The Italian Ministry of Health’s Directorate General for medical devices and the pharmaceutical service has issued a circular setting out indications regarding the application of the new Regulation EU 2017/745 on medical devices (which came into force from 26 May 2021), pending legislative measures for the necessary harmonisation of national and community provisions.

Specifically, the circular clarifies that the provisions of Art. 21 of Legislative Decree 46/1997 regarding the advertising of medical devices continue to apply, since they are compatible with Art. 7 Reg. 2017/745 and, consequently, that the requirements relating to the authorisation of advertising, introduced by ministerial decree 23 February 2006 and by Art. 118 of Legislative Decree 219/2006 (Pharmaceuticals Code), are still valid.

Furthermore, considering that it is the responsibility of the Member States to establish the sanctions to be applied in the event of breaches of the Regulation, pending the introduction of such sanctions, the sanctions envisaged by Art. 23 of Legislative Decree 46/1997 and by Art. 10 of Legislative Decree 507/1992 (e.g., for breaches of the laws governing post-marketing surveillance laws and reporting of accidents, confidentiality, affixing of the CE marking, registration of manufacturers of custom-made devices) remain in effect, with the proviso that sanctions relating to obligations or cases no longer contemplated by Reg. 2017/745 are not to be considered effective.

 The circular also specifies that until the European Databank on Medical Devices (Eudamed) becomes fully operational, the national provisions governing the transmission of information via the new healthcare information system (NSIS) shall continue to apply.

Moreover, the fees currently envisaged by ministerial decree 16 January 2019, by ministerial decree 14 July 2004 and by Ministry of Health circular 25 May 2021 (relating, respectively, to the issue of certificates of free sale and licenses for public advertising, as well as assessment of applications for the authorisation of clinical surveys) continue to be valid, until the fees to be applied for execution of the activities envisaged by Reg. EU 2017/745, in compliance with Art. 111 of the Regulation, have been set.

Additional indications in the circular relate to the products without an intended medical purpose listed in Annex XVI of Reg. 2017/745, recourse to harmonised standards pursuant to Art. 8 Reg. 2017/745 (which establishes that medical devices in conformity with the relevant harmonised standards, whose references have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of the Regulation covered by those standards), notified bodies, legacy devices as at Art. 120, par. 3, Reg. 2017/745, as well as manufacturers of custom-made devices (the circular of 12 November 2021 is available on the website of the Ministry of Health www.salute.gov.it).