1.- Use of the adverse event reporting terminology
This document provides the IMDRF terms, definitions and IMDRF alpha-numerical codes to be used for Adverse Event (AE) reporting concerning medical devices and in vitro diagnostics both pre and post market as described in section 5.
Notably, the precise criteria for reporting adverse events are defined by each regulatory authority and are not subject to this guidance document. Reference is made to the relevant guidance documents of each jurisdiction and the GHTF document on Post Market Surveillance:
Global Guidance for Adverse Event Reporting for Medical Devices (GHTF, 2006).
2.- Intended end-users of the adverse event reporting terminology
The set of terminologies outlined in this document are intended for use by:
(1) reporters of adverse events which are obligated to be reported to the authorities in accordance with the relevant regulations of each jurisdiction;
(2) regulatory authorities, collecting and processing such information and related data in databases and other electronic systems to monitor and analyze adverse events to improve the protection of patients and public health. Regulatory authorities may be national competent authorities (NCAs) or supranational bodies charged with these tasks.