Monthly Archives: July 2025

WHAT’S NEW IN THE UPDATED GUIDELINES ON MEDICAL DEVICE ADVERTISING?

Legal news

The Italian Ministry of Health has published new guidelines on advertising of medical devices (“Guidelines”), which replace all previous guidelines issued by the Ministry over the years.

  • WHAT’S NEW?
  • Advertising aimed at healthcare professionals

When advertising is directed at HCPs, the following requirements must be met:

  • A disclaimer must be included stating that the content is intended exclusively for HCPs; but also
  • a “pop-up” message and/or similar technologies must be implemented to require users to confirm that they are HCPs before accessing the advertising content.
  • Content of the advertising message

Each advertising message must include the following wording: “It is a CE medical device (including the notified body number, if applicable). Read the warnings or instructions for use carefully. Ministerial Authorization of dd/mm/yyyyy”.

  • Expanding use of social networks – including TikTok

The list of approved social networks for medical devices advertising now includes TikTok. However, the following features must be disabled:

  1. Comment function;
  2. Duet function (which allows the user to post his/her video side-by-side with a video from another creator);
  3. Stitch function (which allows a user to crop and integrate scenes from another user’s video into his/her own video).
  • ANY ADVANTAGES FOR COMPANIES?
  • Simplified compliance. Companies now benefit from a single, consolidated regulatory framework gathering all the regulations concerning medical devices’ advertising.
  • Broader digital scope. The inclusion of platforms like TikTok increases the scope of digital channels where advertisement of medical devices is regulated. Regrettably, rules on LinkedIn are lacking.
  • Other marketing channels. The Ministry of Health may admit the use of additional social networks (beyond Facebook, Instagram, YouTube, and TikTok), subject to prior authorization.

Bottom line: a consolidated document is certainly helpful, but we do not understand the choice not to regulate LinkedIn, the channel where the boundary between corporate communication and advertisement of medical devices is more problematic.