SSCP - Summary of Safety and Clinical Performance
The Summary of Safety and Clinical Performance (SSCP) for Class III medical devices and/or implantable devices serves as a direct information source for users and patients. Unlike other benefit-risk assessment documentation for medical devices, the SSCP is made publicly available.
Depending on the device, the SSCP is structured into one section intended for healthcare professionals and another written in lay language. Content-wise, the SSCP includes information on indications, contraindications, warnings/risks, device history, applied standards, medical alternatives, and a summary of the clinical evaluation.
From different perspectives, the SSCP can be viewed as either an enhanced instructions for use or a highly condensed clinical evaluation.
- Builds trust and enhances patient safety
- Provides an efficient summary of clinical evidence
- Includes accessible information for non-specialists
