In line with Medical Device Regulation (MDR) 2017/745s objective to increase transparency and ensure sufficient access to information, in article 32 of the directive, manufacturers are required to prepare a Summary of Safety and Clinical Performance (SSCP) for implantable and class III devices.
To develop correct understanding for both health professionals and patients regarding the risks and benefits of medical devices, SSCP is designed to include
- other information related to the safety and clinical performance of the device, and
- a summary of the updated clinical data.
When this document that is required to be verified by the notified body is published, it will be announced to public through EUDAMED.
All the information in the Summary of Safety and Clinical Performance (SSCP) should be obtained from the information used for the technical documentation of the medical device such as
- Design Verification Reports,
- Risk Management Report/File,
- Clinical Evaluation Report, and
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up Plans and Reports.
IFU includes the information obtained from the same resources with the SSCP, but it can also be used as a resource for SSCP when applicable.
Summary of Safety and Clinical Performance (SSCP) should regularly be updated on EUDAMED, and when PMCF evaluation report and Periodic Safety Update Report (PSUR) are updated at least once a year, in order to ensure that clinical and/or safety information is accurate and complete, Summary of Safety and Clinical Performance (SSCP) should be reviewed and if necessary, updated.
Please contact us to receive support on the preparation of Summary of Safety and Clinical Performance (SSCP).