1.

Notifying Member: EUROPEAN UNION

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

European Commission

EU-TBT Enquiry Point,

Fax: +(32) 2 299 80 43,

E-mail: grow-eu-tbt@ec.europa.eu

Website: https://technical-barriers-trade.ec.europa.eu/en/home

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Medical devices and in vitro diagnostic medical devices

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft Commission Implementing Regulation laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council; (13 page(s), in English)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

European Commission

EU-TBT Enquiry Point

Fax: + (32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu

The text is available on the Website: https://technical-barriers-trade.ec.europa.eu/en/home

6.

Description of content: The notified draft sets out requirements for the harmonised applications of provisions for notified bodies established in Annex VII to Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostics. In particular, those provisions cover quotations, timelines for notified bodies to carry out conformity assessment activities, monitoring of notified bodies' performances as regards timelines and costs and re-certification.

7.

Objective and rationale, including the nature of urgent problems where applicable: The notified draft aims at resolving issues of diverging interpretations and practical application of certain requirements for notified bodies set out in Annex VII to Regulations (EU) 2017/745 and (EU) 2017/746.; Harmonization

8.

Relevant documents:

- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

EUR-Lex - 02017R0745-20200424 - EN - EUR-Lex (europa.eu)

- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117 5.5.2017, p. 176).

EUR-Lex - 02017R0746-20170505 - EN - EUR-Lex (europa.eu)

9.

Proposed date of adoption: March 2026

Proposed date of entry into force: 20 days after its publication in the Official Journal of the European Union

10.

Provision of comments

Final date for comments: 20 February 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

European Commission,

EU-TBT Enquiry Point,

Fax: + (32) 2 299 80 43,

E-mail: grow-eu-tbt@ec.europa.eu