Europe’s new MDR: Is it as scary as you might think?
Chris Newmarker
Editor in Chief of MassDevice, Medical Design & Outsourcing and other Life Sciences publications at WTWH Media | Supporting life sciences innovation with impactful stories
The European Union’s regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off.
In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside Boston.