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CATÉGORIE: DOCUMENTATION
Résumé des caractéristiques de sécurité et de performances cliniques (SSCP)
Un document requis par l'EU MDR pour les dispositifs de Classe III et implantables, résumant les données de sécurité et de performances cliniques.
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
The Summary of Safety and Clinical Performance (SSCP) is an EU MDR document required for implantable devices and Class III devices (with some exceptions). It is intended for healthcare professionals and, where relevant, patients.
PROCESS / STEPS
- Draft SSCP from clinical evaluation, PMS, and risk data using MDCG template expectations.
- Align content with CER conclusions and residual risks.
- Obtain Notified Body validation where required and upload/publish per EUDAMED rules.
- Update SSCP when clinical performance or safety conclusions change.
EXAMPLES
- A Class III implantable sensor SSCP summarizes intended purpose, indications, residual risks, and clinical evidence summary for clinicians.
RELATED GUIDES & TOOLS
SOURCES
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