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类别: CLINICAL
研究用器械
作为临床调查对象的医疗器械。在美国，研究用器械豁免（IDE）允许器械用于临床研究。根据EU MDR，研究用器械遵循第62-82条。
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
An investigational device is used in a clinical investigation to evaluate safety/effectiveness before full marketing authorization—or under research exemptions with controls.
PROCESS / STEPS
- Determine IDE (US) or clinical investigation notification/approval (EU MDR Art. 62+) requirements.
- Secure ethics/IRB approvals, informed consent, and monitoring plans.
- Manufacture under investigational controls; label “investigational use”.
- Report serious adverse events and manage protocol amendments.
EXAMPLES
- A novel implant may require an FDA IDE before pivotal trials supporting PMA.
RELATED GUIDES & TOOLS
SOURCES
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