Fulfil Importer Obligations Before and After Placing High-Risk AI on the EU Market

Sub-obligations

These are independently assessable parts of the parent requirement.

1. Article 23(1)

   Upcoming

   Verify High-Risk AI Conformity Before Market Placement

   Tracker Guidance

   Before placing a high-risk AI system on the market, verify that the provider completed the relevant conformity assessment, prepared the Article 11/Annex IV technical documentation, applied the required CE marking, supplied the EU declaration of conformity and instructions for use, and appointed an authorised representative where required.

   Official text

   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: (a) the relevant conformity assessment procedure referred 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 referred to in Article 47 and instructions for use; (d) the provider has appointed an authorised representative in accordance with Article 22(1).

2. Article 23(2)

   Upcoming

   Do Not Place Non-Conforming or Falsified High-Risk AI on the Market and Report Relevant Risk

   Tracker Guidance

   If there is sufficient reason to consider the high-risk AI system non-conforming, falsified or accompanied by falsified documentation, do not place it on the market until it is brought into conformity. If it presents an Article 79(1) risk, inform the provider, authorised representative and market-surveillance authorities.

   Official text

   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(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.

3. Article 23(3)

   Upcoming

   Identify the Importer and Provide Contact Information

   Tracker Guidance

   Place the importer's name or registered trade name/trademark and contact address on the high-risk AI system and on its packaging or accompanying documentation, where applicable.

   Official text

   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. Article 23(4)

   Upcoming

   Maintain Storage and Transport Conditions That Preserve High-Risk AI Conformity

   Tracker Guidance

   While the high-risk AI system is under the importer's responsibility, ensure storage and transport conditions do not jeopardise compliance with the applicable high-risk requirements.

   Official text

   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.

5. Article 23(5)

   Upcoming

   Retain Required Importer Documentation for Ten Years

   Tracker Guidance

   Keep a copy of any applicable notified-body certificate, the instructions for use and the EU declaration of conformity for 10 years after the high-risk AI system is placed on the market or put into service.

   Official text

   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.

6. Article 23(6)-(7)

   Upcoming

   Provide High-Risk AI Information to and Cooperate With Competent Authorities

   Tracker Guidance

   On a reasoned request, provide competent authorities with the information and documentation needed to demonstrate conformity, ensure the technical documentation can be made available, and cooperate with authority actions intended to reduce or mitigate risk.

   Official text

   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 Section 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. 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.