Summary of Safety and Clinical Performance (SSCP)

A requirement for Class III and implantable medical devices. It provides a concise overview of a device's safety and clinical performance, including relevant clinical evaluation data. 

The SSCP is intended to be accessible to the public, especially healthcare professionals, to aid in informed decision-making about using these higher-risk devices. It includes but not limited to information about the device's intended purpose, indications, contraindications, summary of clinical evaluation, and any residual risks associated with its use.