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EU Artificial Intelligence Act 2024/1689
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Before placing a system on the market the importer verifies four things about the provider, and afterwards carries its own retention, information and notification package with a ten-year term.
Applies to importers of high-risk AI systems. For the standalone Annex III route (Article 6(2)) the date is 2 December 2027; for the embedded Annex I route (Article 6(1)) the date is 2 August 2028.
If you put your own name or trade mark on the system, substantially modify it, or change the intended purpose so that it becomes high-risk, Article 25(1) treats you as a provider and the duties of Article 16 apply instead of those of Article 23.
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.
Move the four verifications of Article 23(1) to the moment before contract signature instead of before delivery. Request the declaration of conformity, the technical documentation, proof of the Article 43 procedure and the authorised representative's details as a condition precedent in the purchase contract.