Medical devices: information for users and patients
Information and guidance on a range of medical devices for users and patients.
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
- condoms
- contact lenses and solutions
- pregnancy test and other self-test kits
- wheelchairs
Regulatory marking
Medical devices must have CE marking, UKCA marking or CE UKNI marking 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, speak to a healthcare professional.
MHRA’s role
The MHRA is the regulator and market surveillance authority for medical devices in the UK. This means that we safeguard patient safety by:
- ensuring that medical devices placed on the UK market meet the essential requirements of the Medical Devices Regulations 2002 and, in relation to Northern Ireland, the general safety and performance requirements in Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- investigating concerns where medical devices do not meet these requirements, working with manufacturers to ensure that their products comply with the regulations;
- prohibiting devices that present a clear and demonstrable risk to patients
- the designation of approved bodies (GB) and notified bodies (NI) in the UK and setting the standards that these organisations need to meet in order to become designated (approved and notified bodies assess and certify medical devices which hold a risk classification of IIa, IIb, III, and devices which have a sterile or measuring function)
MHRA does not itself assess or approve medical devices placed on the UK market. It is also not our role as a responsible regulator to endorse any devices.
Buying medical devices for personal use
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 CE marking, UKCA marking or CE UKNI marking
- 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, see our guidance on buying medicines and medical devices online safely.
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 marking, UKCA marking or CE UKNI marking 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 the device is being used to treat COVID-19, report the problem using the dedicated Yellow Card COVID-19 reporting site.
If you are worried about a result given by a medical device, talk to your doctor, pharmacist or nurse.
Blood glucose meters
Blood glucose meters are commonly used by people with diabetes for monitoring the glucose levels in their blood. They are normally recommended by a healthcare professional such as a GP or a diabetes specialist.
Blood glucose meters mostly use test strips to measure glucose levels and there are several types of meters with different features. The meters can also store your previous test results for review.
Your healthcare professional will help you choose the best meter for you. Make sure you follow the manufacturer’s instructions for your particular meter, these are outlined in the booklet provided with the meter. A member of your diabetes care team should train you correctly before you start using your meter.
It is important that you use your meter correctly to make sure your blood glucose result is accurate.
Safety tips
Only use a blood glucose meter that you have been trained to use. If you intend to buy your meter online, refer to the guidance on buying medical devices for personal use.
Make sure to wash and dry your hands before testing.
Use only the test strips listed by the manufacturer for your device. Don’t use test strips from a different manufacturer even if they fit your meter because they won’t work.
Every time you start to use a new box of test strips, make sure you complete the required system check for your device using the control solutions provided. If you do not have the control solutions you can request these from the manufacturer.
Make sure you undertake display checks to prevent misinterpreting the result and always check your test strips are within their expiry date. You will find the expiry date printed on the container.
Make sure the lid of your test strips is sealed tightly, and stored in the original vial, as moisture from the air may affect the accuracy of the result.
The correct unit of measurement for blood glucose monitoring in the UK is mmol/L. Make sure your meter is set to this unit of measurement and check this regularly.
Blood glucose meters are sensitive to extremes of temperature and altitude differences. In these conditions, don’t ignore any symptoms you may have even if you obtain a normal reading.
Always pay attention to any error codes, including HI and LO prompts your meter may show on the display window. If these persist, you should contact the manufacturer’s customer care line for customer support and your diabetes care team.
You should make sure you complete the warranty cards and return them to the manufacturer. This registers your device and means you can be contacted if your device needs to be changed, for example if it needs to be recalled for safety reasons.
Make sure you know how to clean/disinfect you meter adequately/safely as per the manufacturer’s instructions.
There are several types of meters with different features. It is important to you use your meter correctly to ensure your blood glucose result is accurate.
We encourage patients, manufacturers, distributors, professional users and members of the public to report suspected issues to us via the Yellow Card Scheme.
Fetal dopplers/imaging
Fetal dopplers, also known as “fetal heart monitors”, “baby heartbeat monitors” or other similar names, are handheld devices mainly used by midwives to listen to a baby’s heartbeat during pregnancy.
We are aware that such devices can be purchased by individuals however, the NHS, BMUS , SCoR and the Kicks Count Charity do not recommend the use of fetal dopplers unless you are a midwife or doctor.
More information is available on their websites.
For more information and advice on buying medical devices, see our guidance on buying medical devices for personal use.
We encourage members of the public and healthcare professionals to report any safety concerns with a medical device to us via the Yellow Card Scheme.
The Yellow Card Scheme collects information on suspected problems for medical devices and defective medicines. Reporting helps to improve the safety of medicines and medical devices.
Baby breathing/movement monitors
Baby breathing/movement monitors purchased to use at home typically provide information to the parent or caregiver about a baby’s health and wellbeing. They alert the parent or caregiver if the baby’s vital signs give cause for concern or even intervene automatically to restart the baby’s breathing.
Examples of vital signs include heartbeat, breathing, blood oxygen saturation levels and body temperature. Some products are specifically targeted at premature babies and many imply they can be of use in preventing sudden infant death syndrome (SIDS) and apnoea, both of which are clinical conditions.
Because these products typically offer to identify, monitor, or, in some cases treat a medical condition, the MHRA’s view is that these products meet the legal definition of a medical device and that they should therefore comply with the UK Medical Device Regulations 2002 (as amended).
This means that the device needs to have undergone a conformity assessment to demonstrate that it works as intended and is acceptably safe. Following a positive conformity assessment, the device would need to bear a relevant medical device conformity mark, either a CE mark or a UKCA mark, or a combination of those markings. If the device is being placed on the market in Northern Ireland, then it would also need to be appropriately marked with a UK(NI) indication.
Historically there have been conflicting opinions as to whether these kinds of products should be regulated as medical devices or general consumer goods. The MHRA has undertaken a detailed review and determined that the majority of baby breathing/movement monitors are medical devices. Consequently, we will be working with the relevant manufacturers to bring their products into compliance with the Medical Device Regulations 2002 (as amended).
Manufacturers of baby breathing or movement monitors who may be affected can review MHRA’s decision document:
Note that this decision does not apply to conventional audio-visual baby monitors which only enable a parent to ‘listen to and/or view’ the baby to determine if the baby is awake or asleep.
Buying baby breathing/movement monitors
Consumers wishing to buy a baby breathing/movement monitor should look for one or more of these conformity marks before buying: CE / UKCA /CE UK(NI).
You should be aware that a disclaimer statement from the manufacturer saying that a product is not a medical device, or is not intended to diagnose or treat any specific medical condition, does not automatically mean that a product would not be considered a medical device.
For more information about buying medical devices for personal use, see our guidance on buying medical devices for personal use.
Contact lenses
Contact lenses help correct several eyesight problems, including long-sightedness (hypermetropia), short-sightedness (myopia) and astigmatism. Contact lenses are medical devices and in Great Britain they are regulated under the UK Medical Devices Regulations 2002 (SI 2002 No 618) (as amended). You can read guidance on how devices are regulated in Northern Ireland
Most people can wear contact lenses safely but if you don’t follow the instructions for use you can increase your risk of eye infections, irritation and discomfort.
MHRA has received reports of infections that have led to sight loss and and in very rare cases even eye removal due to Acanthamoeba keratitis (AK). While rare, the outcomes of AK can be devastating. There are webpages from Moorfields Eye Hospital and Fight for Sight which give further information. One of the most common ways to get the infection is exposure to water (for example, swimming, showering, touching the lens with wet hands or rinsing or storing lenses in water). Proper and careful use of lenses is essential to reduce the likelihood of this infection (see safety tips below).
Buying contact lenses
In the UK, only registered medical practitioners, optometrists and dispensing opticians (with suitable qualifications) may prescribe contact lenses. Don’t buy lenses without their professional advice. Contact lens prescriptions are valid until the next suggested date of examination. Even if you buy your lenses online, visit your eye care specialist regularly to check your eye health and ensure your lenses are fitting well and always follow their advice.
Safety tips
Follow the instructions that come with your lenses. Some manufacturers may direct you to ask your eye care specialist for a copy, or to look on the manufacturer’s website rather than supply instructions with each pack of contact lenses. Lens aftercare is essential to prevent injury and infection. The instructions for use will have useful information. Ask your eye care specialist about wearing contact lenses for sports activities to prevent injury and infection.
Keep the packaging while you use the lenses, as you may need the lot (batch) number so you can report to the MHRA if you experience any problems with your lenses. Take the lenses out andseek urgent medical advice if you get any eye pain, blurred vision, swelling or unusual redness or if you think you may have an eye infection. Take your contact lenses, lens case and solution with you.
Common symbols explained
There are several common symbols used with medical devices that might appear on the packaging of your contact lenses. See our a poster explaining symbols on medical devices.
There is also a new symbol, warning against contact with water, which some manufacturers of contact lenses are starting to use. The British Contact Lens Association has a do’s and don’ts factsheet for healthy contact lens care with this symbol.
Report a problem
You can report any problems with your contact lenses to us through the Yellow Card Scheme. This scheme is vital in helping us monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users, and take action if any trends associated to the safety or efficacy are identified. See our guidance on the Yellow Card Scheme
Anti-choking devices
Anti-choking devices, also known as airway clearance devices, are intended for use in the management of choking incidents, by removing obstructions from the airways via manual suction after other approaches have failed. They first became available on the UK market from 2015.
These devices are classified under the Medical Devices Regulations 2002 and Regulation (EU) 2017/745 as class I devices. This means that the manufacturer is responsible for declaring that they conform to the regulatory requirements. The UKCA or CE mark is applied once the manufacturer is satisfied that the essential quality, safety and performance requirements of the regulations have been met.
In 2017, the MHRA investigated concerns about the evidence to support the quality, safety and performance of these devices, engaging with two manufacturers, LifeVac Europe Ltd and Dechoker LLC, which had first introduced these devices to the UK market. This was specifically in light of the use of these devices falling outside the established Basic Life Support protocols and resuscitation guidelines in the UK, produced by the Resuscitation Council UK. These protocols recommend the application of back slaps and abdominal thrusts when managing a choking incident. You can read the recommended resuscitation guidance on the UK Resuscitation Council website. The anti-choking devices manufactured by LifeVac and Dechoker are intended for use only after these established Basic Life Support protocols have been attempted and failed.
Because these devices are intended to be used as part of a response to choking incidents, the MHRA recognised that it was not possible to conduct clinical investigations to gather pre-market clinical data to demonstrate the quality, safety and performance of these devices.
Due to the lack of supportive clinical evidence demonstrating the quality, safety and performance of the anti-choking devices, in August 2017 both LifeVac and Dechoker adopted voluntary restrictions on the use of their devices in the UK. These restrictions limited use of the devices to healthcare professionals trained in advanced life support. They also meant that the devices could be used only for patients in moulded wheelchairs; or where emergency services were unable to respond. The restrictions were intended to facilitate close monitoring of the use of these devices, with the aim of further developing and improving the clinical data and scientific literature available in relation to airway clearance devices.
In 2022, the MHRA undertook a review of the restrictions in place for these anti-choking devices, which considered multiple factors including: the progress made by the manufacturers since the restrictions were adopted; developments in the clinical data and literature surrounding these devices; usage and adverse incident data; regulation on other markets; the remit of MHRA’s regulatory role; and assessing whether the restrictions in place were proportionate to the risk. The MHRA review culminated in a proposed action plan, discussed and approved by the Devices Expert Advisory Committee, to lift the restrictions in place on these devices, once specified actions were completed.
As of June 2023, the voluntary restrictions on the LifeVac anti-choking device have been lifted, meaning that this device may again be made available for purchase on the wider UK market. This brings the regulation of these devices in line with other countries, including the United States, Australia and the EU, where they have always been available to buy and use. The MHRA is continuing to work with the remaining manufacturer Dechoker LLC towards the lifting of restrictions on their device, and we will update this guidance in due course.
The MHRA continues to recommend that users follow the established Basic Life Support protocols in the UK when managing a choking incident. We have worked with both LifeVac and Dechoker manufacturers to ensure that their device instructions clearly explain its intended purpose and set out the established protocols to follow first so that users are able to make informed decisions about using these devices.
Patient safety remains our utmost priority. We continue to monitor the use of airway clearance devices in the UK and will take proportionate action to address any potential risks that are identified. To support this, we request that users report any adverse incidents experienced when using these devices to the legal manufacturer as well as to the MHRA via our Yellow Card scheme.
Counterfeit and unbranded anti-choking devices
The MHRA is aware of numerous unbranded anti-choking devices being sold online which do not comply with the requirements of the Medical Devices Regulations 2002 or Regulation (EU) 2017/745 in relation to Northern Ireland. These devices appear similar or identical in design to legitimately UKCA or CE marked anti-choking devices such as LifeVac or Dechoker and, in some cases, may claim to be these brands. However, they are not the genuine product, and do not include appropriate instructions. They may pose a serious risk if used to address choking incidents due to inadequate instructions, quality and design.
The MHRA has published a Device Safety Information alert which further explains the safety issues regarding these devices. This alert also provides useful guidance to help UK users determine if they have purchased a genuine anti-choking device or a counterfeited or unbranded copy.
We advise users to be cautious when buying these devices online. Ensure that you buy only from reputable sellers and confirm that the device’s manufacturer is registered with the MHRA via our public access database. We have published advice on buying medical devices online for users and the public.
Last updated 21 November 2023 + show all updates
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Included information on Anti-choking devices.
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Added in MHRA’s decision document on baby breathing monitors
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Adding in guidance around baby breathing / movement monitors
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We have added some guidance on the use of fetal dopplers
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First published.