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类别: REGULATORY PATHWAYS

IVDR (法规2017/746)

欧盟体外诊断法规，监管IVD医疗器械，取代之前的IVDD。IVDR引入新的分类体系（A、B、C、D）、高风险类别的强制公告机构参与和增强的性能评估要求。

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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相关术语

EU MDR (法规2017/745)公告机构EUDAMED