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Article 83

Formal Non-Compliance

Updated on May 21st 2024 based on the version and article numbering approved by the EU Parliament on May 14th 2024.

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 48;
  2. the CE marking has not been affixed;
  3. the EU declaration of conformity referred to in Article 47 has not been drawn up;
  4. the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
  5. the registration in the EU database referred to in Article 71 has not been carried out;
  6. where applicable, no authorised representative has been appointed;
  7. 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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

[Previous version]

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

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 48;
  2. the CE marking has not been affixed;
  3. the EU declaration of conformity referred to in Article 47 has not been drawn up;
  4. the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
  5. the registration in the EU database referred to in Article 71 has not been carried out;
  6. where applicable, no authorised representative has been appointed;
  7. 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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

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. a CE marking has been affixed in violation of Article 48;
  2. a CE marking has not been affixed;
  3. a EU declaration of conformity has not been drawn up;
  4. a EU declaration of conformity has not been drawn up correctly;
  5. registration in the EU database has not been carried out;
  6. where applicable, an authorised representative has not been appointed;
  7. 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.

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