As of 1 January 2023, the rules governing the advertising of medical devices, systems, and treatment kits in Poland will change dramatically. On this date, some provisions of the Act of 7 April 2022 on medical devices will come into force. Businesses may be subject to fines of up to PLN 5 million for failing to comply with the requirements of the new regulations.
Diametrical changes
Compared to current regulations, there will be significant changes. The Medical Devices Act (“Act on medical devices”) implements the standards contained in EU regulations, including Regulation 2017/745 and Regulation 2017/746 on medical devices The preambles of which also require EU Member States to regulate or clarify certain issues by law. Therefore, some of the new provisions on the advertising of medical devices have been introduced to counteract unethical advertising. As can be seen from the explanatory memorandum of the bill, it is justified by the overriding public interest in protecting life and public health.
In effect, as of 1 January 2023 the advertising of a device to the public in a way that is explained below will not be allowed:
- using the image of persons engaged in the medical profession or claiming to be such persons, or depict persons presenting a product in a manner suggesting that they are engaged in such a profession;
- containing a direct appeal to children to purchase the advertised products or to persuade parents or other adults to buy advertised products; and
- showing products intended for use by users other than laypersons.
In practice, this means a complete elimination of doctors, dentists, pharmacists, and other medical or health care professionals from advertising messages about medical devices or the services connected to them.
