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Regulation (EU) 2016/425 Article 41

Regulation (EU) 2016/425 Article 41

Formal non-compliance

Article 41

1.   Without prejudice to Article 38, where 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 30 of Regulation (EC) No 765/2008 or of Article 17 of this Regulation; (b) the CE marking has not been affixed; (c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 17 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 8(6) or Article 10(3) is absent, false or incomplete; (g) any other administrative requirement provided for in Article 8 or Article 10 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measures to restrict or prohibit the PPE being made available on the market or ensure that it is recalled or withdrawn from the market.

Read the full instrument → · Read this in context: CHAPTER VI — UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE →

Other provisions in CHAPTER VI — UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 41 of Regulation (EU) 2016/425 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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