Compliance
IVDR
EU In Vitro Diagnostic Regulation (2017/746)
TL;DR
EU regulation for in-vitro diagnostic devices — applied May 2022, brought ~85% of IVDs under Notified-Body oversight (vs ~20% under the old IVDD).
Regulation (EU) 2017/746 reclassified IVDs into four risk classes (A → D), requiring Notified Body involvement for Class B and above. Stricter performance evaluation, clinical evidence, UDI and EUDAMED registration, PMS/PMPF. Transitional deadlines staggered to 2027–2028.
V5 covers the IVDR DHR / design-controls / risk-management evidence needs equivalent to MDR.
Regulatory anchors
- Regulation (EU) 2017/746
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