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Chapter IX

POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

23 articles

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 natur

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 surveill

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 enf

Article 75Mutual assistance, market surveillance and control of general-purpose AI systems

1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same pro

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

Article 77Powers of authorities protecting fundamental rights

1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protectin

Article 78Confidentiality

1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in

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 o

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

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

Article 82Compliant AI systems which present a risk

1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority refer

Article 83Formal non-compliance

1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the r

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 Arti

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 t

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

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

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 gua

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 act

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 genera

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

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

Article 93Power to request measures

1. Where necessary and appropriate, the Commission may request providers to: (a) take appropriate measures to comply wit

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, w