On 20 March 2023, the Ministry of Health published on the website of the Official Journal of the Italian Republic the Decree of 26 January 2023 ‘Identification of the cases of advertising of Medical Devices and In Vitro Diagnostic Medical Devices that do not require ministerial authorisation’.

We would like to remind you that the promotion of Medical Devices is generally regulated at European and national level by Article 7 of MDR (EU) 2017/745 and IVDR (EU) 2017/746 and by the Adaptation Legislative Decrees 137/2022 and 138/2022, which set out the characteristics and modalities for the disclosure of product-related information.

In particular, the aforementioned Article 7 lays down for the first time the general requirements for promotion, which stipulate that in the labelling, instructions for use, in the provision, in the commissioning and advertising of devices, the use of texts, names, trademarks, pictures and figurative or other signs that could mislead the user or patient as to the intended use, safety and performance of the device is prohibited.

But how could the user or patient be misled?

a) attributing to the Device functions and properties it lacks;
b) creating incorrect impressions regarding treatment or diagnosis, functions or properties that the device lacks;
c) failing to inform the user or patient of a potential risk associated with the use of the device in accordance with its intended purpose;
d) proposing uses of the device other than those declared as part of the intended use for which the conformity assessment was carried out.

At national level, advertising in the medical sector is subject to ministerial authorisation to protect the recipient of the communication (patient, user) only for devices intended for the general public. Institutional advertising, on the other hand, is free, while advertising intended for health professionals is subject to specific rules.

The decree thus adds an important piece to the national regulation of advertising in the medical sector. It is necessary to point out, among the most significant information brought by the measure of 26 January, the fact that no authorisation from the Ministry of Health is required for the promotion of the image and graphic representation no longer only of the packaging but also of the medical device or of the actual in vitro diagnostic medical device on sales price lists and on announcements (disseminated for example by means of brochures, posts, newsletters, website pages, etc.) of any discounts aimed at the public.

In addition, in the context of e-commerce, the image and graphic representation of the device as well as its description and intended use exactly as set out in the instructions for use is considered advertising free of authorisation. The latter must, among other things, be able to be consulted in full with the disclosure of information.

In addition to this, it is confirmed in the Decree of 26 January that no authorisation is required in the case of disclosure of the name or field of activity of the manufacturer, provided that no properties of the devices are stated. Authorisation is also excluded for promotions involving the sale of multiple packs at the price of the unit pack (e.g. 2×1) even by exploiting the image of the pack, provided always that the characteristics and properties of the medical device or IVD are not disclosed.

In conclusion, the Decree of 26 January 2023 integrates and completes a system for the management of advertising at national level for devices that increasingly reflects the technological and innovation characteristics of promotion in the medical sector, especially given the widespread means of distance selling and the now indispensable need for product information dissemination.

>> With our strategic-regulatory consultancy services including the analysis of the appropriateness of messages and advertising media in compliance with Italian industry regulations and support in applications for ministerial authorisation for health advertising, Thema can support you in complying with the requirements of the MDR (EU) 2017/745 and IVDR (EU) 2017/746.

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Official Journal