Glossary · EU in vitro diagnostics: IVDR
In Vitro Diagnostic Medical Devices Regulation (IVDR)
Also known as: IVDR, Regulation (EU) 2017/746, EU IVD Regulation
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 is the EU regulation that sets the requirements for placing in vitro diagnostic medical devices and their accessories on the EU market. It applies since May 26, 2022, replaced Directive 98/79/EC and introduced a risk-based classification into classes A to D, with notified-body involvement for all classes except non-sterile class A.
- EU
- IVDR
In one sentence
The IVDR, Regulation (EU) 2017/746, governs in vitro diagnostics in the EU since May 26, 2022, with risk classes A to D and wider notified body involvement.
Example
A manufacturer of a PCR test for a sexually transmitted infection reclassifies it as class C under the IVDR, prepares a performance evaluation report and applies to a notified body, which under the former directive had not been required.
How it applies
- Scope: In vitro diagnostic medical devices such as reagents, kits, analyzers, specimen receptacles and diagnostic software, and their accessories.
- Classification: Seven rules in Annex VIII assign classes A to D. Under the former directive most IVDs were self-declared; under the IVDR most need a notified body.
- Evidence: A performance evaluation covering scientific validity, analytical and clinical performance, supported where needed by performance studies and continued through PMPF.
- Shared framework: Economic operators, PRRC, GSPR, UDI, EUDAMED, post-market surveillance and vigilance largely mirror the MDR, with different article numbers.
- Transition: Legacy devices benefit from staggered transition periods until 2027, 2028 or 2029 depending on class. Health institutions can use the in-house exemption under conditions.
- Technical documentation: Annexes II and III define the technical documentation and the documentation on post-market surveillance; class C and D devices also need a summary of safety and performance (SSP).
IVDR vs. IVDD
The Directive 98/79/EC relied on a list-based approach in which only listed high-risk products and self-tests involved a notified body. The IVDR replaced it with rule-based classes A to D, stricter clinical evidence and post-market requirements, and direct applicability as a regulation. For the line between the IVDR and the MDR, see Medical device vs. IVD: MDR vs. IVDR.