Formal non-compliance 正式不合規

1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation of Article 29 or 30; (b) the CE marking has not been affixed; (c) the identification number of the notified body, where that body is involved in the conformity assessment procedure based on full quality assurance, has been affixed in violation of Article 30 or has not been affixed; (d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly; (e) the technical documentation is either not available or not complete; (f) the information referred to in Article 13(15), (16) or (19) is absent, false or incomplete; (g) any other administrative obligation provided for in Article 13 or Article 19 is not fulfilled.

2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product with digital elements being made available on the market or to ensure that it is recalled or withdrawn from the market.