Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices
06 July 2012
This guide has been written to support, and to be used in association with, the information outlined in the Irish Medicines Board’s (IMB) Guide to the Vigilance System for Medical Devices. This guide focuses on the area of incidents, defining what incidents are and outlines the different roles and responsibilities, which users, distributors and manufacturers have in the handling of such incidents.
The IMB is also the Competent Authority (CA) for in-vitro diagnostic medical devices. However, this guide does not cover the area of in-vitro diagnostic medical devices. This area is dealt with separately in the Guide to Incident Reporting for In-vitro Diagnostic Medical Devices.
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices
This guide has been revised.
Previous version of guide with changes tracked.