New law on medical devices and their advertising

New Law on Medical Devices dated April 7, 2022. (hereinafter “the Law”), with two exceptions, is effective as of May 26, 2022. The law was adopted to bring Polish law in line with EU law and is intended to apply two important regulations for the medical device market, viz:

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 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 (Official Journal of the EU L 117 of 05.05.2017, p. 1, as amended), hereinafter referred to as “Regulation 2017/745” and
2. Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017.
   on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Official Journal of the EU L 117 of 05.05.2017, p. 176, as amended), hereinafter referred to as “Regulation 2017/746”.

Among the provisions for which a longer vacatio legis is provided are regulations on medical device advertising, which will take effect on January 1, 2023.

In the Law, the legislator undertook to comprehensively regulate the issue of advertising medical devices, which, unlike medicinal products, has so far been, under Polish law, not covered by a broader, dedicated regulation.
Time will tell whether this attempt was successful, and whether the new regulations will not distort the market by imposing new restrictions and limitations on entrepreneurs, while at the same time allowing to increase the availability of devices in the diagnosis and treatment of patients and increase their awareness
and will allow you to make rational purchasing choices.
Regardless of the answers to the questions posed in this way, it is certainly impossible to pass by the new regulations indifferently, since their scope covers a very broad market of products and is addressed to a wide range of participants in this market.

Such a conclusion comes if only from the broad and capacious definition of a medical device, which, according to Regulation 2017/745 alone, means a tool, apparatus, device, software, implant, reagent, material or other article intended by the manufacturer for use – singly or in combination – in humans for at least one
Of the specific medical uses listed in the regulation, i.e. Diagnosing, preventing, monitoring, predicting, prognosing, treating or alleviating disease, diagnosing, monitoring, treating, alleviating or compensating for injury or disability, studying, replacing or modifying an anatomical structure or physiological or disease process or condition, providing information through in vitro testing of samples taken from the human body, including those taken from organ, blood and tissue donors, etc.
In addition, medical device advertising regulations are addressed to a wide range of market participants collectively referred to as “economic operators” which include the manufacturer, authorized representative, importer or distributor. The definition is therefore broad and includes all actors in the production and distribution stages of medical devices.

Below we present, in simplified terms, the basic rules on medical device advertising, forms of advertising, restrictions and examples of marketing activities to which the new regulations will apply.

1. Entity authorized to conduct advertising.

   1) Business entity (manufacturer, authorized representative, importer, distributor),

   2) Another entity, upon approval of the advertisement, in writing, by the business entity in question, with the responsibility for the compliance of the advertisement with the law borne by the business entity.

   (A business entity that conducts advertising of a product to the public is required to keep records related
   to the advertisement for a period of 2 years after the end of the calendar year in which the advertisement was distributed.)

2. The form of advertising and how it is presented.
   • Audiovisual, audio or visual form
   • Advertising of a product to the public must be worded
     in a way that can be understood by a layman.
   • Advertising of the product shall include at least the name or trade name of the product and the intended use of the product.
   • Detailed rules defining the necessary data to be included in the advertisement and the manner of its presentation will be determined by an ordinance of the Minister of Health – the draft ordinance has already been published and its discussion will be presented in a future issue of the newsletter.
     
     
3. Advertising restrictions.
   • Advertising of the product to the public may not:
     • use the image of persons engaged in the medical profession or claiming to be such persons, or depict persons presenting a product in a manner suggesting that they are engaged in such a profession;
     • include a direct appeal to children to purchase advertised products or to persuade parents or other adults to buy them advertised products;
     • apply to products intended for use by users other than laypeople.
   • The use of texts, names, trademarks, images and symbols or other signs that may mislead the user or patient about the intended use, safety and performance of the device is prohibited.
   • Advertising of a product must not mislead about the terms and conditions of maintenance, periodic or ad hoc servicing, software updates, periodic or ad hoc inspections, adjustments, calibrations, calibrations, checks or safety inspections of a given type of product, including the requirements for technical equipment of the entities performing these activities and the qualifications of the persons employed therein.
   • Advertising of the product carried out in pharmacies and entities engaged in therapeutic activities, must not impede the activities carried out there.
   
   

4. Application of regulations on advertising of medical devices – examples of marketing activities.

The regulations on the advertising of medical devices will apply to a broad catalog of marketing activities, which, in addition to the classic advertising message in print, visual folk, include:
• Directing opinions to the public by product users, if they receive benefits from it (e.g., the activities of bloggers / vloggers / influencers);
• advertising of business or professional activities that use the product to provide services;
• Presenting products at meetings whose purpose or effect is to encourage the purchase of products, or financing such meetings; sponsoring fairs, exhibitions, shows, presentations, conferences, scientific conventions and congresses, and presenting products at such events;
• Providing samples to promote products.

The new regulations on the advertising of medical devices, are brand new rules of conduct, and it should be remembered that for non-compliance with them, there are significant
and severe administrative fines (up to 50 thousand. PLN, up to PLN 2 million and up to PLN 5 million
depending on the type of violation). For advertising products in a manner contrary to the provisions of the Law (Articles 54-60 of the Law) and EU Ordinances 2017/745
and 2017/746 (Article 7 of both Ordinances), the legislator provided for a sanction in the form of an administrative fine of up to PLN 2 million. The supervisory authority may further order: removal of the violations found, cessation of the publication, appearance or conduct of the advertisement in question, or publication of the issued decision
in the places or mass media in which the advertisement in question appeared.

It should also be mentioned that device advertising, the dissemination of which began before the effective date of the regulations on medical device advertising, which does not meet the requirements set forth in these regulations, may be disseminated, no longer than until June 30, 2023.
For manufacturers and distributors, therefore, this is the time to prepare for the new reality, and it is worth incorporating the new regulations into marketing strategies and policies.