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Medical device adverse incidents

The term 'medical device' covers a broad range of products that are used in healthcare. They can be physical items or software which are used for the diagnosis, prevention, monitoring or treatment of illness or disability.  Products reportable to the Yellow Card scheme as a medical devices will have a CE mark or UKCA mark.

Examples of medical devices include: contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames.

An adverse incident is an event that caused, or almost caused, an injury to a patient or other person, or a wrong or delayed diagnosis and treatment of a patient.

Examples of problems:

  • faulty brakes on a wheelchair

  • a faulty ear thermometer giving a low reading

  • a faulty batch of test strips for a blood glucose meter giving wrong readings

  • labelling or instructions on the device are not clear

  • unsafe design

  • quality issues that impact safety

If your equipment has a safety issue you should let us know as soon as you can. Please do not send your device to the MHRA. Hold onto it once you have reported it to us. The manufacturer may need it to investigate your report.

Specific reporting routes for adverse medical device incidents by healthcare professionals in the UK

Adverse incidents involving medical devices in England and Wales should be reporting using the Yellow Card scheme or via the Yellow Card app. Please note that such incidents should be reported to the Northern Ireland Adverse Incident Centre in Northern Ireland and to Health Facilities Scotland online incident reporting system in Scotland.

Reporting adverse medical device incidents by members of the public in the UK

Patients, parents, carers and their representatives should report adverse incidents involving medical devices directly to the MHRA using the Yellow Card scheme or via the Yellow Card app.

Industry reporting

The Manufacturer's On-line Reporting Environment (MORE) is the MHRA's system for device manufacturers and suppliers and their authorised representatives to report adverse medical incidents and provide responses to MHRA incident investigations.

More information can be found on the MHRA website:

In Vitro Diagnostics

Medical device management and decontamination

Specific device guidance