Joint discussion paper on the future governance of medical technologies in Europe

In this joint discussion paper, which builds on MedTech Europe’s 2023 position paper, the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM and FIDE, makes the case for a reform of the way that European regulatory system for medical technologies is governed. ​

The document emphasizes the importance of first establishing key guiding principles for a patient-centric and empowered medical technology specific single governance structure, which will ensure availability of safe devices for patients, health professionals and health systems. The joint paper clearly outlines the roles and responsibilities that need to be centralized and reshaped under this structure in order to deliver on this goal:​

• Notified Body oversight & harmonization​
• Dedicated pathways, such as innovation, orphan devices and unmet need​
• Promoting alignment internationally & within EU legislation ​
• Appeal possibility & resolution of disputes​
• Guidance development & harmonized application​
• Stakeholder engagement​
• Innovation & Competitiveness​
• Accountability​

Once these foundational elements are in place, a detailed impact assessment can be carried out to define the optimal setup and functioning of the central structure. ​

This discussion paper is meant to facilitate and stimulate exchanges with all involved stakeholders.​

Read full discussion paper in the report below.​