The Polish Medical Devices Act of 7 April 2022 (the MDA) imposes certain restrictions on the medical device advertising that is addressed to the general public. Such advertising activities must not be misleading (Article 7 of the MDR or the IVDR, and Article 55(3) of the MDA), but also must not:
- concern medical devices intended for use by non-laymen,
- be worded in a way that is hard to understand by a layman (this also applies to medical and scientific wording, opinions, literature or scientific studies and other material aimed at professionals),
- use the image of persons practising or claiming to practise a medical profession or depict persons presenting a device in a manner suggesting that, and
- be directed at children.
The draft regulation of the Minister of Health on the medical device advertising provides for further restrictions and requirements applying to advertising to the public.
Problem with the qualification of the medical devices for users other than laymen
Because of the variety of medical devices available on the market and their practical use, it can in some situations be difficult to establish if the specific device is or is not intended for the use by the non-laymen. As a result, it can be hard to determine what restrictions in advertising of such devices in fact apply.
In the absence of more precise guidelines, the evaluation will always need to be made on a case-by-case basis. The legislator’s intention behind the MDA was, in case of doubts, to follow the previous decisions of the regulatory authorities and courts for medicines. In practice, adopting a very strict approach could not only significantly limit advertising activities in the medical device sector, but also make it more difficult for patients to access information about possible therapeutic options, including new and innovative medical devices. Such approach may not always respond properly to the needs of the market and the patients.
Problem with assessing whether an advertisement is directed to the public
When assessing whether an advertisement is directed to the public, it is necessary to take into account not only the intentions of the advertiser, but also the actual availability of the message.
With respect to medicines, the competent authorities considered situations in which an advertisement intended to be directed to professionals accidentally reached the laymen as advertising directed to the public (e.g. patients being able to read leaflets at the doctor’s office or the availability to the postman of an envelope with the medicine's logo). The time will tell what the actual practice of the regulatory authorities in fact is with respect to medical devices.
In online advertising of medical devices addressed to professionals, care will need to be taken to ensure that access to the advertisement is appropriately secured (e.g. a login requirement for registered professional users).
By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal