SG2-n054-r8-2006-MD Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.pdf
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SG2-n054-r8-2006-MD Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices
GHTF/SG2/N54R8:2006
FINAL DOCUMENT
Global Harmonization Task Force
Title: Medical Devices Post Market Surveillance: Global Guidance for
Adverse Event Reporting for Medical Devices
Authoring Group: Study Group 2
Date: 30 November 2006
Georgette Lalis, GHTF Chair
The document herein was produced by the Global Harmonization Task Force, which is comprised of
representatives from medical device regulatory agencies and the regulated industry. The document is
intended to provide non-binding guidance for use in the regulation of medical devices, and has been
subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use of this document; however,
incorporation of this document, in part or in whole, into any other document, or its translation into
languages other than English, does not convey or represent an endorsement of any kind by the Global
Harmonization Task Force.
Copyright © 2000 by the Global Harmonization Task Force
Medical Devices: Post Market Surveillance: Global Guidance for Adverse Event Reporting
for Medical Devices – GHTF/SG2/N54R8:2006
Study Group 2 Final Document
Table of Contents
1.0 Scope 4
2.0 Definitions 5
3.0 Decision Process 5
3.1 An Event has Occurred 6
3.2 The Manufacturer’s Device is Associated with the Event. 7
3.3 The Event Led to One of the Following Outcomes: 7
3.3.1 Death of a Patient, User or Other Person 7
3.3.2 Serious Injury of a Patient, User or Other Person 7
3.3.3 No Death or Serious Injury Occurred but the Event Might Lead to Death or
Serious Injury of a Patient, User or Other Person if the Eve
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