Art. 83 Formal non-compliance | AI act regulation | AI act

This article deals with formal, procedural non-compliance by providers of high-risk AI systems — as distinct from the more substantive safety or fundamental rights risks addressed in surrounding articles like Article 79.

It sets out a specific list of documentation and marking failures that trigger intervention by a market surveillance authority, such as missing CE markings, absent or incorrectly drawn up EU declarations of conformity, failure to register in the EU database, lack of an authorised representative, or unavailable technical documentation.

If a provider does not remedy the identified non-compliance within the prescribed period, the authority is empowered to escalate to market restriction, recall, or withdrawal.

Important points:

Market surveillance authorities are required to order providers to remedy any of the listed formal non-compliance issues within a period the authority sets.
Ensure CE markings are correctly affixed, EU declarations of conformity are properly drawn up, registration in the EU database is completed, an authorised representative is appointed where applicable, and technical documentation is available.
If non-compliance persists, market surveillance authorities are required to take measures to restrict, prohibit, recall, or withdraw the high-risk AI system from the market.

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.