Medical Device Incident Reporting – Yellow Card Scheme

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health. They are responsible for regulating all medical devices and medicines in the UK by ensuring they work and are acceptably safe.

A large part of their work consists of investigating adverse incidents that are reported and they encourage all persons working with or using medical devices to play an important role in helping to improve safety by reporting incidents to:

Every report matters, and reports of an adverse incident enable the MHRA to develop a robust evidence base of device safety, so they can take action, if necessary. All incidents reported are evaluated through the Yellow Card Scheme together with additional sources of information such as clinical trial data, medical literature or data from international regulators. The purpose of the evaluation is to identify unknown safety issues.

Another role of the MHRA involves issuing safety information concerning medical devices to the health service. They are continually seeking new mechanisms for distributing messages ensuring they reach as wide an audience as possible.

If you are interested in hosting medical device safety related warnings i.e. Field Safety Notices from device manufacturers and Medical Device Alerts from the MHRA, on your website, please contact