The update to The Danish Medicines Agency's guideline on advertising, etc. on medical devices has been adopted on 25 June 2024.
As also covered in our previous article of 21 May 2024, the update to the Danish Medicines Agency's guideline on advertising, etc. on medical devices has now been adopted.
The new guideline is extended and more precise than the previous one and now provides guidance on matters such as:
- Interactions of employees in medico companies on social media can be considered advertising of medical devices.
- Influencers and bloggers can be held responsible for advertising medical devices.
- More detailed conditions and extended rules on the documentation and reporting requirements on financial benefits for healthcare professionals.
- A few sections of the guideline now also apply to products without an intended medical purpose.
- The Danish Medicines Agency can allow companies to mention serious diseases in extraordinary cases if it is justified for special health reasons. However, this will never apply to advertising on television, videos, in movies, or the like.
The new guideline refers to rules in regulation (EU) 2017/745 on medical devices, regulation (EU) 2017/746 on medical devices for in vitro diagnostics, the Danish Advertising Order of 24 May 2022 and the Danish Order of 20 June 2023 on advertising, etc. for products without an intended medical purpose.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.