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

From Book News, Inc.
A guide for in vitro diagnostic medical device manufacturers who are interested in selling their products in Europe, providing a systematic comparison of the laws regarding the development, production, distribution, and use of such devices within the five states. The coverage is both very specific and selective, including the general features of the national requirements, different product classes, placing devices on the market, the conformity of business operations, distribution to the patient or user, and post-marketing control. Based on a report requested by the European Commission. No index. Annotation copyright Book News, Inc. Portland, Or.

Book 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.


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A guide for in vitro diagnostic medical device manufacturers who are interested in selling their products in Europe, providing a systematic comparison of the laws regarding the development, production, distribution, and use of such devices within the five states. The coverage is both very specific and selective, including the general features of the national requirements, different product classes, placing devices on the market, the conformity of business operations, distribution to the patient or user, and post-marketing control. Based on a report requested by the European Commission. No index. Annotation c. Book News, Inc., Portland, OR (booknews.com)


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