Article 23: obligations of importers

Article 23(1) requires importers, before placing a high-risk AI system on the market, to verify that the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider (point (a)), that the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV (point (b)), that the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use (point (c)), and that the provider has appointed an authorised representative in accordance with Article 22(1) (point (d)). Article 23(2) provides that an importer with sufficient reason to consider that the system is not in conformity, is falsified or is accompanied by falsified documentation shall not place it on the market until it has been brought into conformity, and that where the system presents a risk within the meaning of Article 79(1) the importer shall inform the provider, the authorised representative and the market surveillance authorities. Paragraph 3 requires indication of name, registered trade name or registered trade mark and contact address. Paragraph 4 requires storage and transport conditions that do not jeopardise compliance with Section 2. Paragraph 5 requires keeping, for 10 years, a copy of the certificate issued by the notified body and, where applicable, of the instructions for use and of the EU declaration of conformity referred to in Article 47. Paragraph 6 requires providing all necessary information and documentation upon a reasoned request in a language easily understood by the authority, and ensuring the technical documentation can be made available. Paragraph 7 requires cooperation with the competent authorities.

Article 23 gets underestimated because it looks like document control, and largely it is: you do not have to revalidate the model, you have to be able to show that you checked the four points. The pain sits elsewhere. Point (d) is the one that most often fails in practice: many providers outside the EU have not appointed an authorised representative, and then you simply may not place the system on the market, however far along the deal is. And paragraph 5 puts the ten-year term on you, not on the supplier: if that supplier no longer exists in five years, you still have to produce the documents.