Both the United States (U.S.) and the European Union (E.U.) employ different systems and regulation policies on the approval and marketing procedures for medical devices. This article looks at their differences, challenges they face, and offers recommendations for improvement.
Issues regarding mandates, centralization, data requirements, transparency, funding, access, and how the approval systems differ among the two bodies are discussed in this article. The device-approval system in the E.U. has often been compared with the U.S. and reports suggest that patients in the E.U. have access to medical devices long before patients in the United States.