Regulation (EU) 2023/6072023/0005(COD)COM(2023)10

Transitional provisions for certain medical devices and in vitro diagnostic medical devices

Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Stage: In force, reached 20 Mar 2023
In force: In force since 20 Mar 2023 · CELEX 32023R0607
Procedure: Ordinary legislative procedure
Last activity: 24 Mar 2023

20 entries · record as of 14 Sept 2026

Where it stands

Latest: Discussions within the Council or its preparatory bodies, 24 Mar 2023.

Show the earlier record: 10 dates, 10 Jan 2023 to 16 Feb 2023

10 Jan 2023
- Adoption by Commission
11 Jan 2023
- Discussions within the Council or its preparatory bodies
18 Jan 2023
- Feedback on adopted proposal closed: Extension of the transition period for medical devices, 246 responses · Commission
25 Jan 2023
- Discussions within the Council or its preparatory bodies
26 Jan 2023
- Referred to committee
27 Jan 2023
- Discussions within the Council or its preparatory bodies
1 Feb 2023
- Discussions within the Council or its preparatory bodies
13 Feb 2023
- Plenary sitting
14 Feb 2023
- Plenary vote
16 Feb 2023
- Discussions within the Council or its preparatory bodies
- Plenary adopted first-reading position
- Plenary vote

17 Feb 2023
- Discussions within the Council or its preparatory bodies
24 Feb 2023
- Discussions within the Council or its preparatory bodies
7 Mar 2023
- Approval of the EP's first reading position by the Council (adoption of the legislative act)
13 Mar 2023
- Plenary sitting
15 Mar 2023
- Signed
20 Mar 2023
- Published in the Official Journal
23 Mar 2023
- Discussions within the Council or its preparatory bodies
24 Mar 2023
- Discussions within the Council or its preparatory bodies

4 documents

Documents

Newest first. Each opens at its source.

Proposal · COM(2023)0010Parliament
Text adopted · OJ L 080 20.03.2023, p. 0024Commission
Text adopted · Regulation 2023/0607Commission
Text adopted · T9-0052/2023Parliament

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.

Consultation	Feedback deadline	Feedback received
Extension of the transition period for medical devices Who filed what · Follow the consultation	18 Jan 2023	246

Summary

Generated

This regulation amends the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to extend transition periods for certain higher-risk devices. Manufacturers gain more time to obtain certification under the new EU rules, affecting notified bodies and healthcare providers. Adopted under urgent procedure, it entered into force in March 2023.

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Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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