Advertising rules
Medical device advertising is regulated by the UK MDR 2002 and, for consumer advertising, by the Advertising Standards Authority (ASA) through the CAP Code (non-broadcast) and BCAP Code (broadcast). MHRA has enforcement powers regarding misleading or unlawful device advertising.
General advertising principles
Medical device advertising and promotion must:
- Not be misleading
- Not attribute functions or properties to the device that it does not have
- Not create a false impression about the device
- Be consistent with the device's registered intended purpose
- Be consistent with the approved labelling and IFU
A device can only be advertised for its registered intended purpose. Promoting a device for an off-label use is a regulatory risk and may mislead healthcare professionals or patients.
Advertising must not promote unregistered devices
A device that has not been registered with MHRA cannot legally be advertised for supply on the GB market. Advertising an unregistered device is both a regulatory violation under UK MDR 2002 and potentially misleading to consumers.
Consumer-facing advertising: ASA oversight
For advertising directed at consumers (patients, members of the public), the Advertising Standards Authority (ASA) regulates against the CAP Code (for non-broadcast media: websites, leaflets, social media) and BCAP Code (for TV and radio). Key ASA requirements:
- Advertising must be obviously identifiable as advertising
- Claims must be substantiated
- Testimonials must be genuine and must not create misleading impressions
- Before/after images must not be misleading
MHRA and the ASA liaise on medical device advertising complaints.
Healthcare professional advertising
Advertising directed at healthcare professionals (HCPs) is subject to less prescriptive advertising rules but remains subject to UK MDR 2002 requirements that information must not be misleading and must be consistent with the intended purpose.
Symposia, exhibitions, and promotional activities directed at HCPs are all subject to these principles.
Special rules for certain device types
Implantable devices: Advertising of implantable devices to the general public requires particular care — MHRA expects that any advertising is balanced and does not promote surgical intervention in a manner that is disproportionate to the clinical evidence.
IVDs: Direct-to-consumer advertising of IVD self-test kits must not make claims that exceed the device's registered performance characteristics. Claims of diagnostic certainty that exceed the device's validated sensitivity and specificity are misleading and actionable.
Annex XVI-type aesthetic devices: Non-corrective contact lenses, fillers, and similar products — not currently regulated as medical devices in GB — may still be subject to ASA advertising standards and general consumer protection law even outside the UK MDR 2002 framework.
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 | Prohibition on misleading advertising of devices |
| ASA: CAP Code | Non-broadcast advertising standards |
| ASA: BCAP Code | Broadcast advertising standards |
| MHRA: Advertising medical devices | MHRA advertising guidance |