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.
The European Commission published a proposal for new European medical device regulations in September 2012. The regulations have been moving through the legislative process ever since, and most observers expect them to be published in late 2015.
While the final text of the regulation is still being massaged, there are some key aspects that will have a profound impact on medical device manufacturers, as well as their suppliers, doing business in the European Union, the second largest medtech market in the world. Those elements include the requirement to hire a Qualified Person, the institutionalization of unannounced audits, and the establishment of a scrutiny procedure, which could cause delays in bringing products to market.