Danish Consumer Council
Recent concern has arisen over multi-national medical device manufacturers using European patients as metaphorical guinea pigs for testing their devices before seeking approval in stricter regulatory environments. We worked with the Danish Consumer Council to recommend changes to European Union medical device regulation that should help improve patient safety without stifling innovation. We gathered public opinion regarding medical device safety through a survey, and conducted in-depth interviews with key stakeholders. Our end result is a set of proposed reforms to the current EU regulations, including increasing transparency and requiring more clinical trials. Our sponsor will use these recommendations in policy discussion to influence legislation that will increase patient safety.
Worcester Polytechnic Institute
Interactive Qualifying Project
All authors have granted to WPI a nonexclusive royalty-free license to distribute copies of the work, subject to other agreements. Copyright is held by the author or authors, with all rights reserved, unless otherwise noted.