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In vitro diagnostic medical devices : law and practice in five EU member states : France, Germany, Italy, Spain, and the United Kingdom
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In vitro diagnostic medical devices : law and practice in five EU member states : France, Germany, Italy, Spain, and the United Kingdom

Author: Bernhard Maassen; Robin Whaite; et al
Publisher: Dordrecht ; Boston : Kluwer Academic Publishers, ©1994.
Edition/Format: Book : English
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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Bernhard Maassen; Robin Whaite; et al
ISBN: 0792329961 9780792329961
OCLC Number: 30700255
Description: xi, 117 p. ; 25 cm.
Contents: Ch. 1. Law and Practice in France. 1. General Features. 2. The 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. The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account. 6. Post-Marketing Control: Quality Control Applicable to Laboratories -- Ch. 2. Law and Practice in the Federal Republic of Germany. 1. General Features of National Regulation. 2. The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatment. 3. Substantive Requirements Relating to the Placing of IVDMDs on the Market.
Responsibility: Bernhard Maassen ... [et al.] ; editors, Bernhard Maassen, Robin Whaite.
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