Leaflet: Towards a revised EU regulatory framework for medical devices
Posted on 07.05.2025
MedTech Europe has published a new leaflet outlining four urgent targeted measures to support an effective implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
The four targeted measures are urgently needed to improve system functionality and thus to ensure the availability of device in Europe and to restore the innovation-capacity and competitiveness of the medical technology sector. They are needed way before the broader legislative reform expected in 2026 will kick-in.
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.
The leaflet reflects the position and collective insights of our members and are intended to foster an active exchange with all stakeholders for solutions.
We invite you to share and use these resources for the ongoing discussions on a successful implementation of MDR and IVDR.
Download the leaflet below.