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A New Model for European Medical Device Regulation; A Comparative Legal Analysis in the EU and the USAAuthor: Dr. S. Frank, Dutch Ministry of Justice, October 2003, 311p. Binding: hardback. ISBN: 9076871183. Price: €62, $104. Language: English. |
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About the bookThis book analyses the regulation of medical devices at the federal level in the United States and in the European Union. It covers fundamental aspects (substantive and procedural) of the regulation of medical devices in both regimes, in order to assess the current European institutional framework. The author proposes regulatory reforms for the regulation of medical devices. It is suggested to create a new Community body, the European Medical Device Agency. The US Food and Drug Administration has served as a source of inspiration. This book gives answers to the question why a European Medical Device Agency is needed, its legal implications and its competences and structure (including how to organise all relevant parties concerned). It is proposed that the European Medical Device Agency should have a central role in the regulation of medical devices throughout the European Union. |
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About the authorSharon Frank (1972, Utrecht, the Netherlands) studied law at the Free University of Amsterdam, the University of Amsterdam, the Hebrew University in Jerusalem and Saint Louis University School of Law (US). From 1999-2002 she was a Ph.D candidate at the E.M.Meijers Institute for Legal Studies at Leyden University. In the frameworkof her Ph.D research, she visited the European University Institutein Florence in 2001. In 2000-2002 she was affiliated with the University of Amsterdam, lecturing European law at the Europa Institute and the Tulane-Amsterdam Summer School. Since 2003 she has been working at the Dutch Ministry of Justice. |
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ReviewsClinica 1082, November 7, 2003:
The Regulatory Affairs Journal, 2004, p. 3-5: "a comprehensive work"; "Ms Frank covers a number of issues that are extremely relevant today"; "In conclusion, the book may become a valuable reference. It raises a number of important issues".
Jason Bright (Barlow, Lyde & Gilbert; London, UK) in Journal of Medical Device Regulation, 2005, 2(4), 76: "there is no doubt that this book would be an extremely valuable addition to any manufacturer’s library."
Christopher Hodges in 128 MEDICAL LAW REVIEW [2005]: "stimulating book"; "This work is to be commended in exploring new and important ground." |
Europa Law PublishingPO Box 6047
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