Spain · Advertising framework
Influencer marketing for digital health products in Spain
General market orientation, not campaign clearance. Research scope and dates
Product and service rules
Medical-device claims must match the assessed purpose
Legal requirement — paraphrased
Applies when: The advertised product or software function is a medical device under the MDR.
For a regulated medical device, Article 7 prohibits misleading text, names and images, including unsupported functions, a false impression of treatment or diagnosis, omission of likely risks, and uses outside the purpose assessed for conformity. This includes software when it meets the medical-device definition.
Check professional-use and publicly funded product restrictions
Legal requirement — paraphrased
Applies when: The product falls within the relevant Spanish health-product provisions, including a separate IVD assessment where appropriate.
Article 80 restricts public advertising of health products financed by the national health system and products intended exclusively for healthcare professionals. Check the precise product definition, the applicable device or IVD framework and regional advertising controls; a CE mark alone is insufficient to determine public-ad eligibility.
Sources: RDL 1/2015: guarantees and rational use of medicines and health products; Real Decreto 192/2023 on medical devices
Channel rules
Check the complete consumer-facing message
Regulator guidance
The EU consumer-protection framework addresses misleading actions and omissions, including an overall deceptive presentation and undisclosed commercial intent. Review benefits, risks, qualifications and prices as a whole under the national implementing law. Space limits do not provide an automatic exemption from material information requirements.
Sources: EU Unfair Commercial Practices Directive 2005/29/EC
Identify the advertisement and advertiser
Regulator guidance
LSSI guidance requires online commercial communications to be recognisable as advertising and identify the advertiser. This applies alongside health-sector restrictions; a label does not authorise a prohibited health claim.
Sources: LSSI: Publicidad en Internet
Review personal data separately from the advertisement
Legal requirement — paraphrased
Identify an Article 6 basis for personal-data processing and an applicable Article 9 condition for health data. Provide appropriate transparency and honour the right to object to direct marketing. Permission to deliver healthcare does not automatically authorise advertising use of patient data; electronic contact and trackers also need their own local review.
Brief the creator on the permitted message
Editorial recommendation
Check whether endorsements are permitted for the selected offer before contracting a creator. Record payments, gifts and affiliate links; specify the required advertising identification, approved claims, editing controls and takedown process.
Campaign workflow
Digital Health Products: prepare the review
Editorial recommendation
Classify each software function separately: lifestyle, medical software or delivery of care. Link accuracy and clinical outcome claims to the advertised software version and population. Review tracking and marketing data flows separately from permission to provide care.
Keep a traceable campaign decision
Editorial recommendation
Keep one review record linking the offer, local market status, claim evidence, exact creative, media settings and any regulatory or professional clearance. Record who checked each condition. Reopen the review when the offer, claim, source rule or execution changes.
Pre-publication checklist
- Classify each software function separately: lifestyle, medical software or delivery of care.
- Link accuracy and clinical outcome claims to the advertised software version and population.
- Review tracking and marketing data flows separately from permission to provide care.
- Record product or provider eligibility before approving claims.
- Archive the final creative and its evidence, permissions and review decisions.
- Assign an owner for source updates, complaints and prompt withdrawal of inaccurate material.
Scope and unresolved questions
- Retained IVD advertising rules, Madrid device-ad approval and provider registration-number requirements are documented. Determine the actual autonomous community before filing; other regional procedures, profession-specific codes and the exact promotion remain to be checked.
- This national baseline does not review every broadcaster rule, platform policy, regional licensing condition, promotion mechanic or data-transfer arrangement. No format-specific warning dimensions or durations should be inferred where none are supplied.
Research scope, introduction and dates
A digital-health offer promoted through influencer collaborations in Spain may combine a lifestyle function, medical software and a clinical service. Identify each advertised function and software version, then review clinical claims and the use of personal data separately.
Creator selection and commercial disclosure are only part of an influencer review. Examine the person's role, the spoken and visual claims, supplied benefits and the final publication together; a personal experience can still communicate a regulated claim.
General market orientation, not legal, regulatory or medical advice, a complete compliance plan or clearance of an advertisement. Actual requirements depend on the specific offer and campaign.
How to use this national baseline
Editorial overview
This framework combines researched national rules with editorial review steps. Spanish national health-advertising baseline plus EU requirements; autonomous-community rules remain relevant. A visible channel workflow does not establish that the selected product or service may be advertised there. Read the category restrictions first.
The review date identifies when the cited provisions or regulator excerpts were checked. It does not mean that every local rule, exception, professional standard or platform policy has been reviewed.
Sources
- EU Medical Devices Regulation 2017/745
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
- RDL 1/2015: guarantees and rational use of medicines and health products
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
- Real Decreto 192/2023 on medical devices
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
- EU Unfair Commercial Practices Directive 2005/29/EC
EU framework implemented through national law; sector rules and local implementation also apply.
- LSSI: Publicidad en Internet
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
- EU General Data Protection Regulation 2016/679
Targeted source review; apply the cited provision to the exact offer and check subsequent changes before launch.
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