The main provisions regulating the advertising of medical devices in Italy are the following:

  • Regulation (EU) 2017/745 and, in particular, Article 7, which dictates, inter alia, general principles on the advertising of medical devices;
  • Legislative Decree 137/2022 and, in particular, Article 26, which regulates the advertising of medical devices;
  • Decree of the Minister of Health of 26 January 2023 on “Identification of cases of advertising of medical devices that do not require ministerial authorisation”[1] .

The sector regulations listed above are part of the general regulatory framework that governs communications in Italy (think, by way of example only, of Legislative Decree 205/2006, the so-called "Consumer Code", Legislative Decree 145/2007 on misleading advertising to protect professionals, the regulations on the protection of copyright under Law 633/1941 and the protection of privacy under EU Reg. 679/2016 and Legislative Decree 196/2003, etc.).

In addition, there are self-regulatory codes, which provide guidelines that communications must adhere to in order to respect the general principles of honesty, truthfulness, and fairness (see the Self-Regulatory Code for Commercial Communications of the Istituto di Autodisciplina Pubblicitaria, an Italian association founded in 1966, whose members include numerous companies and audiovisual publishers, and whose goal is to promote responsible commercial communications, for the benefit of both companies and citizens - consumers).

Returning to the sector regulations, Article 26 of Legislative Decree 137/2022 imposes a ban on advertising to the public of the following devices, without prejudice to the possibility of the Ministry of Health to identify additional types of medical devices for which advertising to the public is not permitted:

  1. custom-made devices;
  2. devices for the use of which the assistance of a doctor or other health professional is provided for as obligatory by the regulations in force;
  3. devices for whose use the assistance of a doctor or other health professional is prescribed as mandatory according to the manufacturer's instructions;
  4. medical devices the sale of which to the public is subject, according to the regulations in force, to the prescription of a physician.

For types of devices other than those listed above, advertising to the public of medicinal products is allowed subject to prior authorisation by the Ministry of Health (whereas advertising to healthcare professionals is always allowed and not subject to prior authorisation procedures).

In particular, with regard to the procedure to be followed for the issue of the prior authorisation, Article 26 cit. recalls, in so far as compatible, the provisions of Article 118(8) to (13) of Legislative Decree No. 219/2006.

Subsequently, with the decree of 26.1.2023, the Ministry of Health identified certain types of devices for which advertising to the public is permitted without the need to obtain prior authorisation. These are condoms and medical device accessories, such as spectacle frames, provided that the advertising message refers exclusively to non-health properties. The decree also states that the following are not subject to authorisation:

  1. advertising, carried out by a manufacturer or distributor, which refers to its name or field of activity (so-called 'institutional advertising') provided that no specific properties of the devices are claimed, which may be referred to individually or as a whole;
  2. forms of promotion of medical devices carried out by offering multiple packages for sale at the price of the unit pack or by means of different methods of prize operations or competitions, without prejudice to the prohibition to disseminate messages referring to the properties and characteristics of the medical device without authorisation;
  3. 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;
  4. limited to distance selling, the publication of the image of the device or its packaging as well as the description and intended use, provided that the full version of the instructions for use is present and accessible.

With reference to advertising to the public, the Minister of Health, in application of the provisions of art. 26, paragraph 5, cited (according to which “with regard to the devices for which advertising to the public is permitted, the Ministry of Health, having consulted the most representative associations of operators in the sector, by means of guidelines shall regulate the operating methods permitted for carrying out advertising, including those involving the use of electronic systems”), published on 21 July 2025 the new Guidelines for the health advertising of medical devices, in vitro diagnostic medical devices and medical-surgical aids, which brings together the still valid contents of the previous Guidelines and updates them, taking into account, where possible, the needs expressed by operators in the sector.

After providing an overview of the regulatory framework of reference on the subject of the advertising of medical devices and medical-surgical devices, the Guidelines detail the procedure for obtaining the ministerial authorisation for advertising, with indications on the documents to be attached and on the payment methods, confirming the possibility of extending the authorisation already granted to other media, provided that the message remains identical to the original one.

Clarifications are then provided on the information aimed exclusively at healthcare workers (which does not require authorisation), reiterating the need to provide exclusively reserved sites/areas, by means of disclaimers and 'pop-ups' and/or equivalent technologies with which the interested party is asked to declare that he is a healthcare worker.

The Guidelines regulate the ways in which toll-free numbers may be included in the message and recall the principles already expressed in the 2017 Guidelines on the use of testimonials, and then dwell on the cases of advertising of medical-surgical devices that do not require the prior authorisation of the Ministry of Health (for medical devices, on the other hand, they merely refer to the provisions of the decree of 26.1.2023 cited above).

Finally, the document addresses the issue of advertising on the different types of websites (institutional websites, product websites, thematic websites other than product websites, etc.) and, in closing, it focuses on advertising through social media, listing in an annex the detailed forms dedicated to the individual social channels for which it is permitted to submit an application for authorisation for advertising (Facebook, Instagram, Youtube, Tik Tok), providing, however, a significant opening compared to the previous Guidelines, as well as to the Guidelines on advertising to the public of OTC and SOP medicines of 19.7.2023, since the possibility of using social channels other than those indicated in the Guidelines is expressly allowed, subject to a prior application to the Ministry of Health, which will assess whether the conditions for allowing it are met.

Without prejudice to the specific indications provided with reference to the individual cases of social media expressly contemplated in the Guidelines, as a general rule, the Guidelines specify that the use of such social networks for the dissemination of authorised advertising messages is permitted only if the following conditions are met:

  • the social network must technically allow all functions concerning ‘comments’ and reactions (public likes, emoticons and the like) to be disabled; the 'sharing' function must also be disabled and, where this is not technically possible, all messages disseminated on social networks must contain the following disclaimer: “The Ministry of Health exclusively authorises the content of the advertising message. Any comments are the sole responsibility of the user, the company dissociates itself from user comments”;
  •  it is permitted to include in authorised advertising messages disseminated via social pages and/or profiles links that can be activated in the following cases:
  1. links referring to websites and/or pages and/or social profiles containing promotional material already authorised by the Ministry;
  2. links that refer to content aimed at the public that does not require ministerial authorisation (e.g. containing health education information, self-medication, etc.). In the second case, the company responsible for the material on the network shall warn the user with the following wording: “you are leaving the site (insert name) containing promotional material authorised under current legislation on health advertising”;
  • in the application for authorisation, the applicant must indicate the sites and pages and/or social profiles to which reference is made, if they are not explicitly mentioned in the message.

Finally, links to other content aimed at the public (including in foreign languages), which require ministerial authorisation and have not been obtained, are not permitted.

Lawyer Claudia Pasturenzi (*)

[1] This paper focuses on the advertising of non-diagnostic in vitro medical devices, however, it should be noted that the legislation on the advertising of the latter type of products follows that of the other types of medical devices and is currently governed:

- by Regulation (EU) 2017/746 (Article 7);

- by Legislative Decree 138/2022 (Article 22);

- by the Decree of the Minister of Health of 26 January 2023, on “Identification of cases of advertising of in vitro diagnostic medical devices that do not require ministerial authorisation”.

(*) Astolfi e Associati Studio Legale, Milan.

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