Summary of Safety and Clinical Performance (SSCP)
The SSCP encompasses an overview of the medical device itself and a synopsis of the Clinical Evaluation (CER). It is intended to provide public access to a summary of clinical data and other information about the safety and clinical performance in case your medical device is implantable and/or class III but not custom-made or for investigational use only. The SSCP is therefore an important source of information for users – both healthcare professionals and lay users and-if relevant-for patients.
- If required for your device, LITERO prepares a SSCP according to MDR Article 32 and the corresponding MDCG guideline. As it will be available online for patients and users, it should be prepared with great care ensuring risk mitigation.