EUDAMED Status

What do Draft, Discarded, Submitted, and Registered mean for UDI data?

Anyone maintaining UDI data in EUDAMED or transmitting it via XML/M2M will regularly encounter different dataset statuses. In practice, understanding these statuses is crucial, as they influence not only data visibility but also whether records can be further edited, discarded, or finally registered after a review process. For the UDI/Device module, the European Commission specifically describes the states Draft, Submitted, and Registered; additionally, “Discard” is the function used to logically delete submitted or registered datasets.

Draft

A dataset in Draft status has not yet been finally submitted. It has been saved but not officially registered or—if required—forwarded for further confirmation. Such drafts are not publicly visible. Within EUDAMED, manufacturers or producers can create draft data, and users with the appropriate roles are permitted to delete these drafts. According to the Commission, only datasets in Registered status are available to the public.

Discarded

In EUDAMED, “Discard” is not merely a cosmetic marker but the function for the logical deletion of data that has already been transmitted or registered. This ensures the dataset is no longer displayed publicly. If the last or only UDI-DI under a Basic UDI-DI is discarded, the associated Basic UDI-DI is subsequently discarded as well, as it cannot exist without an assigned UDI-DI. This point is particularly important in practice when erroneous registrations need to be properly retracted.

Submitted

The Submitted status is an intermediate state for specific devices that require confirmation by a Notified Body. The Commission explicitly states that the “Submitted” state is only relevant for devices where registration requires validation by a Notified Body. Therefore, it does not apply to every registration. As long as this confirmation is pending, the dataset is not yet in its final public state.

Registered

Registered is the final target status. Devices that do not require confirmation by a Notified Body can reach this status immediately, provided the data submitted is complete and correct. For datasets linked to certificates, the transition to Registered only occurs after the corresponding confirmation step. Only datasets in Registered status are publicly visible in EUDAMED.

Important Practical Note

EUDAMED operates with strict uniqueness checks for Basic UDI-DI and UDI-DI. Official documentation clearly states that duplicate entries are not permitted. Regarding the observation that Draft data can block subsequent uploads with the same keys, this should be noted with care: EUDAMED strictly verifies the uniqueness of identifiers; therefore, existing datasets that have not yet been cleared can lead to conflicts during new submissions. While official documents clearly prove the uniqueness check, they do not explicitly detail every possible draft scenario involving third-party providers.