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In Vitro Diagnostic Medical Devices : Law and Practice in Five Eu Member States - Bernhard M. Maassen

In Vitro Diagnostic Medical Devices

Law and Practice in Five Eu Member States

By: Bernhard M. Maassen (Editor), Robin Whaite (Editor)

Hardcover Published: 30th November 1994
ISBN: 9780792329961
Number Of Pages: 118

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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.

Editor's Note
Preface
Law and Practice in Francep. 1
General Featuresp. 1
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatmentp. 4
Substantive Requirements Relating to the Placing of IVDMDs on the Marketp. 7
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 Accountp. 12
The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Accountp. 16
Post-Marketing Control: Quality Control Applicable to Laboratoriesp. 19
Law and Practice in the Federal Republic of Germanyp. 27
General Features of National Regulationp. 27
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatmentp. 28
Substantive Requirements Relating to the Placing of IVDMDs on the Marketp. 34
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 Accountp. 47
The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Accountp. 55
Post-Marketing Control: the Requirements Relating to the Control of the Reliability of IVDMDs in View of Their Usep. 57
Law and Practice in Italyp. 59
General Features of National Regulationp. 59
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatmentp. 62
Substantive Requirements Relating to the Placing of IVDMDs on the Marketp. 63
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 Accountp. 68
The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Accountp. 75
Post-Marketing Control: the Requirements Relating to the Control of the Reliability of IVDMDs in View of Their Usep. 77
Law and Practice in Spainp. 78
General Features of National Regulationp. 78
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatmentp. 80
Substantive Requirements Relating to the Placing of IVDMDs on the Marketp. 80
Procedures Relating to the Establishment of the Conformity of IVDMD Business Operations and of IVDMDs Against Operation-Related and/or Product-Related Requirementsp. 81
Requirements Relating to the Distribution of IVDMDs to the Patient/Userp. 82
Post-Marketing Controlp. 82
Law and Practice in The United Kingdomp. 84
General Features of National Regulationp. 84
Different Product Classesp. 85
Substantive Requirements Relating to the Placing of IVDMDs on the Marketp. 86
Procedures Relating to the Establishment of the Conformity of IVDMD Business Operations and of IVDMDs against Operation-Related and/or Product-Related Requirementsp. 100
Requirements Relating to the Distribution of IVDMDs to the Patient/Userp. 101
Post-Marketing Controlp. 103
Summary of Findings of the National Reportsp. 105
General Overviewp. 105
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatmentp. 107
Substantive Requirements Relating to the Placing of IVDMDs on the Marketp. 108
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 Accountp. 113
Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Accountp. 115
Post-Marketing Control: Requirements Relating to Control of Reliability of IVDMDs in View of Their Usep. 116
Table of Contents provided by Blackwell. All Rights Reserved.

ISBN: 9780792329961
ISBN-10: 0792329961
Audience: General
Format: Hardcover
Language: English
Number Of Pages: 118
Published: 30th November 1994
Publisher: Springer
Country of Publication: NL
Dimensions (cm): 23.39 x 15.6  x 0.97
Weight (kg): 0.37

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