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Registration of MDR compliant medical devices: the Italian MoH database has been updated

The database for medical devices of the Italian Ministry of Health has been object of important updates these days: indeed starting from 01/12/2021 the registration of medical devices compliant to the Regulation (EU) 2017/745 is possible.

Indeed the Italian database was not suitable for collecting data related to medical devices compliant to the MDR; in particular, during the notification step it was possible neither to declare the compliance with the Regulation (EU) 2017/745 nor to select the Annexes indicating the correct conformity assessment procedure according to the MDR.

However the Italian MoH already provided directions (by means of the document “Circolare del 12 novembre 2021” too), stating that the manufacturers of MDR compliant medical devices, made available on the Italian market, are obligated to register their devices in the Italian database, at least until EUDAMED (the European database) is not fully functional.

In particular, the “Circolare” stresses that the national provisions concerning the registration apply, in line with the MDR, artt. 122 and 123.

Then the procedures for the data communication, as defined in the Italian “Ministerial Decree of the 20th of February 2007 bearing new procedures for the obligations established by the Legislative Decree 46/97 and following amendments”, are still effective also for medical devices compliant to the Regulation.

Carrying on with the update of the registrations, made before 01/12/2021, of the MDR compliant medical devices will now be necessary, making use of the new functionalities of the database. The registration number associated to the MDs does not change following this procedure.

The manufacturers must carry out new notifications for all the MDR compliant MDs subject to the registration obligations and not present in the database yet, at least until EUDAMED is not fully functional; this procedure leads to the release of a new registration number.

Di Renzo Regulatory Affairs keeps updated on the basis of the regulatory framework development and it can assist every subject who approaches the registration in the national database, even in the light of the new provisions concerning MDs compliant to the Regulation (EU) 2017/745.

Written by: Riccardo Del Signore

Foto di kkolosov da Pixabay