Theme Summary of Safety and Clinical Performance (SSCP)
Target Audience Manufacturers, Notified Bodies
Products Concerned Implantable and Class III Devices

Products listed in Annex 16 eligible

Regulatory reference MDR (EU) 2017/745

Article 32

Documents mentioned EN ISO 14971 :2012

 

This document clarifies the format, content and validation of the Summary of Safety and Clinical Performance, which is mandatory for implantable medical devices and Class III devices (including eligible Annex XVI products).