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. a)
   the CE marking has been affixed in violation of Article 48; ¶

   Provider Obligations for AI Systems
2. b)
   the CE marking has not been affixed; ¶

   Provider Obligations for AI Systems
3. c)
   the EU declaration of conformity referred to in Article 47 has not been drawn up; ¶

   AI Conformity Declaration Conformity Assessment for AI Systems Provider Obligations for AI Systems
4. d)
   the EU declaration of conformity referred to in Article 47 has not been drawn up correctly; ¶

   AI Conformity Declaration Conformity Assessment for AI Systems Provider Obligations for AI Systems
5. e)
   the registration in the EU database referred to in Article 71 has not been carried out; ¶
6. f)
   where applicable, no authorised representative has been appointed; ¶

   Representatives
7. g)
   technical documentation is not available. ¶

   Documentation Keeping for AI Systems AI Record-Keeping Technical Documentation for AI Systems

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.¶