| In Vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States Contributor(s): Maassen, Bernhard M. (Editor), Whaite, R. (Editor) |
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ISBN: 9048144396 ISBN-13: 9789048144396 Publisher: Springer OUR PRICE: $104.49 Product Type: Paperback - Other Formats Published: December 2010 |
| Additional Information |
| BISAC Categories: - Medical | Laboratory Medicine - Law | Medical Law & Legislation - Law | International |
| Dewey: 341 |
| Physical Information: 0.28" H x 6.14" W x 9.21" (0.43 lbs) 118 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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. |