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IVDR (法規2017/746)

歐盟體外診斷法規，監管IVD醫療器材，取代之前的IVDD。IVDR引入新的分類體系（A、B、C、D）、高風險類別的強制公告機構參與和增強的性能評估要求。

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

  1. Classify the IVD under IVDR rules.
  2. Plan performance evaluation and scientific validity evidence.
  3. Engage an NB for higher classes; prepare technical docs.
  4. 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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相關術語

EU MDR (法規2017/745)公告機構EUDAMED