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NIST GCR 01-815
A Guide to the EU Medical Device Directive

Contents

To Be Considered:
1
Purpose of the Medical Device Directive
2
Basic Steps to Compliance
2
I. Determining Whether or Not the Product Has To Comply with the Medical Device Directive
2
II. Classification of the Medical Device
3
III. Conformity Assessment Routes
16
IV. Compliance to the Essential Requirements of the Directive
17
V. Harmonized Standards
20
VI. Risk Analysis
21
VII. Technical File
22
VIII. Vigilance System
22
IX. EC Verification by Notified Body
25
X. Authorized Representation and Competent Authority Registration
25
XI. CE Marking
25
XII. Declaration of Conformity
26
Text of Directive 93/42/EEC

Annex I Essential Requirements

Annex II EC Declaration of Conformity

Annex III EC Type Examination

Annex IV EC Verification

Annex V EC Declaration of Conformity

Annex VI EC Declaration of Conformity

Annex VII EC Declaration of Conformity

Annex VIII Statement Concerning Devices for Special Purposes

Annex IX Classification Criteria

Annex X Clinical Evaluation

Annex XI Criteria to be Met for the Designation of Notified Bodies

Annex XII CE Marking of Conformity
Medical devices classification guidance chart: Non Invasive Devices *
Medical devices classification guidance chart: Invasive Devices *
Medical devices classification guidance chart: Active Devices *
Medical Device Harmonized Standards *

 

* 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 Medical Device Directive

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

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