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NIST GCR 01-817
A Guide to the EU In vitro Diagnostic Medical Devices Directive


Contents

To Be Considered:
1
Purpose of the In vitro Diagnostic Medical Devices Directive
2
Basic Steps to Compliance
2
I. Determining Whether or Not the Product Has To Comply with the In vitro Diagnostic Medical Devices Directive
2
II. Classification of the In vitro Diagnostics
3
III. Conformity Assessment Routes
3
IV. Compliance to the Essential Requirements of the Directive
5
V. European Harmonized Standards
9
VI. Risk Analysis
10
VII. Technical File
11
VIII.Authorized Representative and Competent Authority Registration
12
IX. Vigilance System
13
X. CE Marking
15
XI. Declaration of Conformity
15

Text of Directive 98/79/EEC 17

Annex I Essential Requirements
Annex II List of Devices Referred to in Article 9(2) and (3)
Annex III EC Declaration of Conformity
Annex IV EC Declaration of Conformity (Full Quality Assurance System)
Annex V EC Type-Examination
Annex VI EC Verification
Annex VII EC Declaration of Conformity (Production Quality Assurance)
Annex VIII Statement and Procedures Concerning Devices for Performance Evaluation
Annex IX Criteria for the Designation of Notified Bodies
Annex X CE Marking of Conformity

In Vitro Diagnostic Medical Devices Harmonized Standards*
Chart of Annex A *
 

 

* PDF file format requires the FREE ADOBE ACROBAT READER Software.

If you are unable to use the ADOBE ACROBAT READER Software and require a copy of a PDF document, please request a copy to be sent to you from maureen.breitenberg@nist.gov


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Technology Services, Standards Services Division, Global Standards and Information Group
Contact: maureen.breitenberg@nist.gov
A Guide to the EU In vitro Diagnostic Medical Devices Directive

Date Created: 08/30/01
Last Modified: 08/30/01

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