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New Legal Framework for Medical Device Advertising in Poland

New Legal Framework for Medical Device Advertising in Poland

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1 January 2023 brought a major change to medical device advertising in Poland. From this date, the new national regime for medical device advertising applies. Therefore, all promotional activities associated with medical devices in Poland need to comply not only with the European Union regulations, but also with the new national requirements.

At the EU level, the legal regime consists of two regulations: Regulation 2017/745 on medical devices (the MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (the IVDR). The MDR applies from 26 May 2021, while the IVDR started to apply from 26 May 2022. They both stipulate a prohibition of misleading advertising in Article 7.

In Poland, the advertising of medical devices must also abide by the Polish Medical Devices Act of 7 April 2022 (the MDA). The MDA came into force on 26 May 2022. Nevertheless, the provisions on medical device advertising started to apply on 1 January 2023. The MDA regulates issues such as restrictions related to advertising to the public, entities responsible for advertising, obligations to keep templates of released advertising, surveillance of competent authorities and sanctions.

Additionally, on 28 July 2022, a draft Regulation of the Minister of Health on the medical device advertising was published (the Draft). The Draft is intended to clarify technical requirements for medical device advertising that have been introduced at the statutory level. The Draft is currently at the public consultation stage.

The general rules on advertising must also be taken into account with respect to medical device advertising. In Poland, these are in particular: Act combating unfair competition, which regulates unfair advertising of goods, including unfair comparative advertising, and Act on radio and television broadcasting, which sets rules for advertising of goods in radio and television.

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