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European Union
Commission Implementing Regulation (EU) 2026/977
Article 8
2.

Commission Implementing Regulation (EU) 2026/977

In forceThis text since 5 May 2026law://eu/reg/2026/977/art_8__para_2@2026-11-11

Version in force onWhereEuropean Union

1. Articles 1, 2 and 3 shall not apply to conformity assessme…
2. Article 4(1), (2) and (3) shall apply to conformity assess…
3. Articles 5, 6 and 7 shall not apply to re-certification re…

Contents

1. Articles 1, 2 and 3 shall not apply to conformity assessme…
2. Article 4(1), (2) and (3) shall apply to conformity assess…
3. Articles 5, 6 and 7 shall not apply to re-certification re…

2.Article 4(1), (2) and (3) shall apply to conformity assessment procedures for which the notified body and the manufacturer signed a written agreement after 25 May 2027.

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

History · 1 version

5 May 2026Reading

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Cites 1: this act