The Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide a definition of medical device advertising or criteria that could allow a clear assessment of whether an activity is advertising and what requirements it should meet.
What activities are considered as advertising under the MDA?
The Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide a definition of medical device advertising or criteria that could allow a clear assessment of whether an activity is advertising and what requirements it should meet.
The following forms of promotional activities are in practice considered the advertisement: advertising spots on the radio, television and on the Internet, advertising leaflets and brochures, advertisements on billboards and in display windows, advertisements in general and trade magazines, as well as educational materials, gadgets or items of a promotional nature.
Depending on their form and content, the following can be also treated as the advertisement: blogs and vlogs, social media posts, websites, articles, interviews, and influencer public statements.
Forms of advertising under Article 58 of the MDA
In addition, the MDA lists examples of activities that the new legislation is about to apply to:
• business activity where the device is used to provide services, insofar as it relates to services provided with the device,
• presenting devices at events whose purpose or effect is to encourage the purchase of the device, and/or financing such meetings,
• visiting healthcare professionals to promote devices,
• sponsorship of trade fairs, exhibitions, shows, presentations, conferences, conventions and scientific congresses, including those for healthcare professionals or traders of devices, and/or presenting devices during such events,
• directing opinions to the public by device users if they receive benefits from it,
• samples to promote devices.
Trade fairs, exhibitions, demonstrations
According to Article 21(3) of the Regulation 2017/745 on medical devices (the MDR) and Article 19(3) of the Regulation 2017/746 on in vitro diagnostic medical devices (the IVDR), it is permissible to display medical devices incompliant with the MDR/IVDR at trade fairs, exhibitions, demonstrations or similar events, if there is a visible sign clearly indicating that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with the MDR.
According to the MDA, violation of the obligation to display such information is punishable by a fine of up to PLN 1 million (approx. EUR 222,000).
By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal
