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Unofficial consolidated textConsolidated 2025-01-10English

Article 9

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

Article 9

Common specifications

1.

Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

2.

Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.

3.

Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.

Official catalogue · non-binding

Related guidance (4)

Current English catalogue entries that refer to Article 9. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2021-21 rev.1Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devicesFebruary 2022
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
February 2022
Topics

Source document

  • MDCG 2021-21 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 2025-4Guidance on the safe making available of medical device software (MDSW) apps on online platformsJune 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2025-4PDF · 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.

MDCG 2019-13 rev.1Guidance on sampling of devices for the assessment of the technical documentationDecember 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
December 2024
Topics

Source document

  • MDCG 2019-13 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 2021-5 rev.1Guidance on standardisation for medical devicesJuly 2024
Non-binding guidanceOpen guidance page
Catalogue section
Standards
Published
July 2024
Topics

Source document

  • MDCG 2021-5 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.

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