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Improving Medical Device Regulation: The United States and Europe in Perspective

Published on Mar 1, 2014in Milbank Quarterly7.425
· DOI :10.1111/1468-0009.12043
Corinna Sorenson14
Estimated H-index: 14
(LSE: London School of Economics and Political Science),
Michael Drummond73
Estimated H-index: 73
(Ebor: University of York)
Sources
Abstract
Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States andEuropetoensuretheirperformance,safety,andquality.Thisarticleprovides 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. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peerreviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring realworlduse,andexchangingpertinentinformationondeviceswithkeyuserssuch as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring
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