Since 1993, every nation in the European Community has been required to have its own system for registering medical devices. The aim is to provide manufacturers with a way to notify the relevant authorities whenever they put a new device on the market.
But in the absence of any distinct guidelines, various systems have been created which are heterogeneous and unable to communicate with each other. This includes the Italian Ministry of Health database. So this is completely at odds with the original objective of bringing together the world of medical devices in Europe.
There is therefore a clear purpose behind the creation of Eudamed, the European database for medical devices set up by through the MDR. The aim is to eliminate differences, and to improve transparency and the coordination of information. After all, these are the aspects that have caused such upheaval in the sector and the recent fluster for all involved.
So what’s the problem? The timescale.
REGISTRATION IN THE MINISTRY ‘S DATABASE CONTINUES TO BE MANDATORY
Just so: it is no coincidence that the transitional provisions of the Regulation were couched in this way from the outset:
if, due to circumstances that could not reasonably be foreseen, Eudamed is not fully operational on 26 May 2021, the obligations and requirements in relation to Eudamed shall take effect from a date 6 months after the date on which the database becomes fully operational.
Until such a time, the relative provisions of the Directives continue to apply, in particular those related to supervisory reports, clinical investigations, the registration of devices and economic operators and notices of certification.
The term fully operational means exactly what it says: the complete functioning of all the six modules provided, of which only one is currently functional.
In addition, a recent guideline published by the Medical Device Coordination Group (MDCG) has reviewed the terms in relation to registering products with Eudamed, moving the timeline from 6 to 24 months from the date given above.
So for now, registration in the Italian Ministry of Health database continues to be mandatory.
In the meantime, there is to be a major upgrade to Eudamed on 30 September, lasting for three days, so maybe there are still new things to come.
REGISTRATION IS ALSO MANDATORY FOR DEVICES WITH MARKINGS COMPLIANT WITH THE MDR
No exceptions for CE-marked products compliant with the MDR. They also have to be registered in the Ministry’s database. With a certain amount of care.
The current database is clearly aligned with the Directive, especially in relation to the choice of annexes with regard to classification. It is impossible to enter consistent information in relation to the MDR just by using the drop-down menus.
So the Ministry asks you to indicate the classification annex for the product in line with the Directive, and then to add an explanatory note quoting the correct references according to the Regulation.
Of course, this applies to Italy. There are only 26 other methods to explore.
