BREXIT – The CAP and BCAP Codes include many rules which seek to reflect significant pieces of EU law or UK law that has been made to implement EU law. As far as CAP is aware, the same rules and laws will apply on the day after exit as on the day before. This CAP News Article explains the position further.
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.
Is your product a medical device?
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). 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. For more information on notified bodies we recommend viewing this government advice.
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).
In 2018 the ASA ruled on an ad for a circulation device which claimed to increase blood flow to the legs and relieve pain and swelling and alleviate circulatory issues including blood clots, swelling, cold feet, cramps, calf pain and numbness. In that case, whilst the device was certified with a notified body, that certification did not take place with a notified body within the EU and as such, did not hold the requisite certification (Comfort Click Ltd, 28 February 2018).
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 2018, the ASA ruled on an ad for a medical device which claimed to treat mild or moderate Alzheimer’s and claimed the benefits of “improved memory, mood and overall daily living. Better language, name and face recognition. Greater independence and social interaction. Noticeable improvements in attention and focus”. The ASA found that whilst the submitted evidence included some robustly designed trials, some of which showed some encouraging results, that evidence was not sufficiently robust to support the significant claims in the ad (Neuronix Medical Ltd, 21 March 2018).
In 2018, the ASA investigated claims that the device could provide relief from knee pain including pain from strained or injured knees. Alongside the lack of evidence to demonstrate the product was CE-marked, the ASA ruled the claims were misleading because no clinical evidence was submitted to support the claims (UK Direct Shop, 11 April 2018).
For information about the level and type of evidence required, see CAP guidance on Health, beauty and slimming claims substantiation.
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 (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.
In 2012, the ASA ruled against an ad for ‘Blood pressure lowering system’ which 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 discourage or delay essential medical treatment for a serious medical condition (Lloyds Pharmacy Ltd, 4 July 2012).
In 2017, the ASA ruled against a website which made claims that a device could be used to treat chronic obstructive pulmonary disease (COPD). The ASA considered that COPD was a condition for which medical supervision should be sought. The ASA considered that by marketing the product as a treatment for COPD, the ad discouraged essential treatment for COPD. Further, because the treatment offered by the product did not take place under the supervision of a suitably qualified health professional, it concluded that the claims breached the Code (Biolife Solutions Ltd, 30 August 2017).
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 ASA. CAP’s Advice Online entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.
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