As part of MTE’s advocacy efforts on the Future of Regulatory System they are pleased to share the new leaflet outlining four key urgent targeted measures. Our sector calls for these key targeted measures to support the implementation of the MDR & IVDR. They should kick-in urgently and ahead of the anticipated legal reform in 2026.
The four targeted measures describe the following critical topics:
- Make initial product approval faster, more efficient, predictable and less costly.
- Make change notification processes faster, more efficient, predictable and less costly.
- Introduce a dedicated and accelerated pathway for breakthrough innovations.
- Shift to lifetime risk-based certification to reduce duplication and lower burden.
