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類別: CLINICAL
研究用器材
作為臨床調查對象的醫療器材。在美國，研究用器材豁免（IDE）允許器材用於臨床研究。根據EU MDR，研究用器材遵循第62-82條。
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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