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Chapter IX

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.