With Circular 0081386 dated 12 November 2021, the Italian Ministry of Health confirmed that the national pre-authorization requirements for the advertising of medical devices not requiring prescription or the assistance of a healthcare professional (Article 21 of Legislative Decree 46/97) will continue to apply despite the application of the new Medical Devices Regulation (Regulation (EU) 2017/745, “MDR”), as it is compatible with and not repealed by Article 7 of the MDR. The circular also specifies that all advertising remains subject to the procedures set forth by Ministerial Decree 23 February 2006 on advertising of medical devices and Article 118 of Legislative Decree 219/2006 on advertising of medicines to the public.
Article 7 of the MDR introduced specific obligations concerning claims including in the context of the advertising of medical devices. This is a new departure compared to the previous Directive 93/42/EEC on medical devices, which did not include specific provisions regulating advertising, leaving room for the member states to adopt national requirements, and resulting in a fragmented regulatory landscape across the EU. In that regard, Italian law provides that all advertising of non-prescription medical devices or medical devices not requiring the assistance of a healthcare professional must obtain a previous authorisation by the Ministry of Health. Advertising to the general public is prohibited for medical devices that require a medical prescription or require the assistance or the intervention of a healthcare professional for their use.
Since the application date of the MDR (26 May 2021), commentators have been debating whether the MDR would pre-empt and invalidate additional restrictions on advertising imposed at the national level, including any pre-authorization requirements, or whether national legislations may still coexist with the new EU regulatory framework. This is on the basis that the MDR aims at introducing harmonized rules for medical devices in the EU, enhancing the free movement of goods and eliminating national restrictions that may represent disguised restrictions to trade within the EU. A prior authorisation requirement could be considered as a measure having equivalent effect.
With the aforementioned circular, the Italian Ministry of Health confirmed the full applicability of the existing restrictions on the advertising medical devices under Italian law, including the pre-authorization requirement and procedures. As a result, while such an interpretation may be questionable, Italian authorities are likely to continue to expect that companies obtain prior authorization before advertising medical devices on the Italian market and to enforce such requirement, potentially issuing sanctions in case of non-compliance. That being said, the Ministerial circular is not legally binding, and the Italian and EU courts may still find such interpretation of Italian law incompatible with EU law and the principle of free movement of goods were the Italian rules to be tested in the context of judicial proceedings.