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Article 3

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

Article 3

Amendment of certain definitions

The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.

Official catalogue · non-binding

Related guidance (3)

Current English catalogue entries that refer to Article 3. Guidance is non-binding and kept separate from the regulation text.

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Q&AQ&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRSeptember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Annex XVI products
Published
September 2023
Topics

Source document

  • Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRPDF · 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.

Manual on BorderlineManual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.April 2026
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
April 2026
Topics

Source documents

  • Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5PDF · 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.

  • Background notePDF · 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 2020-11Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013May 2020
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
May 2020
Topics

Source document

  • MDCG 2020-11PDF · 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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