[co-author: Grégoire Paquet]
On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation 2017/745 (MDR) which will enter into application in May 2020.
Article 32 of the MDR provides that for implantable devices and for Class III devices, other than custom-made or investigational devices, manufacturers shall draw up a SSCP. Once drafted, the SSCP shall be validated by the relevant notified body which will then make it available to the public via the European database on medical devices (Eudamed).
2. General requirements and recommendations for the SSCP
The Guidance includes a number of recommendations regarding the preparation of a SSCP. These include the following recommendations:
3. Specific requirements for the sections of the SSCP document
Article 32 (2) of the MDR provides the different elements that must appear in the SSCP. The MDCG’s document provides guidance on the content of each of the following required sections of the SSCP document:
The Guidance also includes a template for the SSCP.