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Labelling and language requirements

Language, symbol, relabelling, and information-supply requirements.

Official catalogue · non-binding

Labelling and language requirements guidance (2)

Catalogue entries are ordered as they appear in the European Commission catalogue.

Browse topics
MDCG 2021-26Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2021
Non-binding guidanceOpen guidance page
Catalogue section
Authorised Representatives, Importers, Distributors
Published
October 2021
Topics

Source document

  • MDCG 2021-26PDF · 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.

MDR/IVDR Language requirementsOverview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific countryJanuary 2024
Non-binding guidanceOpen guidance page
Catalogue section
Other guidance documents
Published
January 2024
Topics

Source document

  • MDR/IVDR Language requirementsHTML · 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.