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NIST GCR 01-816
A Guide to the EU Active Implantable Medical Devices Directive

Contents

To Be Considered:
1
Purpose of the Active Implantable Medial Devices Directive
2
Basic Steps to Compliance
2
I.    Determining Whether or Not the Product Has To Comply With the Active Implantable Medical Devices Directive
3
II.   Classification of the Active Implantable Medical Device
3
III.  Conformity Assessment Routes
3
IV.  Compliance with the Essential Requirements of the Directive
4
V.    European Harmonized Standards
6
VI.   Risk Analysis
7
VII.  Technical File
8

VIII. Authorized Representative and Competent Authority Registration
8
IX.   Vigilance System
9
X.    CE Marking
11
XI.   Declaration of Conformity
11
Text of Directive 90/385/EEC
12

Annex I     Essential Requirements
24

Annex II    EC Declaration of Conformity
28

Annex III   EC Type-Examination
33

Annex IV   EC Verification
36

Annex V    EC Declaration of Conformity to Type
38

Annex VI   Statement Concerning Device Intended for Special Purposes
41

Annex VII  Clinical Evaluation
43

Annex VIII Minimum Criteria to be Met When Designating Inspection Bodies to be Notified
45

Annex IX    CE Conformity Marking
46
Active Implantable Medical Devices Harmonized Standards *

47

* 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 Active Implantable Medical Devices Directive

Date Created: 08/17/01
Last Modified: 08/17/01

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