Medtech Insight

Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR

19 Sep 2023

The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?

Graphic of two people pushing a cube and a cylinder — Industry Believes Vital Building Blocks Are Missing From The EU Medtech Regulations • Source: Shutterstock

No less than 35 medtech organizations have signed an open letter to the European Commission calling for urgent and comprehensive structural reform of the EU’s Medical Device Regulation (MDR) and the IVD Regulation (IVDR).

They are asking the commission to formally elevate the need for comprehensive structural reforms within Europe’s health policy debates.