Article 23: Obligations of Importers

Official Statutory Text

Article 23 Obligations of importers 1. Before placing a high-risk AI system on the market, import ers shall ensure that the system is inconformity with this Regulation by verifying that: (a) the relevant conformity assessment procedure refer red to in Article 43 has been carried out by the provider of the high-risk AI system; (b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV ; (c) the system bears the required CE marking and is accompanied by the EU declaration of conformity refer red to in Article 47 and instructions for use; (d) 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 inconformity 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 arisk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that eff ect. 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 and 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 ortransport conditions, where applicable, do not jeopardise its compliance with the requirements setout in Section 2. 5. Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the mark etor put into service, a copy of the certif icat e issued by the notified body , where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47. 6. Importers shall provide the relevant competent authorities, upon areasoned request, with all the necessary information and documentation, including that refer red to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements setout in Section 2 in a language which can be easily understood by them. Forthis pur pose, they shall also ensure that the technical documentation can be made available to those authorities. 7. Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the im porters, in particular to reduce and mitigate the risks posed by it.