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

ISBN-13: 9789048144396 / Angielski / Miękka / 2010 / 118 str.

Bernhard M. Maassen; R. Whaite

Opis

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.

Spis treści

Preface; T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Five Separate Chapters on In vitro Diagnostic Medical Devices (IVDMD) in the U.K., France, Germany, Italy and Spain, including: 1. General Features of National Regulation. 2. Different Product Classes and their Definitions: Underlying Rationale for Separate Legal Treatment. 3. Substantive Requirements Relating to the Placing of IVDMDs on the Market. 4. The Procedures Relating to the Establishment of the Conformity of IVDMD Business Operations and of IVDMDs against Operation-Related and/or Product-Related Requirements, Taking Existing Product Classes into Account. 5. Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account. 6. Post-Marketing Control. Chapter 6: Summary of Findings of the National Reports.