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Unofficial consolidated textConsolidated 2026-01-01English

Annex IV

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

EU DECLARATION OF CONFORMITY

The EU declaration of conformity shall contain all of the following information:

  1. 1.

    Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;

  2. 2.

    A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;

  3. 3.

    The Basic UDI-DI as referred to in Part C of Annex VI;

  4. 4.

    Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;

  5. 5.

    Risk class of the device in accordance with the rules set out in Annex VIII;

  6. 6.

    A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;

  7. 7.

    References to any CS used and in relation to which conformity is declared;

  8. 8.

    Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;

  9. 9.

    Where applicable, additional information;

  10. 10.

    Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

Official catalogue · non-binding

Related guidance (10)

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

Browse topics
MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devicesDecember 2019
Non-binding guidanceOpen guidance page
Catalogue section
Class I Devices
Published
December 2019
Topics

Source document

  • MDCG 2019-15 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 2024-5 MDCG 2024-5 Appendix AGuidance on the Investigator’s Brochure contentAppendix A of the MDCG 2024-5April2024April2024
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
April2024April2024
Topics

Source documents

  • MDCG 2024-5PDF · 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 2024-5 Appendix ADOCX · 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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Guidance documentHow to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 contextMay 2020
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
May 2020
Topics

Source document

  • How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 contextPDF · 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 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
April 2020
Topics

Source document

  • MDCG 2020-9PDF · 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 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2019-11 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 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
December 2022
Topics

Source document

  • MDCG 2022-21PDF · 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 2018-1 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

    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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