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Section 1: Post-Market Monitoring

Section 2: Sharing of Information on Serious Incidents

Section 3: Enforcement

Section 4: Remedies

Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models

  • Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
  • Section 3: Enforcement

Article 83: 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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

Relevant recitals