Advertising rules & permitted/prohibited claims
Regulatory basis - MDR Art. 7 (claims); MDR Art. 2(24) (intended purpose shaped by advertising); IVDR Art. 7 (IVDR claims). Advertising and promotional materials are part of the "information supplied by the manufacturer" and shape the legal intended purpose of the device.
This site provides general information only and does not constitute legal or regulatory advice. Advertising law also intersects with national consumer protection legislation — always seek specialist legal and regulatory advice.
Why advertising matters for device regulation
In EU device law, advertising and promotional materials are not separate from regulatory obligations — they form part of the information used to determine the device's intended purpose.
MDR Art. 2(24) defines "intended purpose" as the use for which a device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and in promotional or sales material or statements and as specified by the manufacturer in the clinical evaluation.
This means:
- A claim made in a brochure, website, or sales presentation can expand the intended purpose beyond what is stated in the IFU
- If the expanded intended purpose triggers a higher classification or additional conformity assessment requirements, the advertising claim makes the device non-compliant
- Claims must always be consistent with and supported by the clinical evaluation
MDR Art. 7 — the prohibitions on claims
MDR Art. 7 prohibits claims in labelling, IFU, and any advertising materials that:
| Prohibited claim type | Example |
|---|---|
| Misleading as to intended purpose, safety, or performance | "100% safe"; "eliminates all risk of infection" |
| Likely to mislead the user or patient | Selective presentation of clinical data ignoring adverse events |
| Attributes to the device properties it does not have | "Clinically proven to cure [disease]" when evidence is insufficient |
| Suggests use or clinical performance for which the device is not CE marked | Advertising use cases outside the approved intended purpose |
Permitted claims — what you can say
Permitted advertising claims are those that are:
- Accurate and factual — supported by clinical evidence in the technical documentation
- Consistent with the CE-marked intended purpose — within the scope of the clinical evaluation
- Not misleading — presented in context with relevant limitations, contraindications, and expected side effects
- Appropriately qualified — comparative claims backed by head-to-head data; performance claims linked to specific test conditions
Examples of permitted claims
| Claim | Why permitted |
|---|---|
| "Clinical study showed X% reduction in healing time vs. standard care" | Accurate, referenced to specific study; qualified |
| "CE-marked for treatment of [condition]" | Accurate regulatory status |
| "Indicated for patients with [specific indication]" | Matches CE-marked intended purpose |
| "Designed to minimise infection risk through [specific feature]" | Factual description of device feature |
Prohibited claims — what to avoid
Absolute safety claims
"Safe", "100% safe", "no risk of infection" — these imply zero risk, which no medical device can guarantee. MDR requires that residual risks be acknowledged. Absolute safety claims are misleading.
Unsubstantiated superiority claims
"Best in class", "market-leading efficacy", "superior to all alternatives" — unless supported by direct comparative clinical evidence, these are unsubstantiated and misleading.
Off-label promotion
Promoting use outside the CE-marked intended purpose is prohibited. If the advertising implies an indication not covered by the CE certificate, the device is being promoted for an unauthorised purpose. This also effectively expands the intended purpose, making the device non-compliant for that use.
Testimonials implying guaranteed outcomes
Patient testimonials or clinician endorsements that imply guaranteed outcomes for all users can be misleading — outcomes vary by patient and clinical context.
Unapproved "clinically proven" language
"Clinically proven to [achieve specific outcome]" — the word "proven" implies a certainty that clinical evidence rarely supports. More accurate language: "clinical data demonstrate", "clinical study results showed", "supported by clinical evidence showing".
Digital advertising — websites, social media, apps
Digital advertising channels are subject to the same rules as printed materials:
- Company websites: product pages must be consistent with the CE-marked intended purpose; claims must be substantiated
- Social media: posts, sponsored content, and influencer partnerships must not make claims inconsistent with the IFU
- Mobile apps associated with devices: app content is part of the device information system; claims in the app are subject to Art. 7
- Search advertising: ad copy must not make prohibited claims even in condensed format
Advertising to lay persons vs. healthcare professionals
MDR/IVDR do not distinguish advertising rules between professional and consumer audiences — Art. 7 applies to all promotional materials. However:
- Direct-to-consumer advertising of prescription-only devices is restricted in most member states
- Advertising to healthcare professionals has different practical norms but remains subject to Art. 7
- Some member states have additional national advertising rules for medical devices (particularly those countries with active enforcement of national laws)
Non-EU destinations — consistency requirement
If a device has different intended purposes in different markets (e.g. CE marked in the EU for a narrower indication than it is FDA-cleared for in the US), the manufacturer must ensure advertising in the EU only promotes the EU-intended purpose. Global websites must be geo-located or clearly jurisdictionally qualified to avoid cross-contamination of claims.
Related pages
- Labelling requirements
- What is a medical device? — intended purpose link
- GSPR Chapter III — IFU & labelling
- Clinical evaluation overview
Official references
| Reference | Description |
|---|---|
| MDR Art. 7 | Prohibitions on claims |
| MDR Art. 2(24) | Intended purpose — includes advertising |
| IVDR Art. 7 | IVDR claims prohibition |
| MDR Annex I §23 | IFU and labelling requirements |
| MDCG 2019-16 | IFU guidance (relevance to claims consistency) |
| National consumer protection law | Member-state specific — varies |