Eucomed urges EU lawmakers to grasp medtech needs
This article was originally published in SRA
Executive Summary
The diverse nature of the medical devices industry means that it is inappropriate to try and apply the same type of regulations to all devices and create a “one-size-fits-all regulatory” approach. The European Commission’s proposed Medical Device Regulation is a complex technical dossier that addresses an industry with products ranging from low- to high-risk and therefore must not be treated as a single homogenous group.