Summary of Article 83
- Identification of Non-Compliance: Authorities must require providers to resolve non-compliance issues related to CE marking, declarations of conformity, registration, authorised representation, or technical documentation within a specified timeline.
- Enforcement for Persistent Non-Compliance: If non-compliance persists, authorities can take restrictive measures, including prohibiting, recalling, or withdrawing the high-risk AI system from the market.
Identification of 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:
(a) the CE marking has been affixed in violation of Article 48;
(b) the CE marking has not been affixed;
(c) the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e) the registration in the EU database referred to in Article 71 has not been carried out;
(f) where applicable, no authorised representative has been appointed;
(g) technical documentation is not available.
Enforcement for Persistent Non-Compliance
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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.
