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YellowCard
Making medicines and medical devices safer

Medical devices

YC Defibrillator

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. 

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. 

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.