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Unofficial consolidated textConsolidated 2026-01-01English

Article 79

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

Article 79

Review of coordinated assessment procedure

By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on experience gained from the application of Article 78 and, if necessary, propose a review of Article 78(14) and point (h) of Article 123(3).

Official catalogue · non-binding

Related guidance (2)

Current English catalogue entries that refer to Article 79. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2021-6 - rev.1Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigationDecember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
December 2023
Topics

Source document

  • MDCG 2021-6 - 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 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
December 2025
Topics

Source document

  • MDCG 2025–10PDF · 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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