Chapter IX
Article 79
Formal Non-Compliance
Plain-Language Summary
Covers procedural non-compliance situations: missing CE marking, incorrectly affixed CE marking, missing EU declaration of conformity, or missing registration. Authorities must require the operator to rectify the non-compliance.
Keywords
formal non-complianceCE markingdeclaration of conformityregistrationmarket surveillancerectification
Legal Text
Article 79 — Formal Non-Compliance 1. Without prejudice to Article 76, where a market surveillance authority of a Member State makes one of the following findings, it shall require the relevant operator to put an end to the non-compliance concerned: (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 has not been drawn up correctly; (e) the registration in the EU database referred to in Article 71 has not been carried out. 2. Where the non-compliance referred to in paragraph 1 persists, the Member State authority shall take all appropriate measures to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn.