← 所有術語
類別: CLINICAL
臨床評價
系統性和計畫性地持續產生、收集、分析和評估醫療器材臨床數據的過程。根據EU MDR，需要在器材整個生命週期內進行臨床評價，並記錄在臨床評價報告（CER）中。
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
Clinical evaluation continuously appraises clinical data to support safety and performance claims—central under EU MDR and reflected in CER documentation.
PROCESS / STEPS
- Define clinical questions from intended purpose and risks.
- Identify clinical data (investigations, literature, experience).
- Appraise and analyze; update CER and risk/benefit conclusions.
- Feed PMCF and PMS when residual questions remain.
EXAMPLES
- CER updates after significant design or indication changes.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 臨床評價 across 27 authorities in real time.
START FREE →