Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
Medicinal or medical claims and indications may be made for an appropriately certified medical device (Rule 12.1). A medical/medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis, or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings
Do you hold the appropriate conformity marking for the device?
What does this mean for individual ads?
Is your product appropriately registered?
Do you hold evidence to support all efficacy claims?
Does the position apply to software apps?
Does the position apply to any other products?
What about conditions for which medical supervision should be sought?
What is a medical device?
The Medical Devices Regulations 2002 (“the Regulations”), as amended, transpose various EC Directives into UK law.
The Regulations define a medical device as:
“an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; or control or conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means”.
The definition includes devices that are:
“intended to administer a medicinal product or which incorporate as an integral part a substance of which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.”
Medical devices are of three types: general, active implantable and in-vitro diagnostic (the last two are specifically defined in the Regulations). If a product does not have one or more of the medical purposes referred to (for example, it has a purely cosmetic purpose) it does not fall within the definition of a medical device
If marketers are unsure about the definition of their product, they should contact the Medicines and Healthcare products Regulatory Agency (MHRA). Regulating medical devices in the UK - GOV.UK
Do you hold the appropriate conformity marking for the device?
Following Brexit, the Regulations regarding device certifications changed, meaning that marketers selling in Great Britain would need to ensure medical devices are either CE Marked (the original EU system) or UKCA Marked. In the future, all products (including those previously CE Marked) will need to be UKCA Marked in order for them to be sold in Great Britain. Marketers should refer to MHRA Guidance to establish when this transition deadline will take place
Due to the Northern Ireland protocol, CAP understands that medical devices being sold in Northern Ireland must be CE Marked even if the product is also being sold in Great Britain under a UKCA marking. Marketers seeking to sell their device in Northern Ireland are advised to obtain legal advice to ensure the device is correctly certified.
Under both systems, medical devices are categorised into four classes (I, IIa, IIb and III) according to the degree of risk inherent in the device. Class I general medical devices are generally sold on a self-declaration basis. Other, higher-risk products have to be assessed by ‘notified bodies’ before they can be marketed. Similarly, some in-vitro diagnostic devices (IVDs) may be sold without the intervention of a notified body whereas for higher-risk IVDs a notified body must be involved.
To comply with the Regulations, a device must meet the “essential requirements” set out in the relevant Directive. Among other things, they require the manufacturer to be able to demonstrate that a medical device is safe and fit for its intended purpose taking into account any risks as specified by the manufacturer. Because the onus is on the manufacturer to comply with the Regulations, manufacturers should not state or imply that their device has been “approved” or “certified” by the MHRA.
What does this mean for individual ads?
CAP Code rule 12.1 states:
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a medical device with the applicable conformity marking. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
If ads are making medical /medicinal claims for a product(s), the ASA and CAP are likely to expect the marketer to demonstrate that an appropriate conformity marking is held.
Marketers should carefully consult this MHRA Guidance on Regulating Medical Devices in the UK.
The following rulings illustrate the position by highlighting investigations into ads where medical claims were made for devices without the appropriate conformity marking being held:
Pranamat Sales and Marketing SA, 30 March 2016 - Advertising claims on a website and Amazon page that an ‘Acupressure mat’ could treat lower back pain, sciatic pain and headaches were found problematic because the appropriate conformity marking was not held. The ASA ruled the medical claims were not permitted in the ads.
Jackel International Ltd, 19 December 2012 – A website ad for a baby bottle made medical claims that the device was ‘effective against colic’ despite it not being CE-Marked, the appropriate conformity marking at that time. The ASA ruled that the medical claims were not permitted in the ad.
Comfort Click Ltd, 28 February 2018 – Ads for a circulation device made claims to increase blood flow to the legs, relieving pain and swelling, alongside claims to alleviate blood clots, swelling and numbness (among other things). Although the ASA acknowledged that a CE certification was held, that certification was not considered to meet the requirements of the conformity assessments required under the Medical Device Directive at that time. The ASA subsequently ruled the medical claims were not permitted in the ad.
Prime Star Shop Ltd, 13 November 2024 A press ad for ‘Hear Pods’ made medical claims to alleviate hearing loss without a relevant conformity marking being held. The ASA ruled that the medical claims were not permitted in the ad.
Is your product appropriately registered?
In addition to holding the appropriate device certification, from January 2021, all medical devices must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland). These registration requirements differ for Northern Ireland. This MHRA Guidance on the registration of medical devices explains the requirements in more detail.
Person(s) unknown, 18 December 2024 - A paid website ad made claims that a ‘calming vest’ could help “calm Meltdowns & Outbursts, No More Hyperactivity, Reduce Impulsive Behaviour” in children with ADHD. The ASA ruled that despite holding a conformity marking, the advertiser had not demonstrated that it was the applicable one for the device. It was additionally noted that the device had not been registered with the MHRA.
Shop TJC Ltd, 25 September 2024 – A shopping channel ad included claims that a red light therapy toothbrush device could alleviate various oral health conditions, when such claims were prohibited on teleshopping channels (BCAP rule 11.12.3)
The marketer was also unable to show that an appropriate conformity marking for the device was held, or that it had been registered with the MHRA.
Do you hold evidence to support all efficacy claims?
Marketers need to ensure that they hold robust evidence for their medical or non-medical efficacy claims (Rule 12.1). Whilst CE/UKCA certification may demonstrate that the device is safe and fit for its intended purpose, the ASA has ruled that the certification does not in itself constitute evidence for advertising claims for the purposes of the Code rule.
Marketers are recommended to read CAP Guidance on Substantiation for health, beauty and slimming claims to find out more about the types and levels of evidence that they will likely need to hold in order support efficacy claims for devices.
The following ASA rulings considered the issue of substantiation for the medical claims about the device:
Actegy Ltd, 1 December 2021 – A press ad for a circulation booster made medical claims alongside claims about the suitability of the device for individuals with certain symptoms or conditions. Although the device was appropriately certified, the ASA considered the ad made multiple treatment claims which the CAP Code required were supported by evidence. The ASA noted these claims were not automatically covered by that certification and although evidence was submitted, it considered that it was not sufficient to support the claims.
Neuronix Medical Ltd, 21 March 2018 – Although part of the submitted evidence provided some support for the claims, the ASA considered that the magazine ad claims to treat mild or moderate Alzheimer’s had not been substantiated.
Actegy Ltd. 6 August 2025- TV ad claims that the device could reduce leg swelling and improve walking distance and duration were found to be unsubstantiated by the submitted evidence. However, claims that the device could relieve aching legs and pains were considered acceptable by the ASA because the evidence was found to be sufficiently robust.
UK Direct Shop, 11 April 2018 – National press ad claims that a device could provide relief from knee pain were considered unsubstantiated. In addition, the appropriate conformity marking was not held.
Navi Organics, 11 June 2025 – Website claims to treat conditions such as fibromyalgia, sleep problems and anxiety alongside claims about the use of the bio-resonance device for ‘cellular healing’ were considered unsubstantiated.
Does the position apply to software apps?
In some instances, the MHRA has indicated that software applications might be considered medical devices. MHRA advice on this is available here and includes a helpful flow chart. If marketers are still unsure after using the flowchart, they should contact the MHRA directly to establish the likelihood of their software being classed as a medical device. The same position on conformity marking and substantiation set out above also applies to software medical devices
Oakever Games PTE Ltd , 18 December 2024 – An in-game ad for a mobile game app claimed that the game could prevent Alzheimer’s. The ASA ruled the medical claims were not permitted in ads because there was no evidence that the device had the appropriate conformity marking, or that it was registered with the MHRA.
Nexusbird Inc , 18 October 2023 – A social media ad for an AI controlled calendar claimed, amongst other things, that the product could help alleviate some of the symptoms of ADHD. The ASA ruled the medical claims were not permitted in the ad because there was no evidence that the device had the appropriate conformity marking, or that it was registered with the MHRA.
GMRD Apps Ltd, 21 February 2024 – A social media ad for a puzzle game app made implied claims that the device could help to diagnose ADHD. The ASA ruled those claims breached the Code because it had not seen evidence of MHRA registration or of an appropriate conformity marking.
Does the position apply to any other products?
If an ad is making medical claims, then the position might also apply to other types of products, including items of clothing.
Person(s) unknown t/a Cishx GB, 31 July 2024 – A social media ad for Prostate Therapy Underwear included medical claims that that the underpants could treat prostate issues. The medical claims were ruled problematic by the ASA because evidence of an appropriate conformity marking or an MHRA registration had not been provided.
What about conditions for which medical supervision should be sought?
Claims that a device can be used to diagnose or offer treatments on conditions for which medical supervision should be sought are likely to be considered to discourage essential treatment, unless that treatment is carried out under the supervision of a suitably qualified health professional (Rule 12.2).
Marketers are therefore advised to not state or imply that a medical device can be used to diagnose or treat such medical conditions unless that diagnosis or treatment is carried out under the supervision of a suitably qualified health professional.
Lloyds Pharmacy Ltd, 4 July 2012 - A gift catalogue ad for ‘Blood pressure lowering system’ stated that it was a breathing system which helped lower blood pressure. Whilst it was accepted that the ad stated it could be used alongside medication, the ASA were concerned that the ad could encourage consumers to use the device as an alternative to having a check-up or seeking advice from a suitably qualified health professional, and thereby discouraged or delay essential medical treatment for a serious medical condition
Biolife Solutions Ltd, 30 August 2017 – A website ad for an oxygen therapy device made claims that it could be used to treat chronic obstructive pulmonary disease (COPD). The ASA considered that by marketing the product as a treatment for COPD, the ad discouraged essential treatment because the treatment offered by the product did not take place under the supervision of a suitably qualified health professional
Vita Studio Pte Ltd, 3 December 2024 - An in-game ad for a mobile phone game included claims that it could help people suffering from memory loss. The ASA considered that by marketing the product as a treatment for memory loss, the ad discouraged essential treatment because the treatment offered by the product did not take place under the supervision of a suitably qualified health professional
Flow Neuroscience AB, 7 August 2024 – A social media post for a headset device that featured TV personality Gemma Collins included claims that that it could help with depression and implied that individuals using the device could stop their medication shortly after. It was acknowledged that the sale of the device included an optional pre-consultation and that the ad included text which suggested that users consult their GP prior to starting the device. However, the ASA considered this did not constitute the ongoing supervision which was necessary for this medical condition. It was concluded that the ad trivialised the decision to come off or not use antidepressants and that the ad discouraged essential treatment for depression.
This Guidance on referencing medical conditions includes a non-exhaustive list of the types of conditions that will need to be supported by clinical evidence, and the type that should only be referenced in ads where the treatment is being carried out under the supervision of a suitably qualified health professional.