SG2-n054-r8-2006-MD Post Market Surveillance： Global Guidance for Adverse Event Reporting for Medical Devices.pdfVIP

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