Latest Advertising Updates for Medical Devices: Regulatory Update from the Ministry of Health
Recent updates regarding the advertising of medical devices and in-vitro diagnostic medical devices (IVDM) have led to new regulatory provisions. On March 18, 2023, two decrees from the Ministry of Health, signed on January 26, 2023, were published in the Official Gazette, completely replacing the previous regulations. These decrees establish the following provisions in accordance with Article 26, paragraph 3 of Legislative Decree 137/2022 and Article 22, paragraph 6 of Legislative Decree 138/2022:
- The list of medical devices (MD) and in-vitro diagnostic medical devices (IVDM) that can be advertised without requiring prior authorization from the Ministry of Health.
- Guidelines to follow for the preparation of advertising messages related to MD or IVDM that do not require authorization from the Ministry.
The Regulation of MDR and IVDR on Advertising
As known, Article 7 of the Medical Devices Regulation (MDR) introduced a specific provision for claims or statements related to medical devices (the same applies to Article 7 of the IVDR). This rule states the following: “In labeling, instructions for use, making available, putting into service, and advertising of devices, it is prohibited to use texts, names, trademarks, images, and figurative or other signs that could mislead the user or patient regarding the use, safety, and performance of the device”:
- By attributing functions and properties to the device that it does not possess.
- By creating false impressions regarding treatment or diagnosis, functions, or properties that the device does not have.
- By omitting to inform the user or patient of a potential risk associated with the use of the device as intended.
- By suggesting uses of the device that differ from those declared as part of the intended use for which compliance has been assessed.
This rule applies not only to actual advertising but also to all other “statements” that may be made during the device’s lifecycle.
Decrees 137/2022 and 138/2022
During the approval of Legislative Decrees 137/2022 and 138/2022, which harmonized our legislation with the MDR and IVDR, the Italian legislature decided to reintroduce the previous regulations on advertising by introducing Articles 26 and 22, respectively. It is important to emphasize that these rules apply only to advertising messages and not to all situations listed in Article 7, such as labeling, instructions for use, making available, and putting into service.
The rules specifically establish the following:
- Categories of devices for which advertising is prohibited, such as custom-made MD, MD requiring mandatory assistance from a physician or another healthcare professional, MD for which mandatory assistance from a physician or another healthcare professional is required, and MD that can only be sold with a medical prescription.
- The requirement for authorization for other types of devices, with the authorization criteria established in Article 7 and the procedure defined in Articles 118, paragraphs 8-13 of Legislative Decree 219/2006, or the Drug Code.
Furthermore, it is established that there are situations that do not require authorization from the Ministry, as already provided in the previous decree of February 23, 2006. These situations are defined in the two decrees of the Ministry of Health dated January 26, 2023, one concerning MD and the other IVDM, which are almost identical.
Contents of the January 26, 2023 decrees
Condoms and accessories for MD, such as eyeglass frames, or for IVDM, as long as they do not claim healthcare properties, do not require authorization and can be freely advertised (without requiring prior authorization from the Ministry of Health); therefore, the following is allowed:
- Advertising of accessories that only boast non-healthcare characteristics.
- Advertising of accessories claiming healthcare properties still requires authorization from the Ministry of Health.
What types of advertising do not require authorization from the Ministry of Health?
- Advertisements made by the manufacturer or a distributor that specifically or generally refer to the product, including the image of the packaging, and only include the product name or the product’s field of application without claiming specific properties.
- Promotion of the product, which may also include the image of the packaging, through the sale of multiple packages at the price of a single package or through other means, such as promotions or contests.
However, even in these two cases, claiming healthcare properties or characteristics of the product is not allowed. Additionally, it is permissible to freely publish the image or graphic representation of the product or its packaging in price lists, announcing any discounts offered to the public.
Regarding online sales specifically, it is possible to freely disseminate, without authorization, the image or graphic representation of the product or its packaging, the description, and the use of the product, as stated in the instructions for use. However, the instructions for use must be present on the website and fully accessible.
The Sanctioning Regime
Article 1, paragraph 3 of both decrees establishes that if the above-described messages contain information that poses a risk to consumer health, the Ministry of Health may apply the following sanctions:
- Order the immediate cessation of advertising.
- Order the dissemination, at the expense of the transgressor, of a rectification and clarification statement regarding the content of the advertising message. The Ministry of Health establishes the methods for disseminating such a statement.
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