On March 24, the MDCG published revision 1 of the 2019-9 document: Summary of safety and clinical performance: A guide for manufacturers and notified bodies.
The MDR requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR.
The document can be downloaded in our library.
Source: European Commission