Fulfil Distributor Obligations for High-Risk AI Systems

Sub-obligations

These are independently assessable parts of the parent requirement.

1. Article 24(1)

   Upcoming

   Verify Required High-Risk AI Conformity Indicators Before Distribution

   Tracker Guidance

   Before making a high-risk AI system available on the market, verify the required CE marking, EU declaration of conformity and instructions for use, and verify the specified provider and importer identification and quality-management information.

   Official text

   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 Article 47 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 Article 16, points (b) and (c) and Article 23(3).

2. Article 24(2)

   Upcoming

   Withhold Non-Conforming High-Risk AI From the Market

   Tracker Guidance

   If the information available to the distributor gives reason to consider that the high-risk AI system does not comply with the applicable high-risk requirements, do not make the system available on the market until it has been brought into conformity.

   Official text

   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 Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.

3. Article 24(3)

   Upcoming

   Maintain Storage and Transport Conditions That Preserve High-Risk AI Conformity

   Tracker Guidance

   While the high-risk AI system is under the distributor's responsibility, ensure storage and transport conditions do not jeopardise compliance with the applicable high-risk requirements.

   Official text

   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. Article 24(4)

   Upcoming

   Take or Ensure Corrective Action for Distributed Non-Conforming High-Risk AI

   Tracker Guidance

   If a distributed high-risk AI system is considered non-conforming, take the necessary corrective action to bring it into conformity, withdraw it or recall it, or ensure the appropriate provider, importer or other relevant operator does so. If the system presents an Article 79(1) risk, immediately inform the provider or importer and the competent authorities, including details of the non-compliance and corrective action.

   Official text

   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 authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.

5. Article 24(5)-(6)

   Upcoming

   Provide Distributor Compliance Information and Cooperate With Competent Authorities

   Tracker Guidance

   On a reasoned request, provide competent authorities with the information and documentation concerning the distributor's Article 24 actions needed to demonstrate conformity, and cooperate with authority actions concerning systems the distributor made available, particularly to reduce or mitigate risk.

   Official text

   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.