Advertising of medical devices: Italian Ministry of Health confirms national pre-authorization requirement despite MDR


With circular 0081386 of November 12, 2021, the Italian Ministry of Health has confirmed that the national pre-authorization requirements for the advertising of medical devices that do not require prescription or the assistance of a health professional (article 21 of the decree 46/97) will continue to apply. apply despite the application of the new regulation on medical devices (Regulation (EU) 2017/745, “MDR”), because it is compatible with and not repealed by article 7 of the MDR.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 provided for by the ministerial decree of 23 February 2006 on the advertising of medical devices and article 118 of legislative decree 219/2006 on the advertising of medicines to the public.

Article 7 of the MDR introduced specific obligations concerning claims, including in the context of advertising of medical devices. This is a new departure from the previous Directive 93/42 / EEC on medical devices, which did not include specific provisions regulating advertising, leaving the possibility for Member States to adopt national requirements, and resulting in a fragmented regulatory landscape across the EU. In this regard, Italian law provides that any advertising for non-prescription medical devices or medical devices not requiring the assistance of a health professional must obtain prior authorization from the Ministry of Health. Advertising to the general public is prohibited for medical devices requiring a medical prescription or requiring the assistance or intervention of a healthcare professional for their use.

Since the MDR’s application date (May 26, 2021), commentators have questioned whether the MDR would prevail and invalidate additional nationally imposed restrictions on advertising, including prior authorization requirements, or whether national laws can still coexist. with the new regulatory framework of the EU. It is on the basis that the MDR aims to introduce harmonized rules for medical devices in the EU, improve the free movement of goods and eliminate national restrictions that may represent disguised restrictions on trade within the EU. EU. A prior authorization requirement could be considered 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 of medical devices under Italian law, including the requirement and procedures for prior authorization. As a result, although such an interpretation may be questionable, Italian authorities are likely to continue to expect companies to obtain prior authorization before advertising medical devices on the Italian market and apply this requirement, imposing potentially penalties for non-compliance. That being said, the ministerial circular is not legally binding, and Italian and European courts may still find such an interpretation of Italian law incompatible with EU law and the principle of free movement of goods if Italian rules were to be be tested in legal proceedings. procedure.


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