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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States

  • Book
  • © 1994

Overview

Authors:
  1. Bernhard Maassen

    1. Hengeler Mueller Weitzel Wirtz, Brussels, Belgium

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  2. Robin Whaite

    1. Linklaters & Paines, London, UK

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  3. Wilhelm Kewenig

    1. Hengeler Mueller Weitzel Wirtz, Frankfurt, Belgium

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  4. Giovanni Forlani

    1. Studio Legale de Berti & Jacchia, Milan, Italy

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  5. Jeremy Marriage

    1. Linklaters & Paines, Paris, France

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  6. Gonzalo Ulloa

    1. Gomez-Acebo & Pombo, Madrid, Spain

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Editors:
  1. Bernhard Maassen

    1. Hengeler Mueller Weitzel Wirtz, Brussels, Belgium

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  2. Robin Whaite

    1. Linklaters & Paines, London, UK

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Table of contents (6 chapters)

  1. Front Matter

    Pages i-xiii
    Download chapter PDF

  2. Law and Practice in France

    • Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 1-26

  3. Law and Practice in the Federal Republic of Germany

    • Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 27-58

  4. Law and Practice in Italy

    • Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 59-77

  5. Law and Practice in Spain

    • Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 78-83

  6. Law and Practice in the United Kingdom

    • Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 84-104

  7. Summary of Findings of the National Reports

    • Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 105-117
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About this book

Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association.
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

  • Hengeler Mueller Weitzel Wirtz, Brussels, Belgium

    Bernhard Maassen, Bernhard Maassen

  • Linklaters & Paines, London, UK

    Robin Whaite, Robin Whaite

  • Hengeler Mueller Weitzel Wirtz, Frankfurt, Belgium

    Wilhelm Kewenig

  • Studio Legale de Berti & Jacchia, Milan, Italy

    Giovanni Forlani

  • Linklaters & Paines, Paris, France

    Jeremy Marriage

  • 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

  • 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

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