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Unofficial consolidated textConsolidated 2025-01-10English

Article 30

Reproduced from official EUR-Lex 10/1/2025.

Article 30

European database on medical devices

1.

The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745.

2.

Eudamed shall include the following electronic systems:

  1. (a)

    the electronic system for registration of devices referred to in Article 26;

  2. (b)

    the UDI database referred to in Article 25;

  3. (c)

    the electronic system on registration of economic operators referred to in Article 27;

  4. (d)

    the electronic system on notified bodies and on certificates referred to in Article 52;

  5. (e)

    the electronic system on performance studies referred to in Article 69,

  6. (f)

    the electronic system on vigilance and post-market surveillance referred to in Article 87;

  7. (g)

    the electronic system on market surveillance referred to in Article 95.

Official catalogue · non-binding

Related guidance (4)

Current English catalogue entries that refer to Article 30. Guidance is non-binding and kept separate from the regulation text.

Browse topics
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 2021-27 - 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 2021-23Guidance 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 2023-3 rev.2Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
January 2025
Topics

Source document

  • MDCG 2023-3 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.

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