In vitro Diagnostic Medical Devices

Law and Practice in Five EU Member States: France, Germany, Italy, Spain and the United Kingdom

  • Bernhard Maassen
  • Robin Whaite
  • Wilhelm Kewenig
  • Giovanni Forlani
  • Jeremy Marriage
  • Gonzalo Ulloa
  • Bernhard Maassen
  • Robin Whaite

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 1-26
  3. Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 27-58
  4. Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 59-77
  5. Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 78-83
  6. Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 84-104
  7. Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa
    Pages 105-117

About this book

Introduction

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.

Keywords

English European Union (EU) Germany

Authors and affiliations

  • Bernhard Maassen
    • 1
  • Robin Whaite
    • 2
  • Wilhelm Kewenig
    • 3
  • Giovanni Forlani
    • 4
  • Jeremy Marriage
    • 5
  • Gonzalo Ulloa
    • 6
  1. 1.Hengeler Mueller Weitzel WirtzBrusselsBelgium
  2. 2.Linklaters & PainesLondonUK
  3. 3.Hengeler Mueller Weitzel WirtzFrankfurtBelgium
  4. 4.Studio Legale de Berti & JacchiaMilanItaly
  5. 5.Linklaters & PainesParisFrance
  6. 6.Gomez-Acebo & PomboMadridSpain

Editors and affiliations

  • Bernhard Maassen
    • 1
  • Robin Whaite
    • 2
  1. 1.Hengeler Mueller Weitzel WirtzBrusselsBelgium
  2. 2.Linklaters & PainesLondonUK

Bibliographic information

  • DOI https://doi.org/10.1007/978-94-015-8319-0
  • Copyright Information Springer Science+Business Media B.V. 1994
  • Publisher Name Springer, Dordrecht
  • eBook Packages Springer Book Archive
  • Print ISBN 978-90-481-4439-6
  • Online ISBN 978-94-015-8319-0
  • About this book
Industry Sectors
Biotechnology
Consumer Packaged Goods
Pharma