In vitro diagnostic medical devices : law and practice in five EU member states : France, Germany, Italy, Spain, and the United Kingdom / Bernhard Maassen ... [and others] ; editors, Bernhard Maassen, Robin Whaite
Published
Dordrecht ; Boston : Kluwer Academic Publishers, [1994]
Machine derived contents note: 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
