Registering UDI Codes in Eudamed

Following the latest Eudamed update, it is now possible to register UDI codes. The products to be registered, to which the codes refer, are: CE-marked medical devices under MDR; devices marked according to the Directive by virtue of a valid certificate (called legacy devices) and devices that do not have a medical intended use (according to Annex XVI).

To register UDI codes for medical devices in Eudamed, it is necessary to access the restricted area with EU Login and change the account permissions from viewer to proposer or confirmer. To do this, you must have at least two accounts associated with the company. Once the change is made, you can access the UDI registration area and register the codes.

The UDI codes to be registered in Eudamed are the UDI-DI and the Basic UDI-DI. However, for legacy devices, for which there is no obligation to obtain a UDI code, Eudamed will generate its own EUDAMED DI and, if desired, an EUDAMED ID.

The registration of UDI codes is essentially a registration of medical devices.
The information to be entered includes:

• Medical device details (class, model, if active, if it has a measuring function, if it’s implantable, etc.);
• Information on tissues and substances;
• Trade name and information on UDI-DI and PI;
• Storage/handling conditions;
• Important warnings or contraindications;
• Member States where the device is or will be available on the market;
• Details on clinical investigations.

At present, this registration does not replace the registration in the Italian Ministry of Health’s Database, which remains mandatory.

Application Date for the UDI Registration Obligation

As with other MDR requirements that directly or indirectly concern Eudamed, the obligation to register UDIs will apply within 24 months from the date when the database becomes fully operational.

For this reason, there is currently no obligation. The Eudamed modules that are still inactive are:

• Clinical Investigations and performance studies;
• Vigilance and post-market surveillance;
• Market Surveillance.

The suggestion to start the registration activity anyway remains valid to gain familiarity with Eudamed and collect, for each product, the information required at the time of registration.

Entrust the Registration to Sistemir

UDI code registration is a complex process, both in terms of account activation and entering the correct data. Moreover, this data is visible to the public and the Competent Authority. For this reason, it is advisable to use qualified support to ensure the accuracy of UDI registration in Eudamed.

We have internal resources, experts, dedicated to carrying out this activity. Contact us for a quote to provide you with the training useful to proceed independently or to entrust us with the entire registration process.