CHAPTER III

Article 24: Obligations of distributors

Plain English Summary

What this article does: Sets out obligations for distributors of high-risk AI systems. Who it applies to: Distributors of high-risk AI systems. Key requirements: Para 1: Before making a high-risk AI system available on the market, distributors must verify that it bears the CE marking, is accompanied by the required documentation, and that the provider and importer have complied with their obligations. Para 2: Where a distributor considers a system is non-conforming, they must not make it available on the market until brought into conformity, and must inform the provider or importer and market surveillance authorities. Para 3: Must ensure appropriate storage and transport conditions. Para 4: Must provide competent authorities with all necessary information upon request, and cooperate on corrective actions. Para 5: Must keep a copy of the EU declaration of conformity for 10 years.

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 the EU declaration of conformity referred to in and instructions for use, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as laid down in , points (b) and (c) and (3).

2. Where a distributor considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system is not 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 (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, storage or transport conditions, where applicable, 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 (1), the distributor shall immediately inform the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.

5. Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding their 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 the relevant competent authorities in any action those authorities take in relation to a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by it.

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