KATEGORIE: REGULATORY PATHWAYS

IVDR (Verordnung 2017/746)

Die EU-Verordnung über In-vitro-Diagnostika, die die vorherige IVDD ersetzt. Die IVDR führt ein neues Klassifizierungssystem (A, B, C, D) ein.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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

EUR-Lex IVDR ↗

Track regulatory signals related to IVDR (Verordnung 2017/746) across 27 authorities in real time.

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