SSCP

The Summary of Safety and Clinical Performance (SSCP) for Brainlab Class III medical devices is intended to provide direct information to the intended user on the safety and clinical performance of the medical device. The SSCP provides a summary of the clinical evaluation, information on indication and contraindications as well as warnings and risks related to the device. Furthermore, it contains information on the post-market surveillance and post-market clinical follow-up and it is updated annually.

The SSCP is not intended to give general advice on the diagnosis or treatment of particular medical conditions, nor to replace the Instructions For Use as the main document to ensure the safe use of the device, nor to replace any other mandatory documents.