EU: New MDCG guidance on “Summary of Safety and Clinical Performance” under the Medical Devices Regulation (MDR)

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 (MDR) which will become applicable 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 Summary of Safety and Clinical Performance (SSCP). Once drafted, the SSCP shall be validated by the notified body which will then make it available to the public via the European database on medical devices (Eudamed).

The guidance includes a number of recommendations regarding the preparation of a SSCP and includes also a template for the SSCP.

The guidance can be found here: Guidance on Summary of Safety and Clinical Performance.

 

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