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CATEGORY: CLINICAL
Clinical Investigation
A systematic study in human subjects to assess the safety or performance of a medical device. Under EU MDR, clinical investigations must follow ISO 14155 and be registered in the relevant national database.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Clinical Investigation across 27 authorities in real time.
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