Risk level: general
Title IX — Post-Market Monitoring, Information Sharing, Market Surveillance
Article 83 — Formal Non-Compliance
Formal 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...
Article 83
Formal 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:
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.
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available on the market or to ensure that it is recalled or withdrawn from the market without delay.
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available on the market or to ensure that it is recalled or withdrawn from the market without delay.
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Article 84 — Union AI Testing Support Structures
Related Articles in This Chapter
- high Article 72 — Post-Market Monitoring by Providers
- high Article 73 — Reporting of Serious Incidents
- general Article 74 — Market Surveillance and Control of AI Systems in the Union Market
- general Article 75 — Mutual Assistance, Market Surveillance and Control
- general Article 76 — Supervision of Testing in Real World Conditions
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