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Reasons for the decision

Select one, or multiple, reason(s) for the refusal/withdrawal decision and provide a comment. The Decision on refusal document is optional:

EUDAMED reason for refusal and reason for refusal/withdrawal comment and upload refusal document fields and browse button

You may preview your choice, or click Submit:

EUDAMED save, preview, submit and cancel buttons

A warning message displays.

In case a CECP has been registered for the same conformity assessment application then the system will display an information pop-up with the identified CECP. The CECP record can be viewed by opening the provided link EUDAMED link for the CECP record. For Quality-type certificates, the NB had the option not to provide the Basic UDI-DI, but here they can indicate to which device(s) the refused certificate refers.

In this case, if you select both Basic UDI-DIs, the final CECP status will become Refused certificate. If you select one, the status will become Refused certificate partially, until the remaining device(s) is registered to an issued certificate. Then the status will become Issued refused certificate. See the CECP status here:

EUDAMED is a basic udi-di in scope of the linked cecp applicable for this refused certificate field toggle to yes

Alternatively, toggle to No if you choose not to link the CECP to the refused certificate:

EUDAMED is a basic udi-di in scope of the linked cecp applicable for this refused certificate field toggle to no

Click Submit my request. A confirmation message displays:

EUDAMED confirmation message when submitting a refused certificate registration