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Article 34

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

Article 34

Functionality of Eudamed

1.

The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018.

2.

The Commission shall inform the MDCG when, on the basis of independent audit reports, it has verified that one or more of the electronic systems referred to in Article 33(2) are functional and meet the functional specifications drawn up pursuant to paragraph 1 of this Article.

3.

The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.

Official catalogue · non-binding

Related guidance (8)

Current English catalogue entries that refer to Article 34. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2020-10/1 rev.1 MDCG 2020-10/2 rev.1Guidance on safety reporting in clinical investigationsAppendix: Clinical investigation summary safety report formOctober 2022October 2022
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
October 2022October 2022
Topics

Source documents

  • MDCG 2020-10/1 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.

  • MDCG 2020-10/2 rev.1XLSX · 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.

Gradual roll out of EUDAMEDQ&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1November 2024
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
November 2024
Topics

Source document

  • Gradual roll out of EUDAMEDPDF · 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 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
July 2022
Topics

Source document

  • MDCG 2022-12PDF · 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 2021-13 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 2021-1 rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
May 2021
Topics

Source document

  • MDCG 2021-1 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 2024-4 MDCG 2024-4 AppendixSafety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746Appendix – Performance Study Summary Safety Reporting FormApril 2024
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
April 2024
Topics

Source documents

  • MDCG 2024-4PDF · 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 2024-4 AppendixXLSM · 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 2022-13 rev.1Designation, re-assessment and notification of conformity assessment bodies and notified bodiesJune 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
June 2024
Topics

Source document

  • MDCG 2022-13 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 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

    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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