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In brief

On 18 March 2023, two decrees of the Ministry of Health, dated 26 January 2023, were published in the Official Gazette to implement the advertising provisions laid down in Legislative Decrees No. 137/2022 on medical devices and No. 138/2022 on in vitro diagnostic medical devices.

Key takeaways

In particular, the ministerial decrees exclude from the authorization requirement the advertising of device accessories, advertising that merely refers to the name or field of activity of the manufacturer or distributor, forms of promotion of devices, including through the use of the image of the packaging, carried out through the sale of multiple packages at the price of the unit package and the publication of the image or graphic representation of the device or its packaging on sales price lists and announcements of discounts offered to the public. In all cases, the exclusion applies on the condition that advertising messages refer exclusively to non-health properties of the devices.


Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Francesca R. Baratta is an Associate in Baker McKenzie Rome office.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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