Summary of Safety and Clinical Performance (SSCP) Template


Downloadable MS Word template (.DOTX) file type that is automatically converted to a standard MS Word document (.DOCX) file type upon opening, without deleting or over-writing the original .DOTX file.


This Summary of Safety and Clinical Performance (SSCP) Template is specifically designed to be used in conjunction with the Clinical Evaluation Report (CER) Template for straightforward transfer of information from the CER to the SSCP.

The sections of this SSCP Template include all the fundamental components of an EU MDR 2017/745-compliant SSCP. Moreover, the structure and sections as well as their order and content follow the Medical Device Coordination Group (MDCG) 2019‑9 recommendations conforming to the expectations by the Notified Body (NB). This enables content of the finalized CER to be directly copied into the equivalent sections of the associated SSCP Template, with only minor modifications as instructed throughout.


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