Summary of Safety and Performance (SSP)
The Summary of Safety and Performance, SSP, intends to provide public access to information about the safety and performance of an in vitro diagnostic medical device.
An SSP is required for class C and class D devices, with the exception of devices for performance studies.
The SSP is part of the technical documentation which is submitted to a notified body for review. Upon successful validation, the SSP is intended for upload to Eudamed (the European database on medical devices).
QAdvis can help you to:
- Write the SSP according to regulatory requirements (In Vitro Diagnostic Medical Device Regulation; EU 2017/746)
- Review your SSP
- Resolve non-conformities
- Provide training
QAdvis provides the corresponding services for the Summary of Safety and Clinical Performance – SSCP, which is applicable for certain devices regulated by the Medical Device Regulation; EU 2017/745).
Contact me for further information
Office +46 8 621 01 05 or send me an e-mail