Guidance for safely purchasing medical devices for personal use.
What is a medical device?
A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. It is not a medicine or drug. Medical devices can diagnose, monitor or treat disease and help people with physical impairments become more independent.
Medical devices that people buy for personal use include:
- blood glucose meters
- blood pressure monitors
- contact lenses and solutions
- pregnancy test and other self-test kits
Before you buy the device
Before you buy a medical device for your own use, it’s important to:
- make sure it is suitable for your medical condition
- check it has a CE mark
- check if the manufacturer’s address is on the device or the packaging
- get a demonstration of how to use the device – especially if it’s a complicated device or procedure
If you’re buying online, please see the following guidance:
Before using the device
Before you start using the device, it’s important to:
- check the device is not damaged
- make sure you understand and follow the instructions
- register the device with the manufacturer and fill in any warranty or guarantee cards so that the manufacturer can contact you if there is a fault or safety problem with the device
- make sure you have everything you need, for example, find out if the device needs anything else to make it work such as test strips, batteries and so on
Remember also to:
- keep the device in good condition by following instructions about service and maintenance and keep a record of the service history
- store the device according to the manufacturer’s instructions - for some devices the wrong temperature or humidity can affect how it works or give you wrong results
Problems and troubleshooting
If you have a problem with the device, report it to MHRA using the Yellow Card scheme.
Problems that we’d like to hear about include:
- the device was damaged when you received it
- there isn’t a CE mark on the device or the user manual or packaging
- the instructions aren’t clear
- the manufacturer’s address isn’t on the device or packaging
Do not use the device if you are worried about its quality, for example if it doesn’t feel quite right to use as described in the instructions. Contact your healthcare professional about this and inform the manufacturer and report it to MHRA by Yellow Card.
Contact the distributor or manufacturer to arrange for repairs if your device breaks down. If you think the breakdown might have affected your health, you should report this to the MHRA using the Yellow Card.
These reports could help manufacturers improve their design and product information, and also help the MHRA improve the safety of devices.
If you are worried about a result given by a medical device, talk to your doctor, pharmacist or nurse.
Medical devices must have a CE mark by law. This mark means that, provided you use it correctly, the device will work properly and is safe.
No device is 100% safe or reliable., The known risks of complications must be balanced in comparison to the benefits of the device, as stated by the manufacturer.
If you have any questions about weighing up the pros and cons of using a device for personal use, please speak to a healthcare professional.
NHS Choices - How to use self-test kits safely
NHS Choices - Get online: take control of your health