There has been a major change to laws regarding advertising of medical devices[1] in Poland due to another Act on Medical Devices being passed, of 7 April 2022.[2]

The current rules at EU level have changed in accordance with the adopted premise that more extensive and uniform protection is needed, at least to a minimum extent, i.e. the more general Regulation 2017/745[3] on medical devices, and the specific regulation on in vitro diagnostic medical devices.[4] Regulation 2017/745 lays down a general framework for marketing of devices. Specific rules on marketing medical devices are being formulated in the national laws, such as the Polish Act on Medical Devices that has now been adopted.  Article 7 of Regulation 2017/745 (and in the same way article 7 of Regulation 2017/746) regulates the question of claims made in medical device advertising and prohibits claims that are misleading.

The Sejm adopted a new Polish Act on Medical Devices on 7 April 2022[5] to regulate the issues that under EU Regulations 2017/745 and 2017/746 member states can decide for themselves. The greatest change in the Act on Devices of 7.04.2022 now passed concerns advertising of medical devices (see article 54 et seq.). The adopted Act on Devices of 7.04.2022 lays down specific rules on advertising of medical devices, regulating issues such as advertising message and entities responsible for advertising, keeping records of released information, and regulatory powers of public authorities with regard to advertising.

There is no legal definition of advertising in the Act on Devices of 7.04.2022 that has now been passed. This issue continues to be left for the courts to adjudicate.[6]

Under the new legislation, an advertiser is (solely) an economic operator (art. 56(2) of the AMD 2022). In practice, this will mean primarily a device manufacturer, authorized representative, importer, and distributor. Advertising may be conducted by other types of entities, such as influencers, when the advertisement is approved by the economic operator responsible for it.

The national article 55(3) of the AMD 2022 states specific areas in which device advertising may not be misleading.

In addition, the new act specifies further rules on content not permitted in advertising intended for the public (article 55(2) of the AMD 2022), in particular use of images depicting people who practice medicine or impersonating such people and appealing to children to purchase the devices being advertised.

The new legislation also provides for certain obligations relating to advertising wording, for example advertising intended for the public must be understandable to “laypeople”; see the second sentence of article 55(1)   of AMD 2022. Specifics as to permitted content and form of advertising of devices are provided in a draft Minister of Health Regulation.[7] Advertising intended for the public must state that the product shown is a medical device (see § 4(1) of the draft Minister of Health Regulation) and contain the relevant warning (see § 4(2)).

Additional obligations have been placed on advertisers of devices, and other entities, concerning records of distributed advertisements namely to store advertisement templates and records of where an advertisement was distributed for two years.

Compliance with the fundamental elements of advertising laws i.e. advertising activity described in article 58(1)(2)-(7), will be monitored by the President of the Office for Registration of Medical Devices and other matters.

The new legislation also envisages a system of administrative fines. A fine for breaching advertising rules is expected to be up to PLN 2 m.

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The new rules are very strict and place a range of special obligations and restrictions on businesses in the sector. Clearly, the new legislation will mean additional burdens for businesses on the Polish market, such as the need to devise new advertising strategies and practices, to give one example.

[1] “Devices”.

[2] See the Act on Medical Devices of 7 April 2022 Sejm docket 1764; https://www.sejm.gov.pl/sejm9.nsf/PrzebiegProc.xsp?nr=1764 (AMD 2022).

[3] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017., p. 1; in force as of 26 May 2021.

[4] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on medical devices and on in vitro diagnostic medical devices and repealing Directive 98/79/EEC and Commission decision 2010/227/EU OJ L 117/176, 5.5.2017., p. 1; in force as of 28.01.2022.

[5] See the Act of 7 April 2022 on Medical Devices referred to above; Sejm docket 1764; https://www.sejm.gov.pl/sejm9.nsf/PrzebiegProc.xsp?nr=1764 ;   (the Act of 7 April 2022 on Devices – AMD 2022) (accessed 23.04.2022).

[6] See for example Supreme Court judgment of 26 January 2006, case file number V CSK 83/05, LEX 191239; Supreme Administrative Court judgment of 23 September 2009, case file number I FSK 1381/08, accessible in CBOSA.

[7] See the draft Minister of Health regulation on advertising of medical devices of 12.03.2021, not currently available online, envisaged to be published under article 70 of the previous proposal for the act, the “Minister of Health Regulation”.