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
In force: In force since 25 May 2017 · CELEX 32017R0746
Procedure: Regulation
Last activity: 5 Apr 2017

9 acts

Delegated and implementing acts beneath it

By status: 7 published, 1 adopted, 1 planned.

Act	Kind	Status	Adoption
Medical devices - uniform quality rules for notified bodies	Implementing · Regulation	Adopted	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.

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

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