CHAPTER IX · SECTION 3 — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE / Enforcement
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: §
(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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay. §
Report a problem in this article · provision hashes: provisions/eu-2024-1689/art_083/