information in accordance with Article 70 which comes into their possession during the performance of conformity assessment activities, except when 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.

7. Notified bodies shall have procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the AI system in question.

8. 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.

9. Notified bodies shall be capable of carrying out all the tasks falling to them 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.

10. Notified bodies shall have sufficient internal competences to be able to effectively 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 artificial intelligence systems, data and data computing and to the requirements set out in Chapter 2 of this Title.

11. 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 33a - 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 33 in so far as the applicable harmonised standards cover those requirements.

### Article 34 - Subsidiaries of and subcontracting by notified bodies

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 33 and shall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

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 5 years from the termination date of the subcontracting activity.

### Article 34a - Operational obligations of notified bodies

1. Notified bodies shall verify the conformity of high-risk AI system in accordance with the conformity assessment procedures referred to in Article 43.

2. Notified bodies shall perform their activities while avoiding unnecessary burdens for providers, and taking due account of the size of an undertaking, the sector in which it
operates, its structure and the degree of complexity of the high risk AI system in question.
In so doing, 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. Particular attention shall be paid to minimising administrative burdens
and compliance costs for micro and small enterprises as defined in Commission
Recommendation 2003/361/EC.

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 30 to allow that authority to conduct its assessment, designation, notification, monitoring activities and to facilitate the assessment outlined in this Chapter.

Article 35 - Identification numbers and lists of notified bodies designated under this Regulation

1. The Commission shall assign an identification number to notified bodies. It shall assign a single number, even where a body is notified under several Union acts.

2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them 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 32(2).

-1a. The procedures described in Article 31 and 32 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 the following paragraphs shall apply.

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 one year before ceasing its activities. The certificates may remain valid for a temporary 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 AI systems covered by those certificates. The new notified body shall complete a full assessment of the AI systems affected by the end of that period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.

1. Where a notifying authority has sufficient reasons to consider that a notified body no longer meets the requirements laid down in Article 33, 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 33 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw notification 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.

2a. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.

2b. In the event of restriction, suspension or withdrawal of a notification, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to notifying authorities in other Member States and to market surveillance authorities at their request.

2c. In the event of 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 notification;

(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 conformity of AI systems on the market;
(d) inform the Commission and the Member States about certificates of which it has required their suspension or withdrawal;

(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 for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.

2d. With the exception of certificates unduly issued, and where a notification has been suspended or restricted, the certificates shall remain valid in 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 and actions anticipated 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 authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the provider shall provide to the national competent authorities of the Member State in which the provider of the system covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation 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.

2e. 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 in the following circumstances:

(a) where the national competent authority of the Member State in which the provider of the AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety and fundamental rights associated with the systems in question; and
(b) another notified body has confirmed in writing that it will assume immediate responsibilities for those systems and will have completed assessment of them within twelve 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 further periods of three months, which altogether shall not exceed twelve months.

2f. The national competent authority or the notified body assuming the functions of the notified body affected by the change of notification 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 33 and their 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 70.

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 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 implementing acts, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(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. The notifying authority shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

2a. The Commission shall provide for the exchange of knowledge and best practices between the Member States' 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 in Article 33 or they ensure an equivalent level of compliance.

## Chapter 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) 1025/2012 shall be presumed to be in conformity with the requirements set out in Chapter 2 of this
Title or, as applicable, with the requirements set out in [Chapter on GPAI], to the extent
those standards cover those requirements.

2. The Commission shall issue standardisation requests covering all requirements of Title II Chapter III and as applicable [GPAI Chapter] of this Regulation, in accordance with Article 10 of Regulation EU (No)1025/2012 without undue delay. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems resource performance, such as reduction of energy and other resources consumption of the high-risk AI system during its lifecycle, and on energy efficient development of general-purpose AI models. When preparing 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 consistent, including with the existing and future standards developed in the various sectors for products covered by the existing Union safety legislation listed in Annex II, clear and aimed at ensuring that AI systems or models placed on the market or put into service in the Union meet the relevant requirements laid down in this Regulation.

The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the above objectives in accordance with Article 24 of Regulation EU 1025/2012.

1c The actors involved in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as competitiveness and growth of the Union market, and 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 enhance multi-stakeholder governance ensuring a balanced representation of interests and effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012
1. The Commission is empowered to adopt, after consulting the Advisory Forum referred to in Article 58a, implementing acts in accordance with the examination procedure referred to in Article 74(2) establishing common specifications for the requirements set out in Chapter 2 of this Title or, as applicable, with requirements set out in Article [GPAI Chapter], for AI systems within the scope of this Regulation, where the following conditions have been fulfilled:

(a) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Chapter 2 of this Title; 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 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 Chapter II of this Title 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.

1a. 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 that the conditions in paragraph 1 are fulfilled.

3. High-risk AI systems which are in conformity with the common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title, to the extent those common specifications cover those requirements.
3a. 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 of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal acts referred to in paragraph 1 and 1b, or parts thereof which cover the same requirements set out in Chapter 2 of this Title.

4. Where providers of high-risk AI systems 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 Chapter II to a level at least equivalent thereto.

4b. When a Member State considers that a common specification does not entirely satisfy the requirements set out in Chapter 2 of this Title, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification in question.

### 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 be in compliance with the respective requirements set out 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 of the European Parliament and of the Council¹ and the references of which have been published in the Official Journal of the European Union shall be presumed to be in compliance 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.
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 Chapter 2 of this Title, 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 procedures:

(a) the conformity assessment procedure based on internal control referred to in Annex VI; or

(b) the conformity assessment procedure based on assessment of the quality management system and 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 Chapter 2 of this Title, the provider shall follow the conformity assessment procedure set out in Annex VII in the following cases:

(a) where harmonised standards referred to in Article 40, do not exist and common specifications referred to in Article 41 are not available;

(aa) the provider has not applied or has applied only in part the harmonised standard;

(b) where the common specifications referred to in point (a) exist but the provider has not applied them;

(c) where 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 purpose of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, when the system is intended to be put into service by law enforcement, immigration or asylum authorities as well as EU institutions, bodies or agencies, the market surveillance authority referred to in Article 63(5) or (6), 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, to which legal acts listed in Annex II, section A, apply, the provider shall follow the relevant conformity assessment as required under those legal acts. The requirements set out in Chapter 2 of this Title 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 purpose 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 Chapter 2 of this Title, provided that the compliance of those notified bodies with requirements laid down in Article 33(4), (9) and (10) has been assessed in the context of the notification procedure under those legal acts.

Where the legal acts listed in Annex II, section A, enable the manufacturer of the product 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 make use of that option only if he has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering the requirements set out in Chapter 2 of this Title.

4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure whenever they are substantially modified, 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 73 for the purpose of updating Annexes VI and Annex VII in light of technical progress.
6. The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 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 minimizing 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 II and four years for AI systems covered by Annex III. On application by the provider, the validity of a certificate may be extended for further periods, each not exceeding five years for AI systems covered by Annex II 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 as long as 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 Chapter 2 of this Title, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any 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 issued conformity certificates, shall be available.
1. Notified bodies shall inform the notifying authority of the following:

(a) any Union technical documentation assessment certificates, any supplements to those certificates, 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) EU 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.

3a. The obligations referred to in paragraphs 1 to 3 shall be complied with in accordance with Article 70.
Article 47 - 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 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 and the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period of time 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.

1a. In a duly justified situation of urgency for exceptional reasons of public security or in 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, and if such authorisation is rejected, its use shall be stopped with immediate effect and all the results and outputs of this use shall be immediately discarded.

2. 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 Chapter 2 of this Title. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraph 1. This obligation shall not cover sensitive operational data in relation to the activities of law enforcement authorities.

3. Where, within 15 calendar days of receipt of the information referred to in paragraph 2, 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.

4. Where, within 15 calendar days of receipt of the notification referred to in paragraph 2, 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 2 to be unfounded, the
Commission shall without delay enter into consultation with the relevant Member State;
the operator(s) concerned shall be consulted and have the possibility to present their views.
In view thereof, the Commission shall decide whether the authorisation is justified or not.
The Commission shall address its decision to the Member State concerned and the relevant
operator or operators.

5. If the authorisation is considered unjustified, this shall be withdrawn by the market surveillance authority of the Member State concerned.

6. For high-risk AI systems related to products covered by Union harmonisation legislation referred to in Annex II Section A, only the conformity assessment derogation procedures established in that legislation shall apply.

Article 48 - 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 AI high-risk 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 in question meets the requirements set out in Chapter 2 of this Title. 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 State(s) 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 legislations applicable to the high-risk AI system. The declaration shall contain all the information required for identification of the Union harmonisation legislation to which the declaration relates.