Industry Estimates $23B in Added Costs Related to EU Device Reg Revisions

All of the proposals to overhaul EU medical device regulations will come at a cost to devicemakers, with some expecting the tab at upward of US $23 billion, according to a survey by Eucomed. The trade group asked 19 companies of ranging sizes to determine the cost implications between 2015 and 2020 for the requirements in the proposed medical device and in vitro diagnostic device regulations, now being debated by lawmakers in the EU Parliament’s Committee on the Environment, Public Health and Food Safety.
International Medical Device Regulatory Monitor