New regulations on the advertising of medical devices
On 26 January 2023, two decrees were issued by the Ministry of Health, and published in the Official Gazette on 18 March 2023, which amended the rules on the advertising of medical devices and in vitro diagnostic medical devices. In particular, an exemption to the ministerial authorisation requirement was introduced for certain types of devices and advertising.
The advertising of medical products is regulated, for medical devices, by Article 7 of Regulation (EU) 2017/745 and Article 26 of Legislative Decree 137/2022 and, for in vitro diagnostic medical devices, by Article 7 of Regulation (EU) 2017/746 and Article 22 of Legislative Decree 138/2022. According to these regulations, the advertising of medical devices to the public requires ministerial authorisation, or is completely prohibited, where the use of the device mandates the assistance of a doctor or health professional and a doctor’s prescription.
However, recent legislative decrees, as authorised by this legislation, have firstly defined a list of medical devices and in vitro diagnostic medical devices that may be advertised without prior application for authorisation to the Ministry of Health, also providing guidelines to be followed when drafting advertising messages for these products. Among the medical devices exempt from ministerial authorisation are condoms and medical device accessories such as spectacle frames.
Secondly, the two new decrees also identified categories of advertising that do not require authorisation. These include: i) advertisements made by a company that manufactures or distributes medical devices and which refer only to its name or its field of activity; ii) promotions of medical devices consisting solely of the sale of multiple packs with the same price as the unit packs, or prize operations . In both cases, the prohibition to disseminate, without authorisation, messages referring to the characteristics of the medical device remains in force; iii) the publication of the image or graphic representation of the device or its packaging on sales price lists and on announcements of any discounts offered to the public; iv) limited to distance selling, as referred to in Art. 6 of Regulation (EU) 2017/745, the publication of the image or graphical representation of the device or its packaging, as well as the description and intended use as set out in the instructions for use, provided that the full version of the aforementioned instructions for use is present and can be consulted.
The Ministry of Health has then provided for a system of sanctions that allows for the immediate cessation of the use of the device.
