In March 2026, the State Institute for Drug Control (SÚKL) issued a new notice that deserves close attention. The Czech regulator reiterates a key rule: advertising aimed at the general public must not promote medical devices that, under the manufacturer’s instructions, are intended solely for use by healthcare professionals or that are dispensed only on the basis of a prescription.
Although rules governing advertising of medical devices have been in force since 2021, practice shows that they have yet to become fully embedded in market awareness. Our experience confirms that advertising of medical devices is, in some cases, prepared without sufficient regard for basic regulatory constraints. This is precisely why we consider it useful to revisit the core rules that advertisers and marketing agencies in particular should have firmly in mind.
Which medical devices may not be advertised to the general public?
Advertising aimed at laypersons must not cover medical devices that, under the manufacturer’s instructions, are intended solely for use by healthcare professionals. This typically concerns devices that laypersons do not use independently – for example, products that are implanted or applied by healthcare professionals. Although an amendment to the legislation is currently under discussion and could potentially change this regime, the prohibition remains fully applicable for the time being.
Likewise, medical devices that are dispensed only on the basis of a prescription must not be promoted to the general public. This applies to a relatively limited category of devices which may pose serious risks if used incorrectly.
What information must an advertisement aimed at laypersons contain?
Where an advertisement of a medical device is directed at the general public, it must contain several pieces of mandatory information. In particular, the advertisement must clearly state that the product is a medical device, include its trade name, describe its intended purpose, and contain a prompt encouraging users to read the instructions for use and the relevant safety information.
These requirements represent the absolute minimum that should always be taken into account when preparing advertising communications for laypersons.
What must an advertisement aimed at laypersons not contain?
In addition to mandatory information, content-related restrictions must also be respected. An advertisement aimed at laypersons must not include recommendations by healthcare professionals, sports figures, or other influential individuals. Comparative claims are likewise prohibited.
However, the list of limitations does not end here. The rules governing the content of advertising of medical devices are broader, and in specific cases it is advisable to assess each advertising communication individually.
Attention must also be paid to relationships with professionals
Regulation does not apply only to communication directed at the general public. Providing healthcare professionals with unauthorised gifts or other benefits is also prohibited. As a result, particular caution is warranted where your marketing activities are targeted at the professional community.
What about software?
In practice, it is also often overlooked that software itself may qualify as a medical device. This is typically the case where software serves a therapeutic or diagnostic purpose. Such products may therefore also fall within the scope of the rules governing the advertising of medical devices. Read more on my blog here: Is your software a medical device? | HAVEL & PARTNERS
Liability extends beyond advertisers
Finally, it is important to emphasize that liability for advertising does not rest solely with advertisers. Liability also extends to those who prepare and disseminate advertising, such as marketing agencies. In this respect, liability is shared more broadly than some market participants may assume.
Conclusion
The rules governing the advertising of medical devices are not new. Even so, it is clear that their practical understanding across the market remains uneven. The regulator’s notice issued in March 2026 therefore provides a timely opportunity to revisit the basic regulatory framework.
This article outlines only the fundamental contours of the issue. There are, of course, many more rules, and their application always depends on the specific circumstances. If you have any questions, our team is happy to assist.
