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European Union
Commission Implementing Regulation (EU) 2026/977
Article 5
4.
(f)

Commission Implementing Regulation (EU) 2026/977

law://eu/reg/2026/977/art_5__para_4__pnt_f@2026-11-12

Version in force onWhereEuropean Union

Key facts

Type: Implementing regulation · Commission Implementing Regulation (EU) 2026/977
Adopted: 4 May 2026
In force: 25 May 2026
Applies from: 25 Feb 2027
Applies from: 1 Jan 2028
Made by: Directorate-General for Health and Food Safety, European Commission
Official: EUR-Lex 32026R0977 · ELI

Topics

approval EC conformity marking marketing standard medical device quality standard technical specification Internal market - Principles Medical devices Public health

Contents

1. The notified body shall ensure that the documented procedu…
2. The notified body shall ensure that the documented procedu…
3. Where the changes referred to in paragraph 2 are necessary…
4. The notified body shall assess the documentation referred…
5. If the notified body finds that the documentation received…

Contents

1. The notified body shall ensure that the documented procedu…
2. The notified body shall ensure that the documented procedu…
3. Where the changes referred to in paragraph 2 are necessary…
4. The notified body shall assess the documentation referred…
5. If the notified body finds that the documentation received…

History · 1 version

5 May 2026Reading

This text since 5 May 2026

In force

(f)complete the final review referred to in Section 4.7 of Annex VII to Regulation (EU) 2017/745 or in Section 4.7 of Annex VII to Regulation (EU) 2017/746, as applicable.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Connections

Cited by 1: this act
Cites 2: Regulation (EU) 2017/745; Regulation (EU) 2017/746