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:<\/p>\n
(a) the relevant conformity assessment procedure referred to in Article 43<\/a> has been carried out by the provider of the high-risk AI system;<\/p>\n (b) the provider has drawn up the technical documentation in accordance with Article 11<\/a> and Annex IV<\/a>;<\/p>\n (c) the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47<\/a> and instructions for use;<\/p>\n (d) the provider has appointed an authorised representative in accordance with Article 22<\/a>(1).<\/p>\n 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<\/a>(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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 referred to in Article 47<\/a>.<\/p>\n 6. Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in 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 importers, in particular to reduce and mitigate the risks posed by it.<\/p>\n","protected":false},"template":"","class_list":["post-2980","article","type-article","status-publish","hentry"],"meta_box":{"date_of_eif":"2 August 2026","eif_according_to":"Article 113","eif_inherit_from":"","item_summary":" This article states that before selling a high-risk AI system, importers must ensure it meets all regulations. This includes checking that the system has passed the necessary assessments, has the correct documentation, and is marked with the CE symbol. If the importer suspects the system doesn't meet regulations or has fake documentation, they must not sell it until it complies. Importers must also provide their contact details on the system or its packaging, ensure it's stored and transported safely, and keep a record of its certification and instructions for 10 years. They must also cooperate with authorities if needed.<\/p>\n","item_notes":"","item_order":"23","chapter-article_from":["3448"],"article-recital_to":["2645"],"title-article_from":[]},"_links":{"self":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article\/2980","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article"}],"about":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/types\/article"}],"version-history":[{"count":2,"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article\/2980\/revisions"}],"predecessor-version":[{"id":5232,"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article\/2980\/revisions\/5232"}],"wp:attachment":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/media?parent=2980"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nSection 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.<\/p>\n