New regulations on advertising medical devices – what can we expect?

On 28 July 2022, a draft Regulation of the Minister of Health on the advertising of medical devices (the “Draft Regulation”) was published. The Draft is intended to be a clarification of the technical requirements for advertising medical devices that have been introduced at the statutory level.

The most important areas addressed by the Draft Regulation are:

• The mandatory elements to be contained in advertising directed to the public. According to the Draft Regulation, the advertisement directed to the public must contain: (i) contraindications to the use of the device (if applicable); (ii) information on the probable risks associated with the use of the device in accordance with its application; and (iii) an indication of the name of the manufacturer and the authorised representative (if one has been appointed).
• The content of the mandatory warning. In addition to the mandatory elements described above, a warning must be included in the advertisement directed to the public. Depending on whether or not there are contraindications identified for the device, the content of this warning will be as follows:
  • for a medical device without identified contraindications: „To jest wyrób medyczny. Dla bezpieczeństwa używaj go zgodnie z instrukcją lub etykietą. W przypadku wątpliwości skonsultuj się ze specjalistą.”. [English translation for convenience: “This is a medical device. For your safety, use it in accordance with the instructions or label. If in doubt, consult a specialist.”];
  • for a device with contraindications: „To jest wyrób medyczny. Dla bezpieczeństwa używaj go zgodnie z instrukcją lub etykietą W przypadku wątpliwości skonsultuj się ze specjalistą, gdyż ten wyrób może nie być odpowiedni dla Ciebie.”. [English translation for convenience: “This is a medical device. For your safety, use it in accordance with the instructions or label. In case of doubt, consult a specialist, as this device may not be suitable for you.”].
• The way the warnings are presented. Just like the provisions on the advertising of medicinal products, the draft regulation specifies how mandatory warnings are to be displayed in ads. Depending on the form of an ad (audiovisual, audio or visual), the presentation will vary:
  • in audiovisual ads, the content of the warning must be read clearly in Polish and the duration of the message must not be shorter than 8 seconds;
  • in visual advertising, the content of the warning must be placed (i) at the bottom of the advertisement, on a surface not smaller than 10% of the ad, (ii) so that the text stands out from the background of the surface, is visible, legible, stationary, placed horizontally; (iii) the distance of the letters from the lower and upper edge of the background of the advertising plane must be no more than 1/2 of the height of the letters, and the distance between the lines of the inscription can be no more than the height of the letters;
  • in audio-visual advertising, the content of the warning (i) must be placed at the bottom of the ad, on a surface not smaller than 20% of the ad, (ii) must be read clearly in Polish and the duration of the message must be no less than 8 seconds, (iii) must comply with the requirements for visual advertising set out in points (ii) and (iii) above.
• Manner of presenting data in an ad for a medical device. According to the Draft Regulation, the data presented in a medical device ad must be communicated consistently with the instructions or label of the medical device. Again, this is similar to the regulations currently applicable to the advertising of medicinal products.
• Information on benefits. Medical device advertising must indicate information on all tangible and intangible benefits received from the advertiser. This information should be placed in graphic or audio form. However, the regulation does not provide for the specific content of such information. This is an important provision not only from the regulatory and oversight perspective of URPL, but also of the Office of Competition and Consumer Protection (UOKiK). Recently, we have seen an increased interest on the part of the Office in the activities of influencers - the UOKiK monitors this issue and has recently fined several influencers for conducting surreptitious advertising.

Under the proposed legislation, the regulation is expected to come into force on 1 January 2023 – and therefore parallel to the statutory advertising provisions.

The draft regulation is currently at the public consultation stage, which is scheduled to last 30 days (until the end of August). The full content of the draft, as well as the progress of the legislation, can be followed at: https://legislacja.rcl.gov.pl/projekt/12362406/katalog/12898282#12898282.