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.
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
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.
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:
Assistive technology: definitions, examples and safe use - Section 10 includes links to guidance on bed rails, wheelchairs in transport and hoists
Emollients and risk of burns
In Vitro Diagnostics
In vitro diagnostic medical devices: procurement, safety, quality and performance
Blood glucose meters: point-of-care testing - withdrawn on 26 January 2021
Medical device management and decontamination
Single-use medical devices: implications and consequences of re-use
Medical devices: information for users and patients. Also includes information on blood glucose meters, contact lenses and fetal dopplers.
Specific device guidance
Infusion systems - withdrawn on 18 September 2019
Guidance on the safe use of lasers, intense light source systems and LEDs
Leadless cardiac pacemaker therapy: guidance from an MHRA Expert Advisory Group
Magnetic resonance imaging equipment in clinical use: safety guidelines
Oxygen cylinders and their regulators: tips on how to handle them
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
Paclitaxel Drug Coated Balloons (DCBs) and Drug Eluting Stents (DESs)
Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence