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