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Article 63

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 of this Regulation;
  1. 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 to the Commission about the outcomes of relevant market surveillance activities under this Regulation.

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 or, in justified circumstances and provided that coordination is ensured, another relevant authority identified by the Member State.

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 having the same objective. In such a case, these sectoral procedures shall apply instead.

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.

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(a) in so far as the systems are used for law enforcement purposes, points 6, 7 and 8 of Annex III, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the national authorities supervising the activities of the law enforcement, border control, immigration, asylum or judicial authorities, or the competent data protection supervisory authorities under Directive (EU) 2016/680, or Regulation 2016/679. 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.

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.

8. 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.

9. 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
  1. testing/auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.

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

11. Complaints to the relevant market surveillance authority can be submitted by any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation.

In accordance with Article 11(3)(e) and (7)(a) of Regulation (EU) 2019/1020, complaints shall be taken into account for the purpose of conducting the market surveillance activities and be handled in line with the dedicated procedures established therefore by the market surveillance authorities.

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