Update of the Catalan Guide on Medical Devices advertisement

In October 2024, the Generalitat de Catalunya published the updated guide on the Requirements and conditions for the advertising of medical devices addressed to the public (the "Guide"). The Guide was initially published in 2017 and updated in 2021. This latest update aims to reflect significant changes in the industry and pursues to ensure compliance with health regulations and increase transparency in advertising of medical devices practices.

Although the Guide is addressed to companies domiciled in Catalonia, those that aim to disclose advertising materials only in Catalonia or foreign companies with a legal representative established in Catalonia, it is certainly a useful tool in the design process of advertising materials of medical devices by business operators.

Below, we highlight some of the key items included in the Guide.

• Flexibilization of rules regarding the authorization of advertising materials. Although the general rule is that an application for an authorization of an advertising material to the supervisory authority must refer to one advertising material for one medical device, the Guide allows:
• joint applications of several advertising materials related to one medical device; and
• an application of one or several advertising material(s) related to multiple medical devices, provided all the medical devices are included in all the advertising materials.

• Prohibited claims or distinctive elements. Advertising materials cannot include claims or distinctive elements that attribute a medical device therapeutic action whose mechanism of action is not typical of a medical device, such as pharmacological, metabolic or immunological actions.
• Age and use restrictions. Advertising materials must include the age required for using the medical device at stake in the event the instructions of use of the medical device contain age-restrictions. Likewise, if such instructions of use contain a warning stating that it is necessary to double check whether the medical device can be used at a certain age with a healthcare professional, such warning must also be included in the advertising materials.
• Inclusion of foreign language expressions. The Guide allows the inclusion of advertising expressions in foreign languages, provided they are easily comprehensible to most of the population and do not refer to the indications or safety of the medical device at stake. It should be noted that self-regulation authorities (e.g., Autocontrol) have maintained a strict position regarding the use of foreign language expressions provided they could be misleading for the general public.
• Environmental sustainability claims. Advertising materials that include claims about the environmental sustainability of a medical device, its packaging or the materials on which the advertising claims are based, it is necessary to visually separate the environmental sustainability claims from health-related messages referred to the product. Companies must also provide to supervisory authorities documentation supporting these environmental sustainability claims.
• Compulsory information placement. In this regard, the Guide specifies:
• When an advertisement material includes medical devices of different categories, this disclaimer must follow the CPSP number (i.e., CPSP refers to the authorization code granted by the supervisory authorities): “This CPSP only endorses advertising messages concerning medical devices”.
• On e-commerce websites or pages, the CPSP number and the disclaimer indicating that “the medical device complies with medical device’s regulations” must be placed next to the main image of the product. If the main website or page contains hyperlinks to other websites or pages, it is not necessary to repeat this information on the secondary pages, as long as it is essential to go through the main page to access them.
• For websites that contain hyperlinks to specific product pages, it is acceptable to only include the disclaimer indicating that "the medical device complies with medical devices regulations" and the CPSP number. It is not necessary to include possible adverse effects and contraindications, provided that the website's configuration limits space and has a "more information" button that links to the specific medical device page, which includes all the compulsory information.

• Consumer opinions and testimonials.
• They must be clearly separated from the advertising claims of the medical device. They can be included on an independent website or in a different section of the same website where the advertising materials are located. For instance, it is possible to include them at the bottom of a website under the title "Consumer Opinions".
• They are not subject to evaluation or authorization by the health authority but must be truthful and comply with current legislation. On the page or section that includes these opinions, a warning should be included stating that “these opinions have not been evaluated or authorized by the competent health authority”.
• They cannot be used to support claims related to the efficacy of a medical device.

• Advertising actions that include a promotion, the gift of a consumer product, giveaway, or service. They must include the date until which the promotion is valid or the number of units that are included in the promotion.
  
  As a novelty of the Guide, if there are additional conditions applicable to these advertising actions, the supervisory authority will evaluate on a case-by-case basis which of these conditions are limiting for accessing the promotion and, therefore, if they should be placed in a relevant or prominent manner in the material. In any case, the complete terms of the promotion must be made available to the public, either in the same advertising material, in a brochure available at the point of sale or on the website of the company responsible for the advertising.

• Other elements. The Guide includes other adjustments, such as the explicit mention that advertising addressed to the general public of COVID-19 self-diagnosis tests is not allowed, and that comparative sales data must include a reference to the period and territory on which the analysis was carried out. It also clarifies the wording and adapts it to the applicable regulations and trends (particularly, with regards to social media).

The changes of the Guide reflect a commitment to protecting consumer interests and promoting ethical advertising practices in the medical device industry. Further updates may also be expected in light of the proposal of Royal Decree specifically addressed at regulating the promotion of medical devices which is expected to be approved by the Spanish Government in the following months.