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

Erscheinungsjahr 2013
ISBN: 978-94-015-8319-0
Verlag: Springer Netherland
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 118 Seiten, eBook

Preface by T. Morrison,Director-General of the European DiagnosticManufacturers 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 invitro 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.

Maassen, Bernhard M.

Whaite, R.

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.