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As a rule, medical device advertising can be conducted by economic operators, i.e. manufacturers, distributors, authorized representatives and importers (Article 56 (1) of the Polish Medical Devices Act of 7 April 2022 (the MDA)). Other entities can conduct advertising only after approval of the advertisement in writing by the economic operators.

As in the case of EU Regulations 2017/745 on medical devices (the MDR) and 2017/746 on in vitro diagnostic medical devices (the IVDR), the Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide any definition of advertising. It can therefore be difficult for the industry to understand in practice which activities are likely to be treated as advertising by the regulatory authorities. Whilst the new legislation provides for stricter rules for advertising addressed to the general public, the MDA fails to provide guidance on what the advertising to the general public in fact is and determine a clear distinction between such activities and the advertising directed to non-laymen.

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.

According to publicly available research reports, Poland holds the seventh place in terms of the number of experts working on artificial intelligence (AI) projects in the European Union and even takes the lead in CEE. On the other hand, the level of adoption of AI-based solutions by Polish businesses is relatively disproportionate. The estimations made by the government visualize the potential impact of AI on the Polish economy. According to these calculations, the implementation of AI solutions in the Polish economy could contribute to increasing the GDP growth rate by 2.65% annually.

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