New Polish draft law on medical devices – new regulations on advertising medical devices in Poland

The Polish Ministry of Health continues legislative work on a new draft law on medical devices. The original draft was presented during the previous term of the Polish Sejm. The law is intended to carry over the solutions of the EU Regulation 2017/745 (MDR Regulation) on medical devices which came into force at the end of May 2021.[1]

Advertising medical devices

            One of the most significant changes is expected to be the introduction of certain restrictions on the advertising of medical devices. First of all, advertising of products at fairs, exhibitions, public presentations or scientific symposiums will be prohibited. Sales representatives will not have the opportunity to visit physicians to advertise their product to them. On the other hand, if a person cooperates with the company and receives benefits from it, he or she will not be able to recommend and pass on his or her opinion about the medical device to others. On the other hand, trade catalogs or price lists containing only the trade name and the price of a medical device are not to be regarded as product advertising. The condition is, however, that they do not contain information referring to the characteristics of the medical device or other information with promotional purposes or leading to an increase in sales. In addition to the general prohibition on misrepresentation under the MDR, under the Draft, advertising of a device to the public will not permit the use of images of persons who are or claim to be members of the medical profession or depict persons presenting a device in a manner suggesting that they are members of such profession.

Who will be allowed to advertise a medical device under new Polish law?

            The rule is that the manufacturer, authorized representative, importer or distributor will be able to advertise the medical device. This does not mean that marketing activities cannot be outsourced to, for example, an advertising agency. According to the draft, advertising of a device can also be carried out by other entities after it has been approved, in writing, by a given business entity (i.e. the manufacturer, authorised representative, importer or distributor).[2]

Advertising Regulation

            The so-called “advertising regulation” was also published along with the draft. It specifies permissible forms of conducting and transmitting advertising. It retains the provision on the necessity to inform about any benefits received under certain forms of advertising.

What penalties may be imposed?

Failure to comply with the provisions of the Medical Devices Act is associated with criminal sanctions. The new draft plans to introduce administrative sanctions. A fine of up to PLN 2,000,000 is to be imposed for advertising in breach of the law. The marketing activity is to be supervised by the Polish President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Persons authorised by the President of the Office are to be entitled to free entry to fairs, exhibitions, shows, presentations, conferences, congresses and scientific conventions. According to the draft, the President of the Office will have the right to order, by way of an administrative decision, the removal of any identified infringements and the cessation of any publication, appearance or conduct of a given advertisement.

Entry into force of new rules

The draft assumes that the new Polish advertising regulations will enter into force on 1 January 2022. Such a solution is intended to allow operators to adapt their activities to the new requirements.