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Unique Device Identification (UDI)

UDI system, assignment, and integration requirements.

Official catalogue · non-binding

Unique Device Identification (UDI) guidance (15)

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

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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

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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

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MDCG 2025-7 Rev 1MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectaclesDecember 2025
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
December 2025
Topics

Source document

  • MDCG 2025-7PDF · Unverified extraction previewOfficial source

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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

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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.

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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

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MDCG 2021-10The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devicesJune 2021
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
June 2021
Topics

Source document

  • MDCG 2021-10PDF · Unverified extraction previewOfficial source

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MDCG 2018-1 rev.4Guidance on basic UDI-DI and changes to UDI-DIApril 2021
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
April 2021
Topics

Source document

  • MDCG 2018-1 rev.4PDF · Unverified extraction previewOfficial source

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Show all 15 guidance documentsShow only the first 8
MDCG 2019-2Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017February 2019
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
February 2019
Topics

Source document

  • MDCG 2019-2PDF · Unverified extraction previewOfficial source

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MDCG 2019-1MDCG guiding principles for issuing entities rules on basic UDI-DIJanuary 2019
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
January 2019
Topics

Source document

  • MDCG 2019-1PDF · Unverified extraction previewOfficial source

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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

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MDCG 2018-6Clarifications of UDI related responsibilities in relation to article 16October 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
Topics

Source document

  • MDCG 2018-6PDF · Unverified extraction previewOfficial source

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MDCG 2018-5UDI assignment to medical device softwareOctober 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
Topics

Source document

  • MDCG 2018-5PDF · Unverified extraction previewOfficial source

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MDCG 2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
Topics

Source document

  • MDCG 2018-4PDF · Unverified extraction previewOfficial source

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MDCG 2018-3 rev.1Guidance on UDI for systems and procedure packsJune 2020
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
June 2020
Topics

Source document

  • MDCG 2018-3 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.

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