第1条 規則（EU）2024/1689の改正

Regulation (EU) 2024/1689 is amended as follows:

(1)in Article 1(2), point (g) is replaced by the following:

‘(g)measures to support innovation, with a particular focus on small mid-cap enterprises (SMCs) and small and medium-sized enterprises (SMEs), including start-ups.’

(2)Article 2 is amended as follows:

(a)paragraph 2 is replaced by the following:

‘2. For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. Articles 57, 58 and 59 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.’

(b)paragraph 7 is replaced by the following:

‘7. Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processed in connection with the rights and obligations laid down in this Regulation. Without prejudice to Articles 4a and 59 of this Regulation, this Regulation shall not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680.’

(3)in Article 2, the following paragraph is added:

‘13. For high-risk AI systems referred to in Article 6(1), the application of specific requirements or obligations laid down in Articles 9 to 15 and 17 to 25 may be limited, where and to the extent that:

(a)Union harmonisation legislation listed in Section A of Annex I lays down requirements or obligations providing an equivalent or higher level of protection of health, safety or fundamental rights as the requirement or obligation concerned; and

(b)such limitation does not reduce the overall level of protection provided for by this Regulation.

By 2 August 2027, the Commission shall adopt delegated acts in accordance with Article 97 in order to supplement this Regulation by specifying the high-risk AI systems concerned, the requirements or obligations that may be limited, the conditions under which such limitation applies, and the scope of the limitation.’

(4)Article 3 is amended as follows:

(a)point (14) is amended as follows:

‘(14)“safety component” means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; for the purposes of this definition, a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to health and safety of persons or property;’

(b)the following points are inserted:

‘(14a)“micro, small and medium-sized enterprise” or “SME” means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC;

(14b)“small mid-cap enterprise” or “SMC” means a small mid-cap enterprise as defined in point (2) of the Annex to Recommendation (EU) 2025/1099;’

(5)Article 4 is replaced by the following:

‘Article 4

AI literacy

1. Providers and deployers of AI systems shall take measures to support the development of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used. This obligation does not require providers or deployers to guarantee any specific level of AI literacy of any individual.

2. The Commission and the Member States shall support and facilitate the efforts of providers and deployers of AI systems, in particular SMEs, in fulfilling their obligation under paragraph 1 of this Article. For that purpose, the Commission shall publish practical examples of how to comply with that obligation on the single information platform referred to in Article 62(3), point (b).

3. The Board shall adopt recommendations, taking into account European competence frameworks, to support the Commission and Member States in the promotion of AI literacy required under paragraph 1, including by setting out common objectives.’

(6)the following Article is inserted:

‘Article 4a

Processing of special categories of personal data for bias detection and correction

1. To the extent strictly necessary to ensure bias detection and correction in relation to high-risk AI systems in accordance with Article 10(2), points (f) and (g), of this Regulation, providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable, all the following conditions shall be met in order for such processing to occur:

(a)the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;

(b)the special categories of personal data are subject to technical limitations on the re-use of personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;

(c)the special categories of personal data are subject to measures to ensure that the personal data processed are secured and protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and to ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;

(d)the special categories of personal data are not transmitted, transferred or otherwise accessed by other parties;

(e)the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first; and

(f)the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.

2. Providers and deployers of other AI systems and models and deployers of high-risk AI systems may exceptionally process special categories of personal data to the extent that:

(a)such processing is strictly necessary to ensure bias detection and correction in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited pursuant to Union law, especially where data outputs influence inputs for future operations; and

(b)all of the conditions and safeguards set out in paragraph 1 are applied.

This paragraph does not create any obligation to conduct such bias detection and correction.’

(7)Article 5 is amended as follows:

(a)in paragraph 1, the first subparagraph, the following points are inserted:

‘(ba)the placing on the market, the putting into service or the use of an AI system that generates or manipulates realistic images, videos, audio or similar material of an identifiable natural person’s intimate parts, or of an identifiable natural person engaged in sexually explicit activities, without that person’s freely-given, specific, informed, unambiguous and explicit consent for that generation or manipulation;

(bb)the placing on the market, the putting into service or the use of an AI system that generates or manipulates material or performance within the meaning of Article 2, points (c) and (e), of Directive 2011/93/EU, except where a “without right” defence applies under national law;’

(b)the following paragraphs are inserted:

‘1a. For the purposes of paragraph 1, first subparagraph, points (ba) and (bb):

(a)the placing on the market or putting into service of an AI system that generates or manipulates the material or performance referred to in paragraph 1, first subparagraph, point (ba) or (bb) is only prohibited where:

(i)that generation or manipulation is the intended purpose of the AI system; or

(ii)the system’s design, training, architecture, capabilities or user-facing functionalities make that generation or manipulation a reasonably foreseeable and reproducible outcome, without requiring significant technical modification, and the system does not have reasonable and adequate technical safety measures and other safeguards to reliably prevent that generation or manipulation, taking into account reasonably foreseeable misuse, and to correct observed or reported misuse;

(b)the use of an AI system that generates or manipulates the material or performance referred to in paragraph 1, first subparagraph, points (ba) and (bb) is only prohibited where the deployer uses the system for the purpose of generating or manipulating such material or performance.

1b. For the purposes of paragraph 1, first subparagraph, point (ba), an AI system that manipulates material in a way that does not increase the exposure of any depicted intimate parts or alter the nature of any depicted sexually explicit activities shall not constitute manipulation.’

(8)in Article 6, the following paragraphs are inserted:

‘1a. For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components.

1b. Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.

1c. A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b).’

(9)Article 10 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2, 3 and 4 of this Article and in Article 4a(1) whenever such data sets are used.’

(b)paragraph 5 is deleted;

(c)paragraph 6 is replaced by the following:

‘6. For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2, 3 and 4 of this Article and Article 4a(1) shall apply only to the testing data sets.’

(10)in Article 11(1), the second subparagraph is replaced by the following:

‘That technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, and SMCs, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of SMEs, including start-ups, and SMCs. Where an SME, including a start-up, or an SMC, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.’

(11)in Article 17, paragraph 2 is replaced by the following:

‘2. The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation, in particular, if the provider is an SME, including a start-up, or an SMC. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation.’

(12)Article 25 is amended as follows:

(a)paragraph 2 is replaced by the following:

‘2. Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of this Regulation.

That initial provider shall closely cooperate with new providers and shall make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular with regard to compliance with the conformity assessment of high-risk AI systems.

In particular, the obligation laid down in the second subparagraph shall include, where relevant for the purposes specified therein, the following:

(a)making available of technical documentation sufficient to assess compliance with the requirements laid down in Article 16;

(b)informing the new providers about known limitations and failure modes; and

(c)providing the new providers with targeted technical access, including for testing and validation.

This paragraph shall not apply in cases where the initial provider has clearly specified that its AI system is not to be changed into a high-risk AI system and therefore does not fall under the obligation to cooperate with the new providers and hand over the documentation.’

(b)in paragraph 4, the first subparagraph is replaced by the following:

‘4. The provider of a high-risk AI system and the third party that supplies an AI system, AI model, tools, services, components, or processes that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider of the high-risk AI system to fully comply with the obligations set out in this Regulation. This paragraph shall not apply to third parties making accessible to the public tools, services, processes, or components, other than general-purpose AI models, under a free and open-source licence.’

(13)Article 27 is amended as follows:

(a)paragraph 4 is replaced by the following:

‘4. If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the deployer may, when conducting the fundamental rights impact assessment referred to in paragraph 1 of this Article, include cross-references to the relevant sections of that data protection impact assessment or include relevant parts thereof in the fundamental rights impact assessment.’

(b)paragraph 5 is replaced by the following:

‘5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner. This template shall, where relevant, give deployers the possibility to include cross-references to the relevant sections of the data protection impact assessment or include relevant parts thereof in the fundamental rights impact assessment pursuant to paragraph 4.’

(14)in Article 28, the following paragraphs are added:

‘8. Notifying authorities designated pursuant to this Regulation that are responsible for AI systems covered by the Union harmonisation legislation listed in Section A of Annex I shall ensure that the conformity assessment body that applies for designation both pursuant to this Regulation and the Union harmonisation legislation listed in Section A of Annex I is provided with the possibility to submit a single application and undergoes a unified assessment procedure to be designated pursuant to this Regulation and Union harmonisation legislation listed in Section A of Annex I, where the relevant Union harmonisation legislation provides for such single application and unified assessment procedure. To that end, notifying authorities designated pursuant to this Regulation and those designated pursuant to the Union harmonisation legislation listed in Section A of Annex I shall cooperate in their assessments.

The single application and the unified assessment procedure referred to in this paragraph shall also be made available to notified bodies already designated pursuant to the Union harmonisation legislation listed in Section A of Annex I, when those notified bodies apply for designation pursuant to this Regulation, provided that the relevant Union harmonisation legislation provides for such a procedure.

A conformity assessment body that is designated pursuant to more than one piece of Union harmonisation legislation listed in Section A of Annex I shall have to apply only once to be designated pursuant to this Regulation. A designation pursuant to this Regulation shall be applicable for all Union harmonisation legislation listed in Section A of Annex I for which the conformity assessment body is designated.

The single application and the unified assessment procedure shall avoid any unnecessary duplications, build on the existing procedures for designation in accordance with the Union harmonisation legislation listed in Section A of Annex I and ensure compliance with the requirements relating to notified bodies both in accordance with this Regulation and the relevant Union harmonisation legislation.

9. A notifying authority that has been designated pursuant to the Union harmonisation legislation listed in Section A of Annex I is also the notifying authority for the application of the single application and unified assessment procedure referred to in paragraph 8, unless the Member State designates another notifying authority for this Regulation.’

(15)in Article 29, paragraph 4 is replaced by the following:

‘4. For notified bodies which are designated pursuant to any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support and expedite their designation procedure under this Regulation, as appropriate.

Notified bodies, which are designated pursuant to any of the Union harmonisation legislation listed in Section A of Annex I and which undergo the unified assessment procedure referred to in Article 28(8), shall submit the single application for assessment to the notifying authority designated pursuant to that Union harmonisation legislation.

The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements laid down in Article 31.’

(16)in Article 30, paragraph 2 is replaced by the following:

‘2. Notifying authorities shall notify the Commission and the other Member States, based on the list of codes, categories, and corresponding types of AI systems referred to in Annex XIV, and using the electronic notification tool developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1.

The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIV, in light of technical progress, advances in knowledge or new scientific evidence by adding to the list of codes, categories, and corresponding types of AI systems a new code, a category or a type of AI system, withdrawing an existing code, category or a type of AI system from that list or moving a code or type of AI system from one category to another.’

(17)in Article 40(2), the following subparagraph is added:

‘The Commission shall request, in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council and without undue delay, the European standardisation organisations to develop standardisation deliverables, including, as appropriate, harmonised standards, to facilitate the joint compliance and presumption of conformity with the requirements or obligations set out in Chapter III, Sections 2 and 3 of this Regulation, and the relevant requirements and obligations laid down in the Union harmonisation legislation listed in Annex I to this Regulation.’

(18)in Article 42, the following paragraph is added:

‘3. Where high-risk AI systems fall within the scope of Regulation (EU) 2024/2847 and the conditions laid down in Article 12(1) of that Regulation are fulfilled, such systems shall be deemed to comply with the cybersecurity requirements set out in Article 15 of this Regulation.’

(19)in Article 43, paragraph 3 is replaced by the following:

‘3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider of the system shall follow the relevant conformity assessment procedure as required in accordance with the relevant Union harmonisation legislation. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Assessment of the quality management system set out in Article 17 shall also be undertaken, and points 3, 4.3, 4.4. and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII shall apply.

For the purposes of that conformity assessment, notified bodies which have been notified under the Union harmonisation legislation listed in Section A of Annex I shall have the power to assess the conformity of high-risk AI systems with the requirements set out in Section 2 of this Chapter, provided that the compliance of those notified bodies with the requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure in accordance with the relevant Union harmonisation legislation, which is evidenced through the assessment as part of the existing notification. Without prejudice to Article 28, such notified bodies which have been notified under the Union harmonisation legislation in Section A of Annex I, shall apply for designation in accordance with Section 4 of this Chapter by 28 January 2028.

Where Union harmonisation legislation listed in Section A of Annex I provides the product manufacturer with an option to rely on a conformity assessment that does not involve a third-party, provided that that manufacturer has applied harmonised standards to ensure compliance with all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter. The classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of the conformity assessment procedure provided to the manufacturers of products covered by Union harmonisation legislation listed in Section A of Annex I, including, where applicable, an option to rely on harmonised standards. The manufacturers of such products are not required to choose a conformity assessment procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if this is not required by the Union harmonisation legislation listed in Section A of Annex I.

Where a high-risk AI system is both covered by the Union harmonisation legislation listed in Section A of Annex I and it falls within one of the categories listed in Annex III, the provider of that system shall follow the relevant conformity assessment procedure as required pursuant to the relevant Union harmonisation legislation listed in Section A of Annex I.’

(20)in Article 50, paragraph 7 is replaced by the following:

‘7. The Commission shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection, marking and labelling of artificially generated or manipulated content. The Commission, taking utmost account of the opinion of the Board, shall assess whether adherence to those codes of practice is adequate to ensure compliance with the obligations laid down in paragraphs 2 and 4 of this Article, in accordance with the procedure laid down in Article 56(6). If it deems the code of practice to be inadequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).’

(21)in Article 56, paragraph 6 is replaced by the following:

‘6. The Commission and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The Commission, taking utmost account of the opinion of the Board, shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. The Commission shall publish its assessment of the adequacy of the codes of practice.’

(22)Article 57 is amended as follows:

(a)in paragraph 1, the first subparagraph is replaced by the following:

‘1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2027. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes.’

(b)paragraph 3 is replaced by the following:

‘3. The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions, bodies, offices and agencies. For this purpose, references to national competent authorities in this Chapter shall be construed as references to the European Data Protection Supervisor.’

(c)the following paragraph is inserted:

‘3a. The AI Office may establish an AI regulatory sandbox at Union level for AI systems covered by Article 75(1). For this purpose, references to national competent authorities in this Chapter shall be construed, where relevant, as references to the AI Office. That AI regulatory sandbox shall be implemented in close cooperation with relevant competent authorities, in particular where compliance with Union legislation other than this Regulation is supervised in the AI regulatory sandbox, and shall provide priority access to SMEs, including start-ups, and SMCs.

The establishment of a Union level AI regulatory sandbox by the AI Office shall be without prejudice to the competences of Member States to establish and supervise AI regulatory sandboxes for AI systems under their supervision.’

(d)paragraph 5 is replaced by the following:

‘5. AI regulatory sandboxes established under this Article shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authorities, ensuring that appropriate safeguards are in place. Such sandboxes may include testing in real world conditions supervised therein. Where applicable, the sandbox plan shall incorporate the real-world testing plan referred to in Articles 60 and 60a.’

(e)in paragraph 9, point (e) is replaced by the following:

‘(e)facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups, and SMCs.’

(f)paragraph 10 is replaced by the following:

‘10. National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the competent data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers.’

(g)paragraph 14 is replaced by the following:

‘14. National competent authorities, the European Data Protection Supervisor and the AI Office, shall, as appropriate and within their respective competences, coordinate their activities and cooperate within the framework of the Board. They may support the joint establishment and operation of AI regulatory sandboxes, including in different sectors, and exchange best practices on related matters.’

(23)in Article 58(1), the first subparagraph is amended as follows:

(a)the introductory part is replaced by the following:

‘1. In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the detailed arrangements for the establishment, development, implementation, operation, governance, and supervision of the AI regulatory sandboxes. Those implementing acts shall include common principles on the following issues:’

(b)the following point is added:

‘(d)the detailed rules applicable to the governance of AI regulatory sandboxes covered pursuant to Article 57, including as regards the involvement of and supervision by the competent data protection authorities, where relevant, and the coordination and cooperation at national and Union level.’

(24)Article 60 is amended as follows:

(a)in paragraph 1, the first subparagraph is replaced by the following:

‘1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.’

(b)paragraph 2 is replaced by the following:

‘2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I in real world conditions at any time before the placing on the market or the putting into service of the high-risk AI system on their own or in partnership with one or more deployers or prospective deployers.’

(25)the following Article is inserted:

‘Article 60a

Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

1. Member States may allow, in accordance with this Article, the testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes by providers or prospective providers of AI enabled products covered by the Union harmonisation legislation listed in Section B of Annex I, with a view to assessing and verifying the conformity of those systems with the requirements laid down in Articles 8 to 15.

2. Member States that choose to allow testing as referred to in paragraph 1 shall, individually or jointly, adopt frameworks for real-world testing.

3. Each Member State shall notify the Commission of any real-world testing framework it adopts before implementing it. This shall not affect the competences of the Commission under the Union harmonisation legislation listed in Section B of Annex I.

4. Member States that have adopted real-world testing frameworks shall ensure that the relevant national competent authorities, relevant authorities and public authorities responsible for the management and operation of infrastructure and products covered by Union harmonisation legislation listed in Section B of Annex I cooperate closely with each other in good faith and remove any practical obstacles, including on procedural rules providing access to physical public infrastructure, where this is necessary, to successfully implement those real-world testing frameworks and test AI-enabled products covered by Union harmonisation legislation listed in Section B of Annex I.

5. The frameworks for real-world testing shall lay down the requirements under which testing in real-world conditions shall occur. Those frameworks shall:

(a)include the provision of a mandatory real-world testing plan to be agreed between the provider or prospective provider and the national competent authority or relevant authority in accordance with the Union harmonisation legislation listed in Section B of Annex I;

(b)ensure compliance with the requirements laid down in Article 60(2), (3), (4)(d)-(j) and (5)-(9), where any reference to market surveillance authorities in those provisions shall be read as a reference to the national competent authority or relevant authority, as appropriate in accordance with the Union harmonisation legislation listed in Section B of Annex I;

(c)include effective governance and accountability arrangements;

(d)ensure a high level of protection of health safety and fundamental rights.

6. The real-world testing shall comply with the applicable provisions laid down in the Union harmonisation legislation listed in Section B of Annex I. Any requirements laid down in those provisions shall not affect the application of this Article to the extent necessary to enable the testing referred to in paragraph 1.’

(26)in Article 63, paragraph 1 is replaced by the following:

‘1. SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.’

(27)in Article 64, the following paragraph is added:

‘3. Without prejudice to the budgetary procedure, the AI Office shall be allocated adequate resources to effectively perform its duties and exercise its powers in relation to the enforcement of this Regulation.’

(28)in Article 69, paragraph 2 is replaced by the following:

‘2. The Member States may be required to pay fees for the advice and support provided by the experts at a rate equivalent to the remuneration fees applicable to the Commission pursuant to the implementing act referred to in Article 68(1).’

(29)in Article 70, paragraph 8 is replaced by the following:

‘8. National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs, including start-ups, and SMCs, taking into account the guidance and advice of the Board and the Commission, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as appropriate.’

(30)in Article 72, paragraph 3 is replaced by the following:

‘3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission, taking utmost account of the opinion of the Board, shall adopt guidance, including a template, on the post-market monitoring plan by 2 September 2027.’

(31)Article 75 is amended as follows:

(a)the heading is replaced by the following:

‘Market surveillance and control of AI systems and mutual assistance’

(b)paragraph 1 is replaced by the following:

‘1. The AI Office shall be exclusively competent for the supervision and enforcement of the obligations under this Regulation in relation to the following AI systems:

(a)AI systems based on general-purpose AI models where the model and the system are developed by the same provider, or by providers forming part of the same undertaking as that provider, with the exception of:

(i)AI systems related to products covered by the Union harmonisation legislation listed in Annex I;

(ii)AI systems referred to in point 2 of Annex III;

(iii)AI systems provided by law enforcement authorities, border management authorities and financial institutions, insofar as those AI systems fall under Article 74(6); and

(iv)AI systems referred to in point 8 of Annex III as regards the administration of justice;

(b)AI systems that constitute or that are integrated into a very large online platform or very large online search engine designated in accordance with Regulation (EU) 2022/2065.

The exclusive competence referred to in the first subparagraph shall apply to the providers of those systems. It shall apply to the deployers of those systems only when they are also the provider or form part of the same undertaking as the provider.’

(c)the following paragraphs are inserted:

‘1a. By way of derogation from Article 73, providers of high-risk AI systems subject to the competence of the AI Office pursuant to paragraph 1 of this Article shall report any serious incidents to the AI Office. Article 73 (2) to (9), shall apply mutatis mutandis. The AI Office shall promptly transmit the relevant information to the market surveillance authority of the Member State in the territory of which the provider or its legal representative is situated.

1b. The authorities involved in the application of this Regulation shall cooperate actively with the AI Office and provide the AI Office the necessary assistance for the exercise of its powers, including, where necessary, in connection with inspections or other enforcement measures carried out in the territory of a Member State. To that end, those authorities shall enjoy the powers provided for pursuant to this Regulation and Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks under this paragraph, in accordance with the applicable national procedures.

1c. When taking investigatory or enforcement action in the territory of a Member State that involves access to a public authority’s data or AI system, the AI Office shall be assisted by the relevant market surveillance authority.

1d. Before taking a decision that would have the effect of prohibiting or restricting the AI system being made available or put into service on a national market, or a decision to withdraw or recall the AI system from such market, the AI Office shall, without undue delay, notify the market surveillance authority competent for that market of its intention to take such a decision. The AI Office shall consult the authorities involved in the application of this Regulation, where appropriate, on any matter relating to the application and enforcement of this Regulation.

1e. The AI Office shall be responsible for conformity assessments and tests of AI systems referred to in paragraph 1 of this Article that are classified as high-risk and subject to a third-party conformity assessment pursuant to Article 43 before such AI systems are placed on the market or put into service. Those tests and assessments shall verify that the systems comply with the relevant requirements of this Regulation and may be placed on the market or put into service in the Union in accordance with this Regulation. The Commission shall entrust the performance of those tests or assessments to notified bodies designated in accordance with this Regulation, in which case the notified body shall act on behalf of the Commission. If a notified body to which the Commission has delegated tasks under this paragraph does not perform those tasks adequately, the Commission may withdraw the delegation with immediate effect.

The fees for testing and assessment activities shall be levied on the provider of a high-risk AI system who has applied for a third-party conformity assessment to the Commission. The provider shall pay the costs related to the services entrusted by the Commission to the notified bodies in accordance with this Article directly to the notified body.’

(d)the following paragraph is inserted:

‘2a. Where a market surveillance authority has well-founded and sufficient reasons to suspect that a provider or a deployer of an AI system referred to in paragraph 1 of this Article has infringed this Regulation, it may request, through the relevant single point of contact designated in accordance with Article 70(2), the AI Office to assess the matter in order to take the necessary supervisory and enforcement measures to ensure prompt compliance with this Regulation. Such a request shall be duly reasoned and shall include at least:

(a)the name of the provider or the deployer concerned;

(b)a description of the relevant facts, the provisions of this Regulation that have allegedly been infringed, and any well-founded and sufficient reasons for suspecting an infringement, including, where applicable, the description of the negative effects of the alleged infringement;

(c)the market surveillance authority making the request.

The AI Office shall take utmost account of the request and the market surveillance authority shall cooperate actively and provide the AI Office the necessary assistance for the exercise of its powers in accordance with paragraph 1a.

The AI Office shall, without undue delay and in any event no later than four months following receipt of the request, inform the single point of contact of its intention to exercise its powers in accordance with Article 75a or of its reasons for not exercising its powers. If the AI Office decides to exercise its powers in accordance with Article 75a, it shall periodically inform that single point of contact about major developments in the proceedings and the outcome of such proceedings, without disclosing any confidential information.’

(32)the following articles are inserted:

‘Article 75a

Supervisory and enforcement powers of the AI Office

1. When exercising its tasks of supervision and enforcement laid down in Article 75(1) of this Regulation, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and in Article 14(4) and Article 16(3) of Regulation (EU) 2019/1020. The AI Office shall be authorised to fully reclaim from the relevant operator the totality of the costs of its supervision and enforcement activities with respect to instances of non-compliance, including costs for human and technical resources, in accordance with Article 15 of Regulation (EU) 2019/1020. Article 17 of Regulation (EU) 2019/1020 shall apply mutatis mutandis.

2. Where the AI Office has reasonable grounds to suspect non-compliance with this Regulation by a provider or a deployer of an AI system referred to in Article 75(1) of this Regulation, it may adopt a decision to start an investigation into that non-compliance in accordance with Article 14(4), point (f) of Regulation (EU) 2019/1020. Upon starting such an investigation, the AI Office shall notify the operator of the AI system concerned. The AI Office may exercise the powers referred to in paragraph 1 of this Article on its own initiative or following a complaint received pursuant to Article 85 of this Regulation, even before starting an investigation pursuant to Article 14(4), point (f) of Regulation (EU) 2019/1020.

Where a market surveillance authority has reason to suspect non-compliance with this Regulation by a provider or a deployer of an AI system referred to in Article 75(1), it may send a request to the AI Office to assess the matter.

3. The AI Office may exercise the powers listed in Article 14(4), points (a), (b) and (c) of Regulation (EU) 2019/1020 and Article 74(12) and (13) of this Regulation by simple request or by decision.

When requesting information, the AI Office shall state the legal basis and the purpose of the request, specify what information is required, and set the period within which the information is to be provided. Where the request is a simple request, the AI Office shall additionally indicate that although there is no obligation to provide the information requested, in the case of a voluntary reply, the information must be correct and not misleading, and indicate the potential fines provided for in Article 99(5) for supplying incorrect or misleading information. Where the request is made by decision, the AI Office shall additionally indicate the fines provided for in Article 99(5) for supplying incorrect, incomplete or misleading information and indicate the right to have the decision reviewed by the Court of Justice of the European Union. The AI Office shall send a copy of the request to the market surveillance authority of the Member State in the territory of which the operator or its legal representative is situated.

4. In order to carry out the tasks assigned to it under this Section, the AI Office may conduct all necessary remote or on-site inspections pursuant to the powers laid down in Article 14(4), points (d) and (e) of Regulation (EU) 2019/1020 and Article 74(5) of this Regulation. When conducting an inspection, the AI Office shall inform the provider concerned of the subject matter and purpose of the investigation, the relevant fines referred to in Article 99(5) of this Regulation, and the right to have the decision reviewed by the Court of Justice of the European Union. Prior to conducting an inspection, the AI Office shall inform the market surveillance authority of the Member State in the territory of which the operator or its legal representative is situated.

During such an inspection, the officials of the AI Office shall be empowered to:

(a)enter any of the business premises, land or property located in the Union of the operator concerned;

(b)examine the books, data and other material relevant to the execution of their tasks, irrespective of the medium on which they are stored;

(c)take or obtain in any form copies of or extracts from books, data and other records;

(d)ask any of the persons subject to the inspection, or their representatives, or staff, for oral or written explanations on factors or documents relating to the subject matter and purpose of the inspection, and to record the answers;

(e)seal any business premises and books or records for the duration of, and to the extent necessary for, the inspection.

Where the AI Office finds that a natural or legal person opposes or obstructs an inspection, the national competent authority of the Member State concerned shall afford it the necessary assistance, requesting, where appropriate, the assistance of the police or an equivalent enforcement authority, to enable it to conduct its on-site inspection.

Where an on-site inspection of business premises, land or property requires authorisation by a judicial authority in accordance with national law, the AI Office shall apply for such an authorisation. The AI Office may also apply for such authorisation as a precautionary measure. Where such an authorisation is applied for, the national judicial authority shall promptly verify that the coercive measures envisaged are neither arbitrary nor excessive having regard to the subject matter of the investigation or inspection and the documents provided by the AI Office with the decision. In its verification of the proportionality of coercive measures, the national judicial authority may ask the AI Office for detailed explanations, in particular relating to the grounds the AI Office has for suspecting that an infringement of this Regulation has taken place and the seriousness of the suspected infringement and, where relevant, the nature of the involvement of the person subject to the coercive measures. The national judicial authority shall not review the necessity of the investigation or inspection nor demand information from the case file of the AI Office. In accordance with the Treaties, the legality of the decision of the AI Office is subject to review only by the Court of Justice of the European Union.

5. At the request of the AI Office, the competent market surveillance authority of a Member State may in its own territory carry out any investigation, inspection or other fact-finding measure on behalf and for the account of the AI Office in order to establish whether there has been an infringement of this Regulation. The officials of the competent authorities of the Member States who are responsible for conducting such investigations, inspections, or fact-finding measures, as well as those authorised or appointed by them, shall exercise their powers in accordance with their national law.

6. In addition to the powers set out in paragraph 1 of this Article, the AI Office, in the exercise of its competences referred to in Article 75(1), may:

(a)order operators to provide access to, and explanations relating to, their AI systems;

(b)impose an obligation on an operator to retain all data and documents deemed to be necessary to assess the implementation of and compliance with the obligations under this Regulation.

7. To assist it in monitoring the effective implementation and compliance with the relevant provisions of this Regulation and to provide it with specific expertise or knowledge in the exercise of its competences under Article 75(1), the AI Office may appoint independent external experts and auditors, as well as experts, investigative teams and auditors from the Member State’s competent authorities with the agreement of the authority concerned. Information obtained as a result of such monitoring actions shall be shared with the relevant competent authorities of the Member States.

8. Information collected pursuant to this Article shall be used only for the purpose of this Regulation.

Article 75b

Commitments

If, during proceedings under Article 75a(2), the operator concerned offers commitments to ensure compliance with the relevant provisions of this Regulation, the AI Office may, by decision, make those commitments binding on the operator concerned and declare that there are no further grounds for action. The AI Office may, upon request or on its own initiative, reopen the proceedings where:

(a)there has been a material change in any of the facts on which the decision was based;

(b)the operator acts contrary to its commitments; or

(c)the decision was based on incomplete, incorrect or misleading information provided by the operator concerned.

Where the AI Office considers that the commitments offered by the operator concerned are unable to ensure effective compliance with the relevant provisions of this Regulation, it shall reject those commitments in a reasoned decision when concluding the proceedings.

Article 75c

Non-compliance, fines and periodic penalty payments

1. Where the AI Office finds that an operator falling within the scope of Article 75(1) does not comply with the relevant provisions of this Regulation or with commitments made binding pursuant to Article 75b, it shall adopt a decision establishing such non-compliance.

2. Before adopting a decision pursuant to paragraph 1, the AI Office shall communicate its preliminary findings to the operator concerned. In the preliminary findings, the AI Office shall explain the measures that it is considering taking, or that it considers that the operator concerned should take, in order to effectively address the preliminary findings.

3. In the decision pursuant to paragraph 1 of this Article, the AI Office shall, where relevant, order the operator concerned to take the necessary measures to ensure compliance with the relevant provisions of this Regulation within a reasonable period specified therein and to provide information on the measures that that operator intends to take to comply with the decision. The operator concerned shall provide the AI Office with a description of the measures it has taken to ensure compliance with the decision upon their implementation. Prior to requesting any measure, the AI Office may engage in a structured dialogue with the operator of the AI system in question. During this dialogue, the operator may propose commitments in accordance with Article 75b.

4. A decision adopted pursuant to paragraph 1 of this Article may be accompanied by the imposition of penalties in accordance with Article 99(3) to (7), which provisions shall apply mutatis mutandis to the AI Office in the execution of its supervision and enforcement tasks referred to in Article 75(1).

In particular, the following shall be subject to administrative fines as referred to in Article 99(4):

(a)infringement of any applicable provision of this Regulation, including those not listed in Article 99(4);

(b)failure to comply with decisions or measures adopted pursuant to the powers listed in Article 14(4) or Article 16(3) of Regulation (EU) 2019/1020, as well as those specified in Article 75a of this Regulation;

(c)failure to comply with a commitment made binding by a decision pursuant to Article 75b.

The supply of incorrect, incomplete or misleading information to the AI Office in reply to a request shall be subject to administrative fines as referred to in Article 99(5).

5. The AI Office may adopt a decision imposing periodic penalty payments to compel the operators subject to its competence pursuant to Article 75(1) to the following:

(a)to submit to an investigation;

(b)to comply with an information request ordered by a decision adopted under Article 75a(3);

(c)to submit to an inspection ordered by a decision pursuant to Article 75a(4);

(d)to provide correct or complete answers or explanations in the context of an inspection ordered by a decision pursuant to Article 75a(4);

(e)to comply with corrective actions ordered pursuant to the power listed in Article 16 of Regulation (EU) 2019/1020;

(f)to comply with commitments made legally binding by a decision pursuant to Article 75b; or

(g)to comply with a decision pursuant to the paragraph (1) of this Article.

Those penalty payments shall be effective and proportionate, and, where applicable, shall not exceed 5 % of the average daily income or worldwide annual turnover in the preceding financial year per day, calculated from the date appointed by the decision.

6. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the AI Office fixing a fine or periodic penalty payment pursuant to this Article. It may cancel, reduce or increase the fine or periodic penalty payment imposed.

7. Funds collected through the imposition of fines or periodic penalty payments pursuant to this Article shall contribute to the general budget of the Union.

8. The powers conferred on the AI Office by this Article shall be subject to a limitation period of five years. The limitation period shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, the limitation period shall begin to run on the day on which the infringement ceases.

The power of the AI Office to enforce decisions taken pursuant to this Article shall be subject to a limitation period of five years. The limitation period shall begin to run on the day on which the decision becomes final.

The implementing act referred to in Article 75d(3) shall specify the first and second subparagraphs of this paragraph, including the circumstances in which the limitation periods shall be interrupted.

9. Where the AI Office determines that there are no grounds to adopt a decision of non-compliance, it shall close the proceeding by a decision. That decision shall apply with immediate effect.

Article 75d

Safeguards and further specification

1. Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to operators subject to the AI Office’s competence pursuant to Article 75(1) of this Regulation, without prejudice to more specific procedural rights provided for in this Regulation.

2. The rights of defence and of access to the file of operators falling within the scope of Article 75(1) shall be fully respected in proceedings. In view of the possible adoption of decisions on the basis of Article 75c(1), those operators shall be entitled to have access to the AI Office file under the terms of a negotiated disclosure, subject to the legitimate interest of the operator or other person concerned in the protection of their business secrets. The AI Office shall have the power to adopt decisions setting out such terms of disclosure in the case of disagreement between the parties. The right of access to the file shall not extend to confidential information and internal documents of the AI Office, the Board, competent market surveillance authorities or other public authorities of the Member States. In particular, the right of access shall not extend to correspondence between the AI Office and those authorities. Nothing in this paragraph shall prevent the AI Office from disclosing and using information necessary to prove an infringement.

3. The Commission may adopt implementing acts concerning the practical arrangements for access to the file and the negotiated disclosure of information provided for in paragraph 2.

4. The AI Office shall publish the decisions it adopts pursuant to Articles 75b and 75c. Such publication shall state the names of the parties and the main content of the decision, including any penalties imposed. The publication shall have regard to the rights and legitimate interests of any person concerned in the protection of their confidential information.’

(33)in Article 76(1), the following subparagraph is added:

‘Where testing in real world conditions is based on Article 60a, any reference to a market surveillance authority in this Article shall be construed as a reference to the national competent authority or appropriate authority under the Union harmonisation legislation listed in Section B of Annex I, and references to Article 60 shall be construed as references to Article 60a, as appropriate.’

(34)Article 77 is amended as follows:

(a)the heading is replaced by the following:

‘Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities’

(b)paragraph 1 is replaced by the following:

‘1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, shall have the power to request and access any information or documentation created or maintained from the relevant market surveillance authority pursuant to this Regulation in accessible language and machine-readable format by electronic means where access to that information or documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. This Article is without prejudice to the competences, tasks, powers and independence of the relevant national public authorities or bodies under their mandates.’

(c)the following paragraphs are inserted:

‘1a. Subject to the conditions specified in this Article, the market surveillance authority shall grant the relevant public authority or body referred to in paragraph 1 access to such information or documentation, including by requesting such information or documentation from the provider or the deployer, where necessary and without undue delay.

1b. Market surveillance authorities and public authorities or bodies referred to in paragraph 1 shall cooperate closely and provide each other with the mutual assistance necessary to fulfil their respective mandates, with a view to ensuring the coherent application of this Regulation and Union law protecting fundamental rights and streamlining procedures, while respecting their respective competences, tasks, powers and independence. This shall include, in particular, exchange of information where necessary for the effective supervision or enforcement of this Regulation and the respective other Union legislation.’

(35)in Article 95, paragraph 4 is replaced by the following:

‘4. The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, and SMCs, when encouraging and facilitating the drawing up of codes of conduct.’

(36)in Article 96, paragraph 1 is amended as follows:

(a)in the first subparagraph, point (a) is replaced by the following:

‘(a)the application of the requirements and obligations referred to in Articles 8 to 15 and in Articles 25 and 26;’

(b)in the first subparagraph, the following point is added:

‘(g)the practical implementation of Article 8(2), Article 9(10) and Article 17(3) in accordance with the principle of complementarity and proportionality, with a view to ensuring consistency, avoiding duplication and minimising additional burdens when complying with the requirements of this Regulation and the requirements of the Union harmonisation legislation listed in Section A of Annex I; such guidelines shall be published by 1 August 2027.’

(c)the second subparagraph is replaced by the following:

‘When issuing such guidelines, the Commission shall involve the Board and pay particular attention to the needs of SMEs, including start-ups, and SMCs, of local public authorities and of the sectors most likely to be affected by this Regulation.’

(37)Article 97 is amended as follows:

(a)paragraphs 2 and 3 are replaced by the following:

‘2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for a period of five years from 1 August 2024. The power to adopt delegated acts referred to in Article 2(13) and Article 30(2) shall be conferred on the Commission for a period of five years from 27 July 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period.

3. The delegation of power referred to in Article 2(13), Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 30(2), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.’

(b)paragraph 6 is replaced by the following:

‘6. Any delegated act adopted pursuant to Article 2(13), Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 30(2), Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.’

(38)Article 99 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include administrative fines, warnings and non-monetary measures, applicable to any infringement of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. The Member States shall take into account the interests of SMEs, including start-ups, and SMCs, and their economic viability when imposing penalties.’

(b)in paragraph 4, the following point is inserted:

‘(da)obligations of providers and operators pursuant to Article 25(2) and (4)’

(c)the following paragraph is inserted:

‘6a. In the case of SMCs, each fine referred to in paragraphs 4 and 5 shall be up to the percentages or amount referred therein, whichever is lower.’

(39)Article 111 is amended as follows:

(a)paragraph 2 is replaced by the following:

‘2. Without prejudice to the application of Article 5 as referred to in Article 113, third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before the date of application of Chapter III referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down in this Regulation by 2 August 2030.’

(b)the following paragraph is added:

‘4. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, that have been placed on the market before 2 August 2026 shall take the necessary steps in order to comply with Article 50(2) by 2 December 2026.’

(40)in Article 113, the third paragraph is amended as follows:

(a)point (a) is replaced by the following:

‘(a)Chapters I and II shall apply from 2 February 2025, with the exception of Article 5(1), first subparagraph, points (ba) and (bb), and Article 5(1a) and (1b) which shall apply from 2 December 2026;’

(b)point (c) is replaced by the following:

‘(c)Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply from:

(i)2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III; and

(ii)2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I;’

(c)the following point is added:

‘(d)Articles 102 to 110 shall apply from 27 July 2026.’

(41)Annex I is amended as follows:

(a)in Section A, point 1 is deleted;

(b)in Section B, the following point is added:

‘21.Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1230/oj).’

(42)in Annex VIII, section B, points 7 and 9 are deleted;

(43)the following Annex is added:

The list of codes, categories and corresponding types of AI systems for the purpose of the notification procedure referred to in Article 30 specifying the scope of the designation as notified bodies

Conformity assessment of high-risk AI systems pursuant to this Regulation may require the involvement of conformity assessment bodies. Only conformity assessment bodies that have been designated in accordance with this Regulation may carry out conformity assessments and only for the activities related to the types of AI systems concerned. The list of codes, categories, and corresponding types of AI systems sets the scope of the designation of conformity assessment bodies notified under Article 30.

Conformity assessment bodies shall use the lists of codes, categories and corresponding types of AI systems set out in this Annex when specifying the types of AI systems in the application for designation referred to in Article 29.’.