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 XML format.
The UDI Submission Viewer presents these complex XML files in a user-friendly format, allowing your organization to:
- Review Vault-identified validation errors.
- Flag problematic or missing content.
- Download a report which includes validation error details, user comments, and suggestions for how to correct source data.
- Change the states of the related records and XML file to reflect the review outcome.
- Submit UDI data to EUDAMED directly from Vault Registrations, when configured.
Note: This feature is only available on RIM Registrations Vaults. Using the UDI Submission Viewer assumes an Admin has configured the feature as described here.
Configuration Overview
The UDI Submission Viewer facilitates two distinct user activities: viewing complex UDI XML data in a user-friendly format, and submitting the data to EUDAMED directly from your Registrations Vault.
The ability to submit to EUDAMED requires viewer configuration, however you can configure and use the viewer without this additional capability.
UDI Submission Viewer Configuration
To configure the UDI Submission Viewer in your Vault:
- Configure your Vault to allow users to generate UDI data.
- Configure the UDI Submission and Registered Device Identifier objects and their object types.
- Configure object lifecycles for the UDI Submission and Registered Device Identifier objects. Both lifecycles must be configured prior to enabling the viewer, and both must utilize all of the UDI Submission state types.
- Configure the UDI Submission document subtype to use the UDI Submission document lifecycle as its Available Lifecycle.
- Enable the UDI Submission Viewer application setting. You cannot enable the viewer without first completing lifecycle configuration for the UDI Submission and Registered Device Identifier objects. Use the Enable enhanced UDI attribute locations setting to use the latest source data locations for UDI Submission XML generation.
EUDAMED Submission Configuration
To configure the UDI Submission Viewer to allow users to submit UDI data to EUDAMED:
- Complete all UDI Submission Viewer configuration steps.
- Configure the UDI Submission document lifecycle to use the Sending to HA state.
- Assign the Resubmit UDI Submission action to the UDI Submission object.
- Configure the UDI Submission and Registered Device Identifier object lifecycles to utilize the UDI Submission Sending to Health Authority state type.
- Configure the UDI Submission lifecycle to use the Resubmit UDI Submission Action.
- Create and configure a new EU EUDAMED UDI gateway profile.
- Enable the Machine-to-machine UDI submissions to EUDAMED viewer sub-setting.
Object Configuration
To configure the UDI Submission and Registered Device Identifier objects and their object types, navigate to Admin > Configuration > Objects, then complete the below for each object.
Configuring the UDI Submission Object
Object Types
- Activate the Additional UDI-DI object type by updating its Status to Active.
- Update the Label and Plural Label of the remaining existing object types to better align with EUDAMED terminology, per the table below.
| Old Object Type Label | New Label | New Plural Label |
|---|---|---|
UDI Combined Submission (udi_combined_submission__v) |
New Device / SPP Registration | New Device / SPP Registrations |
UDI Group Submission (udi_group_submission__v) |
Basic UDI / EUDAMED DI Updates | Basic UDI / EUDAMED DI Updates |
UDI Submission (udi_submission__v) |
UDI-DI / EUDAMED ID Updates | UDI-DI / EUDAMED ID Updates |
Fields & Page Layouts
- Assign the Medical Device Type field to all object types.
- Add the Medical Device Type field to the page layouts of all object types.
- Create a page layout for the Additional UDI-DI Registration object type.
Additionally, when configuring your Vault for direct submission to EUDAMED:
- Assign the Correlation ID field to all object types.
- Add the Correlation ID field to the page layouts of all object types.
- Add related object sections for Health Authority Messages and UDI Submission Errors to the page layouts of all object types.
Object Actions
The UDI Submission Viewer and its EUDAMED submission capability include several actions you must assign to the UDI Submission object.
For the viewer only, these actions are:
- Review UDI Submission
- UDI Submission Accepted by HA
- UDI Submission Rejected by HA
For EUDAMED submission, you must also assign the Resubmit UDI Submission action.
Configuring the Registered Device Identifier Object
- Assign the Version field to all object types.
- Add the Version field to the page layouts of all object types.
Object Lifecycle Configuration
The UDI Submission and Registered Device Identifier object lifecycles support both the viewer and submitting to EUDAMED.
To configure them, navigate to Admin > Configuration > Object Lifecycles, then complete the below for the lifecycles as indicated.
UDI Submission Viewer
To configure the UDI Submission and Registered Device Identifier object lifecycles for the viewer:
- Create an object lifecycle, then enable the object to use the new lifecycle.
- Define object lifecycle states according to your organization’s requirements, one for each state type to which you will map the new states in the next step. We recommend labeling each state to match or closely resemble the existing state type labels. For example, you can label a state “Ready to Review” and map it to the “UDI Submission Ready to Review” state type.
- Associate each state with the below corresponding state type:
- UDI Submission Data Failed to Generate
- UDI Submission Ready to Review
- UDI Submission Canceled
- UDI Submission Ready to Submit
- UDI Submission Rejected by HA
- UDI Submission Accepted by HA
- For the state configured to use the UDI Submission Ready to Review state type, define the Review UDI Submission user action to Always apply.
- For each state configured to use the UDI Submission Ready to Submit state type, define the below user actions to Always apply:
- Set UDI Submission to Accepted by HA
- Set UDI Submission to Rejected by HA
- For the Registered Device Identifier object lifecycle only: On the object lifecycle state configured to use the UDI Submission Accepted by HA state type, define an entry action to always set the Version field using the formula
If(IsBlank(version__v), 1, version__v+1). To do this, select Always, then Update Field. Select Version from the Fields drop-down, then enter the formula in the Set to value field.
EUDAMED Submission
To configure the UDI Submission and Registered Device Identifier object lifecycles for EUDAMED submission:
- Define a new lifecycle state to indicate the submission is en route to EUDAMED, then map it to the UDI Submission Sending to Health Authority state type. We recommend labeling the new state to match or closely resemble the state type. For example, the new state can be called “Sending to Health Authority”.
- For the UDI Submission lifecycle only: For the state configured to use the UDI Submission Ready to Submit state type, define the Resubmit UDI Submission action to Always apply.
- For the UDI Submission lifecycle only: For the state configured to use the UDI Submission Sending to Health Authority state type, define the following user actions to Always apply:
- Set UDI Submission to Accepted by HA
- Set UDI Submission to Rejected by HA
- Resubmit UDI Submission
- Optional: Review the following standard notifications and update them per your organization’s requirements:
- UDI Submission Accepted by HA
- UDI Submission Rejected by HA
- UDI Submission Failed to Send
- UDI Submission Sent but No Response
- UDI Submission Unexpected Response
Enablement
Enabling the Viewer
When you enable the viewer’s application setting, Vault verifies that the UDI Submission and Registered Device Identifier objects are configured to use an object lifecycle. You cannot enable the viewer without first completing lifecycle configuration for these objects.
Once object lifecycle configuration is complete, navigate to Admin > Settings > Application Settings and click Edit. Under the Registrations Features heading, select Enable UDI Enhancements, then Enable UDI Submission Viewer.
Enabling the primary setting also displays additional settings described in the sections below.
Enabling UDI Submission to EUDAMED
The Enable machine-to-machine UDI submissions to EUDAMED sub-setting directly controls the Review UDI Submission action. It must be enabled in Admin > Settings > Application Settings prior to configuring the action within the UDI Submission object lifecycle.
See the EUDAMED Submission configuration overview.
Enabling Enhanced UDI Attribute Locations
Note: This sub-setting was introduced in 23R3 to relocate the source locations of some UDI attributes. If your Vault was configured to generate and view UDI data prior to 23R3, we recommend working with your Veeva representative for configuration guidance or assistance. Otherwise, you can enable the setting when you enable the UDI Submission Viewer.
When the Enable enhanced UDI attribute locations setting is enabled, Vault processes Registered Product Characteristic records that reference:
- A Basic UDI Attributes record, instead of processing Registered Product records.
- A UDI Attributes record, before processing Registered Packaged Product records.
- A Registered Packaging Characteristic record, instead of Registered Product Characteristic records for clinical size information (Product Variant Clinical Size).
Vault also processes Registered Nomenclature Code relationship records so that they are matched against the UDI-DI on the new Packaging field on the Registered Nomenclature Code record, if populated. Otherwise, Vault continues with the current matching against Product Variant, if populated, then Product.
Vault no longer processes Registered Product or Registered Organization records, as well as records with the legacy object types for Registered Product Characteristics or Registered Packaging Characteristics.