On July 21, 2025, the Italian Ministry of Health published its long-awaited Guidelines on Healthcare Advertising for Medical Devices, consolidating and replacing previous scattered instructions into a single, authoritative reference. The document took effect immediately upon publication, meaning any advertising disseminated from that date onward must comply.
This is not a minor administrative update, it is a significant recalibration of how medical devices, in vitro diagnostics (IVDs), and surgical devices can be promoted in Italy. These guidelines are important because advertising in the medical device sector sits at the intersection of public health protection, patient rights, and fair market competition.
The Ministry’s goal is clear in ensuring that all advertising is accurate, evidence-based, and free from exaggerated claims that could mislead consumers or healthcare professionals. For manufacturers, whether established in the Italian market or planning entry, this is a call to strengthen internal controls, adjust marketing strategies, and plan for additional lead time in campaign rollouts.
Regulatory Background
Italy has historically taken a more prescriptive approach to device advertising than many other EU member states. While the EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746) set broad prohibitions against misleading promotional practices, they leave room for member states to impose additional requirements.
Italy has long required prior Ministry authorization for advertising aimed at the public and enforced specific content rules. Before the new guidelines, rules existed in multiple ministerial decrees and circulars, which sometimes led to interpretive uncertainty.
For example, the distinction between “information” and “advertising” was not always consistently applied, leaving manufacturers unsure whether certain patient education materials needed prior approval. The Ministry of Health’s role has always extended beyond passive oversight, it actively reviews, approves, and monitors advertising materials.
With the updated guidelines, this oversight is reinforced with modernized definitions, expanded digital oversight, and clarified procedural steps. The alignment with EU MDR/IVDR language is deliberate, but Italy’s national guardrails remain stricter, particularly for content targeting the public.
Key Changes in the New Guidelines
The 2025 guidelines make several structural and substantive changes:
- Clearer Definitions
“Advertising” now explicitly includes any communication, direct or indirect, designed to promote prescription, supply, sale, or use of a device. This can include traditional media, digital content, sponsored events, and even indirect promotion through brand imagery.
“Information,” by contrast, refers to neutral, factual materials (e.g., instructions for use, regulatory notices) that do not encourage purchase or use. This sharper distinction aims to prevent disguised promotional content from escaping regulatory review.
- Audience-Specific Rules
Advertising aimed at healthcare professionals is exempt from prior authorization but must be delivered via professional channels, such as restricted-access portals, industry newsletters, or medical conferences. Public-facing advertising remains tightly regulated and often requires pre-approval.
Materials that could be accessed by the public—even if primarily aimed at professionals—may trigger stricter review.
- Content and Format Requirements
All advertising must be accurate, verifiable, and proportionate. The use of superlatives (“best,” “safest,” “most effective”) is prohibited unless scientifically substantiated.
Clinical claims must be backed by robust evidence, preferably peer-reviewed studies or regulatory submissions, and this evidence must be available for Ministry inspection. The guidelines forbid patient testimonials, celebrity endorsements, and imagery implying outcomes beyond the device’s authorized indications.
Visuals must match the approved intended use and not create unrealistic expectations.
- Digital Advertising Oversight
The rules extend explicitly to websites, social media, mobile apps, and online videos. This includes paid ads, sponsored posts, and influencer-created content. Notably, the Ministry may require disabling public comments, “likes,” or other engagement features to avoid unverified claims appearing in connection with approved ads.
Approval Process and Documentation
For public-facing advertising, prior Ministry approval remains a cornerstone.
Manufacturers must submit:
- The complete content of the advertisement (text, images, scripts, etc.)
- Supporting scientific documentation for each claim
- Details of distribution channels and intended audiences
- All Italian translations to ensure linguistic accuracy and compliance
Once granted, approval is valid for 24 months, provided the content remains unchanged. Minor adaptations, such as resizing or reformatting for a different medium, may be permissible without re-approval if the substance is untouched.
Even when prior approval is not required, such as for strictly HCP-targeted materials, manufacturers must maintain a detailed advertising dossier. This includes dated copies of all materials, claim substantiation, and internal review records.
In practice, this means marketing and regulatory teams need integrated workflows to document each step from concept to dissemination.
Enforcement and Penalties
The Ministry will monitor compliance through inspections, random checks, and digital monitoring. Non-compliance can trigger administrative fines, suspension of the advertisement, or orders for public retraction.
Examples of violations include:
- Publishing a public-targeted ad without prior authorization
- Including unverified efficacy claims in a brochure
- Using imagery that exaggerates the device’s intended use
- Allowing unmoderated user comments on a social media ad
These penalties are not just financial, they can delay product uptake, harm brand credibility, and complicate relationships with Italian distributors.
Impact on Manufacturers
The guidelines’ immediate applicability means manufacturers cannot rely on a grace period. Marketing teams must anticipate longer lead times for campaign launches to accommodate the approval process.
Content creators must collaborate closely with regulatory affairs from the earliest drafting stages to ensure that claims, imagery, and tone meet requirements. For multinational companies, there is an added challenge: aligning global marketing materials with Italy’s stricter national rules without fragmenting brand messaging.
This may require creating Italy-specific campaign adaptations or building modular marketing content that can be customized to meet local laws.
Best Practices for Compliance
Manufacturers can mitigate risks by:
- Establishing an internal advertising review committee with regulatory, legal, and marketing stakeholders.
- Maintaining real-time monitoring of Ministry publications and industry association updates.
- Investing in regulatory intelligence platforms to track developments in both EU and national advertising rules.
- Training all marketing and sales personnel on the distinction between “information” and “advertising” under Italian law.
- Documenting all decision-making processes related to promotional materials, including rationale for claim inclusion or exclusion.
These practices do more than prevent enforcement actions, they demonstrate a culture of compliance that can build trust with both regulators and customers.
Conclusion
Italy’s July 21, 2025 advertising guidelines represent both a consolidation of existing law and a modernization of oversight for today’s media landscape. They provide clearer definitions, bring digital content firmly into scope, and reinforce the divide between professional and public communications.
For manufacturers, the message is unequivocal: compliance is not optional and cannot be left to last-minute checks. Those who adapt early by embedding compliance into creative processes, building robust review pipelines, and staying agile with local adaptations will not only meet regulatory obligations but also protect their market position.
In the evolving European device landscape, Italy’s stance is a reminder that even within the harmonized EU framework, national rules matter and they matter from the very first day they take effect.
How Can RegDesk Help?
Regulatory change is inevitable. The real differentiator is how you respond.
At RegDesk, we help MedTech companies anticipate and adapt to evolving regulatory landscapes, like Nigeria’s, with speed and confidence.
Our platform offers:
- Real-time regulatory intelligence to monitor updates and guidance
- Centralized document management for submissions and postmarket activities
- Country-specific insights to align your strategy with local requirements
- Automated workflows to manage product changes, renewals, and compliance documentation
Whether you’re expanding into new markets or optimizing existing ones, RegDesk helps your team stay ahead, so compliance becomes a competitive advantage, not an obstacle. Want to get ahead of Nigeria’s regulatory transformation?
