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KATEGORIE: CLINICAL
Klinische Bewertung
Ein systematischer Prozess zur kontinuierlichen Erzeugung, Sammlung, Analyse und Bewertung klinischer Daten zu einem Medizinprodukt.
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.
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