When Europe’s medical device directives were first introduced 25 years ago, they represented a novel, so-called “light touch” approach to the regulation of medical devices compared with the heavy hand of FDA. While the directives had their flaws, the system served the medical device industry and healthcare consumers relatively well. In particular, industry appreciated the predictability of the regulatory pathway and the timelines, and many U.S. medical device manufacturers famously adopted a “Europe first” strategy to bring products to the marketplace. Those days may be numbered. Tagging Options Domain:  All Sites Keywords:  medical Polymers read more

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Three ways the new EU medical device regulations will fundamentally affect your business