Italy continues with the harmonisation of its system with the MDR and IVDR.
Previous measures (commencing with Legislative Decrees 137/2022 and 138/2022) established the categories of devices for which advertising is prohibited: i.e. (i) custom-made MDs; (ii) MDs requiring the mandatory assistance of a doctor or other health professional for use; (iii) MDs requiring a doctor’s prescription prior to sale to the public); (iv) the authorisation requirement for other products.
With two new decrees (one relating to MDs and the other to IVDMs) dated 26 January 2023 (published in the Official Gazette on 18 March, repealing the previous Ministerial Decree of 23 February 2006, (the “New Decrees”)), the Ministry of Health (“MoH”) specifies the cases that do not require authorisation from the MoH.
· condoms;
· MDs accessories (such as spectacle frames), or IVDMs accessories, provided no health properties are claimed;
The New Decrees also state that no ministerial authorisation is required for:
· advertising, carried out by a company that manufactures or distributes medical devices, which discloses its name or field of activity, provided no specific properties of the device are stated;
· forms of promotion (including those that exploit the image of a product packaging or pack) involving multiple pack offers (e.g. 2×1 product offers), sweepstakes, or competitions, provided always that the characteristics and properties of the MD or IVDM are not disclosed;
· the publication of the image or graphic representation of a device or its packaging on sales price lists and on announcements of any discounts offered to the public;
· 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 (“IFU”), provided that the full version of the IFU is present and can be consulted; this exception is limited to distance selling (Article 6 of Regulation 2017/745).
Finally, with regard to sanctions, the legislation provides that, where the messages described above contain information that represent a health risk for consumers, the MoH may apply the following sanctions:
· order the immediate cessation of the advertising;
· order the publication, at the transgressor’s expense, of a notice to rectify or clarify the advertising message in accordance with the instructions provided by the MoH.
Please contact Masotti Cassella should you have any questions.
