The new medical device regulations, adopted by the European Union (MDR and IVDR regulations), are accompanied by local regulations which are being adopted in the EU Member States. While the EU regulations define the rules for assessing the conformity of medical devices (and, accordingly, in vitro diagnostic medical devices), placing them on the market and exercising post-market surveillance over them, the issues of advertising and promoting these devices are subject to local rules. The provisions of the MDR and IVDR regulations are limited in this respect only to the prohibition of using misleading information / advertising activities.
Economic operators carrying out their business activity in EU Member States, including in particular importers and distributors of medical devices, must adapt their marketing activities to local regulations, ensuring their compliance with national advertising rules. Failure to adapt their marketing activity to local regulations poses the risk of the competent authorities questioning the advertising materials, their forced withdrawal, and even the risk of financial penalties imposed by those local authorities.
For example, Poland introduced new rules on advertising medical devices as of 1 January 2023. The new rules cover forms of advertising, guidelines regarding the content of the advertising, conditions for the commissioning of advertising, archiving advertising materials, supervision of the official authorities over advertising and imposing financial penalties for the violation of local regulations. Generally, these new provisions have a lot in common with the principles of advertising of medicinal products, as specified by the Polish Pharmaceutical Law.
We took a closer look at the national regulations governing advertising and marketing activities also in other countries of Central and Eastern Europe, including Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Romania, Slovakia and Slovenia. Some of them have not stipulated specific rules on advertising medical devices, so the general advertisement provisions of local law govern advertisement of these products (including Bulgaria, Estonia, Latvia, Slovakia). Whereas, other countries have already set specific regulation in this regard (including Croatia, the Czech Republic, Hungary, Poland, Romania, Slovenia) and for example in case of Hungary, these provisions are quite complex. On next page you will find comparison of the main features of these local regulations.
The scope of our report also covers local regulations on the registration of the distributors of medical devices who make them available in those countries. Moreover, we took into account the issues of recognizing expenses incurred on the advertising of medical devices as tax costs.
We hope that the information presented in our report will be useful for you and will allow you to get an idea of the local regulations on the advertising of medical devices applicable in each of these jurisdictions.