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.
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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:
• Clinical strategy is developed by the manufacturer far in advance (months or even years) before the application for MDR/IVDR conformity assessment; hence the need to discuss it before submission of the application for conformity assessment.
• Early alignment on expectations in this area between the manufacturer and the Notifies Body leads to dossiers of better quality and, in turn, reduction of conformity assessment timelines.
• The lack of possibility to discuss clinical strategy pre-submission is expected to have a particularly negative effect on small & medium sized enterprises. Due to their limited resources (financial and personnel) and the already high regulatory burden it will be extremely difficult for SMEs to perform re-working of applications and it might be impossible to re-invest in new data gathering projects…
