Open letter to EU Commissioner for Health

Posted on 05.10.2023

On 14 September, together with 34 national associations, MedTech Europe has sent an open letter to Commissioner for Health, Stella Kyriakides, regarding the need for comprehensive structural reform in the European regulatory framework for medical technologies (IVDR and MDR).

MedTech Europe acknowledges the considerable work which has been done by the European Commission and Medical Device Coordination Group (MDCG) to address the short-term implementation challenges. But reaching the objectives of the IVDR and MDR in full will require comprehensive change across the areas of efficiency, innovation, and governance – all while maintaining the highest standards of patient safety.

In our letter, we ask the European Commission to elevate these pressing issues in relevant health policy debates and work with all medical technology stakeholders to jointly craft lasting solutions.

For further information, please contact Petra Zoellner, Director IVDR-MDR or Merlin Rietschel, Senior Manager IVDR-MDR.