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Unofficial consolidated textConsolidated 2026-01-01English

Article 7

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

Article 7

Claims

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

  1. (a)

    ascribing functions and properties to the device which the device does not have;

  2. (b)

    creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

  3. (c)

    failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

  4. (d)

    suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Official catalogue · non-binding

Related guidance (4)

Current English catalogue entries that refer to Article 7. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2022-5 rev.1Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devicesOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
October 2024
Topics

Source document

  • MDCG 2022-5 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 2019-15 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 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.

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