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Unofficial consolidated textConsolidated 2026-01-01English

Article 20

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

Article 20

CE marking of conformity

1.

Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.

2.

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

3.

The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.

4.

The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.

5.

Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.

6.

Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.

Official catalogue · non-binding

Related guidance (2)

Current English catalogue entries that refer to Article 20. Guidance is non-binding and kept separate from the regulation text.

Browse topics
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 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.

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