Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts
Abstract
Background
Medical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood.Methods
The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Authority website to determine the...Paper Details
Title
Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts
Published Date
May 15, 2011
Journal
Volume
1
Issue
1
Pages
e000155 - e000155
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Notes
History