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

Sorenson, Corinna and Drummond, Michael (2014) Improving medical device regulation: the United States and Europe in perspective. The Milbank Quarterly, 92 (1). pp. 114-150. ISSN 0887-378X

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Identification Number: 10.1111/1468-0009.12043


Context 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. Methods We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed 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 real-world use, and exchanging pertinent information on devices with key users such 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 high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices.

Item Type: Article
Additional Information: © 2014 Milbank Memorial Fund
Divisions: Management
Subjects: R Medicine > R Medicine (General)
Sets: Departments > Management
Research centres and groups > Information Systems and Innovation Group
Date Deposited: 18 Jul 2014 09:52
Last Modified: 20 Oct 2020 07:18

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