Medical devices
You can report any safety concerns involving medical devices to our Yellow Card scheme. We advise that you complete the report as soon as possible and keep hold of the device, as a further review might be needed from us or the manufacturer.
What is a ‘medical device’?
The term ‘medical device’, or medical appliance, covers a broad range of healthcare products, including physical items such as:
prescription contact lenses and crutches
implantable medical device such as a breast implant or pacemaker
defibrillator
x-ray machine
ophthalmoscope (Fundoscope) that is used by opticians
blood glucose monitors
or software such as:
computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer
apps and software that are intended to calculate the dose of insulin a diabetic needs to treat their diabetes based on carbohydrate in a meal
They can be used for the diagnosis, prevention, monitoring, or treatment of illness. The products you can report to the Yellow Card scheme as medical devices will have a CE or UKCA mark on them, or their packaging/associated leaflet.
Safety concerns related to medical devices
An adverse incident in relation to a medical device, is an event that caused (or almost caused) an injury to someone or affected the treatment or diagnosis one could receive.
Practical examples of problems with medical devices include:
faulty brakes on a wheelchair
wrong readings on a thermometer
blood glucose strips giving the wrong readings
unclear labelling or instructions
unsafe design
other quality issues that impact safety, such as a cracked screen
Medical devices can be found to be faulty, defective, fake/counterfeit, poor quality or have inherently unsafe design. If any of these could cause an adverse incident or have a safety concern, these can all be reported through the Yellow Card scheme.
Faulty medical devices
A faulty or defective medical device is a product that is not working properly or not to the manufacturer’s specifications.
Fake medical devices
A fake or counterfeit medical device is a product that tries to pass off as a real, authorised medical device.
Look out for signs such as:
being different to what it is described as
misrepresenting its identity, source, or history
Poor quality
This may be manufactured to a poor standard mean it does not last as expected.
Inherently unsafe design
Inherently safe design means that through design mistakes in how the device is used can be avoided e.g. components of a device can only be assembled in the correct way.
We would like to know when something easily be done with a medical device that is unsafe but could be avoided through better design.
If you suspect any of the above applies to a medical device, report it to the MHRA Yellow Card scheme as soon as possible.
Medical devices reporting in Scotland and Northern Ireland by healthcare professionals
In England and Wales, adverse incidents involving medical devices should be reported using the Yellow Card scheme.
We work closely together with Northern Ireland and Scotland, who have their own reporting systems for healthcare professionals to report medical devices.
Northern Ireland incidents should be reported to the
Scotland incidents should be reported to the
Medical device reporting from manufacturers, suppliers, and their representatives
The Manufacturer's Online Reporting Environment (MORE) is the system for device manufacturers or suppliers and their authorised representatives to report adverse medical incidents and provide responses to MHRA incident investigations.
Why report side effects to the Yellow Card scheme?
Everyone has a different genetic makeup and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to the MHRA Yellow Card scheme. Reports help us gain a better understanding of medicine interactions and safeguard patients through vigilant monitoring.
Further information
Medicines and medical devices: product-specific information
Find out more about the Yellow Card scheme, including how to report.