Formal non-compliance

Chapter 9 (Art. 72 — 94) — Post-market monitoring, information sharing and market surveillance

Article 83

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:
- (a) the CE marking has been affixed in violation of Article 48;
- (b) the CE marking has not been affixed;
- (c) the EU declaration of conformity referred to in Article 47 has not been drawn up;
- (d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
- (e) the registration in the EU database referred to in Article 71 has not been carried out;
- (f) where applicable, no authorised representative has been appointed;
- (g) 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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.