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

1994
ISBN: 978-0-7923-2996-1
Verlag: Springer Netherlands

Buch, Englisch, 118 Seiten, HC runder Rücken kaschiert, Format (B × H): 160 mm x 241 mm, Gewicht: 377 g

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.

Zielgruppe

Research

Autoren/Hrsg.

Whaite, R.

Maassen, Bernhard M.

Fachgebiete

• Rechtswissenschaften Öffentliches Recht Medizin- und Gesundheitsrecht Arzneimittelrecht und Medizinprodukterecht, Apothekenrecht, Krankenhausrecht
• Rechtswissenschaften Internationales Recht und Europarecht Europarecht Europäisches Verwaltungs-, Umwelt- und Gesundheitsrecht
• Rechtswissenschaften Internationales Recht und Europarecht Europarecht Europäisches Handels-, Wirtschafts- und Gesellschaftsrecht, Währungsrecht
• Rechtswissenschaften Wirtschaftsrecht Gewerblicher Rechtsschutz Wettbewerbs- und Kartellrecht, Werberecht
• Rechtswissenschaften Ausländisches Recht Common Law (UK, USA, Australien u.a.)
• Rechtswissenschaften Recht, Rechtswissenschaft Allgemein Rechtsvergleichung
• Rechtswissenschaften Ausländisches Recht Westeuropa, Südeuropa

Inhaltsverzeichnis

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.