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.
This guidance represents CAP’s understanding of the application of the Medical Devices Regulations 2002 but manufacturers might want to check with the Medicines and Healthcare products Regulatory Agency (MHRA) or take legal advice.
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.
Under the Regulations, all medical devices must be CE marked. Medical devices are classified either as Class I, IIa, IIb or III. CAP understands that the product’s classification relates to the potential safety risk associated with the device. Class I general medical devices are sold on a self-declaration basis unless the device incorporates a measuring function or is sterilised. Other, higher-risk products are assessed by ‘notified bodies’, third party independent certification organisations designated by Competent Authorities in the EU. 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 in Bulletin Number 12 on the MHRA web-site. 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. The onus is on the manufacturer to comply with the Regulations and the MHRA does not undertake a pre-market approval of individual devices. Manufacturers should not, therefore, state or imply that their device has been “approved” or “certified” by the MHRA. Furthermore, manufacturers should, for a medicinal device, avoid making claims that cannot be substantiated. Marketers, especially of Class I devices, should not assume or imply that their device’s classification necessarily allows them to make a health benefit claim. The risks, classification rules, levels of control and conformity assessment routes are outlined in Bulletin Numbers 4 and 10 on the MHRA website.
The Regulations cover labelling and information to be supplied with medical devices but do not cover separate advertising material. But that is regulated under general consumer legislation such as the Trades Description and Sale of Goods Acts and the Control of Misleading Advertising Regulations, which are enforced by Trading Standards Departments and the Office of Fair Trading respectively. CAP or the ASA may ask marketers of devices to provide evidence for efficacy claims in an advertisement that does not accompany the product when supplied. Rule 12.2 of the CAP Code states “Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered." Marketers must comply with the relevant legislation to ensure they do not make unlawful claims and must ensure that they do not claim to treat, diagnose or cure serious ailments or conditions.
The ASA has ruled against ads, for medical devices, that claim or imply efficacy (BIOlamps Ltd, 16 April 2008). The Copy Advice team receives enquiries from marketers who, given they have CE certification, argue they may make claims for efficacy without having to hold or submit on request evidence to support those claims. In an adjudication on 7 May 2008, the ASA laid down its position on medical devices. Despite the advertiser having had the product’s performance assessed by a notified body, the ASA reviewed the evidence and considered it did not prove the advertiser’s claims (Goldshield Ltd, 7 May 2008).
The ASA criticised that same advertiser for making medicinal claims that implied changes would be achieved only through a modification of physiological function by either metabolic or pharmacological means. That is to say, it made claims, such as “Helps to suppress appetite” and “helps lower blood cholesterol” that were not relevant for a medical device.
More advice can be obtained either from the CAP Copy Advice team or from the MHRA on www.mhra.gov.uk.
See 'Medicinal Claims'.
Last modified : 26 July 2010