Summary of safety and clinical performance (SSCP)
This document is prepared according to MDCG 2019-9 Rev.1 Summary of safety and clinical performance A guide for manufacturers and notified bodies.
This Summary of safety and clinical performance (SSCP) is intended to provide public access to an updated summary of the main aspects of the safety and clinical efficacy of the device.
The SSCP is not intended to replace the Instructions For Use, which is the main document guaranteeing the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions for intended users or patients.
The following information is intended for users/healthcare professionals.Until the EUDAMED database is fully functional, the SSCPs for CERKAMED products can be found here.