UDI-DIs

All relevant information of medical devices is managed in so-called UDI-DIs, which are assigned to an Item or an Item variant. UDI-DIs aim to be exported to the central database of the respective public agency after they have been registered and approved. This is done in the case of FDA UDI-DIs to the GUDID, and in the case of EU UDI-DIs to the EUDAMED.

A separate UDI-DI is maintained for each public agency. This means that several UDI-DIs can be assigned to one item or one item variant. The registration is largely independent of each other.

Important

Depending on the public agency (FDA, EU), the application area must be activated to be visible. This is done in the UDI setup by setting the fields Activate FDA Appl. Area or Activate EU Appl. Area.

Create and edit UDI-DI

To create a new UDI-DI or edit existing ones, you can use the corresponding actions on the following pages:

Page	Actions
Item	Item > FDA UDI-DI Item > EU UDI-DI
Item Card	Item > FDA UDI-DI Item > EU UDI-DI
Item Variants	FDA UDI-DI EU UDI-DI

After confirming, the new record opens. Depending on the setup, the first fields of the UDI-DI card are already filled.

Tip

In the new Item variants UDI-DIs, choose the Copy from Item action to copy data from another UDI-DI of the same public agency. These can then be added to.

Data maintenance

UDI data entry is supported by the system in terms of error reduction and user convenience. Already during data entry, important plausibilities are checked and the user is guided through the necessary data entry with dynamically displayed fields.

The following table describes a sequence of tasks, with links to the topics that describe them.

Public Agency	To	See
FDA	Set up FDA UDI-DI Card	FDA UDI-DI Card
EU	Set up Basic UDI-DI Card	Basic UDI-DI Card
EU	Set up EU UDI-DI Card	EU UDI-DI Card
All	Set up Packaging Lines	UDI-DI Packaging Lines
All	Set up Storage and Handling Conditions	UDI-DI Storage & Handling Conditions

Tip

While a UDI-DI is still empty, you can use the Copy from UDI-DI action to copy data from another UDI-DI of the same public agency. Source DI table data can be selected individually. The copy function will skip the DI No. and UDI Status fields, among others. This action is enabled for non-parent UDI-DIs with an open UDI Status only.

Release

Upon release, all mandatory fields and dependencies are checked again. This results in a list which contains warnings and errors.

Warnings can be ignored. The data set can be released despite existing warnings.
Error messages prevent the release of the data set.

Export

After successful approval, UDI-DIs can be exported to the public agency database.