Translated with AI

On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical Devices, in vitro diagnostic Medical Devices, and medical-surgical products. The document consolidates and updates existing provisions for greater clarity, particularly concerning websites and social media.

As the document itself states, the objective was to “incorporate, where possible, the needs expressed by interested parties,” expanding the section dedicated to social networks to account for recent industry developments.

The guidelines fit into the following regulatory framework:

• MDR (EU) 2017/745 and IVDR (EU) 2017/746: define the general principles, particularly Article 7.
• Legislative Decrees 5 August 2022, n. 137 and n. 138: regulate the advertising of Medical Devices and in vitro diagnostic Medical Devices, respectively.
• Decree of the Minister of Health 26 January 2023: identifies cases where ministerial authorization is not necessary.
• Decree of the President of the Republic 6 October 1998, n. 392: governs the authorization procedures for medical-surgical products.

While the new guidelines do not introduce revolutionary changes, they bring order to a field subject to multiple interpretations. The document was created to answer numerous questions from manufacturers on the most critical points, such as the management of websites and social media.

Below are some key points of medical device advertising, highlighting the most important new features and clarifications brought by the guidelines.

Ministerial Authorization and the Distinction between the General Public and Healthcare Professionals

The fundamental rule remains the same: advertising aimed at the general public (end consumers) requires ministerial authorization, which must be requested through the Ministry of Health’s web portal. Conversely, messages intended exclusively for healthcare professionals do not require authorization.

For websites, it is sufficient for companies to include a disclaimer and use a pop-up or similar technology to ask the user to confirm they are a healthcare professional before they can access the content. This clarifies once and for all that the principle of self-declaration is sufficient and more complex procedures, such as verifying registration in a professional register, are not necessary.

The authorization is valid for 24 months, but if the message features novelty characteristics, the validity is only 12 months. If such references to novelty are removed, the authorization can be extended for another 12 months.

Content and Requirements of the Advertising Message

As provided by regulations MDR (EU) 2017/745 for Medical Devices and IVDR (EU) 2017/746 for in vitro diagnostic Medical Devices, the message must not mislead the user regarding the device’s intended use, safety, or performance. It must be consistent with the information provided by the manufacturer on the label, in the instructions for use, and with the declared intended use. It is forbidden to attribute functions to the device that it does not have, to create false impressions, or to hide potential risks.

The mandatory wordings to be included, depending on the type of product, are as follows:

• For Medical Devices: “It is a CE medical device (with the optional presence of the number of the Notified Body that certified the product). Carefully read the warnings or instructions for use. Aut. Min. of dd/mm/yyyy.”
• For in vitro diagnostic Medical Devices: “It is a CE in vitro diagnostic medical device (with the optional presence of the number of the Notified Body that certified the product). Carefully read the warnings or instructions for use. Aut. Min. of dd/mm/yyyy.”
• For medical-surgical products: “It is a medical-surgical product Reg. n. xxxx. Carefully read the warnings or instructions for use. Aut. Min. of dd/mm/yyyy.”

Toll-Free Numbers and Testimonials: A Clearer Picture

The guidelines consolidate and clarify the rules on two often-debated aspects:

• Toll-free number: if a company includes one in an advertising message, it must specify its purpose (e.g., “for information on points of sale”). If the toll-free number has promotional content, specific authorization is required, and the message must state “advertising message” at the beginning along with the authorization details.
• Testimonials: the use of people known to the public (excluding scientists and healthcare professionals) is allowed, provided that their presence does not imply a recommendation or preference for the product. It is forbidden to show symptoms of the pathology for which the product is indicated.

Internet and the Evolution of Social Networks: The Crucial Point

The real novelty of the document is the expansion and specificity of the section dedicated to social networks, with the introduction of detailed fact sheets for each platform. The document confirms that the Internet is a medium that requires authorization, distinguishing between:

• Corporate-institutional websites: do not require authorization if they do not contain advertising messages.
• Product websites: require ministerial authorization.
• Thematic websites: do not require authorization if they do not contain advertising messages.

Social Networks: Between Specificity and Limitations

The guidelines introduce specifications for platforms like Facebook, Instagram, YouTube, and, for the first time, TikTok. Advertising is allowed but under restrictive conditions: interactive features such as comments, reactions, and shares must be disabled. If it is not technically possible, as is the case for most platforms, all messages must include this disclaimer:

“The Ministry of Health exclusively authorizes the content of the advertising message. Any comments are the sole responsibility of the user; the company disassociates itself from user comments.”

The operational specifics for each platform are detailed, for example, on TikTok, it is possible to request authorization for a campaign with a maximum of 10 posts (text and/or images) and 3 videos, with at least 45 days between one campaign and the next.

Conclusion

In conclusion, the new guidelines are not revolutionary, but they provide a solid and long-awaited basis for all medical device manufacturers that engage in medical advertising, especially on the web. It is a first step to bridge the gap between regulation and the digital reality. However, there are still points that would benefit from specific treatment, such as the regulation of e-commerce sites and the Digital Service Act (DSA), which are not covered in these guidelines. It is up to professionals and manufacturers to integrate all regulatory details to operate within a complex but now slightly clearer framework.

Do you want to ensure that the advertising of your Medical Devices is compliant? The Thema specialists are at your disposal for a strategic and regulatory consultation. Make your communication compliant.