Action Required in the Ministry’s Database

In December 2021, the Ministry of Health’s database was modified to allow the insertion of all information, certificates, and documentation related to devices marked according to the Regulation (MDR).

Before this modification, manufacturers had registered these devices with essentially incorrect information, as it was still according to the Directive (MDD).

From now on, to register a new device, it is mandatory to select the reference legislation by choosing one of the following options:

• Legislative Decree 46/97 implementing EC Dir. 93/42 (medical devices marked according to the Directive)
• Legislative Decree 507/92 implementing EC Dir. 90/385 (active implantables according to the Directive)
• EU Reg. 2017/745 (medical devices according to the Regulation)

What should I Do?

The following instructions concern registrations already present in the database, made before December 2021, to be managed as indicated.
The following does not apply to new registrations. In such cases, the aforementioned selection of the correct certification scheme at the start of registration applies.

Device Certified and Registered According to MDD, which Remains under MDD

If the registration concerns medical devices CE marked according to the Directive, which remain marked according to the Directive: no action is required.

Device Certified and Registered According to MDD, Now Compliant with MDR

If the registration concerns medical devices CE marked according to the Directive, which are now compliant with the Regulation: it is necessary to proceed with a new registration obtaining a new notification number.

In the database, there will therefore be two registrations for the same product. One according to MDD, the other according to MDR. If applicable, it is possible to indicate the end of marketing date for the MDD product.

Device Certified According to MDR, Registered before December 2021

In this case, the registration was made before the modification of the database, reasonably in the period May/December 2021 and concerns medical devices CE marked according to the Regulation.
The product was therefore registered, in agreement with the Ministry, with incorrect information because it referred to the previous Directive (MDD).

It is necessary to correct the registration, with the following methods:

• Use the “put back in progress” function indicating “SPECIFIC LEGISLATION 745” as the reason;
• Correct the legislation by selecting “EU Reg. 2017/745”;
• Indicate the legislation “EU Reg. 2017/745” also for the certificates possibly connected to them;
• Consolidate;
• Electronically sign the data.

We Can Help You

Where required, we are available to analyze the situation regarding all present registrations and proceed with the necessary modifications.
It remains valid that the cases and operational methods are exactly those indicated, therefore, to avoid increased costs, it is possible to proceed autonomously, contacting us in case of doubts during the process.