European Union regulations require medical device manufacturers to submit Unique Device Identification (UDI) data for medical devices to the European Databank on Medical Devices (EUDAMED) in a complex XML format. Vault Registrations allows users to generate XML files for product registrations for devices marketed under new EU Medical Device Regulations (EU MDR) and In Vitro Diagnostic Regulations (EU IVDR), as well as devices marketed under legacy EU directives (MDD, AIMDD, IVDD).
Vault generates submission XML using the EUDAMED XML Schema v2.0.8.
Note: This feature is only available on RIM Registrations Vaults and requires configuration by an Admin.
To generate unique device identification (UDI) data for EUDAMED:
- Navigate to a Registration record with a Registration Type field value of Marketed Device Product Registration and Country field value of European Union.
- In the Registration record’s Actions menu, select Generate UDI Submission.
- Select a Medical Device Type and a UDI Submission Type.
- Optional: Override the pre-populated EUDAMED XML Version if, for example, you are creating a submission for the EUDAMED Playground using a test version.
- Optional: Select a Regulatory Objective to limit the submission to only include devices that were impacted by that Regulatory Objective. This drop-down is pre-filtered based on the Medical Device Type and UDI Submission Type values you selected above.
- Click Continue.
- Vault runs the Create UDI Submission job. When finished, you’ll receive a Vault notification and email with a CSV file of successes, warnings, and errors. You can download the file from the in-Vault notification or email notification.
- Repeat these steps for all Medical Device Types on the selected Marketed Device Product Registration, as applicable.
Viewing UDI Data
When the Create UDI Submission job completes successfully, Vault creates one or more UDI Submission records and relates them to the Registration from which the job was started. Each record contains details about the Device Identifiers included in that UDI Submission (for example, Basic UDI DIs and UDI DIs).
Vault also stores an XML file in the Library under the UDI Submission document subtype for each UDI Submission record. You can view the XML from the document’s viewable rendition, or download the source XML file and open it in an XML viewer. When configured in your Vault, you can also launch the UDI Submission Viewer to display the XML in a readable format.
If there are any XML validation errors based on the EUDAMED XML schema, a CSV file with the validation errors will be attached to the XML file.
About the UDI Submission Viewer
When configured by an Admin, you can view XML in a readable format in the UDI Submission Viewer. The viewer also allows your organization to submit UDI data to EUDAMED directly from Vault Registrations. See Using UDI Submission Viewer.
Resolving Source Data Errors
You can use the information in the results files as well as any responses from EUDAMED to identify and troubleshoot source data errors. Once you’ve made corrections, you can create, review, and submit a new UDI submission.
To correct source registration data errors, Veeva recommends using the Manage Registered Details wizard to withdraw the incorrect registered join record (e.g., Registered Nomenclature Code) and replace it with a new record. If the root cause of a UDI submission error is in the core source data (e.g., Nomenclature Code), you may need to correct the source record directly.
When you run the Generate UDI Submission action, the asynchronous Create UDI Submission job evaluates all active source records where the Use for UDI field value is “Yes”. The job only evaluates Registered Product and Registered Packaged Device Product records that match the selected Medical Device Type as well as any other registered details related to those products and packaging.
As the job runs, Vault creates one (1) UDI Submission XML document in the Library for every 300 devices in the selected registration. These documents correspond to UDI Submission and UDI Submission DI object records, which Vault also creates during the job run to map UDI data to corresponding submissions and registrations.
When complete, Vault sends a notification and email with a CSV file summarizing the job run. You can use this data to locate the XML documents and related object records in your Vault.
If the UDI Submission Viewer is enabled, Vault updates the UDI Submission object record, Registered Device Identifier object records, and UDI Submission XML document lifecycle states to either Ready to Review or Failed to Generate.