Global Guidance for Adverse Event Reporting for Medical Devices

The objective of the adverse event reporting and subsequent evaluations is to improve protection of the health and safety of patients, users and others by disseminating information which may reduce the likelihood of, or prevent repetition of adverse events, or alleviate consequences of such repetition. This document has been created by the Global Harmonization Task Force Study Group 2: Medical Device Vigilance/Post Market Surveillance. Study Group 2 is made up of representatives of the regulatory authorities and industry representatives of the USA, Europe, Canada, Japan and Australia.