Advertising and Marketing of Medical Devices
The advertising of medical devices, systems, and procedure packs is subject to strict regulations with severe penalties for non-compliance.
Importers and distributors bear the responsibility for the form and content of advertising. They may choose to outsource this task to an external company, but written approval of the advertisement is required before publication.
The entity responsible for advertising is obligated to retain samples of advertisements and a record of where they were published for a period of two years from the end of the calendar year in which their dissemination was completed. The President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products may request access to these records.
Essential Components of a Medical Device Advertisement
The advertisement should be formulated in a manner that can be understood by individuals without specialized medical training.
At a minimum, the advertisement should include the name or trade name of the device and its intended use. It can be presented in various formats, such as video, sound recording, or graphics. However, it’s important to note that pharmacies and health facilities are restricted to displaying advertisements in graphic form only.
Advertisements targeting the public should provide the following information:
- the name of entity conducting the advertisement
- the name of the product manufacturer and authorized representative
- a warning message informing users about proper usage, such as ‘This is a medical device. Please use it according to the instructions for use or label’ or ‘For your safety, please use it according to the instructions for use or label’ for products without medical purposes.
The detailed requirements for the warning messages are specified in the Polish Regulation of the Minister of Health on Advertising of Medical Devices of April 21, 2023.
Additionally, the advertisement should include information about any potential risks associated with the intended use of the product.
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Prohibited Content in Medical Device Advertisements
When targeting the public, it is not allowed to include images of medical professionals, such as doctors, nurses, or dentists in the advertisement or imply that the individuals presenting the products have such professions.
Advertisements should not be directed towards children, encouraging them to purchase products or persuade their parents or other adults to do so.
Products not intended for use by laypeople should not be advertised.
Labels or instructions for use should not contain information, names, trademarks, pictures, or symbols that may mislead users or patients. This includes attributing functions or properties to a device that it does not possess or creating a false impression regarding treatment or diagnosis.
Advertising must not suggest uses other than those indicated as the intended use and for which a conformity assessment has been conducted.
Advertisements should not be misleading regarding maintenance, inspections, updates, or other related aspects.
Other Forms of Medical Device Advertising
The same advertising rules as for medical devices apply to:
- advertising business activities involving the use of medical devices
- device presentations at meetings where participants are encouraged to purchase the devices or contribute to funding the meetings
- publication of opinions from device users who receive benefits for providing feedback
- visiting medical professionals to promote devices
- sponsoring industry events, including those for medical practitioners or device retailers, and showcasing products at such events
- providing samples to promote products
Trade catalogs, price lists, and information included on packaging or accompanying materials do not fall under the category of advertising.
Consequences of Violating Medical Device Advertising Rules
In case of violation of medical device advertising rules, the President of the Office has the authority to issue a decision that mandates rectification of the violations or prohibits any further publication of the advertisement. These decisions are immediately enforceable, and the President of the Office may also order the publication of the decision’s content in the locations where the advertisement appeared.
Violations of advertising requirements for medical devices, systems, and procedure packs can result in financial penalties ranging from PLN 50,000 to as much as PLN 5 million.
We can support you in evaluating information intended for users such as instructions, labels, and packaging.
We offer support in marketing and distributing your products in the EU market.