Poland adopts new regulation regarding advertisement of medical devices

After months of preparation, Poland has approved a new Regulation regarding advertisement of medical devices, which will come into force on 13 May 2023.

In addition to the statutory requirements on advertising medical devices, the Regulation sets out the following requirements for advertising of medical devices:

• Information about the product must be presented in wording consistent with the instruction for use or the label attached to the product.
• Ads for medical devices aimed at general public must include:
  • name of the advertising entity;
  • name of the manufacturer or an authorised representative (if applicable);
  • the following warning: “To jest wyrób medyczny. Używaj go zgodnie z instrukcją używania lub etykietą”. (“This is a medical device. Use it in accordance with the instruction or the label.”)
• Ads for devices without a non-medical intended purpose must include:
  • name of the advertising entity;
  • name of the manufacturer or an authorised representative (if applicable);
  • the following warning: “Dla bezpieczeństwa używaj zgodnie z instrukcją używania lub etykietą” (“For your safety, use it in accordance with the instruction or the label.”)
• Depending on the type of ad (e.g. audiovisual, visual or audio), there are specific requirements on how the warning must be displayed.
• Opinions addressed to the general public presented by the users of products who receive compensation (e.g. influencers) must clearly be marked as ads. The same applies for sponsorships of fairs, exhibitions or congresses - this indication is only required if it is not clear from the character of the event.
• Advertisement of such products in medical facilities, pharmacies, and feldsher points cannot be in the form of an audiovisual or sound message. Visual ads can only be displayed in waiting rooms.
• Non-compliant materials circulated prior to 13 May 2023 can only be circulated until 30 June 2023. If rendered compliant through changes, these materials can be propagated in the updated form.
• New materials (i.e. circulated for the first time after 13 May 2023) need to be complaint immediately.

For more information on this regulation and opportunities in Poland's medical devices sector, contact your CMS client partner or local CMS experts.