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As of 27 June 2025, Italy has taken a major step in modernizing the advertising of medical devices by issuing new guidelines tailored to the realities of digital communication.
The Italian Ministry of Health published the updated Guidelines on Healthcare Advertising for Medical Devices, including in vitro diagnostics and medical-surgical equipment, marking a long-awaited overhaul of a system previously governed by rules dating back as far as 2010.
This is more than a regulatory update—it’s a reflection of how Italy is trying to walk the tightrope between innovation and oversight in one of the most sensitive areas of public communication: health.
Why This Matters for Italy’s Healthcare and Advertising Sectors
The newly issued guidelines—officially dated 4 April 2025 but effective from the end of June—aim to simplify compliance while reinforcing transparency and public trust. They replace the outdated 2010-2020 framework, bringing Italy closer in alignment with EU Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The core principles of truthfulness, accuracy, and transparency in advertising medical devices remain untouched. However, the regulatory landscape now includes detailed operational procedures for social media and online communication, recognizing their increasing relevance in health-related marketing.
And this is where the change gets interesting.
Advertising Medical Devices in the Age of TikTok
One of the most striking changes is the Ministry’s decision to explicitly regulate platforms like Facebook, Instagram, YouTube—and for the first time, TikTok.
TikTok’s inclusion isn’t symbolic. The platform’s explosive growth has made it a staple in consumer engagement strategies, even in the highly regulated world of medical device advertising in Italy. But the Ministry is treading carefully:
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Corporate/institutional profiles are permitted without prior approval as long as they remain non-promotional.
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Product or brand profiles, however, are heavily restricted: All interactive features (comments, likes, shares, emojis) must be disabled. Each post—including scientific ones—must receive prior authorization, unless the product falls outside advertising approval requirements.
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Thematic corporate profiles walk a fine line. They’re allowed without prior clearance—only if no advertising is included. Otherwise, the same restrictions apply.
In other words: creativity is encouraged, but spontaneity is not.
A Step Forward, but Not Without Friction
The guidelines also introduce:
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A streamlined application process for advertising approval, including payment methods and supporting documentation;
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The option to extend previous authorizations to new media (provided content remains unchanged);
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Clear boundaries between public content and materials intended solely for healthcare professionals, which don’t require pre-approval as long as access is limited (via disclaimers, pop-ups, etc.);
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A standardized campaign structure: up to 10 posts (three can be videos) per campaign, each requiring a separate fee.
These procedural shifts will likely ease the burden on compliance teams, especially those operating across multiple digital platforms. Yet, the strict control of interactivity feels slightly out of sync with how communication—and especially engagement—actually works in 2025.
How do you create awareness in a social-first world while eliminating the very functions that make content discoverable?
Italy Balances Innovation and Caution
The intent behind the new guidelines is clear: to prevent misinformation, protect public health, and maintain accountability in a world where content can go viral in seconds. But critics may argue that Italy’s advertising rules for medical devices still reflect a defensive mindset, trying to adapt to digital trends while keeping a firm grip on legacy control mechanisms.
What’s evident is that digital health marketing in Italy now requires a nuanced understanding of both regulatory nuance and platform dynamics. Social media managers and regulatory officers alike will need to collaborate more than ever to ensure compliance—without sacrificing campaign effectiveness.
Where Do We Go From Here?
These new guidelines are not the final word—they’re a living framework that will need to evolve alongside digital platforms, consumer habits, and medical innovation. They present a necessary reset, but also raise important questions:
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Can the system keep up with the pace of change?
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Will advertisers feel empowered or constrained by the rigid control over interactivity?
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Is there a middle ground between strict oversight and genuine engagement?
As the digital landscape continues to evolve, Italy’s approach to medical device advertising will serve as a case study in balancing safety, innovation, and public trust.
Let’s see if regulation can lead—rather than just follow—the conversation. On a similar topic, you can read the article “How Artificial Intelligence is Revolutionizing Medical Devices Following the EU AI Act“.
Authors: Nicola Landolfi and Nadia Feola