1. AI systems presenting a risk shall be understood as a product presenting a risk defined in Article 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the health or safety or to fundamental rights of persons are concerned.
2. Where the market surveillance authority of a Member State has sufficient reasons to consider that an AI system presents a risk as referred to in paragraph 1, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups (referred to in Article 5). When risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 64(3). The relevant operators shall cooperate as necessary with the market surveillance authority and the other national public authorities or bodies referred to in Article 64(3); Where, in the course of that evaluation, the market surveillance authority and where applicable in cooperation with the national public authority referred to in Article 64(3) finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period it may prescribe and in any event no later than fifteen working days or as provided for in the relevant Union harmonisation law as applicable The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph.
3. Where the market surveillance authority considers that non-compliance is not restricted to its national territory, it shall inform the Commission, and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
5. Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures.
6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, (the market surveillance authorities) shall indicate whether the non-compliance is due to one or more of the following:
(-a) non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5;
(a) a failure of a high-risk AI system to meet requirements set out in Title III, Chapter 2;
(ba) non-compliance with provisions set out in Article 52.
7. The market surveillance authorities of the Member States other than the market surveillance authority of the Member State initiating the procedure shall without undue delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.
8. Where, within three months of receipt of the notification referred to in paragraph 5, no objection has been raised by either a market surveillance authority of a Member State or the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This is without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The period referred to in the first sentence of this paragraph shall be reduced to thirty days in the event of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5.
9. The market surveillance authorities of all Member States shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.