← 所有術語
類別: CLINICAL
臨床調查
在人體受試者中評估醫療器材安全性或性能的系統性研究。根據EU MDR，臨床調查必須遵循ISO 14155並在相關國家資料庫中註冊。
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 臨床調查 across 27 authorities in real time.
START FREE →