Data Export to EUDAMED

COSMO Unique Device Identification supports the upload of UDI data to the EU EUDAMED database. The connection to the EUDAMED is not a machine-to-machine connection, but a manual upload based on a generated XML data set.

Depending on how many records you selected and how the EUDAMED requires them to be grouped, either one XML file or a zip file with multiple XML files will be downloaded to the Downloads folder on your computer. Each XML file name begins with EUDAMED, followed by the actor single registration number (SRN), an operation description, and a timestamp.

To upload the file(s), see Upload to EUDAMED.

Basic UDI-DIs and EU UDI-DIs that have already been submitted to EUDAMED are called registered devices in COSMO Unique Device Identification.

Tip

To see which records are exportable on the Basic UDI-DIs and EU UDI-DIs list pages, select a view name beginning with Exportable.

EUDAMED Version FastTab

In the EUDAMED database, records for registered devices hold a version state (such as Submitted), a version number (such as 1) and a version date.

Both the Basic UDI-DI Card and EU UDI-DI Card hold corresponding fields in the EUDAMED Version FastTab and need to be manually adjusted.

Note

Devices with a Version No. set to 0 are regarded as unregistered, and devices with a Version No. greater than 0 as registered.

Once the Version No. is set to a value greater than 0, certain fields are no longer editable.

Setting the Version No. to value 0 on a Basic UDI-DI will automatically pass the value to all attached EU UDI-DIs.

Important

It is essential to keep the Version No. field up-to-date.
Every time (unless the Skip Export Data Update field is enabled in the UDI Setup page) the Create EUDAMED export file or Add or Update UDI-DI action is invoked and confirmed, the Version No. counter for all included devices will be automatically increased by 1 to reflect the future version number in the EUDAMED database.

Export Basic UDI-DIs

To create XML files for one or more Basic UDI-DIs, open a list (or card) of released and registered Basic UDI-DIs.

  1. Select the records you need and then choose Export > Create EUDAMED export file.
  2. Confirm the dialog by choosing the Yes button.
Note

The Create EUDAMED export file action is only active if the selected UDI-DI has the Released status and was already registered.

You cannot directly export new Basic UDI-Ds. Instead, export one or more unregistered EU UDI-DIs attached to the Basic UDI-DIs.

Export EU UDI-DIs

To create XML files for one or more UDI-DIs, open a list (or card) of released EU UDI-DIs.

  1. Select the records you need and then choose Export > Add or Update UDI-DI.
  2. Confirm the dialog by choosing the Yes button.
Note

The Add or Update UDI-DI action is only active if the selected UDI-DI has the Released status, is a base package (the Is Parent Package toggle is turned off), and the Legacy toggle is turned off. Parent packages are automatically included in export files for their base packages.

Update Market Information

When only market information needs to be updated for an EU UDI-DI, you can create and download an export file for this specific task.

To create XML files for one or more UDI-DIs, open a list (or card) of released EU UDI-DIs.

  1. Select the records you need and then choose Export > Update Market Information.
  2. Confirm the dialog by choosing the Yes button.
Note

The Update Market Information action is only active if the selected UDI-DI has the Released status, is a base package (the Is Parent Package toggle is turned off), the Legacy toggle is turned off, and the UDI-DI has been already uploaded to EUDAMED, hence the Version No. is greater than zero. The market information update is always exported with version number 1.

Update Product Designer Information

Once you have submitted an EU UDI-DI to EUDAMED (Version No. > 0), the Product Designer Contact No. cannot be changed because EUDAMED allows the correction of contact information, but not the addition, change or removal of the product designer itself.

If you need to update the contact information, you must use the Update Product Designer export function. The Add or Update UDI-DI action does not include any product designer data.

Empty Product Designer Contact No. Warning

When a new EU UDI-DI is released, an empty Product Designer Contact No. field will generate a warning because the information cannot be changed after an upload to EUDAMED. Regardless of whether there is a product designer number or not, the EU UDI-DI will be released:

  • If there is no product designer number, you can ignore the message.
  • If there is a product designer number, you must reopen the EU UDI-DI, add the product designer number, and then release it again.

Product Designers without Single Registration Number

In the UDI FastTab of the Contact Card, the product designer's single registration number (SRN) is stored in the EUDAMED SRN field. The contact information from this SRN is used when exporting the product designer information. For product designers without an SRN, the information from the fields within the EUDAMED Product Designer field group will be exported.

When an EU UDI-DI is released, an empty EUDAMED SRN field in the related Contact Card will generate a warning and the fields in the EUDAMED Product Designer field group will be tested. The message states that the EUDAMED SRN field is empty and that the contact's EUDAMED Product Designer data will be exported instead. The release depends on whether issues are found in the contact information:

  • If no issues are found, the EU UDI-DI will be released.
  • If issues are found, the fields with errors will be listed. You must correct the field(s) in the UDI FastTab of the Contact Card and then release the EU UDI-DI again.

Create Upload File with Product Designer Changes

On the EU UDI-DI Card page, choose the Update Product Designer action on the Export menu to create an upload file with contact data changes, which can be uploaded to the EUDAMED website using the "Update product original manufacturer" upload service.

If run from the EU UDI-DIs page, one or more update files can be created for the selected UDI-DIs.

Update Container Packages

An export is required after container package changes, such as, after adding new parent packages, or changing the Device Status of existing parent packages. After the changes, the root UDI-DI needs to be selected for export.

On the EU UDI-DI Card page, choose the Update Container Packages action on the Export menu to create the export file, named EUDAMED_PUT_PACKAGE_UDI*.xml, which contains the complete package structure of the root UDI-DI, and not just the updated packages.

Note

The Update Container Package action is enabled only for the following UDI-DIs: released, already uploaded to EUDAMED, no legacy device, and no parent package.

The EUDAMED also requires a new container version number added to the file. The system calculates it per root UDI-DI by finding the highest Version No. in any of its parent packages to export, and then it increases it by one. After the export, all exported parent packages are set to the increased version number, unless the Skip Export Data Update field is enabled in the UDI Setup page.

Important

Whenever a (non parent package) EU UDI-DI is set to Device Status = No longer placed on the EU market or Not intended for the EU market, all its direct or indirect parent packages will be automatically set to the same value. If that UDI-DI was already uploaded to EUDAMED, an immediate export and upload to EUDAMED is required (Export > Add or Update UDI-DI, but not Export > Update Container Packages). Although not included in the resulting EUDAMED_PATCH_UDI_DI*.xml export file, EUDAMED will also automatically update the status of all packages within a new container packages version.

When changing to Device Status = No longer placed on the EU market, all DI EU Market Info valid to the current work date and beyond, are set to Ending Date = work date minus 1.

Upload to EUDAMED

  1. In EUDAMED, choose: Data transfer > Bulk Upload > New upload.
  2. Select the required service according to the export file name:
Export file name contains EUDAMED service
PATCH_BASIC_UDI Update Basic UDI
PUT_PACKAGE Update container package
PUT_MARKET_INFO Update market information
PATCH_UDI_DI Update of UDI-DI / Master UDI-DI
PUT_PRODUCT_DESIGNER Update product original manufacturer
POST_DEVICE Upload of Legacy / Regulation Device / SPP (Basic UDI and UDI-DI / Master UDI-DI)
POST_UDI_DI Upload of UDI-DI / Master UDI-DI for existing Basic UDI-DI

Feedback
Submit feedback for this page .