Brussels, 27 February 2025 – 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.
In this joint position paper, we:
- Outline the reasons why the timing of these discussions is of key importance
- Suggest concrete principles for how the discussion on clinical strategy could work in practice
- Call on the European Commission and the EU Member States to address this situation as a matter of priority via the foreseen implementing act for the application of uniform rules for Notified Body requirements.
Document
Read the joint paper below.