Guide to Incident Reporting for In-vitro Diagnostic Medical Devices
01 August 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 for in-vitro diagnostic medical devices (IVDs), defining what incidents are and outlining the different roles and responsibilities which users, distributors and manufacturers have in the handling of such incidents.
This document has been updated.
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices
A version of the document with changes tracked is attached below.
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices with changes tracked