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Article 25

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

Article 25

Identification within the supply chain

1.

Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.

2.

Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):

  1. (a)

    any economic operator to whom they have directly supplied a device;

  2. (b)

    any economic operator who has directly supplied them with a device;

  3. (c)

    any health institution or healthcare professional to which they have directly supplied a device.

Official catalogue · non-binding

Related guidance (10)

Current English catalogue entries that refer to Article 25. Guidance is non-binding and kept separate from the regulation text.

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MDCG 2021-27 - rev.1Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746December 2023
Non-binding guidanceOpen guidance page
Catalogue section
Authorised Representatives, Importers, Distributors
Published
December 2023
Topics

Source document

  • MDCG 2021-27 - 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 2021-26Q&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.

Q&A rev.2Q&A Obligation to inform in case of interruption or discontinuation of supplyApril 2026
Non-binding guidanceOpen guidance page
Catalogue section
Article 10a – interruption or discontinuation of supply
Published
April 2026
Topics

Source document

  • Q&A rev.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.

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 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2025-6PDF · 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 2022-4 rev.2Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDDMay 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
May 2024
Topics

Source document

  • MDCG 2022-4 rev.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.

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 2025-8 - rev.1Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectaclesMarch 2026
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
March 2026
Topics

Source document

  • MDCG 2025-8 - 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 2024-14 - rev.1Guidance on the implementation of the Master UDI-DI solution for contact lensesAugust 2025
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
August 2025
Topics

Source document

  • MDCG 2024-14 - 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 2022-7Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)May 2022
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
May 2022
Topics

Source document

  • MDCG 2022-7PDF · 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.

Show all 10 guidance documentsShow only the first 8
MDCG 2021-19Guidance note integration of the UDI within an organisation’s quality management systemJuly 2021
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
July 2021
Topics

Source document

  • MDCG 2021-19PDF · 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 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
Topics

Source document

  • MDCG 2018-7PDF · 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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