According to the amendment to the Medical Devices Act of April 7, 2022, a number of changes and prohibitions will come into effect on January 1, 2023, affecting not only the medical and aesthetic medicine industries, but also, among others, influencers. Among the most significant changes are a ban on advertising medical products and specialized equipment that can only be used by doctors (e.g., specialized lasers, hyaluronic acid, implants, etc.), as well as a ban on using the image of doctors or pharmacists in promotions of similar products. The goal is to ensure that the promotion of medical products or devices is not misleading, meaning that it is understandable to the average viewer of such advertising, regardless of whether they are knowledgeable in the field. The act also prohibits messages that directly encourage children to purchase advertised products or encourage parents or other guardians to purchase advertised products for children. This will curb advertising of medical products modeled on sweets or toys, which appeal to the youngest audience. The changes are intended to provide better protection for public health and patient safety.
The changes in regulations result from the need to adapt Polish law to EU regulations (including Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulation (EC) No 765/2008 and (EU) No 305/2011).
Most of the amended regulations will come into force on January 1, 2023, and any violation or breach of the applicable prohibitions will result in a financial penalty of up to PLN 2 million.
This alert is for informational purposes only and does not constitute legal advice.
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