Permitted & prohibited claims
Regulatory basis
The basis for permitted and prohibited claims is the intended purpose registered with MHRA and the clinical and performance evidence in the technical file. Claims that exceed the intended purpose or are not supported by evidence are misleading and violate UK MDR 2002 and advertising law.
The fundamental rule: claims must match evidence
Every claim made about a medical device — whether on the label, in the IFU, in promotional materials, or in advertising — must be:
- Within the registered intended purpose — the device cannot be promoted for uses not included in the registered intended purpose
- Substantiated by evidence — the claim must be supported by clinical, performance, or technical data in the technical file
- Not misleading — the claim must not create a false impression about the device's benefits, performance, or risks
Permitted claims
| Claim type | Requirements |
|---|---|
| Performance claims (e.g., accuracy, sensitivity, specificity for IVDs) | Must reflect validated performance data; must state the conditions under which performance was measured |
| Clinical outcome claims (e.g., "reduces hospitalisation by X%") | Must be supported by clinical data in the CER; must not overstate statistical certainty |
| Indication claims (which patient population, clinical condition) | Must match the registered intended purpose exactly |
| Comparison claims (vs. standard of care or competitor) | Must be based on direct, rigorous comparative data; must not cherry-pick favourable comparisons |
| Quality/manufacturing claims (e.g., "ISO 13485 certified") | Must be accurate; ISO 13485 certification must be current |
| Regulatory status claims (e.g., "UKCA marked," "CE marked") | Must be accurate; the device must currently hold the stated status |
Prohibited claims
| Prohibited claim | Why it is prohibited |
|---|---|
| Claims for indications not in the registered intended purpose | Off-label promotion — violates UK MDR 2002 and may mislead |
| Performance claims not substantiated by evidence | Misleading |
| "Completely safe" or "no side effects" | No device is completely safe; this creates a false impression |
| Claims implying MHRA or government endorsement | MHRA does not endorse devices |
| Claims that UK MDR 2002 registration is equivalent to clinical proof of efficacy | Registration confirms conformity with essential requirements, not clinical superiority |
| Testimonials that do not reflect typical outcomes | Misleading under ASA codes |
| Before/after images that exaggerate results | Misleading |
| Claims for a device that is not registered with MHRA | Device cannot be advertised for supply in GB without MHRA registration |
Social media and digital marketing
All requirements apply equally to social media posts, influencer marketing, website content, email campaigns, and digital advertising. There is no "informal" online channel that is exempt from UK MDR 2002 and ASA requirements.
Key points for digital marketing:
- Social media posts about a device constitute advertising and are subject to all applicable rules
- Influencer endorsements must comply with ASA rules on disclosure and substantiation
- Website claims about the device must be consistent with the registered intended purpose and evidence
- Patient testimonials on websites must be genuine, representative, and not misleading
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 | Prohibition on misleading claims |
| ASA: CAP Code — Medical and Healthcare | Specific rules on health claims |
| MHRA: Advertising medical devices | MHRA's guidance on claims |