The Medical Devices Regulation (MDR, 2017/745) requires that manufacturers 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 must be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).
The Commission has updated its previous guidance on the SSCP, which is available from here.
The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals and if relevant for patients. It is one of several means intended to fulfil the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information.
The SSCP is not intended to:
The main purpose of the guidance is to provide guidance on the presentation, content and validation of the SSCP.