THE ORIGIN OF CHANGES

The Medical Devices Act of 7 April 2022 has been in force since 26 May 2022. It adapts the Polish legislation to the new EU requirements and introduces provisions to enforce and apply the obligations under Regulation 2017/745 on medical devices (“MDR”) and Regulation 2017/746 on in vitro medical devices (“IVDR”). Additionally, apart from setting out sanction provisions for violations of the EU MDR and IVDR provisions, the legislator has also introduced significant changes to the medical device advertising rules, which will be effective from 1 January 2023.

INTRODUCTION OF A PROHIBITION OF ADVERTISING OF AESTHETIC MEDICINE

In the Medical Devices Act of 7 April 2022, Articles 54 to 61 govern the advertising of medical devices. The new legislation provides for a total ban on advertising of specialised equipment targeted at the public from 1 January 2023. The entire sector of aesthetic medicine services will have to adapt to the new regulations, as advertising in this area most often refers to various types of implants, laser- and hyaluronic acid-based cosmetic medicine treatments.

The amendment to the Medical Devices Act also clarifies the rules for the advertising of medical devices. Such advertising, if addressed to the general public, must be expressed in a way that can be understood by a layperson, i.e. an individual who has no formal education in the relevant field of health care or medicine. This requirement also applies to the medical and scientific phrases referred to in the advertisement.

The legislator further details that an advertisement of a medical device may not use the image of persons practising or claiming to practise a medical profession, or depict persons presenting the device in a manner suggesting that they practise such a profession.

Furthermore, the advertisement must not contain a direct invitation, addressed to children, to purchase the advertised products. It must not urge parents or other adults to buy the advertised medical devices for their children. Nor may the medical device advertisement apply to devices intended for use by professional users.

AESTHETIC MEDICINE ON THE INTERNET

When browsing social media, we often see advertisements of the aesthetic medicine sector. This advertising is done both by beauty influencers, who promote particular medical services and products as their users, and by professionals (cosmetologists, aesthetic medicine practitioners) who, in order to promote their services, often publish the effect of the treatment performed by posting a ‘before and after’ photo on their social media profiles. Therefore, as a result of the new regulations, people operating on the internet, beauty parlours and aesthetic medicine clinics will have to pay particular attention to ensure that products that are intended to be used by a doctor only do not become the subject of advertising communication targeted at observers and patients.

NEW LEGAL REQUIREMENTS FOR AESTHETIC MEDICINE ADVERTISEMENTS

The Act of 7 April 2022 on medical devices also introduces fines set out in Article 103 for the use of misleading language and signs and for violating the principle of advertising medical devices. According to clause 2 of this article, anyone who advertises medical devices in a manner contrary to Article 7 of Regulation 2017/745, Article 7 of Regulation 2017/746 or Articles 54-60 shall be subject to a fine of up to PLN 2,000,000.

The so-called transition period allows advertisers who have started broadcasting advertisements that do not comply with the requirements of the Act before 1 January 2023 to have six months to bring them in line with the new regulations (until 30 June 2023).

Where the Office President ascertains violations of Article 7 of Regulation 2017/745 or Article 7 of Regulation 2017/746 with respect to advertising or Article 55 or Article 56, the following shall be ordered by way of an administrative decision:

• removal of the violations found, or
• cessation of the publication, broadcasting or performance of the advertising concerned, or
• publication of the issued decision in the places or mass media in which the specific advertisement has been published.