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Article 63

Derogations for Specific Operators

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

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

2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.

[Previous version]

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

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

2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Market Surveillance and Control of AI Systems in the Union Market

1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. However, for the purpose of the effective enforcement of this Regulation:

  1. any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
  2. any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.

2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually, to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.

3. For high-risk AI systems, related to products to which legal acts listed in Annex II, section A apply, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts. By derogation from the previous paragraph in justified circumstances, Member States may designate another relevant authority to act as a market surveillance authority provided that coordination is ensured with the relevant sectoral market surveillance authorities responsible for the enforcement of the legal acts listed in Annex II.

3a. The procedures referred to in Articles 65, 66, 67 and 68 of this Regulation shall not apply to AI systems related to products, to which legal acts listed in Annex II, section A apply, when such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such a case, these sectoral procedures shall apply instead.

3b. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4)(d) and (j) of Regulation 2019/1020 remotely as appropriate.

4. For high-risk AI systems placed on the market, put into service or used by financial institutions regulated by Union legislation on financial services, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placement on the market, putting into service or the use of the AI system is in direct connection with the provision of those financial services.

4a. By way of a derogation from the previous subparagraph, in justified circumstances and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation.

National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism (SSM) established by Council Regulation No 1204/2013, 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.

5. For high-risk AI systems listed in point 1 in so far as the systems are used for law enforcement purposes and for purposes listed in points 6, 7 and 8 of Annex III, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation 2016/679, or Directive (EU) 2016/680 or any other authority designated pursuant to the same conditions laid down in Articles 1 to 44 of Directive or Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities or otherwise interfere with their activities when acting in their judicial capacity.

6. Where Union institutions, agencies and bodies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority except in relation to the Court of Justice acting in its judicial capacity.

7. Member States shall facilitate the coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex II or other Union legislation that might be relevant for the high-risk AI systems referred to in Annex III.

7a. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness 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 in accordance with Article 9 of the 2019/1020. The AI Office shall provide coordination support for joint investigations.

7a. Without prejudice to powers provided under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by the provider to the documentation as well as the training, validation and testing datasets used for the development of the high-risk AI system, including, where appropriate and subject to security safeguards, through application programming interfaces (‘API’) or other relevant technical means and tools enabling remote access.

7b. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when the following cumulative conditions are fulfilled:

  1. access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Title III, Chapter 2; and
  2. testing/auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.

7c. Any information and documentation obtained by market surveillance authorities shall be treated in compliance with the confidentiality obligations set out in Article 70.

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