MedTech Europe, AESGP, MedTech & Pharma Platform and COCIR would like to express their concerns that the recently updated MDCG 2019-6: Requirements relating to notified bodies revision 5, while providing further framework for structured dialogue, has not addressed the ongoing absence of clinical strategy discussion in the pre-submission space. As a consequence, the gap in clinical evidence expectations will persist – with serious consequences for our industry and for the continuity of devices.
It must be urgently clarified that pre-submission dialogue between Notified Bodies and manufacturers can include a high-level discussion of the manufacturer’s proposed clinical strategy…
