We focus on a number of topic areas identified by state health policy leaders as important to population health.
Keep up with news and updates from the Milbank Memorial Fund. Get the latest from thought leaders, including Christopher F. Koller, president of the Fund.
We publish The Milbank Quarterly, as well as reports, issues briefs, and case studies on topics important to population health.
The Center for Evidence-based Policy at Oregon Health & Science University is a national leader in evidence-based decision making and policy design.
The Milbank Memorial Fund is an endowed operating foundation that publishes The Milbank Quarterly, commissions projects, and convenes state health policy decision makers on issues they identify as important to population health.
March 2014 (Volume 92)
March 2014 | Corinna Sorenson, Michael Drummond | Featured Article, Original Investigation
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.
Author(s): Corinna Sorenson, Michael Drummond
Keywords: medical devices, regulation, health care reform, comparative studies
Read on Wiley Online Library
Volume 92, Issue 1 (pages 114–150) DOI: 10.1111/1468-0009.12043 Published in 2014
Previous article
Commentary: Regulatory Reticence and Medical Devices
Next article
Trends in Health Care Financial Burdens, 2001 to 2009