Advertising of medical devices and in vitro diagnostic medical devices to the general public: When ministerial authorization is not required
On March 18, two decrees of the Ministry of Health were published in the Official Gazette, both dated January 26, 2023. They identify scenarios when advertising of medical devices and in vitro diagnostic medical devices to the general public is not subject to the ministerial authorization procedure under the current national legislation.[1]
They are the following:
- A ministerial decree containing “Identification of cases of advertising of medical devices that do not require ministerial authorization,” issued in implementation of Legislative Decree 137/2022 (Art. 26(2)), which repeals and replaces the previous decrees on the subject;[2]
- A ministerial decree containing “Identification of cases of advertising of in vitro diagnostic medical devices that do not require ministerial authorization,” issued in implementation of Legislative Decree 138/2022 (Art. 22(6)), which contains provisions mirroring those for medical devices.
First, the decrees reiterate that advertising for accessories for medical devices[3] (such as eyeglass frames) and accessories for in vitro diagnostic medical devices[4] is not subject to authorization, provided that the messages refer exclusively to non-health-related properties of these products.
In addition, promotional messages for condoms—which qualify as medical devices—are exempt from the prior authorization requirements for health advertising, as provided in the ministerial decree of October 6, 2020.
Second, for both medical and in vitro devices, the following are not subject to authorization:
- advertising carried out by the manufacturer or distributor that relates to the company’s name or field of activity (known as institutional advertising), provided that no specific properties of the devices, individually or as a whole, are claimed, including by means of packaging images;
- advertising carried out by offering multiple packages for sale at a unit price or via various types of prize events,[5] provided that the message makes no reference to the promotional methods or to the properties and characteristics of the device;
- the publication of images or graphic representations of devices or their packaging on sales price lists and announcements of any discounts offered to the public;
- for remote sales of devices to the public only, the publication of images or graphic representations of devices or their packaging, as well as descriptions and intended use as set out in instructions for use (provided that the full version of these instructions is present and accessible).
Beyond these scenarios, advertising to the public of medical devices and in vitro diagnostic medical devices must be authorized in advance by the Ministry of Health in accordance with the procedure set out in Article 118(8) to (13) of Legislative Decree No. 219/2006 and the additional operating instructions published on the Ministry’s website,[6] without prejudice to the ban on advertising devices that can only be sold with a doctor’s prescription or that must be used with the assistance of a doctor or other health professional.[7]
[1] Art. 118(8) to (13), Legislative Decree 219/2006.
[2] These are the Decree of the Ministry of Health of February 23, 2006, “Advertising of medical devices,” and the Decree of the Deputy Minister of Health of October 6, 2020, “Exclusion of condom advertising from Ministry of Health authorization.”
[3] Pursuant to Regulation (EU) 2017/745, an “accessory to a medical device” is a product that, although not itself a medical device, is intended by the manufacturer to be used with one or more specific medical devices and more specifically to enable those devices to be used in accordance with their intended purpose, or to specifically and directly assist the medical function of the medical devices in relation to their intended purpose.
[4] Pursuant to Regulation (EU) 2017/746, an “in vitro diagnostic medical device accessory” is a product that, although not itself an in vitro diagnostic medical device, is intended by the manufacturer to be used with one or more specific in vitro diagnostic medical devices and more specifically to enable in vitro diagnostic medical devices to be used in accordance with their intended use, or to specifically and directly assist the medical function of in vitro diagnostic medical devices in relation to their intended purpose.
[5] Governed by Presidential Decree 430/2001.
[6] Authorization to carry out health advertising for medical devices and in vitro diagnostic medical devices (salute.gov.it).
[7] Prohibitions provided for medical devices and in vitro diagnostic medical devices, respectively, by Legislative Decree 137/2022 (Art. 26) and Legislative Decree 138/2022 (Art. 22).
