alt text Open/Close

Don't forget: SSCP for implants and class III devices

Don't forget about the SSCP

Obligatory even before the start of EUDAMED

For implants and Class III devices, a Summary of Safety and Clinical Performance (SSCP) is mandatory (MDR). This report summarizes the main results of the clinical evaluation and market surveillance. It is therefore recommended to process the SSCP together with the clinical evaluation to benefit from synergy effects. If relevant, the SSCP must also include a lay-specific summary of the data. The requirements for the SSCP can be found in MDCG 2019-9. The SSCP, which usually has to be updated annually, should later be publicly available on EUDAMED. But already now, a SSCP must be available and is requested by the Notified Bodies!

Contact us, we will be happy to advise you!