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Advertising of Medical Devices in Poland: Surveillance and Sanctions

Advertising of Medical Devices in Poland: Surveillance and Sanctions

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Under the Polish Medical Devices Act of 7 April 2022 (the MDA), surveillance over medical device advertising is exercised in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL), and in certain cases, by the Minister of Health or the Chief Sanitary Inspector.

Surveillance authorities

Under the Polish Medical Devices Act of 7 April 2022 (the MDA), surveillance over medical device advertising is exercised in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL), and in certain cases, by the Minister of Health or the Chief Sanitary Inspector.

Administrative fines

Failure to comply with the rules on medical device advertising can be expensive. According to the MDA, advertising against the rules of Article 7 of the Regulation 2017/745 on medical devices (the MDR), the Regulation 2017/746 on in vitro diagnostic medical devices (the IVDR) or the advertising rules under the MDA, can be subject to financial penalty of up to PLN 2 million (approx. EUR 444,000). Anyone who advertises in breach of the rules can be sanctioned.

A failure to keep or make available to the competent authorities advertising templates or information about the places where the advertisement is distributed is punishable by a fine of up to PLN 50,000 (approx. EUR 11,000). Presenting devices at trade fairs, exhibitions or similar events in a manner contrary to Article 21(3) of the MDR or Article 19(3) of the IVDR is punishable by a fine of up to PLN 1 million (approx. EUR 222,000).

Such high sanctions for regulatory infringements have been adopted in the medical sector for the first time. The practice of the regulatory authorities is yet to be observed.

Other sanctions

In case of a breaches of Article 7 of the MDR or the IVDR, Article 55 or 56 of the MDA, the President of the URPL will be entitled to issue an administrative decision ordering: removal of the identified violation, cessation of the non-compliant advertisement, or publication of the issued decision in the places or mass media where the advertisement appeared (Article 57 of the MDA).

Mitigation of the fines

Pursuant to the MDA (Article 104), the amount of the penalties specified above may not exceed:
• 10% of the maximum fine – If the violation could not cause danger to life or health of users or patients,
• 50% of the maximum fine – If a fine is to be imposed on the same basis for a repeated failure to comply with obligations, and the violation could not cause danger to the life or health of users or patients.
The authority may optionally waive the fine, if the breach was incidental in nature, did not pose any risk, and the entity took corrective action within the prescribed time.

Sanctions under general rules on advertising

Unlawful advertising of medical devices can be also sanctioned under general laws on advertising: Act on radio and television broadcasting, act on combating unfair competition, Act on combating unfair market practices and Act on competition and consumer protection. The most severe among these sanctions can be imposed in case unlawful advertising is considered a practice infringing collective consumer interest – financial penalty of up to 10% of the annual turnover in a year preceding imposing of the penalty.

By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal