Chapter IXPOST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Section 1 – Post-market monitoring

• Article 72Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

  1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the…

Section 2 – Sharing of information on serious incidents

• Article 73Reporting of serious incidents

  1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident…

Section 3 – Enforcement

• Article 74Market surveillance and control of AI systems in the Union market

  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…

• Article 75Market 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…

• Article 75aSupervisory 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…

• Article 75bCommitments

  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,…

• Article 75cNon-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…

• Article 75dSafeguards 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…

• Article 76Supervision of testing in real world conditions by market surveillance authorities

  1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation. Where testing in real world…

• Article 77Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

  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…

• Article 78Confidentiality

  1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union…

• Article 79Procedure at national level for dealing with AI systems presenting a risk

  1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3 , point 19 of Regulation (EU) 2019/1020 ,…

• Article 80Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

  1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk,…

• Article 81Union safeguard procedure

  1. Where, within three months of receipt of the notification referred to in Article 79(5) , or within 30 days in the case of non-compliance with the prohibition…

• Article 82Compliant AI systems which present a risk

  1. Where, having performed an evaluation under Article 79 , after consulting the relevant national public authority referred to in Article 77(1) , the market surveillance authority of…

• Article 83Formal non-compliance

  1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the…

• Article 84Union AI testing support structures

  1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area…

Section 4 – Remedies

• Article 85Right to lodge a complaint with a market surveillance authority

  Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this…

• Article 86Right to explanation of individual decision-making

  1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex…

• Article 87Reporting of infringements and protection of reporting persons

  Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.

Section 5 – Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models

• Article 88Enforcement of the obligations of providers of general-purpose AI models

  1. The Commission shall have exclusive powers to supervise and enforce Chapter V , taking into account the procedural guarantees under Article 94 . The Commission shall entrust…

• Article 89Monitoring actions

  1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation…

• Article 90Alerts of systemic risks by the scientific panel

  1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that: (a) a general-purpose AI model poses concrete identifiable…

• Article 91Power to request documentation and information

  1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and…

• Article 92Power to conduct evaluations

  1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned: (a) to assess compliance of the provider with obligations under this…

• Article 93Power to request measures

  1. Where necessary and appropriate, the Commission may request providers to: (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54 ;…

• Article 94Procedural rights of economic operators of the general-purpose AI model

  Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in…