# Configuring the UDI Submission Viewer (RIM)

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 a Registrations Vault, when configured.


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      <p><strong>Note</strong>:  This feature is only available on RIM Registrations Vaults. <a href="/en/gr/4667940/">Using the UDI Submission Viewer</a>
 assumes an Admin has configured the feature as described here.</p>
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## Configuration Overview

The UDI Submission Viewer facilitates two distinct user activities: <a href="/en/gr/4667940/">viewing</a>
 complex UDI XML data in a user-friendly format, and <a href="/en/gr/4667940/#submitting-to-eudamed">submitting</a>
 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:

1. <a href="/en/gr/165020/">Configure</a>
 your Vault to allow users to <a href="/en/gr/75823/#generate-udi-data">generate UDI data</a>
.
2. Configure the [_UDI Submission_][1] and [_Registered Device Identifier_][2] objects and their object types.
3. Configure [object lifecycles][3] 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.
   * This configuration includes adding user actions referencing the _Review UDI Submission_, _UDI Submission Accepted by HA_, and _UDI Submission Rejected by HA_ [object actions][8] you created in Step 2.
4. <a href="/en/gr/618/#settings-at-all-levels">Configure</a>
 the _UDI Submission_ document subtype to use the _UDI Submission_ document lifecycle as its _Available Lifecycle_.
5. [Enable][4] 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.
6. Ensure users are assigned the appropriate [permissions][9] to work with this feature.

### EUDAMED Submission Configuration {#eudamed-submission-configuration}

To configure the UDI Submission Viewer to allow users to submit UDI data to EUDAMED:

1. Complete all UDI Submission Viewer configuration steps.
2. <a href="/en/gr/2306/">Configure</a>
 the _UDI Submission_ document lifecycle to use the _Sending to HA_ state.
3. <a href="/en/gr/43127/#assign-actions">Assign</a>
 the _Resubmit UDI Submission_ action to the _UDI Submission_ object.
4. [Configure][7] the _UDI Submission_ and _Registered Device Identifier_ object lifecycles to utilize the _UDI Submission Sending to Health Authority_ state type.
5. [Configure][7] the _UDI Submission_ lifecycle to use the _Resubmit UDI Submission Action_.
6. <a href="/en/gr/49062/">Create</a>
 and configure a new EU EUDAMED UDI gateway profile.
7. [Enable][6] the _Machine-to-machine UDI submissions to EUDAMED_ viewer sub-setting.
8. Ensure users are assigned the appropriate [permissions][10] to work with this feature.

## 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 {#configuring-udi-submission}


#### Object Types

1. <a href="/en/gr/32857/#create">Activate</a>
 the **Additional UDI-DI** object type by updating its **Status** to **Active**.
2. <a href="/en/gr/32857/#create">Update</a>
 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

1. <a href="/en/gr/32857/#assign">Assign</a>
 the _Medical Device Type_ field to all object types.
2. <a href="/en/gr/26387/#fields">Add</a>
 the _Medical Device Type_ field to the page layouts of all object types.
3. <a href="/en/gr/26387/#object-type-layout">Create</a>
 a page layout for the _Additional UDI-DI Registration_ object type.

Additionally, when configuring your Vault for direct submission to EUDAMED:
1. Assign the _Correlation ID_ field to all object types.
2. Add the _Correlation ID_ field to the page layouts of all object types.
3. Add related object sections for _Health Authority Messages_ and _UDI Submission Errors_ to the page layouts of all object types.

#### Object Actions {#object-actions}

The UDI Submission Viewer and its EUDAMED submission capability include several actions you must <a href="/en/gr/43127/#assign-actions">assign</a>
 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 {#configuring-registered-device-identifier}

1. <a href="/en/gr/32857/#assign">Assign</a>
 the _Version_ field to all object types.
2. <a href="/en/gr/26387/#fields">Add</a>
 the _Version_ field to the page layouts of all object types.

## Object Lifecycle Configuration {#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:

1. <a href="/en/gr/30683/#create-object-lifecycles">Create</a>
 an object lifecycle, then <a href="/en/gr/30683/#enable-lifecycles">enable</a>
 the object to use the new lifecycle.
2. <a href="/en/gr/30683/#define-states">Define</a>
 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.
3. <a href="/en/gr/30683/#associate-state-type">Associate</a>
 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_
4. For the state configured to use the _UDI Submission Ready to Review_ state type, <a href="/en/gr/59885/#define-actions">define</a>
 the _Review UDI Submission_ user action to **Always** apply.
5. For each state configured to use the _UDI Submission Ready to Submit_ state type, <a href="/en/gr/59885/#define-actions">define</a>
 the below user actions to **Always** apply:
    * _Set UDI Submission to Accepted by HA_
    * _Set UDI Submission to Rejected by HA_



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      <p><strong>Note</strong>: These instructions previously included a step to define an entry action within the <em>Registered Device Identifier</em> lifecycle’s <em>Submission Accepted by HA</em> state, or whichever state is mapped to the <em>UDI Submission Accepted by HA</em> state type. As of 25R3, the entry action to always set the <em>Version</em> field using a formula is not required, and should be removed in UDI Submission Viewer-configured Vaults.</p>
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### EUDAMED Submission {#object-lifecycle-eudamed-submission}

To configure the _UDI Submission_ and _Registered Device Identifier_ object lifecycles for EUDAMED submission:

1. <a href="/en/gr/30683/#define-states">Define</a>
 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 "Sending to Health Authority".
2. For the _UDI Submission_ lifecycle only: For the state configured to use the _UDI Submission Ready to Submit_ state type, <a href="/en/gr/59885/#define-actions">define</a>
 the _Resubmit UDI Submission_ action to **Always** apply.
3. For the _UDI Submission_ lifecycle only: For the state configured to use the _UDI Submission Sending to Health Authority_ state type, <a href="/en/gr/59885/#define-actions">define</a>
 the following user actions to **Always** apply:
    * _Set UDI Submission to Accepted by HA_
    * _Set UDI Submission to Rejected by HA_
    * _Resubmit UDI Submission_
4. For the UDI Submission lifecycle only: Define a new lifecycle state to indicate the submission is partially accepted by EUDAMED, then map it to the _UDI Submission Partially Accepted by Health Authority_ state type. We recommend labeling the new state "Partially Accepted by HA".
5. 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_
    * _UDI Submission Partially Accepted by HA_

## Enablement

### Enabling the Viewer {#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 {#enabling-udi-submission}

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][5].

### Enabling Enhanced UDI Attribute Locations



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      <p><strong>Note</strong>: 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.</p>
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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_.

See additional details on [permissions requirements][11].

## Related Permissions {#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 EUDAMED {#eudamed-permissions}

To submit to EUDAMED from the viewer, users must be assigned a permission set with **UDI Submission: Submit UDI** permission, located in the permission set's **Application** tab. 

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.


### Enhanced UDI Attribute Locations {#attribute-locations}

When the _Enable enhanced UDI attribute locations_ setting is enabled, users must have _Read_ permission for the _Basic UDI Attributes_ object type of both the _Registered Product Characteristic_ and _Registered Packaging Characteristic_ objects. Otherwise, Vault only generates the UDI submission for records for which the user has _Read_ permission.

[1]: #configuring-udi-submission
[2]: #configuring-registered-device-identifier
[3]: #object-lifecycle-configuration
[4]: #enabling-the-viewer
[5]: #eudamed-submission-configuration
[6]: #enabling-udi-submission
[7]: #object-lifecycle-eudamed-submission
[8]: #object-actions
[9]: #permissions
[10]: #eudamed-permissions
[11]: #attribute-locations