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CECP status change

During the registration of an issued certificate for MDR, the respective CECP will be linked within the mechanism for scrutiny step of the issued certificate registration. However, when registering a refused certificate or withdrawn application, the CECP will be linked based on the Application ID provided.

The following table describes the statuses of a CECP:

CECP status

Description

FOLLOWED

Notified Body follows the CECP.

ASSIGNED

Rapporteur and Co-rapporteur for this CECP dossier are assigned by the European Commission.

OPINION

The screening panel decided to provide their opinion on this CECP dossier. The CECP status is changed upon an action by Rapporteur or Co-rapporteur. This status implies that the NB must provide the scientific opinion document and the justification for not following the opinion (if applicable) within the mechanism for scrutiny step.

NO-OPINION

The screening panel decided not to provide any opinion on this CECP dossier. The CECP status is changed upon an action by Rapporteur or Co-rapporteur.

ISSUED-CERTIFICATE-PARTIALLY

This status occurs when the CECP is linked to an issued certificate and there is at least one Basic UDI-DI in the scope of the CECP that is not referenced in the issued certificate.

REFUSED-CERTIFICATE-PARTIALLY

This status occurs when the CECP is linked to a refused certificate and there is at least one Basic UDI-DI in the scope of the CECP that is not referenced in the refused certificate.

WITHDRAWN-APPLICATION

Final status. When the CECP is linked to a withdrawn application.

REFUSED-CERTIFICATE

Final status. When all Basic UDI-DI(s) in the CECP scope are referenced in a refused certificate.

ISSUED-CERTIFICATE

Final status. When all Basic UDI-DI(s) in the CECP scope are referenced in an issued certificate.

ISSUED-REFUSED-CERTIFICATE

Final status. When some Basic UDI-DI(s) within the CECP scope are referenced in an issued certificate and other Basic UDI-DI(s) within the CECP scope are referenced in a refused certificate.

NOT-FOLLOWED

Final status. Notified Body does not follow the CECP.