Summary of Safety and Clinical Performance (SSCP)

What is a Summary of Safety and Clinical Performance?

The Summary of Safety and Clinical Performance (SSCP) is a document, which is made public and summarizes the clinical data and other information about the safety and clinical performance for your medical device. The SSCP shall be objective and adequately summarise both favourable and unfavourable data for your device. As such, the SSCP ensures transparency and provides important information to the end user (and patient, if relevant). Under the European Medical Device Regulation (MDR), the SSCP is required for class III devices and implantable devices, except for custom-made or investigational devices.