Already on January 1, 2023, the Act on Medical Devices of April 7, 2022 entered into force.
Firstly, advertisements for medical devices, systems or procedure packs addressed to the public must be formulated in such a way that a person without specialist knowledge in a given field has no problem understanding the message. This requirement also applies to medical and scientific wordings and references in advertising to scientific research, opinions, literature or scientific studies and other materials aimed at users other than lay people. Therefore, emphasis was placed on ensuring that any person without professional knowledge could easily find out whether a given product or treatment is suitable for them. Thanks to this requirement, consumers will not be misled.
Secondly, advertisements for medical devices, systems or procedure packs addressed to the public cannot contain:
- persons practicing medical professions or claiming to be such persons,
- persons disguised and/or having items indicating the practice of a medical profession,
- children persuading parents to buy advertised products or persuading parents to buy advertised products for children,
- devices intended for use by non-lay users.
Therefore, advertisements may not mislead the consumer as to the principles and conditions of maintenance, periodic or ad hoc service, software updates, periodic or ad hoc inspections, adjustments, calibrations, calibrations, checks or safety inspections of a given type of products, including the requirements concerning the technical equipment of entities performing these activities and the qualifications of the persons employed in them.
Thirdly, product advertising may only be carried out by an economic entity. However, it is possible to advertise medical devices by other entities, provided that this activity is approved in writing by the given economic entity. At the same time, the economic entity is responsible for the compliance of the advertisement with the provisions of law.
Fourthly, it is the duty of the business entity that advertises medical devices to store advertising templates and information on the method, period of its dissemination and places of its dissemination for a period of 2 years from the end of the calendar year in which the advertisement was disseminated.
The ban on advertising medical devices includes, among others:
- presenting products during events such as fairs, exhibitions, shows, presentations, conferences, conventions and scientific congresses, and sponsoring them; including for people practicing a medical profession or trading in products
- visiting medical professionals to promote products
- providing samples to promote products
- advertising business or professional activity in which the product is used to provide services - to the extent that it concerns services provided with the use of a given product, including rental, rental or lending services of products
In addition, advertising is NOT a commercial catalog or price lists containing only the trade name, product price or technical specification