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.,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.

The 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;2017/746
• investigating concerns where medical devices do not meet these requirements, working with manufacturers to ensure that their products comply with the regulations;regulations
• prohibiting devices that present a clear and demonstrable risk to patients;patients
• theappointing designationapproved ofbodies Approvedin BodiesGreat (GB)Britain and Notifiednotified Bodiesbodies (NI) in the UK and setting the standards that these organisations need to meet in order to become designated.appointed Approved(approved /and Notifiednotified Bodiesbodies undertakeassess the assessment and certificationcertify of medical devices which hold a risk classification of IIa, IIb, III, and devices which have a sterile or measuring function.function)

The MHRA does not itselfcarry assessout assessments 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, please 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 MHRAus using the Yellow Card scheme.

Problems that we’dwe likewant to hear about include:include if:

• 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 thisthis, and inform the manufacturer and report it to MHRAus byusing the Yellow Card scheme.

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 theus MHRA using the Yellow Card scheme.

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, please report the problem using the dedicated Yellow Card COVID-19 reporting site.

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 purchasebuy your meter online, please refer to ourthe 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 viausing the Yellow Card Schemescheme.

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.

MoreFor informationmore can be found on their websites.

More information and advice regardingon purchasingbuying medical devicesdevices, pleaseread see our guidance on buying a 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 viausing the Yellow Card Schemescheme.

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/movementbreathing and movement monitors

Baby breathing/movementbreathing and 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 suspect they may be affected can review the MHRA’s decision documentdocument: to learn more. Decision document on baby breathing / movement monitors (PDF, 243 KB, 12 pages)

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 purchasebuy a baby breathing/movement monitor should look for one or more of these conformity marks before buying:

• CE /
• UKCA
• CE /CE UK(NI).
  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, visitread our guidance on webpagebuying 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.

MHRAWe hashave 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).infection.

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. Also check the NHS and Love your Lenses websites. 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 toany theproblems MHRA if you experience any problems with your lenses.lenses to the MHRA. Take the lenses out andseekand seek 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. We have a poster thatexplaining explainssymbols themon 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’sdo’s &and Don’tsdon’ts Factsheetfactsheet for healthy contact lens care with this symbol.

Report a problem

You can report any problems with your contact lenses to us throughusing the Yellow Card Schemescheme. 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.

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’sCouncil 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.

Since these devices were first marketed in the UK, the MHRA has not received any reports of adverse incidents attributed to these devices.

In 2022, the MHRA undertookreviewed 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.

TheWe MHRAcontinue 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 viathrough ourthe Yellow Card scheme.

Counterfeit and non-compliantunbranded anti-choking devices

The MHRA is aware of numerous unbranded anti-choking devices being sold online via marketplaces (such as Amazon and eBay) 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.

TheWe MHRAhave ispublished workinga Device withSafety onlineInformation marketplacesalert which further explains the safety issues regarding these devices. This alert also provides useful guidance to removehelp themUK fromusers sale,determine andif wethey have purchased a genuine anti-choking device or a counterfeited or unbranded copy. 

We advise users to exercisebe cautioncautious when purchasingbuying these devices online.online. Ensure Ensure that you purchasebuy only from reputable sellers and confirm that the device’s manufacturer is registered with the MHRA via our our public access database.. We We have published published advice on buying medical devices online for users and the public.

OtherMobility guidance:scooters for personal use 

NHSMobility -scooters Howare typically used by individuals with limited mobility and are classed as medical devices. 

Choosing the appropriate mobility scooter can be a complex task due to the variety of options available on the market. It is important to choose a scooter that is safe and meets your specific needs.  

When using mobility scooters outdoors, certain restrictions apply. Not all mobility scooters are designed for outdoor use. Therefore, it is important to understand the restrictions and the intended use self-testas kitsspecified by the manufacturer. 

The following guidance documents may assist you in determining the type of scooter that best meets your needs: Using mobility scooters and powered wheelchairs and Mobility Scooters. 

When buying a mobility scooter, in addition to general advice on Buying medical devices for personal use and Ten top tips for buying medicines and medical devices online safely, it is important to: 

• buy directly from the manufacturer or a reputable retailer* that sells disability equipment and has qualified personnel to assist you in choosing the right scooter, 
• ensure it is classed as a medical device and has the necessary CE marking, UKCA marking or CE UKNI marking (this should usually be displayed on the device label and supporting documents), 
• ensure that you know the intended service life of the scooter (it is defined by the manufacturer based on testing), as it is not recommended to use it beyond this period, 
• ensure you know how often the scooter requires maintenance and where it can be serviced (for example, the retailer might offer this service). It is important to note that the cost of scooter maintenance and service is covered by the owner, 
• if the scooter has a freewheel device (often referred as a freewheel mode) which allows it to be used without engaging the motor, check if it has brakes that allow you to stop the scooter safely when it is in freewheel mode. This is a critical safety feature to prevent uncontrolled movement when in freewheel mode. 

Once you got your mobility scooter, it is important to follow the manufacturer’s instructions on charging battery operated devices including ensuring correct frequency of charge, use of compatible charger otherwise there is a risk of batteries overheating or not charging properly. 

^{*Some retailers may be members of the British Healthcare Trades Association (BHTA) and adhere to their guidance.} 

Buying second-hand mobility scooter 

Buying a second-hand mobility scooter carries certain risks. Similar to when buying a new scooter, users should follow the same approach and ensure that the device: 

• has CE, UKCA or CE UKNI markings,  
• remains within its indicated service life,  
• has instructions for use/owner’s manual,  
• has undergone all necessary service checks as per the manufacturer’s recommendations before making a purchase, 
• and has safety features that would allow to stop the device when in freewheel mode. 

Another important aspect when buying a second-hand mobility scooter is to ensure that it comes with the original battery and compatible battery charger provided by the manufacturer, or a reputable retailer based on manufacturer specification. Using medical devices with non-approved batteries and chargers, as well as modified batteries, can lead to battery failure and fire, causing injuries or even death. Manufacturers test their batteries and chargers to ensure safety when used with their devices. 

Report a problem 

You can report any problems and concerns with mobility scooters or any other medical devices though the Yellow Card Scheme. See our guidance on the Yellow Card Scheme 

Other guidance documents and useful information

MHRA

Assistive technology: definition and safe use 

NHS

Walking aids, wheelchairs and mobility scooters - Social care and support guide 

British Health Care Trades Association (BHTA)

Buying a mobility vehicle: A guide to helping you make an informed choice - British Healthcare Trades Association 

Get online:wise taketo controlBuying ofa yourMobility healthVehicle  

How to access a wheelchair or mobility scooter - British Healthcare Trades Association 

Focus on Disability

Buying a Mobility Scooter - A Guide - Focus on Disability