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Article 23

Obligations of Importers

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:

  1. the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
  2. the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
  3. the system bears the required CE marking and is accompanied by the EU declaration of conformity and instructions for use;
  4. the provider has appointed an authorised representative in accordance with Article 22(1).

2. Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representatives and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted in relation to the high-risk AI system on its packaging or its accompanying documentation, where applicable.

4. Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.

5. Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity.

6. Importers shall provide national competent authorities, upon a reasoned request, with all the necessary information and documentation, including that kept in accordance with paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.

7. Importers shall cooperate with national competent authorities in any action those authorities take in relation to a high-risk AI system the importers placed on the market, in particular to reduce and mitigate the risks posed by it.

[Previous version]

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Cooperation with Competent Authorities

1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title, in a language which can be easily understood by the authority in an official Union language determined by the Member State concerned.

1a. Upon a reasoned request by a national competent authority providers shall also give the requesting national competent authority, as applicable, access to the logs referred to in Article 12(1) automatically generated by the high-risk AI system to the extent such logs are under their control.

1b. Any information obtained by a national competent authority pursuant to the provisions of this Article shall be treated in compliance with the confidentiality obligations set out in Article 70.

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