Article 83: Formal Non-Compliance

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.

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.