Free Shipping In the UK
Currency:
GBP £ GBP
In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States By Edited by Bernhard M. Maassen

In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States
by Edited by Bernhard M. Maassen

In Stock
£97.99
This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available.
Only 1 left

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


In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States by Edited by Bernhard M. Maassen

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.

Why buy from World of Books

Our excellent value books literally don't cost the earth
Free delivery in the UK
Read more here
Every used book bought is one saved from landfill

Table of Contents


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.

Additional information

GOR010204778
In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States by Edited by Bernhard M. Maassen
Edited by Bernhard M. Maassen
Used - Very Good
Hardback
Springer
1994-11-30
118
0792329961
9780792329961
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
This is a used book - there is no escaping the fact it has been read by someone else and it will show signs of wear and previous use. Overall we expect it to be in very good condition, but if you are not entirely satisfied please get in touch with us.