Configuring the UDI Submission Viewer (RIM)

Health Authorities require medical device manufacturers to submit Unique Device Identification (UDI) data for medical devices in XML format. The UDI Submission Viewer presents these complex XML files in a human-readable 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 the EU (EUDAMED) or US (GUDID) Health Authorities directly from a Registrations Vault, when configured.

Feature Dependencies

Generally, Vault supports three distinct UDI activities:

• Generating complex UDI XML data for EUDAMED or GUDID. This baseline functionality must be configured to support all other activities.
• Viewing the data in a human-readable format in the UDI Submission Viewer.
• Submitting the data to a Health Authority directly from the UDI Submission Viewer.
  • Vault currently supports submission to the EU (EDUAMED) and US (GUDID) authorities.
  • EUDAMED submission capability was released prior to GUDID. If you configured EUDAMED submission prior to 26R2, some configuration steps for GUDID may already be complete.

Configuring the UDI Submission Viewer

To configure the UDI Submission Viewer in your Vault:

1. Configure the UDI Submission object:
   • Assign the Medical Device Field to all object types, then add it to the corresponding object page layouts.
   • Activate the Additional UDI-DI Registration object type (additional_udi_submission__v) and create a corresponding object page layout.
   • Review the below object types and update the object type’s label and plural label, if required:
     • udi_combined_submission__v : New Device / SPP Registration
     • udi_group_submission__v : Basic UDI / EUDAMED DI Update
     • udi_submission__v : UDI-DI / EUDAMED ID Update
   • Create the following object actions using the standard actions of the same names, then assign them to all object types:
     • Resubmit UDI Submission
     • Review UDI Submission
     • UDI Submission Accepted by HA
     • UDI Submission Rejected by HA
2. Configure the Registered Device Identifier object: Assign the Version field to all object types, then add it to the corresponding object page layouts.
3. For each of the below state types within the UDI Submission and Registered Device Identifier object lifecycles, define and associate a corresponding lifecycle state. We recommend labeling each state to closely resemble the state type, for example the UDI Submission Data Ready to Submit state type and corresponding “Ready to Submit” and “Submission Ready to Submit” states for UDI Submission and Registered Device Identifier, respectively.
   • UDI Submission Accepted by HA
   • UDI Submission Partially Accepted by Health Authority
   • UDI Submission Ready to Submit
   • UDI Submission Rejected by HA
4. Configure the below user actions to always apply within the indicated UDI Submission and Registered Device Identifier object lifecycle states, using the object actions you created in Step 1.
   • Ready to Review state: Review UDI Submission user action
   • Ready to Submit state: Set UDI Submission to Accepted by HA and Set UDI Submission to Rejected by HA
5. Assign the UDI Submission document lifecycle to the UDI > UDI Submission document subtype.
6. Navigate to Admin > Settings > Application Settings and select the Enable UDI Enhancements setting and Enable UDI Submission Viewer subsetting.
7. Review your Vault’s security configuration and ensure users are granted the appropriate permissions to work with this feature.

Configuring EUDAMED Submission

To configure machine-to-machine submission to EUDAMED:

1. Navigate to Admin > Settings > Application Settings and enable the Enable machine-to-machine UDI submissions to EUDAMED subsetting. The subsetting must be enabled in order to configure this feature’s object actions.
2. Configure the UDI Submission object:
   • Assign the Correlation ID field to all object types, then add it to all object page layouts.
   • For each object page layout, add related object sections for the Health Authority Messages and UDI Submission Errors objects.
   • Create a Resubmit UDI Submission object action using the standard action of the same name.
3. Configure the Registered Device Identifier lifecycle with a new lifecycle state, then associate it with the UDI Submission Sending to Health Authority state type. We recommend labeling the new state “Sending to HA”.
4. Configure the UDI Submission object lifecycle with new lifecycle states, then associate each with the UDI Submission Sending to Health Authority and *UDI Submission Partially Accepted by Health Authority *state types. We recommend labeling the new states “Sending to HA” and “Partially Accepted by Health Authority”, respectively.
5. Configure the below user actions to always apply within the indicated UDI Submission lifecycle states:
   • Ready to Review state: Resubmit UDI Submission user action
   • Sending to HA state: Resubmit UDI Submission, UDI Submission Accepted by HA, and UDI Submission Rejected by HA user actions.
6. Ensure the UDI Submission document lifecycle’s Sending to HA state (sending_to_ha__v) is active.
7. Configure the EU EUDAMED UDI gateway profile.
8. Review your Vault’s security configuration and ensure users are granted the appropriate permissions to work with this feature.

Configuring GUDID Submission

1. Configure the UDI Submission object:
   • Assign the Correlation ID field to all object types, then add it to all object page layouts.
   • For each object page layout, add related object sections for the Health Authority Messages and UDI Submission Errors objects.
   • Create a Resubmit UDI Submission object action using the standard action of the same name.
2. Configure the Registered Device Identifier lifecycle with a new lifecycle state, then associate it with the UDI Submission Sending to Health Authority state type. We recommend labeling the new state “Sending to HA”.
3. Configure the UDI Submission object lifecycle with new lifecycle states, then associate each with the UDI Submission Sending to Health Authority and *UDI Submission Partially Accepted by Health Authority *state types. We recommend labeling the new states “Sending to HA” and “Partially Accepted by Health Authority”, respectively.
4. Configure the below user actions to always apply within the indicated UDI Submission lifecycle states:
   • Ready to Review state: Resubmit UDI Submission user action
   • Sending to HA state: Resubmit UDI Submission, UDI Submission Accepted by HA, and UDI Submission Rejected by HA user actions.
5. Ensure the UDI Submission document lifecycle’s Sending to HA state (sending_to_ha__v) is active.
6. Activate the Heath Authority Message object’s AS2 Message object type (as2_message__v).
7. Configure the US GUDID UDI gateway profile.
8. Review your Vault’s security configuration and ensure users are granted the appropriate permissions to work with this feature.

Related Permissions

UDI Submission Viewer users must be assigned a permission set with View and Execute permissions for the Review UDI Submission action within Objects > UDI Submission > Object Action Permissions.

When your Vault is not configured to submit to EUDAMED, users additionally require View and Execute permissions for the UDI Submission Accepted by HA and UDI Submission Rejected by HA actions.

UDI Submission to a Health Authority

To submit from the viewer, users must be assigned a permission set with the Application > UDI Submission: Submit UDI permission.

When a user does not have this permission, they cannot view the option to submit within the viewer’s Next Steps page, nor execute the Resubmit UDI Submission action where configured.