Urgent call for clarity on clinical strategy discussions

Posted on 06.03.2025

MedTech Europe, the European Self-Care Industry Association (AESGP), the MedTech & Pharma Platform and COCIR have expressed their concerns that the recently updated Medical Device Coordination Group (MDCG) 2019-6 Requirements relating to notified bodies revision 5, although providing further framework for structured dialogue, has not addressed the ongoing absence of clinical strategy discussion in the pre-submission space. Therefore, 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.. 

Read the joint paper here. 

For more information, please contact Jana Russo, Manager Medical Devices.