What is SSCP?
The summary of safety and clinical performance (SSCP) is a new requirement of the EU Medical Devices Regulation (EU MDR). SSCP provides a summary of the risks and benefits of certain devices and must be provided for all Class III and implantable devices (other than custom-made or investigational devices) and will be available in EUDAMED. The IFU shall contain all that is needed to directly find the SSCP in EUDAMED (https://ec.europa.eu/tools/eudamed).
Purpose of SSCP
The SSCP allows 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 (HCPs) and for patients. It is one of several means intended to fulfill the objectives of EU MDR to ensure a robust, transparent, and sustainable regulatory framework and maintain a high level of safety.