Summary of Safety and Clinical Performance (SSCP)
The Summary of Safety and Clinical Performance, SSCP, intends to provide public access to information about the safety and clinical performance of a medical device.
An SSCP is required for implantable devices and class III devices, with the exception of custom-made or investigational devices.
The SSCP is part of the technical documentation which is submitted to a notified body for review. Upon successful validation, the SSCP is intended for upload to EUDAMED (the European database on medical devices).
An important aspect of the SSCP is to give intended users and patients insight into the safety and functionality of a medical device, including presentation of potential therapeutic or diagnostic alternatives, in a language easily understandable by the reader. Thus, one part of the SSCP should normally be written with specific focus on readability from a lay person perspective.
QAdvis can help you to:
- Write the SSCP according to regulatory requirements (Medical Device Regulation; EU 2017/745) and recommendations (MDCG 2019-9)
- Review your SSCP
- Resolve non-conformities
- Provide training
QAdvis provides the corresponding services for the Summary of Safety and Performance – SSP, which is applicable for certain IVD devices.
Contact me for further information
Office +46 8 621 01 05 or send me an e-mail