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
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, please speak to a healthcare professional.
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.
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, please 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.
Only use a blood glucose meter that you have been trained to use. If you intend to purchase your meter online, please refer to our 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, 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 can be found on their websites.
More information and advice regarding purchasing medical devices please see our guidance on buying a medical devices for personal use.
We encourage members of 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 / movement monitors who suspect they may be affected can review MHRA’s decision document 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 purchase 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, visit our webpage.
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.
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 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. We have a poster that explains them.
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 & Don’ts Factsheet 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.
NHS - How to use self-test kits safely
Published 11 February 2019
Last updated 1 March 2021 +show all updates
Added in MHRA’s decision document on baby breathing monitors
Adding in guidance around baby breathing / movement monitors
We have added some guidance on the use of fetal dopplers(Video) Webinar // Cybersecurity in the medical devices – How to show compliance to regulatory requirements
What is the FDA IFU for medical devices? ›
The IFU provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal.Is an IFU the same as a user manual? ›
Summarizing it, operation manuals focus on how to operate a medical device, while IFU focuses on instructions for performing tasks on a medical device.Is IFU required for medical devices? ›
Regulations for developing IFUs or “labeling” for medical devices can be found in the Code of Federal Regulations (CFR), and are specifically covered in 21 CFR 801.1–801.437. Thus, 21 CFR 801.1–801.437 are mandatory requirements.How write instructions with examples? ›
- Use short sentences and short paragraphs.
- Arrange your points in logical order.
- Make your statements specific.
- Use the imperative mood.
- Put the most important item in each sentence at the beginning.
- Say one thing in each sentence.
We use the imperative form to give orders or directions in English. “Eat your vegetables!” “Turn left and go straight on.”How do you validate IFU? ›
The best method for validating your IFU is to perform a simulated use study or human factors study. The FDA published a human factors guidance document that can help you assess the risk of human factors and ergonomics. The FDA guidance requires that you identify your intended user population(s).Is IFU part of Labelling? ›
Instructions for Use (IFU) are part of the labeling regulations.Is IFU part of labeling? ›
The FDA defines Instructions for Use (IFU) as a part of labeling, which includes all the documentation of the product, its certifications, a guide for users on how to use the product, and much more.Does FDA allow electronic IFU? ›
Still, FDA does allow manufacturers to deliver eIFU rather than in paper form.What is an IFU and why are they important? ›
Every medical device has its own instructions for use (IFU). In fact, before a medical device can be sold, the Food and Drug Administration (FDA) requires validation testing to demonstrate that the device can be effectively cleaned and disinfected or sterilized in healthcare facilities by following the IFUs.
Why is IFU important? ›
Products used during cleaning, disinfection and sterilization have their own IFUs to ensure effectiveness and/or confirmation that cleaning, disinfection or sterilization cycles are successful. It is critical to follow these instructions to ensure quality control of the process.What are essential requirements for medical devices? ›
- Establishment registration,
- Medical Device Listing,
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Investigational Device Exemption (IDE) for clinical studies.
The standards of quality and safety of medical devices are regulated in India by a law called The Drugs and Cosmetics Act, 1940 (“DCA”). The scope of DCA is restricted to only those medical devices which are notified by the Government from time to time as “drugs” (commonly referred to as “notified medical devices”).Can medical devices be used without FDA approval? ›
If the device is of significant risk, it requires both the approval of the FDA and an institutional review board (IRB). If the device is of non-significant risk, it only needs the approval of the IRB.How do you write a good set of instructions? ›
- Clear, precise, and simple writing.
- A thorough understanding of the procedure in all its technical detail.
- The ability to put yourself in the place of the reader, the person trying to use your instructions.
A basic computer has three instruction code formats such as the memory reference instruction, the register reference instruction, and the input-output instruction format.What are instruction words examples? ›
- Instruction word. What it means.
- Account for Explain how something happens or happened.
- Analyse Examine in close detail. Identify important points and primary features.
- Comment on. Identify and write about the main issues. ...
- Compare. Show how two or more things are similar. ...
- Contrast. ...
- Critically evaluate. ...
- Use Clear and Precise Language. ...
- Repeat Your Directions. ...
- Explain the Purpose of the Task. ...
- Make Sure Your Students Understand. ...
- Use an Appropriate Tone. ...
- Describe the Specifics. ...
- Provide Examples. ...
- Break Tasks into Manageable Chunks.
Fast Facts: 5 E Instructional Model
It includes five stages: engage, explore, explain, extend, and evaluate. Each stage of instruction details the ideas, concepts, and skills needed for student inquiry.
- Identify what processes you're documenting. Start with the basics and define the processes you want to document. ...
- Know your audience. ...
- Outline each step of the process. ...
- Write the content. ...
- Leverage digital tools.
How do you write an instructions document? ›
- Step 1: Write a Clear and Easy-to-Understand Title. ...
- Step 2: Write a Descriptive Introduction. ...
- Step 3: Describe the Purpose of the Task. ...
- Step 4: Describe How To Do the Task. ...
- Step 5: Format for Easy Reading. ...
- Step 6: Validate the Information. ...
- Step 7: Rewrite and Simplify.
- Create a header. Before you write the content of the letter, create a header at the top left-hand corner of the document. ...
- Address the reader. ...
- Explain the project or task. ...
- List each step. ...
- Conclude your letter. ...
- Revise the document.
- Know exactly how to do the task.
- Plan how to write steps in order.
- Write instructions beginning with a verb.
- Write each step as a small piece.
- Include warnings as pre-steps.
- Write the steps in logical order.
- Review and edit instructions carefully.
- Express steps in the positive.