Towards a revised EU Regulatory Framework for medical devices

MedTech Europe has developed concise one-pagers outlining how to support the effective implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), ahead of the broader legal reform expected in 2026.

Targeted at a broad and non-technical audience, these one-pagers summarise our recommendations on four key areas where urgent targeted measures will help improve system functionality and sustainability:

1. Make initial product approval faster, more efficient, predictable and less costly.
2. Make change notification processes faster, more efficient, predictable and less costly.
3. Introduce a dedicated and accelerated pathway for breakthrough innovations.
4. Shift to lifetime risk-based certification to reduce duplication and lower burden.

These documents reflect the collective insights and positions developed in collaboration with our members and are intended as tools to foster continued dialogue with all stakeholders.

We invite all stakeholders to share and use these resources as part of ongoing discussions to ensure the successful implementation of MDR and IVDR.

Download the one-pagers below.