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

THE IMPACT ON BASIC UDI-DI CONFIRMATION

The origin of these technical complications lies in the very nature of Annex X. Indeed, this procedure applies 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 that—even if belonging to these classes—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 confirmation of the Basic UDI-DI if the registration is incorrect. The reason is simple: Annex X does not fall within our current scope of designation, and therefore no Annex X certificates issued by ECM can exist. Without proper matching 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 covered and managed by ECM are those relating to Annex IX or Annex XI. We invite all manufacturers to carefully review the technical documentation prior to registration. Correcting the certificate type associated with the device is the only way to unblock the procedure: once the correct Annex is selected, EUDAMED will no longer require Basic UDI-DI approval, thus ensuring a smooth placement on the market.