The EU regulations (Regulations 2017/745 on medical devices (the MDR) and 2017/746 on in vitro diagnostic medical devices (the IVDR)), introduced a prohibition of misleading advertising of medical devices.
According to Article 7 of the MDR or the IVDR, it is prohibited to use in the advertising of devices text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
• ascribing functions and properties to the device which the device does not have,
• creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have,
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose,
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
In addition, the Polish Medical Devices Act of 7 April 2022 (the MDA; Article 55(3)) stipulates that medical device advertising cannot be misleading as to the conditions of maintenance, servicing, software updates, inspections, adjustments, calibrations, and safety checks, including the requirements for technical equipment, entities performing these activities and their qualifications.
In practice, advertising can be regarded misleading not only if it contains false information, but also if it provides information that is incomplete, unclear, hardly verifiable or difficult to access (even if it is objectively true). Advertising can also be considered misleading if it creates perception of the device inconsistent with the real state of affairs, contains generalizations, presents the device in a biased view, or guarantees effect.
Additionally, not only advertising, but also other types of communication about medical devices need to comply with applicable laws.
Sanctions for violations of Article 7 of the MDR/IVDR
Conducting misleading advertising in breach of Article 7 of the MDR or the IVDR, or Article 55(3) of the MDA is punishable by a fine of up to PLN 2 million (approx. EUR 444,000). Anyone who advertises medical devices in breach of these regulations can be sanctioned.
Breaches of Article 7 of the MDR or the IVDR other than those related to the advertisement are subject to financial penalty of up to PLN 5 million (approx. EUR 1.1 million).
By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal