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

Corinna Sorenson; Michael Drummond

doi:10.1111/1468-0009.12043

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

Corinna Sorenson, Michael Drummond

Centre for Health Economics

Research output: Contribution to journal › Article › peer-review

Abstract

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 language	English
Pages (from-to)	114-50
Number of pages	37
Journal	The Milbank Quarterly
Volume	92
Issue number	1
DOIs	https://doi.org/10.1111/1468-0009.12043
Publication status	Published - Mar 2014

Bibliographical note

Keywords

Medical devices
Regulation
Health care reform
Comparative studies

Access to Document

10.1111/1468-0009.12043

Cite this

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abstract = "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.",

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