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In brief

On November 17, 2021, the Ministry of Health published a circular letter to clarify certain aspects related to the application of Regulation (EU) 2017/745 on medical devices (MDR), including those concerning the registration in the national database of medical devices, custom-made devices, and medical device advertising.


With regard to the registration, the circular clarifies that, until Eudamed is fully operational, the obligations relating to the registration of economic operators and medical devices in the national database continue to apply.

As regards custom-made devices, the circular confirms that the manufacturer or the authorized representative making these products available on the Italian market must first provide the Ministry of Health with the list of the relevant devices and the data necessary to identify the same manufacture or authorized representative in accordance with existing procedures. Furthermore, the circular highlights that, according to the provisions of the MDR, mass-produced devices that must be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorized person shall not be considered to be custom-made devices.

Finally, with regard to advertising to the general public, the circular clarifies that the authorization mechanism pursuant to Article 21 of Legislative Decree No. 46/1997 continues to apply together with the prohibitions and exclusions set out in the Ministerial Decree of February 23, 2006, as well as paragraphs 8 to 13 of Article 118 of Legislative Decree No. 219/2006 regarding authorization procedures for advertising.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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