Summary of Safety and Clinical Performance FAQ
What is the Summary of Safety and Clinical Performance (SSCP)?
Does it apply to your device? Where can you find guidance?
Read on to learn more…
SSCP
CER, SSCP and PSUR
What’s the difference between CER, SSCP, and PSUR? Clin-r+ provides a break-down of the aspiration and content of each report, and explains why the reports are required under the EU MDR.
Summary of Safety and Clinical Performance
A Summary of Safety and Clinical Performance (SSCP) is an external document that includes information about a medical device, such as general information about the device, a summary of the clinical data for the device, and possible therapeutic alternatives. Clin-r+ provides information on what is required under EU MDR and how it is used.
