The Summary of Safety and Clinical Performance (SSCP) is a new requirement dictated by EU-MDR applicable to implantable devices and class III medical devices, other than custom-made or investigational devices, which will go virtual when EUDAMED becomes fully functional.
The SSCP must be validated by the Notified Body.
The document is intended to provide a publicly-accessed summary of clinical and other information about the safety and clinical performance of a medical device addressed to both healtcare professionals and patients and/or laypersons. This renders its preparation quite tricky as two (very) different language registers must be included in the same document. For this reason, we have prepared this document as a guide of contents while outlining the main characterstics of a MDR-compliant SSCP. Download it here.
Contact Evnia today if you are looking for a team of experts that will guide you through the preparation of your SSCPs!
