MedTech Europe, AESGP, MedTech &Pharma Platform and COCIR would like to express their concern 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 result, unfortunately, the gap in clinical evidence expectations will persist – with serious consequences for our industry and for devices continuity.
This situation needs to be addressed by the European Commission and the EU Member States as a matter of priority to enable legacy medical devices and IVDs to transition on time and support the introduction of innovative technologies: