The correct registration of medical devices within the European EUDAMED database is a mandatory step for regulatory compliance. Recently, we have observed that many manufacturers incorrectly register Annex X of Regulation (EU) 2017/745 (MDR) as the conformity assessment procedure. This error, while seemingly formal, creates significant operational blockages within the system.

THE IMPACT ON BASIC UDI-DI CONFIRMATION

The technical complications stem from the very nature of Annex X. This procedure is applicable exclusively to Class III or Class IIb implantable devices, in combination with the procedure set out in Annex IX. For these categories, Article 29 of the MDR stipulates that the Basic UDI-DI must be confirmed by the Notified Body (NB) at the time the certificate is uploaded to the portal. If a manufacturer selects Annex X for a device that does not fall into these classes, or which belongs to these classes but is certified under a different procedure, EUDAMED will automatically trigger a validation request to the NB.

THE ROLE AND LIMITATIONS OF THE NOTIFIED BODY

It is essential to clarify that ECM – Ente Certificazione Macchine cannot proceed with the Basic UDI-DI confirmation if the registration is incorrect. The reason is straightforward: Annex X does not fall within our current scope of designation; therefore, no Annex X certificates issued by ECM can exist. Without an exact match between the issued certificate and the procedure declared in the system, the Notified Body is unable to validate the data, and the Basic UDI-DI will never be confirmed.

HOW TO PROCEED CORRECTLY

For a compliant assessment, the procedures actually provided and managed by ECM are those related to Annex IX or Annex XI. We urge all manufacturers to carefully verify their technical documentation before registration. Correcting the certificate type associated with the device is the only way to unblock the process: once the correct Annex is set, EUDAMED will no longer require Basic UDI-DI approval, thus ensuring a smooth market entry.