← All terms
CATEGORY: DOCUMENTATION
Summary of Safety and Clinical Performance (SSCP)
A document required under EU MDR for Class III and implantable devices, summarizing safety and clinical performance data. SSCPs are published in EUDAMED and intended for both healthcare professionals and patients.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
Track regulatory signals related to Summary of Safety and Clinical Performance (SSCP) across 27 authorities in real time.
START FREE →