Reporting Adverse Incidents and Disseminating Medical Device Alerts

This document explains MHRA’s voluntary adverse incident reporting system.

1. Introduction& Explanation of Medical Device
2. When to report an adverse incident & explanation of an adverse incident
3. How to report one.
4. How to dispose of devices that have been involved in incidents.
5. What is done by the MHRA when a report has been received?
6. Disseminating medical device alerts and the role of the MDLO
7. Field Safety Notices & Field Safety Corrective Actions.
8. Other reporting systems.

For more detail on the above please follow the source link below where you can download a copy of the full report.

Source - http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON068594