Medical device advertising in Italy: is authorisation by the Ministry of Health still required?
Published on 28th Jan 2022
Italian Ministry of Health departs from harmonised EU regulatory framework on advertising medical devices by continuing authorisation regime
EU Regulation 2017/745 on medical devices (MDR ) entered into force on 26 May 2021 , with the aim of introducing uniform medical device regulation in all Member States, thus ensuring an equal regulatory framework throughout the EU . EU regulations – unlike directives which must be implemented with national measures – apply directly to Member States. One of the most important innovations introduced by the MDR is that for the first time the advertising of medical devices is regulated. In particular, the MDR regulates in general terms the content that an advertisement for a medical device must have.
Medical device advertising
Article 7 of the MDR provides that:
"In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
- ascribing functions and properties to the device which the device does not have;
- creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
- failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
- suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out".
Once the MDR came into force in Italy, doubts have arisen as to the validity of existing national regulations on medical devices with which Italy implemented the Directive 93/42/EEC on medical devices. Specifically: with the MDR, has the requirement of prior ministerial authorisation for the advertising of medical devices disappeared, or does it still apply?
The Directive and article 21 of Legislative Decree 46/1997
The Directive 93/42/EEC concerning medical devices, implemented in Italy by Legislative Decree n. 46 of February 24, 1997 , did not provide for any specific discipline regarding the advertising of medical devices, leaving space to the individual legislators of the various countries of the European Union for its possible regulation.
As far as Italy is concerned, when transposing the directive, the legislator provided for a specific article relating to the advertising of medical devices (article 21 of the Legislative Decree), which introduced an authorisation regime. This article provides that:
- "Advertising to the public of devices which, according to provisions adopted by decree of the Minister of Health, may only be sold with a medical prescription or used with the assistance of a doctor or other health professional is prohibited.
- Advertising to the public of devices other than those referred to in paragraph 1 is subject to authorisation by the Ministry of Health. The commission envisaged in article 6, paragraph 3, of legislative decree no. 541 of 30 December 1992 shall express its opinion on the request for authorisation, and for this purpose it shall be integrated by a representative of the Department of the Ministry of Health responsible for medical devices and one from the Ministry of Economic Development".
Ministry of Health, circular No. 0081386
The doubt as to whether or not Article 21 of Legislative Decree 46/1997 is valid following the entry into force of Article 7 of the MDR was resolved by the Ministry of Health itself in circular no. 0081386 of November 12, 2021.
With this circular, the Ministry of Health clarified that advertising to the public of medical devices not subject to prescription and devices that can be used without the assistance of a physician will continue to be subject to the prior authorisation requirement set forth in article 21 of the Legislative Decree, since, according to the Ministry, this article would be compatible with article 7 of the MDR.
This interpretation by the Ministry has not been received without criticism.
Compatibility of national law with MDR
Some commentators start from the assumption that the MDR, which, among other things, repeals Directive 93/42/EEC, is a community act that applies directly within the legal systems of Member States and prevails (according to the jurisprudential principle of the pre-eminence of community law over national laws) over national regulations that conflict with the MDR, and therefore must be disapplied. Since article 7 of the MDR expressly regulates the advertising of medical devices and does not provide for any form of authorisation, nor allows Member States to supplement this provision with national implementing rules, article 21 of the Legislative Decree would be in conflict with the MDR and, therefore, would be repealed by the MDR.
Although debatable, the Ministry's position will most likely be the one that will be followed by the control authorities responsible for verifying the compliance of entities marketing medical devices with advertising requirements, with the consequent application of sanctions in case of unauthorised advertising.
The uncertainty as to the compatibility of article 21 of the Legislative Decree with article 7 of the MDR will probably remain until a jurisprudence is formed in the national and European courts regarding the possible contrast of the Italian legislation with European law.
Until then, despite the fact that the MDR has the purpose of creating uniform regulation in the European Union, Italy will continue to have a different regime from the majority of Member States with respect to the advertising of medical devices.
If you would like to discuss any of these issues further, please do not hesitate to contact the authors or your usual Osborne Clarke contact.