Action Required in the Database for Legacy Devices

If your organization has registered or intends to register legacy devices in the Ministry of Health’s database, it is considered a declarant. Declarants are required to follow through with the mandatory actions recently established by the Ministry of Health for managing legacy devices that benefit from the extension under Regulation (EU) 2023/607.

Medical Devices with Expired MDD Certificate

For CE-marked devices covered by an MDD certificate, it is necessary to intervene in the section dedicated to certificate uploading and choose the option “Extension of certificate validity – EU Regulation 2023/607” from the available options.

Based on the specified cases, the system will automatically determine the new expiration date of the certificate. Declarants must also carry out this procedure for certificates issued by Italian notified bodies, setting the option “Search for Certificates notified in the Medical Devices Database by Italian Notified Bodies” in the search.

Class I medical devices for which the MDR conformity assessment procedure requires the involvement of a notified body

For CE-marked devices not covered by an MDD certificate (Class I), for which the MDR conformity assessment procedure requires the involvement of a notified body, it is necessary to intervene in the section dedicated to medical devices, use the reprocessing function, and select the appropriate case in the “Device Documentation” section.

The system will automatically determine the end date for placing on the market of the device based on what is provided for the specific situation.

We Can Manage the Activity

We are in contact with the Ministry to whom we have reported the needs they have addressed.
The management methods indicated by the Ministry and summarized above may not represent all possible cases or may require additional steps.

We can provide support to declarants in order to establish the applicability of the above and directly manage the necessary actions.