Medicoindustrien launches a new guide for influencer marketing of medical devices in Denmark

Background and objectives

Medicoindustrien has published a guide addressing the use of influencer marketing for medical devices in Denmark. This guidance applies solely to medical devices that may lawfully be marketed directly to end-users (consumers). Accordingly, the guide is not intended for products requiring professional use, as advertising such products to the public is prohibited under applicable legislation. 

The guide emphasizes that influencer marketing of medical devices is subject to a multi-layered legal framework, including the EU Medical Device Regulation (MDR) and Danish national legislation, particularly the Danish Executive Order on Advertising of Medical Devices and the Danish Marketing Act. Oversight is shared between the Danish Medicines Agency, which supervises compliance with medical device advertising requirements, and the Danish Consumer Ombudsman, who focuses on marketing and transparency obligations. 

Key takeaways

The guide outlines several critical compliance requirements that medical device companies must follow when engaging in influencer marketing:

• Medical device companies can use influencers in advertising medical devices that may lawfully be marketed directly to consumers
• All claims made by influencers must be accurate, evidence-based, and consistent with the medical device's intended use as supported by the clinical evaluation
• Clear disclosure requirements must be met - any compensation must be disclosed using explicit language such as, for example, "reklame" (advertisement), "ad", or "sponsoreret indhold" (sponsored content) placed prominently
• Companies should establish clear contracts with influencers, implement content approval processes, and monitor published content
• Advertising medical devices that require professional use to the general public through influencers is strictly prohibited

Note that different rules apply for medicinal products: Danish legislation strictly prohibits the use of persons who enjoy special recognition or authority in advertising, including publicly known persons such as influencers and bloggers.

You are welcome to contact Plesner's Regulatory Life Science team with any related questions.

Read Medicoindustrien's full guide