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Article 83

Formal Non-Compliance

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

[Previous version]

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

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

AI Systems Already Placed on the Market or Put Into Service

1. Without prejudice to the application of Article 5 as referred in Article 85 (3) (-aa) AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service before 12 months after the date of application of this Regulation referred to in Article 85(2) shall be brought into compliance with this Regulation by end of 2030.

The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts and whenever those legal acts are replaced or amended.

2. Without prejudice to the application of Article 5 as referred in Article 85 (3) (-aa ) this Regulation shall apply to operators of high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [date of application of this Regulation referred to in Article 85(2)], only if, from that date, those systems are subject to significant changes in their designs. In the case of high-risk AI systems intended to be used by public authorities, providers and deployers of such systems shall take the necessary steps to comply with the requirements of the present Regulation four years after the date of entry into application of this Regulation.

3. Providers of general purpose AI models that have been placed on the market before [date of application of this Regulation referred to in point a) Article 85(3)] shall take the necessary steps in order to comply with the obligations laid down in this Regulation by [2 years after the date of entry into application of this Regulation referred to in point a) of 85(3)].

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