Advertising for Medical-surgical Aids (PMCs) and other healthcare products (such as medical devices and diagnostic medical devices) has been subject to authorization for many years in Italy.
Please note that PMCs are disinfectants (for human hygiene and for surfaces), insecticides, and repellents subject to national authorization under Article 89 of the BPR.
A new guideline was published on July 21, 2025, setting new standards for the advertising methodologies of medical-surgical devices (PMC) and medical devices.
What’s the focus of the new guideline?
The guideline offers a clear framework for faster authorization practices while maintaining the message to be communicated to the consumer as is, without ambiguity generated due to unwanted cuts.
In addition, it clearly highlights the content and delivery methods subject to authorization, avoiding unpleasant penalties or damage to the image due to, for example, the company’s website ban.
What are the rules for effective advertising?
According to the guidelines, these are some rules of thumb to follow for clear and compliant advertising:
- Authorization is required only when advertising to the end consumer.
- Only claims already authorized on the label can be approved; for example, a disinfectant product approved only for bactericidal activity cannot have the claim “virucidal” as well.
- Images are considered a communication tool, so, for example, a product approved for use inside homes cannot feature images of gardens or outdoor life on its label.
- Approval is also required for company websites promoting the product’s image.
- Advertising on social networks (such as Facebook, TikTok, Instagram, and YouTube) is permitted provided that all features relating to “comments and reactions” are disabled (for instance public likes, emoticons, comments).
- The Internet is also subject to authorization as it is considered a means of dissemination.
- Testimonials and notorious people cannot recommend or say their preference when it comes to the usage of the product.
- Comparative advertising is not permitted.
- The authorization of an advertising message already granted by the Italian Ministry of Health for one or more media (print, television, radio, internet, etc.) may be extended to other media that support the same mode of representation (audio, audio-video, or image-text).
Cases in which authorization is not required
Authorization is not required for activities relating to the promotion of the company brand in general, provided that no specific product, image, or label is mentioned.
At the same time, all messages aimed at professional operators are also not subject to authorization.
Understanding how to move with these advertisement matter is crucial, we recommend that you read the guideline carefully.
If you have any questions or need clarification, please do not hesitate to contact us, where you will find expert regulatory consultants who are up to date with the latest developments and in constant contact with the competent authorities. They will be able to provide you with comprehensive support in evaluating your material.
