KATEGORIE: CLINICAL

Nutzen-Risiko-Bewertung

Eine systematische Bewertung, die den wahrscheinlichen Nutzen eines Medizinprodukts mit seinen Risiken vergleicht.

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

Benefit-risk determination weighs clinical benefits against residual risks and uncertainties. It is central to FDA PMA/De Novo decisions and EU MDR GSPR/clinical evaluation conclusions.

PROCESS / STEPS

Quantify benefits (clinical outcomes, claims) with appropriate evidence.
Characterize residual risks after mitigations and probability/severity.
Address uncertainty, alternatives, and state of the art.
Document decision logic for regulators and update with PMS data.

EXAMPLES

A high-risk implant may be favorable if life-saving benefit outweighs known complication rates with informed consent and monitoring.

RELATED GUIDES & TOOLS

SOURCES

FDA benefit-risk guidance (devices) ↗

Track regulatory signals related to Nutzen-Risiko-Bewertung across 27 authorities in real time.

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