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2019 J. Int'l Com. & Econ. 1 (2019)
The EU Medical Device Regulation and the U.S. Medical Device Industry

handle is hein.journals/jice2019 and id is 217 raw text is: The EU Medical Device Regulation and the U.S. Medical Device Industry Brian Daigle and 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. Suggested citation: Daigle, Brian and Mihir Torsekar. The EU Medical Device Regulation and the U.S. Medical Device Industry. Journal of International Commerce and Economics. November 2019. https://www.usitc.gov/joumals. This article is the result of the ongoing professional research of U.S. Internationli Trade Coiiission (ITC) staff and is solely ieant to represent the opinions and professional research of the authors. It is not ieant to represent in any way1 the v icws of the USITC or an\ of its individual Coiiissioners. Please direct all correspondence to Brian Daigle at briandaica(usitc.gol and Mihir Torsekar at niiir.torsekar ,usitc.gol . Journal of International Commerce and Economics |1

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