NBCG-Med and Team-NB Position Paper: Notified Body Perspective on the Future Governance of the EU Medical Device Sector

This document, co-authored by the executive committees of NBCG-Med and Team-NB, reflects the common vision of notified bodies on the necessary evolution of the European regulatory framework.

Objective:

To propose a more coherent, transparent, and sustainable governance model, incorporating:

• The creation of a centralized Medical Device Coordination Office (MDCO) for effective coordination,
• A strengthening of the role of notified bodies as technical and clinical partners,
• Specific assessment pathways for innovative or rare devices,
• An early advice mechanism to support manufacturers with technical and clinical guidance upstream of the conformity assessment process.

This document is a continuation of recent European discussions on health strategy and improving the legislative framework regarding devices.

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