Item Details

In Vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States : France, Germany, Italy, Spain, and the United Kingdom

Bernhard Maassen ... [et al.] ; editors, Bernhard Maassen, Robin Whaite
Format
Book
Published
Dordrecht ; Boston : Kluwer Academic Publishers, c1994.
Language
English
ISBN
0792329961, 9780792329961
Related Resources
Publisher description Table of contents only
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.
Description
xi, 117 p. ; 25 cm.
Technical Details
  • Access in Virgo Classic

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    a| In vitro diagnostic medical devices : b| law and practice in five EU member states : France, Germany, Italy, Spain, and the United Kingdom / c| Bernhard Maassen ... [et al.] ; editors, Bernhard Maassen, Robin Whaite.
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    a| Dordrecht ; a| Boston : b| Kluwer Academic Publishers, c| c1994.
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    a| xi, 117 p. ; c| 25 cm.
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    a| 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.
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    a| 17
    650
      
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    a| Diagnostic equipment industry x| Law and legislation z| European Economic Community countries.
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    a| Prenatal care x| Law and legislation z| European Economic Community countries.
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    a| Prenatal diagnosis z| European Economic Community countries.
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    a| Laboratoriumdiagnostiek. 2| gtt
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    a| Prenatale diagnose. 2| gtt
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    a| Diagnostics x| Appareils et matériel x| Industrie x| Droit z| Pays de l'Union européenne.
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    a| Soins prénatals x| Droit z| Pays de l'Union européenne.
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    a| Diagnostics prénatals z| Pays de l'Union européenne.
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    a| Medical equipment
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    a| Europe
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    a| Maassen, Bernhard.
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    a| Whaite, Robin.
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    a| KJC6229 .M42 I5 1994 w| LC i| 35007002287922 l| STACKS m| LAW t| BOOK

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