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Article 68

Formal Non-Compliance

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

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 CE marking has been affixed in violation of Article 49;
  2. the CE marking has not been affixed;
  3. the EU declaration of conformity has not been drawn up;
  4. the EU declaration of conformity has not been drawn up correctly; (ea) the registration in the EU database has not been carried out;

     eb. where applicable, the authorised representative has not been appointed; (ec) the 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to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn from the market without delay.

[Previous version]

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to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn from the market.

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