This publication provides guidance on the MHRA's voluntary adverse incident reporting system and encourages users to report adverse incidents involving medical devices.
Topics covered include:
- what an adverse incident is and when to report it
- how to make reports
- what to do with a device that has been involved in an adverse incident
- the role of the medical device liaison officer in disseminating Medical Device Alerts.
This is a website-only publication; we do not supply printed copies. Please download a copy of the PDF below.
Note: this replaces previous versions of this publication.

