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Regulating human implant technologies in Europe - Understanding the new era in medical device regulation

Faulkner, Alex; Kent, Julie

Authors

Alex Faulkner

Julie Kent



Abstract

It has been suggested that we are entering a new era in medical device regulation in Europe. This paper discusses the implementation of the European Medical Devices Directive (EMDD) in EU member states with a particular focus on the UK. Case studies are then presented of two models of implant technologies-Trilucent breast implants and the 3M Capital hip prosthesis. Both have been withdrawn from the marketplace recently in controversial circumstances. Different aspects of regulatory activity are outlined with a bearing upon benefits and safety from national health services' and consumers' perspectives, and a number of issues concerned with the ability of regulatory mechanisms and practices to serve public health and safety are identified. Our analysis of the case studies draws parallels with studies of drug regulation, and explores the construction of risk and public participation in policy making. We argue that there are weaknesses in the regulation of medical devices and that commercial interests have dominated regulatory policy. Our case studies, however, suggest a shift towards a more user-oriented shaping of regulation.

Citation

Faulkner, A., & Kent, J. (2002). Regulating human implant technologies in Europe - Understanding the new era in medical device regulation. Health, Risk and Society, 4(2), 189-209. https://doi.org/10.1080/13698570220137060

Journal Article Type Article
Publication Date Jul 4, 2002
Journal Health, Risk and Society
Print ISSN 1369-8575
Publisher Taylor & Francis (Routledge)
Peer Reviewed Peer Reviewed
Volume 4
Issue 2
Pages 189-209
DOI https://doi.org/10.1080/13698570220137060
Keywords risk, regulation, medical devices, hip prostheses, breast implants
Public URL https://uwe-repository.worktribe.com/output/1082789
Publisher URL http://dx.doi.org/10.1080/13698570220137060
Additional Information Additional Information : The proportional contribution from Kent was 75%.


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