Regulation of Medical Devices in the United States and European Union

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.

Key Findings:

  • Systems for medical device approval must bear in mind the safety of the patient, as well as the pathway in which it reaches the market.  While both the U.S. and E.U. share common goals, they do so “ … with some marked contrasts in their approaches.”
  • While neither system should be considered as having a better approach, they do need to consider areas for improvement and reform while continuing to address the need for policy adjustment and modification.

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