Formal non-compliance

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:

• (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.

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.