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Unofficial consolidated textConsolidated 2026-01-01English

Article 41

Reproduced from official EUR-Lex 1/1/2026.

Article 41

Language requirements

All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned.

Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned.

The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 39(3).

Official catalogue · non-binding

Related guidance (1)

Current English catalogue entries that refer to Article 41. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2022-13 rev.1Designation, re-assessment and notification of conformity assessment bodies and notified bodiesJune 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
June 2024
Topics

Source document

  • MDCG 2022-13 rev.1PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

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