The adoption of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) triggered changes in the medical devices law on the national level in Poland. The new Polish Medical Devices Act of 7 April 2022 (MDA) stipulates entirely new restrictions to advertising of medical devices (Articles 54-61) that were previously unknown to this industry sector and heavy sanctions for infringements of the new rules (Articles 103 and 104).
The MDA has come into force on 26 May 2022, whilst provisions for advertising of medical devices will start to apply from 1 January 2023.
Definition, scope and exemptions
As in the MDR, the MDA does not provide for a definition of advertising. The MDA also fails to provide guidance on what the advertising to the general public is and determine a clear distinction between such activities and the advertising directed to non-laymen.
The MDA lists examples of activities that the new legislation is about to apply to, including the sponsoring of medical events, visits at the HCP entities or offering samples. For the first time, the MDA introduces the concept of advertising by sharing opinions by the device’s users, including the influencers.
According to the MDA, the product catalogues or price lists will not be considered as advertisement.
Advertising medical devices to the public
The MDA imposes certain restrictions on the advertising that is addressed to the general public. Such advertising activities must not:
- concern medical devices intended for use by a non-lay person,
- be worded in a way that is hard to understand by a lay person,
- 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.
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 only by the non-laymen. As a result, it can be hard to determine what restrictions in advertising of such devices apply.
Who’s subject to the new rules?
The new rules of advertising must be obeyed by all legal entities that advertise the devices in their own name, including the producers, importers and the distributors.
The above provisions will also apply to advertising of business or professional activities (e.g. HCPs or other professional users) in which a medical device is used to provide services, insofar as it concerns services provided with the use of the specific device in question.
Supervision and administrative penalties
Violations of the advertising rules can be subject to a fine of up to PLN 2 million (approx. EUR 412,688).
Supervision of advertising will be conducted in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).
By Agnieszka Majka, Partner, and Paulina Rosłon-Horosz, Junior Associate, NGL Legal