Registering Medical Devices in the Ministry’s Database

Since 1993, every nation in the European Community has been required to have its own system for medical device registration; its purpose is to allow manufacturers to notify the relevant competent authority of the market launch of a new device.

In the absence of uniform guidelines, heterogeneous systems incapable of communicating with each other have emerged. Among these is the Italian Ministry of Health’s database. This is diametrically opposed to the desire to unify the world of medical devices in Europe.

Therefore, the objective behind the creation of Eudamed, the European database for medical devices required by the MDR, is clear: to eliminate differences, improve transparency, and coordinate information. These aspects are, after all, the foundations of the sector’s upheaval and everyone’s recent rush.

The problem? Timing.

Registration in the Ministry’s Database Continues to be Mandatory

That’s right, it’s no coincidence that the Regulation’s transitional provisions have, from the outset, addressed this issue:

If, due to circumstances that could not have been reasonably foreseen, Eudamed is not fully operational by May 26, 2021, the obligations and requirements related to Eudamed shall apply from the date corresponding to 6 months after the date when the database becomes fully operational.

Until that date, the corresponding provisions of the directives continue to apply, particularly those concerning vigilance reports, clinical investigations, registration of devices and economic operators, and certification notifications.

Fully operational means exactly what it says: the full functionality of the six planned modules, of which, to date, only one is functioning.

Moreover, a recent guideline published by the MDCG reconsiders the application terms of Eudamed-related requirements for product registration, extending them from 6 to 24 months from the aforementioned date.

Thus, in the meantime, registration in the Italian Ministry of Health’s database continues to be mandatory.

Meanwhile, tomorrow (September 30) a major upgrade is scheduled for Eudamed that will last three days; perhaps some new developments await us.

Obligation Extended to Devices Marked under MDR

No exemption for products CE marked under MDR. Registration in the Ministry’s database is mandatory for them as well. With some considerations.

The current database is clearly aligned with the Directive, especially regarding the selectable classification annexes. It’s impossible, from the drop-down menus, to enter information consistent with the MDR.

The Ministry therefore asks to indicate the product’s classification annex according to the Directive and then add a note in the description with the correct references according to the Regulation.

This, of course, is for Italy. There are only 26 other methods left to discover.