At a glance
- No claims beyond the intended purpose
- Efficacy claims need studies
- Biocides: “skin-friendly” not allowed
Medical devices range from plasters to apps and implants. Advertising is governed by the EU Medical Device Regulation (MDR), the HWG and the UWG.
Art. 7 MDR
Labelling, instructions and advertising must not ascribe functions the device does not have, create false impressions about treatment or diagnosis, fail to inform about risks, or suggest uses beyond the intended purpose stated in the technical documentation.
HWG for medical devices
The HWG largely applies as for medicines. Efficacy claims must reflect established scientific knowledge; courts generally require randomised, placebo-controlled, double-blind studies.
Cosmetics and biocides
Cosmetics may not claim curative effects; Regulation (EU) No 655/2013 sets common criteria for claims. Biocidal products must not be advertised as “non-toxic”, “harmless”, “natural” or “environmentally friendly” (Art. 72(3) BPR); the BGH also prohibited “skin-friendly” (BGH, 23 January 2025, I ZR 197/22).
Digital health
Certified apps and digital health applications follow the same rules; AI-based diagnostic tools may be high-risk AI systems whose obligations apply from August 2028.
