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On 1 January 2023, an amendment to the Act on Significant Market Power in the Sale of Agricultural and Food Products and Its Abuse (the “Act”) comes into effect. The amendment significantly expands the Act’s scope both in terms of who is affected as well as the obligations it imposes.

Poland is experiencing a lot of regulatory and legislative changes, primarily driven by (new) EU directives. The energy, commercial, employment, and consumer protection sectors are all in flux, according to Cezary Zelaznicki, PwC Legal Poland Managing Partner and PwC EMEA Legal Business Solutions Leader.

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.

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