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类别: CLINICAL
临床调查
在人体受试者中评估医疗器械安全性或性能的系统性研究。根据EU MDR，临床调查必须遵循ISO 14155并在相关国家数据库中注册。
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
A clinical investigation is a systematic study in humans to assess device safety/performance, often required for high-risk or novel devices and governed by GCP (e.g., ISO 14155) and local ethics/regulatory approvals.
PROCESS / STEPS
- Define endpoints and investigational plan.
- Obtain ethics/IRB and regulatory authorizations (e.g., IDE).
- Conduct monitoring and safety reporting.
- Analyze results into clinical evaluation / submissions.
EXAMPLES
- EU MDR may require clinical investigations when equivalent data are insufficient.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 临床调查 across 27 authorities in real time.
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