2012/0267(COD)

In Vitro Diagnostic Medical Devices Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices

Stage: In force, reached 5 May 2017
In force: In force since 25 May 2017 · CELEX 32017R0746
Procedure: Regulation · Ordinary legislative procedure
Last activity: 25 May 2017

1 entry · record as of 30 Sept 2026

Where it stands

Latest: Implementing act published: Medical devices - uniform quality rules for notified bodies, 5 May 2026.

5 May 2026
- Implementing act published: Medical devices - uniform quality rules for notified bodies

1 amendment

Amendments

Tabled on 29 Mar 2017. The texts are in the amendment documents below.

By article

–1

9 acts

Delegated and implementing acts beneath it

By status: 8 published, 1 planned.

Act	Kind	Status	Adoption
Commission Implementing Regulation (EU) 2026/977	Implementing · Regulation	Published	Q1 2026
Commission Implementing Regulation (EU) 2025/2526	Implementing · Regulation	Published
Common specifications for in vitro diagnostic medical devices	Implementing · Regulation	Planned	Q1 2026
Commission Implementing Decision (EU) 2024/2120	Implementing · Decision	Published
Commission Implementing Regulation (EU) 2023/2713	Implementing · Regulation	Published
Commission Delegated Regulation (EU) 2023/503	Delegated · Regulation	Published	Q4 2022
Commission Implementing Regulation (EU) 2022/1107	Implementing · Regulation	Published	Q1 2022
Commission Implementing Regulation (EU) 2022/944	Implementing · Regulation	Published
Commission Implementing Regulation (EU) 2022/945	Implementing · Regulation	Published

Titles link to EUR-Lex where the act has been published.

19 documents

Documents

Newest first. Each opens at its source.

Report · A7-0327/2013Parliament
Report · A8-0069/2017Parliament
Proposal · COM(2017)0127Commission
Text adopted · Corrigendum to final act 32017R0746R(02)Commission
Text adopted · Corrigendum to final act 32017R0746R(03)Commission
Text adopted · OJ L 117 03.05.2019, p. 0011Commission
Text adopted · OJ L 117 05.05.2017, p. 0176Commission
Text adopted · OJ L 334 27.12.2019, p. 0167Commission
Report · PE506.196Parliament
Committee opinion · PE506.246Parliament
Committee opinion · PE508.086Parliament
Amendments · PE510.740Parliament
Amendments · PE510.755Parliament
Report · PE601.101Parliament
Text adopted · Regulation 2017/0746Commission
Text adopted · SP(2014)471Parliament
Text adopted · T7-0267/2014Parliament
Text adopted · T7-0427/2013Parliament
Text adopted · T8-0108/2017Parliament

Summary

Generated

Regulation (EU) 2017/746 governs placing on the market and putting into service of in vitro diagnostic medical devices, replacing Directive 98/79/EC. It applies from 26 May 2022, with transitional provisions allowing certain legacy devices on the market until 31 December 2027–2029 depending on class.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.

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