Section 12 of the CAP Code (Medicines, Medical Devices, health-related products and beauty products) can seem a complicated area, but CAP’s prescription is just the medicine to help you get your ads right.
The Medical Devices Regulations 2002, as amended, underpin this section of the code and they define a medical device as, broadly, an article intended to be used for people to diagnose, prevent or monitor an injury or handicap. Under the regulations (and therefore the Code) all medical devices must carry a CE mark and be classified as either a Class I, IIa, IIb or III medical device, as issued by a relevant Notified Body. Being issued with certification demonstrates that a device is safe and fit for its intended purpose. But unless it is one of the highest classifications (or the manufacturer specifically opts to have it assessed), it does not prove efficacy and advertisers will need to ensure they hold robust evidence to support their claims. The code also states that ads should not discourage essential treatment for conditions for which medical supervision should be sought. (Home Test Direct (UK) Ltd, 30 May 2012).
A medicine can be defined in two ways. It might be medicinal by presentation or medicinal by function. Medicines must have a marketing authorisation from the MHRA before they are advertised and claims made for products must conform with the Summary of Product Characteristics (SPC). Advertisers who are unsure whether their product is a medicine should contact the MHRA borderlines team for clarification. Advertisers should take care to avoid making medicinal claims for products that don't have a marketing authorisation (Dulwich Health Ltd, 6 February 2013).
Here's our at-a-glance guide:
Ensure you have a marketing authorisation from the MHRA
|Ensure your device holds a relevant medical device certification |
|Check with the MHRA Borderlines team if you’re not sure||Ensure you hold evidence to support claims, if this has not already been assessed by the Notified Body |
|Claims must conform with the Summary of Product Characteristics (SPC) |
|X Discourage essential treatment for conditions for which supervision should be sought, unless specifically cited in the product’s SPC|
X Advertise a prescription-only medicine
|X Use a celebrity or health professional to endorse a medicine|
|X Claim a medicine is completely safe or without side effects|
Advertisers may find the MHRA’s “A guide to what is a Medicinal Product” useful.
The Copy Advice team has plenty of guidance on Section 12, including Medicines, Medical Devices and Electrical Stimulation Devices to name just a few.
As always, the Copy Advice team are happy to advise you on non-broadcast advertising. For more information about the service we provide, please see our website.