Jul 2013

Author: Jean-Pierre Boutrand, DVM


The EU has the second largest medical device market globally, with emerging technologies typically available 2-3 years ahead of the US market and 5 years ahead of the Japanese market. Two recent high-profile medical device cases have created controversy within the EU medical device regulatory framework and led to a push to replace the former, less restrictive EU Medical Device Directive (MDD) with more formalized (although still not binding) device regulations and biocompatibility testing requirements. This white paper reviews the context that led to the political momentum for more regulation of medical devices in the EU, the potential impact of the new medical device regulations, and the effects this change may have on the time frame for approval and implementation of medical devices.