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Unofficial consolidated textConsolidated 2026-01-01English

Annex V

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

CE MARKING OF CONFORMITY

1.

The CE marking shall consist of the initials ‘CE’ taking the following form:

CE marking initials shown on the official construction grid
Unofficial consolidated source figure, rendered from the acquired EUR-Lex TIFF as a local PNG derivative. Source version

2.

If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.

3.

The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.

Official catalogue · non-binding

Related guidance (3)

Current English catalogue entries that refer to Annex V. 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 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 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.

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