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类别: CLASSIFICATION
IIb类(EU MDR)
EU MDR下的中高风险器械类别。IIb类器械需要更广泛的公告机构审查。例如呼吸机、骨固定板和血袋。
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
EU MDR Class IIb includes higher medium-risk devices (e.g., many long-term invasive, active therapeutic devices). Clinical evaluation and NB scrutiny are substantially deeper than IIa.
PROCESS / STEPS
- Confirm rule-based classification and borderline analysis if needed.
- Plan clinical evidence strategy early (equivalent device literature vs investigations).
- Select NB with appropriate designation codes and capacity.
- Implement robust PMS/PMCF and, when implantable/high-risk, SSCP expectations.
EXAMPLES
- Ventilators, dialysis equipment, and many implantable devices (depending on rules) sit in IIb/III bands.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to IIb类(EU MDR) across 27 authorities in real time.
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