The Articles of the EU Artificial Intelligence Act (25.11.2022)



Article 65, Procedure for dealing with AI systems presenting a risk at national level, Artificial Intelligence Act (Proposal 25.11.2022)


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, they 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. When risks to fundamental rights are identified, the market surveillance authority shall also inform the relevant national public authorities or bodies referred to in Article 64(3). The relevant operators shall cooperate as necessary with the market surveillance authorities 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 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.

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.


4. The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the market throughout the Union.


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, to withdraw the product from that market or to recall it. That authority shall notify the Commission and the other Member States, without undue delay, 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, 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;


(b) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity.


(c) non-compliance with provisions set out in Article 52;


(d) non-compliance of general purpose AI systems with the requirements and obligations referred to in Article 4a;


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 Member State or the Commission in respect of a provisional measure taken by a 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 30 days in the case 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 then ensure that appropriate restrictive measures are taken in respect of the AI system concerned, such as withdrawal of the product from their market, without undue delay.


Important note: This is not the final text of the Artificial Intelligence Act. This is the text of the proposal from the Council of the European Union (25.11.2022).


The Articles of the EU Artificial Intelligence Act, proposal from the Council of the European Union (25.11.2022):

https://www.artificial-intelligence-act.com/Artificial_Intelligence_Act_Articles_(Proposal_25.11.2022).html