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 a CE Marked medical device. 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, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
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 it does not have one or more of the medical purposes referred to (for example, it has a purely cosmetic purpose) a product does not fall within the definition of a medical device.
If marketers are unsure about the definition on their product, they should contact the Medicines and Healthcare products Regulatory Agency (MHRA). https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety.
Is your product appropriately classified?
Under the Regulations, all medical devices must be CE marked. 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. The conditions for the sale and supply of IVDs are outlined on the MHRA website. Notified bodies are always involved in the assessment of active implantable devices.
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.
In 2016 the ASA investigated a marketer’s claims that its “Acupressure Mat” could treat lower back pain, sciatic pain and headaches. Because the device was not CE Marked it was ruled that the medical claims breached the Code (Pranamat Sales and Marketing SA, 30 March 2016).
Similarly, in 2012 the ASA ruled against a marketer which claimed that one of its infant drinking bottles was “effective against colic” because the bottle was not a CE Marked medical device (Jackel International Ltd, 19 December 2012).
Do you hold evidence to support all efficacy claims?
Marketers need to ensure that they hold robust evidence for their medical claims (Rule 12.1) and are reminded that whilst CE certification may demonstrate that the device is safe and fit for its intended purpose, a CE certification in itself does not constitute evidence for the purposes of the rule.
In 2016, the ASA ruled against claims that a respiratory device could reduce shortness of breath, improve respiratory fitness and improve mucus and phlegm clearance because although clinical evidence was submitted, that evidence was not considered to be sufficiently robust (Actegy Ltd t/a Aerosure Medic, 1 June 2016).
For information about the level and type of evidence required, see CAP guidance on Health, beauty and slimming claims substantiation.
Updated 29 December 2016.
See also ‘Healthcare: Medicinal claims’.