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Standards and standardisation

Medical-device standardisation and harmonised standards.

Official catalogue · non-binding

Standards and standardisation guidance (3)

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

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MDCG 2023-2 MDCG 2023-2 MDR form MDCG 2023-2 IVDR formList of Standard FeesJanuary 2023
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
January 2023
Topics

Source documents

  • MDCG 2023-2PDF · 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.

  • MDCG 2023-2 MDR formDOCX · 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.

  • MDCG 2023-2 IVDR formDOCX · 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 2021-5 rev.1Guidance on standardisation for medical devicesJuly 2024
Non-binding guidanceOpen guidance page
Catalogue section
Standards
Published
July 2024
Topics

Source document

  • MDCG 2021-5 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 2021-5 rev.1 - AppendixTransition to the "EU REP" symbol in EN ISO 15223-1June 2026
Non-binding guidanceOpen guidance page
Catalogue section
Standards
Published
June 2026
Topics

Source document

  • MDCG 2021-5 rev.1 - AppendixPDF · 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.