European Commission Adds To Advice On High Risk Device Safety And Performance Requirements

25 Mar 2022

The European Commission’s MDCG has issued revised guidance and advice on safety and clinical performance data required for implantable and class III devices under the MDR.

Concept of national healthcare system - EU - European Union

A revised document setting out the information that manufacturers of implantable and class III (high risk) devices are required to submit to be in compliance with the EU Medical Device Regulation has been released by the European Commission.

MDCG 2019-9 Rev.1 – “Summary of safety and clinical performance ̶ A guide for manufacturers and notified bodies” –...