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.
The following table describes a sequence of tasks, with links to the topics that describe them.
| Public Agency | To | See |
|---|---|---|
| FDA | Export data | Data Export to GUDID |
| EU | Export data | Data Export to EUDAMED |
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