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CATEGORY: REGULATORY PATHWAYS
IVDR (Regulation 2017/746)
The EU In Vitro Diagnostic Regulation governing IVD medical devices, replacing the previous IVDD. IVDR introduces a new classification system (A, B, C, D), mandatory Notified Body involvement for higher risk classes, and enhanced performance evaluation requirements.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
IVDR (EU) 2017/746 governs in vitro diagnostic devices with risk classes A–D, more NB involvement, and stronger performance evaluation than the old IVDD.
PROCESS / STEPS
- Classify the IVD under IVDR rules.
- Plan performance evaluation and scientific validity evidence.
- Engage an NB for higher classes; prepare technical docs.
- Register actors/devices in EUDAMED modules as required.
EXAMPLES
- Companion diagnostics and high-risk IVDs face the most stringent IVDR routes.
RELATED GUIDES & TOOLS
SOURCES
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