1.
Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
(a)
any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(b)
any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
2.
As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
3.
For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
4.
The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
5.
Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6.
For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services.
7.
By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that Regulation.
8.
For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
9.
Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
10.
Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
11.
Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations.
12.
Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
13.
Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled:
(a)
access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(b)
testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
14.
Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.
Market surveillance and control of AI systems and mutual assistance
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.
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.
2.
Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
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.
3.
Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall apply mutatis mutandis .
