Smarter MDR and IVDR oversight for safer and more innovative medical technologies

MedTech Europe, together with six other associations, developed a joint position paper highlighting how the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) simplification proposal provide a more proportionate approach to life-cycle oversight.

Europe needs a regulatory system that protects patients while supporting innovation and competitiveness. The proposed simplification of the MDR and IVDR offers a more proportionate and efficient approach to life cycle oversight.

While the regulations have strengthened safety, they have also increased complexity, costs and administrative burden, particularly for small and medium-sized enterprises. This risks reducing the availability of essential medical technologies.

The European Commission’s proposal introduces a more targeted, risk-based model. By removing duplicative processes and focusing oversight where risks are highest, it enables earlier detection of safety issues and better use of regulatory resources.

Notified bodies and authorities can prioritise meaningful surveillance rather than routine tasks, while core responsibilities across the product life cycle remain unchanged.

A simpler system does not reduce safety. It strengthens it by focusing effort where it matters most, supporting innovation and ensuring patients continue to benefit from safe and effective medical technologies.

Read our joint position paper below.