Formal Non-Compliance

Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.

1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:

1. the CE marking has been affixed in violation of Article 48;
2. the CE marking has not been affixed;
3. the EU declaration of conformity referred to in Article 47 has not been drawn up;
4. the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
5. the registration in the EU database referred to in Article 71 has not been carried out;
6. where applicable, no authorised representative has been appointed;
7. technical documentation is not available.

2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.