Improving medical device regulation: the United States and Europe in perspective

Corinna Sorenson, Michael Drummond

Research output: Contribution to journalArticlepeer-review


Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients.
Original languageEnglish
Pages (from-to)114-50
Number of pages37
JournalThe Milbank Quarterly
Issue number1
Publication statusPublished - Mar 2014

Bibliographical note

© 2014 Milbank Memorial Fund.


  • Medical devices
  • Regulation
  • Health care reform
  • Comparative studies

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