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Importers and distributors

Regulatory obligations of importers and distributors.

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Importers and distributors guidance (3)

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

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MDCG 2021-13 rev.1Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDRJuly 2021
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
July 2021
Topics

Source document

  • MDCG 2021-13 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.

MDCG 2021-23Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746August 2021
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
August 2021
Topics

Source document

  • MDCG 2021-23PDF · 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.

MDCG 2026-5Position Paper: UDI assignment between manufacturers and distributorsJuly 2026
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
July 2026
Topics

Source document

  • MDCG 2026-5PDF · 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.