As in the case of EU Regulations 2017/745 on medical devices (the MDR) and 2017/746 on in vitro diagnostic medical devices (the IVDR), the Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide any definition of advertising. It can therefore be difficult for the industry to understand in practice which activities are likely to be treated as advertising by the regulatory authorities. Whilst the new legislation provides for stricter rules for advertising addressed to the general public, the MDA fails to provide guidance on what the advertising to the general public in fact is and determine a clear distinction between such activities and the advertising directed to non-laymen.
Therefore, in order to determine whether an activity can be considered advertising, it is necessary to refer to:
- case law on advertising,
- provisions of the Polish pharmaceutical law and the interpretation of administrative authorities regarding medicine advertising.
Certain types of materials are expressly mentioned in the MDA as excluded from the scope of advertising:
- trade catalogs and price lists containing only the trade name, device price and/or technical specifications;
- information on packaging and information attached to the device packaging as required by law.
Nevertheless, the above catalog of exemptions should not be considered as exhaustive. Indeed, not every message regarding medical devices will automatically be considered as advertising. The consideration as to whether a certain message has an informational or advertising nature should be made on a case-by-case basis.
The key aspect of advertising of medical devices, which distinguishes it from other activities, is its promotional purpose. An activity can be found to constitute advertising of medical devices, if it is aimed at achieving certain promotional effect (i.e. increasing number of sale, deliveries or consumption of medical device).
Communication and other activities concerning medical devices may contain elements that cause them to be considered advertising, in particular:a
- promotion of the sale or paid use of a device or service as the purpose of the message,
- elements of an incentive to purchase a medical device or service,
- eye-catching graphic design of the material or persuasive language,
- elements specific to medical device advertising (e.g. warnings),
- information about places and opportunities to purchase the medical device or service,
- offering the medical device as part of a promotion, including price or discount,
- additional information that is not necessary to make an offer or conclude a contract.
By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, Paulina Roslon-Horosz, Junior Associate, NGL Legal