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.

• This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on its website without editorial or peer review.

Creator

• Gillis, Kathryn Anna
• Keller, Joshua E
• Bindas, Mary Kathryn
• Jacobs, Samuel Donlon

Subject

• Health
• Security
• Well-Being
• Industry

Publisher

• Worcester Polytechnic Institute

Identifier

• E-project-050115-172541

Keyword

• Product safety
• Public health
• Medical care

Advisor

• Belz, Melissa
• Hou, Zhikun

Year

• 2015

Center

• Copenhagen, Denmark Project Center - IQP

Sponsor

•  Jensen, Sine
• Danish Consumer Council

Date created

• 2015-05-01

Location

• Copenhagen

Resource type

• Interactive Qualifying Project

Rights statement

• In Copyright