Article 83(1)
CurrentFrom 2 Aug 2026Remedy Specified Formal High-Risk AI Non-Compliance Within the Authority's Deadline
Applies to Provider; High-Risk AI; market-surveillance authority has identified formal non-compliance under Article 83(1).
- Actors
- Provider
- AI class
- High-Risk AI
- Context
- EU Market Access
- Themes
- Monitoring, Reporting & ImprovementGovernance & Accountability
Tracker Guidance
If a market-surveillance authority identifies one of the formal non-compliance conditions in Article 83(1), bring the matter into compliance within the period prescribed by the authority. The listed conditions concern CE marking, the EU declaration of conformity, EU database registration, appointment of an authorised representative where required, and availability of technical documentation. If non-compliance persists, the authority may restrict, prohibit, recall or withdraw the high-risk AI system.
Official text
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.
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