On 13 May 2023, a new regulation with detailed requirements for advertising of medical devices enters into force. Advertisers of such products, including influencers, must include warnings in advertising messages, similar to those familiar from drug advertisements.
Executive regulation on medical device advertising
Recently, the European Union and national lawmakers have paid much attention to the safety of medical devices. Although medical devices are used for health purposes, defective or improperly used devices can be harmful to the user’s health. In recent years, the desire to counter such risks more effectively prompted the adoption of new provisions at the EU level comprehensively regulating the medical devices market. And in Poland, a new Medical Devices Act was passed last year, including rules on advertising of medical devices.
Although the advertising provisions of the act entered into force at the beginning of 2023, they were incomplete, as an executive regulation under the act was missing. This state of affairs is about to change, as the executive regulation has finally been adopted and enters into force on 13 May 2023. It specifies:
- General requirements for advertising (advertising must comply with the instructions for use or the label, and information regarding the device must be presented in advertising in a visible, legible and clear manner)
- The scope of required information accompanying the advertisement (indication of the manufacturer, the manufacturer’s representative, and the entity conducting the advertisement, and placement of a warning in the advertisement)
- Specific requirements for presentation of the mandatory warning (“This is a medical device. Use it in accordance with the instructions for use or the label”)—the regulation sets forth technical requirements for e.g. the size of the warning
- Requirement to state the advertising nature of the message in certain situations (e.g. when a user, such as an influencer, has received a benefit for expressing an opinion about the device, or when sponsoring events for professionals)
- Detailed requirements for presentation of advertising in healthcare facilities (e.g. concerning the space where placing advertising is allowed in pharmacies and clinics).
Warnings in ads for medical devices—familiar from drug advertisements
A key change introduced by the new regulation is the need to add a warning to a medical device advertisement: “This is a medical device. Use it in accordance with the instructions for use or the label” (or for devices with no intended medical use, such as contact lenses changing the user’s eye colour, the text is to read: “For safety, use in accordance with the instructions for use or the label”). This solution is being introduced following the model of the warning accompanying drug advertisements, and as in the case of drug warnings, a medical device warning must also meet rigorous requirements regarding the method of presentation.
For advertisements in visual or audiovisual form:
- The warning is to be placed at the bottom part of the advertisement, on a surface taking up no less than 10% of the area of the entire advertisement for visual advertising (or 15% for audiovisual advertising)
- The text of the warning must stand out from the background of the surface, be visible, legible, non-moving and placed horizontally
- The distance between the letters and the upper edge of the background of the advertising surface may not be greater than half the height of the letters, and the distance between the lines of the inscription may not be greater than the height of the letters
- When the advertisement is placed on several pages, the warning is to be placed on the first page (this applies only to visual form).
For advertisements in audio form, the warning must be read clearly in Polish for no less than four seconds.
Cooperation with influencers
The regulation provides that an advertising warning must be placed not only when advertising is carried out directly by the authorised business itself (e.g. manufacturer or distributor). If such a business enters into cooperation with an influencer and provides the influencer a benefit in exchange for expressing the influencer’s opinion on the device, under the new regulation the influencer’s public message must also contain an advertising warning.
However, this does not mean that all the liability rests with the influencer and the business does not have to worry about whether the influencer’s message meets the legal requirements. On the contrary, the provisions require that a business authorised to conduct advertising (i.e. business entity) approve the influencer’s advertising message in writing. Additionally, the regulations expressly state that it is the business’s responsibility to comply with the requirements; thus it should ensure that the influencer’s sponsored opinion meets the requirements (e.g. sign an agreement with the influencer obliging the influencer to include any necessary additional information required by the provisions in the message).
Under the regulation, this type of influencer message should include not only a warning, but also information that the message is advertising in nature. Also, the message should identify the manufacturer and the manufacturer’s authorised representative. And it is necessary to mention the name or trade name of the device and its intended use (the latter requirements have their source in the act and not the new regulation).
When must the new requirements be applied?
Medical device advertisements first published on or after 13 May 2023 will have to include the new warnings and meet the remaining requirements of the regulation.
A transition period is provided for advertisements that began to be distributed before 13 May 2023 (e.g. a TV spot aired at least once before that date). Such advertisements can be distributed no longer than until 30 June 2023. Therefore, by the end of June, such advertisements must be withdrawn or replaced with a version adapted to the requirements of the new regulation.
The regulation does not resolve the fate of social media advertisements that were posted before 13 May 2023, but remain available after the end of the transition period (30 June 2023). The necessity to delete past posts can be burdensome for businesses. While it can be expected that archival ads from social media will not be a priority for regulators, given the lack of transitional provisions in this regard it cannot be ruled out that a business will suffer consequences from not removing old advertisements (i.e. not meeting the new requirements) by the end of June 2023, as the regulations provides that after 30 June 2023, “only advertisements meeting the new requirements may be present on the market.”
In practice, compliance with the medical device advertising provisions is critical, due to the severe sanctions. Pursuant to the act, conducting product advertising in violation of the provisions is subject to an administrative fine of up to PLN 2,000,000.
But this is the upper limit. The authority will moderate the fine depending on the circumstances of the offence (for example, it may take into account the benefit obtained in connection with illegal advertisement). Additionally, the act expressly states that if the violation has not caused a threat to life or health, the upper limit is reduced to 10% of the initial value (i.e. PLN 200,000). Under certain circumstances, it is even possible to waive imposition of a penalty (when the event was incidental, did not pose a risk, and the entity cured the violation and informed the authority in a timely manner).
Joanna Krakowiak, attorney-at-law, Marcin Rytel, adwokat, M&A and Corporate practice, Life Sciences & Healthcare practice, Wardyński & Partners