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Article 68

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:

  1. the conformity marking has been affixed in violation of Article 49;
  1. the conformity marking has not been affixed;
  1. the EU declaration of conformity has not been drawn up;
  1. the EU declaration of conformity has not been drawn up correctly;
  1. the identification number of the notified body, which is involved in the conformity assessment procedure, where applicable, has not been affixed;

2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn from the market.

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