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The EU Medical Device Regulation and the U.S. Medical Device Industry

Author(s)

Brian Daigle , Mihir Torsekar


Abstract

The United States has long had the world’s most successful medical device (or medtech) industry, with the European Union (EU) serving as its largest export market. The trading bloc’s reputation for relatively timely market approvals has long benefited these U.S. manufacturers. However, the EU’s soon-to-be-implemented Medical Device Regulation (MDR)—an overhaul of the previous medtech regulatory regime—may present a number of obstacles for U.S. and other medtech firms that could limit their access to a critical market.