RQM+ Blog Greenlit in Europe, Grounded in America: A Medtech Paradox

Despite growing complaints that the EU-MDR is choking MedTech innovation, recent regulatory outcomes reveal a more complex truth. Several medium- and high-risk devices, such as Boston Scientific's ACURATE valve and Becton Dickinson's Phasix mesh, have earned CE marking under the MDR, yet failed or stalled in the U.S. due to lacking clinical evidence. This article argues that innovation isn't being stifled by MDR; it's being redefined through a framework of transparency, post-market evidence, and proportionality. If innovation is struggling, it may be due to resistance against these evolving standards, not the standards themselves.