EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

What this entry covers

Regulation (EU) 2017/746 on in vitro diagnostic medical devices replaces Directive 98/79/EC and has applied since 26 May 2022. The European Commission summarizes it as introducing a new risk-based device classification system, more detailed and stringent rules on the evaluation of device performance, and greater involvement of notified bodies, with device information held in EUDAMED. Regulation (EU) 2022/112 and Regulation (EU) 2024/1860 extended the transitional provisions for qualifying legacy devices.

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Official documentation

• Primary official source: https://health.ec.europa.eu/medical-devices-new-regulations_en
• European Commission: IVD overview: https://health.ec.europa.eu/medical-devices-vitro-diagnostics/overview_en
• European Commission: IVDR transitional provisions: https://health.ec.europa.eu/medical-devices-vitro-diagnostics/transitional-provisions_en

Recent changes

• 2026-05-28: Use of the first four EUDAMED modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) became mandatory under Commission Decision (EU) 2025/2371. European Commission
• 2024-06-13: Regulation (EU) 2024/1860 further extended the IVDR transition periods for qualifying legacy devices that need a notified body, to December 2027 (class D), December 2028 (class C) and December 2029 (class B and sterile class A), subject to conditions. European Commission

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