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AuthorMaassen, Bernhard. author
TitleIn vitro Diagnostic Medical Devices [electronic resource] : Law and Practice in Five EU Member States: France, Germany, Italy, Spain and the United Kingdom / by Bernhard Maassen, Robin Whaite, Wilhelm Kewenig, Giovanni Forlani, Jeremy Marriage, Gonzalo Ulloa ; edited by Bernhard Maassen, Robin Whaite
ImprintDordrecht : Springer Netherlands : Imprint: Springer, 1994
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Descript XIV, 118 p. online resource


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


1 Law and Practice in France -- 2 Law and Practice in the Federal Republic of Germany -- 3 Law and Practice in Italy -- 4 Law and Practice in Spain -- 5 Law and Practice in The United Kingdom -- 6 Summary of Findings of the National Reports

Law Laboratory medicine Commercial law Medical laws and legislation Public international law Law Medical Law Commercial Law Laboratory Medicine Public International Law


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