The Medical Device Coordination Group
published in April 2020 MDCG 2020-6, a guide
for manufacturers and notified bodies on
Regulation (EU) 2017/745: Clinical evidence
needed for medical devices previously CE
marked under Directives 93/42/EEC or
90/385/EEC. This document seeks to provide guidance for
clinical data collection providing sufficient clinical evidence necessary to demonstrate conformity of legacy devices with the relevant General
Safety and Performance Requirements (GSPRs),
as per Article 61(1) of the Medical Device Regulation (MDR) 2017/745.
Download this White Paper to read all about the impact of MDCG 2020-6 on clinical investigations under MDR.