In vitro Diagnostic Medical Devices

Law and Practice in Five EU Member States

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

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Hardcover | 30 November 1994

At a Glance

Hardcover
136 Pages

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24.77 x 16.51 x 1.91

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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.

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Non-Fiction Law Laws of Specific Jurisdictions Social Law Medical & Healthcare Law International Law Medicine Medicine in General Medical Equipment & Techniques Medical Laboratory Testing & Techniques Pre-Clinical Medicine & Basic Sciences

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Published: 1st December 2010

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Editor's Note
Preface
Law and Practice in France	p. 1
General Features	p. 1
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatment	p. 4
Substantive Requirements Relating to the Placing of IVDMDs on the Market	p. 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 Account	p. 12
The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account	p. 16
Post-Marketing Control: Quality Control Applicable to Laboratories	p. 19
Law and Practice in the Federal Republic of Germany	p. 27
General Features of National Regulation	p. 27
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatment	p. 28
Substantive Requirements Relating to the Placing of IVDMDs on the Market	p. 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 Account	p. 47
The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account	p. 55
Post-Marketing Control: the Requirements Relating to the Control of the Reliability of IVDMDs in View of Their Use	p. 57
Law and Practice in Italy	p. 59
General Features of National Regulation	p. 59
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatment	p. 62
Substantive Requirements Relating to the Placing of IVDMDs on the Market	p. 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 Account	p. 68
The Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account	p. 75
Post-Marketing Control: the Requirements Relating to the Control of the Reliability of IVDMDs in View of Their Use	p. 77
Law and Practice in Spain	p. 78
General Features of National Regulation	p. 78
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatment	p. 80
Substantive Requirements Relating to the Placing of IVDMDs on the Market	p. 80
Procedures Relating to the Establishment of the Conformity of IVDMD Business Operations and of IVDMDs Against Operation-Related and/or Product-Related Requirements	p. 81
Requirements Relating to the Distribution of IVDMDs to the Patient/User	p. 82
Post-Marketing Control	p. 82
Law and Practice in The United Kingdom	p. 84
General Features of National Regulation	p. 84
Different Product Classes	p. 85
Substantive Requirements Relating to the Placing of IVDMDs on the Market	p. 86
Procedures Relating to the Establishment of the Conformity of IVDMD Business Operations and of IVDMDs against Operation-Related and/or Product-Related Requirements	p. 100
Requirements Relating to the Distribution of IVDMDs to the Patient/User	p. 101
Post-Marketing Control	p. 103
Summary of Findings of the National Reports	p. 105
General Overview	p. 105
The Different Product Classes and Their Definitions. Underlying Rationale for Separate Legal Treatment	p. 107
Substantive Requirements Relating to the Placing of IVDMDs on the Market	p. 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 Account	p. 113
Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account	p. 115
Post-Marketing Control: Requirements Relating to Control of Reliability of IVDMDs in View of Their Use	p. 116
Table of Contents provided by Blackwell. All Rights Reserved.

In vitro Diagnostic Medical Devices

Law and Practice in Five EU Member States

At a Glance

Hardcover

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