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About this book
Contributors: W. Kewenig; G. Forlani, J. Marriage, G. Ulloa
This book is based upon a report prepared at the request of the European Commission. Its purpose is to set out the existing laws regulating the development, production, distribution and use of in vitro diagnostic medical devices (IVDMD) in the U.K., Germany, France, Italy and Spain. Each national section has the same structure and covers the same ground in order to enable comparisons. IVDM Devices includes not only reagents, but also technical instruments, or combination of both, for human use. The book is directed towards industry and the regulation is covered with a high degree of specificity. This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available. It is also the most convenient means of comparing those laws. As such, it will be a useful guide to all IVDM Devices manufacturers interested in the European market.
Authors, Editors and Affiliations
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Hengeler Mueller Weitzel Wirtz, Brussels, Belgium
Bernhard Maassen, Bernhard Maassen
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Linklaters & Paines, London, UK
Robin Whaite, Robin Whaite
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Hengeler Mueller Weitzel Wirtz, Frankfurt, Belgium
Wilhelm Kewenig
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Studio Legale de Berti & Jacchia, Milan, Italy
Giovanni Forlani
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Linklaters & Paines, Paris, France
Jeremy Marriage
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Gomez-Acebo & Pombo, Madrid, Spain
Gonzalo Ulloa
Bibliographic Information
Book Title: In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States
Authors: Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
Editors: Bernhard Maassen, Robin Whaite
DOI: https://doi.org/10.1007/978-94-015-8319-0
Publisher: Springer Dordrecht
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eBook Packages: Springer Book Archive
Copyright Information: Springer Science+Business Media B.V. 1994
Hardcover ISBN: 978-0-7923-2996-1Published: 30 November 1994
Softcover ISBN: 978-90-481-4439-6Published: 01 December 2010
eBook ISBN: 978-94-015-8319-0Published: 09 March 2013
Edition Number: 1
Number of Pages: XIV, 118
Topics: Medical Law, Commercial Law, Laboratory Medicine, Public International Law