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Article 23

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

Article 23

Parts and components

1.

Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States.

2.

An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.

Official catalogue · non-binding

Related guidance (6)

Current English catalogue entries that refer to Article 23. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2021-24 rev.1Guidance on classification of medical devicesApril 2026
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
April 2026
Topics

Source document

  • MDCG 2021-24 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 2024-2 rev.1Procedures for the updates of the EMDNJanuary 2025
Non-binding guidanceOpen guidance page
Catalogue section
European Medical Device Nomenclature (EMDN)
Published
January 2025
Topics

Source document

  • MDCG 2024-2 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 2021-12 rev.2FAQ on the European Medical Device Nomenclature (EMDN)April 2026
Non-binding guidanceOpen guidance page
Catalogue section
European Medical Device Nomenclature (EMDN)
Published
April 2026
Topics

Source document

  • MDCG 2021-12 rev.2PDF · 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.

Guidance documentThe CND nomenclature – Background and general principlesJanuary 2020
Non-binding guidanceOpen guidance page
Catalogue section
European Medical Device Nomenclature (EMDN)
Published
January 2020
Topics

Source document

  • The CND nomenclature – Background and general principlesPDF · 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 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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