Before placing a high-risk AI system on the market, importers of such system shall ensure that such a 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 that AI system;

2. the provider has drawn up the technical documentation in accordance with Annex IV;

3. the system bears the required CE conformity marking and is accompanied by the EU declaration of conformity and instructions of use;

4. the authorised representative referred to in Article 25 has been established by the provider.

2. Where an importer has sufficient reasons 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 that system on the market until that AI system has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 65(1), the importer shall inform the provider of the AI 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 on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable.

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

4a. Importers shall keep, for a period ending 10 years after the 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.

5. Importers shall provide national competent authorities, upon a reasoned request, with all 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 Chapter 2 of this Title in a language which can be easily understood by that national competent authority. To this purpose they shall also ensure that the technical documentation can be made available to those authorities.

5a. Importers shall cooperate with national competent authorities on any action those authorities take in relation to an AI system, of which they are the importer.