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類別: DOCUMENTATION
安全和臨床性能摘要(SSCP)
EU MDR要求III類和植入式器材提供的文件，總結安全性和臨床性能數據。SSCP在EUDAMED中發布，面向醫療專業人員和患者。
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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