Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.
1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of EU declaration of conformity and instructions for use, and that the provider and the importer of the system, as applicable, have complied with their respective obligations as laid down in Article 16, points (b) and (c) and Article 23(3).
2. Where a distributor considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system not to be in conformity with the requirements set out in Section 2, it shall not make the high-risk AI system available on the market until the system has been brought into conformity with those requirements. Furthermore, where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.
3. Distributors shall ensure that, while a high-risk AI system is under their responsibility, where applicable, storage or transport conditions do not jeopardise the compliance of the system with the requirements set out in Section 2.
4. A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform the provider or importer of the system and the national competent authorities of the Member States in which it has made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective actions taken.
5. Upon a reasoned request from a national competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding its actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of that system with the requirements set out in Section 2.
6. Distributors shall cooperate with national competent authorities in any action those authorities take in relation to a high-risk AI system they made available on the market, in particular to reduce or mitigate the risk posed by it.
[Previous version]
Removed on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd
[Deleted]
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