On July 28th, 2025, TEAM-NB and NBCG-Med released a position paper proposing a new centralized governance structure for the EU medical device sector.
The document recommends the creation of a Medical Device Coordination Office (MDCO) to:
- Coordinate the designation and monitoring of Notified Bodies;
- Harmonize classification and technical guidance;
- Facilitate early regulatory dialogue for innovative devices;
- Support pediatric, orphan, and emerging technologies.
These proposals aim to strengthen consistency and efficiency across the MDR/IVDR framework, addressing long-standing challenges in the European regulatory landscape.
👉 At the Instituto Pedro Nunes (IPN), we closely follow regulatory developments and provide expert support to medical device companies throughout their compliance journey — from market access strategy to technical documentation.
Our mission is to help innovative companies bring safe, effective medical devices to the EU market with confidence.
🔗 Read the full position paper (PDF)