Configuration for Generating UDI Data

Helth Authority regulations require medical device manufacturers to submit Unique Device Identification (UDI) data for medical devices in a complex XML format. RIM Registrations allows users to generate and view these XML files.

Feature Dependencies

Generally, Vault supports three distinct UDI activities:

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

Configuration Overview

See additional details about configuring the UDI Submission Viewer, allowing users to review UDI XML files in a user-friendly format and, optionally, submit UDI data to a Health Authority directly from your Vault.

EUDAMED Data Generation

1. Activate the UDI and UDI Submission document type and subtype.
2. Assign the Generate UDI Data action to the Registration object, then assign it to the Marketed Device Product Registration object type.
3. Add the Generate UDI Data user action to the desired Registration object lifecycle states, for example Approved/Authorized, Planned, and Withdrawn. Define the action to appear conditionally, when the selected Country is “European Union”.
4. Ensure the objects, object types, and fields for supporting UDI data in your Vault are active and available within page layouts.
5. Load or update Controlled Vocabulary, Constraint, and Publishing Validation Criteria records to support UDI data.
6. 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 Canceled state type and corresponding “Canceled” and “Submission Canceled” states for UDI Submission and Registered Device Identifier, respectively. * UDI Submission Canceled * UDI Submission Failed to Generate * UDI Submission Ready to Review
7. Optional: Activate the Enable default EUDAMED XML Version Application Setting. This setting supports situations where, for example, a newer XML version is required, but there have not been any XSD updates for UDI submissions. When Vault uses the setting’s version, users generating EDUAMED UDI data are not required to manually override the default version. This setting is also useful for managing different version requirements for the EUDAMED Playground.
8. Optional: Configure UDI-DI Container Package submission support.
9. Optional: Configure your Vault to support UDI submissions for multiple Products with the same Basic UDI.
10. Optional: Configure Market Information submission support.
11. Navigate to Admin > Settings > Application Settings and enable the Enable enhanced UDI attribute locations setting, allowing Vault to use the latest source data locations for UDI Submission XML generation.

GUDID Data Generation

1. Activate the UDI and UDI Submission document type and subtype.
2. Assign the Generate UDI Data action to the Registration object, then assign it to the Marketed Device Product Registration object type.
3. Add the Generate UDI Data user action to the desired Registration object lifecycle states, for example Approved/Authorized, Planned, and Withdrawn. Define the action to appear conditionally, when the selected Country is “United States”.
4. Ensure the objects, object types, and fields for supporting UDI data in your Vault are active and available within page layouts.
5. Load or update Controlled Vocabulary, Constraint, and Publishing Validation Criteria records to support UDI data.
6. 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 Canceled state type and corresponding “Canceled” and “Submission Canceled” states for UDI Submission and Registered Device Identifier, respectively. * UDI Submission Canceled * UDI Submission Failed to Generate * UDI Submission Generated * UDI Submission Ready to Review
7. Within the UDI Submission object, activate the UDI Submission and UDI Submission Group object types, then create a corresponding object page layout for each.
8. Within the Registered Device Identifier object, assign the Submission Set ID and Latest Submitted Version fields to the UDI DI object type (udi_di__v), then add it to the corresponding object page layout.
9. Within the Registration object’s Device with UDI (Marketing) object page layout: * Add a new related object section for the UDI Submission Group object, filtered by this object type. * Update the “Hide US Sections” and “Hide EU Region Sections” layout rules to also hide the UDI Submission Groups section.
10. Navigate to Admin > Settings > Application Settings and enable the Enable enhanced UDI attribute locations setting, allowing Vault to use the latest source data locations for UDI Submission XML generation.

UDI-DI Container Package Submission Support

Vault can generate compliant XML submissions for all levels of medical device packaging that are not the smallest unit of use, such as boxes or shipping containers.

To configure your Vault to support this capability:

1. Within the UDI Submission object:
   • Activate the UDI-DI Container Packages object type (udi_submission_container_packages__v)
   • Create a corresponding object page layout for the newly-activated object type. We recommend labeling the layout “UDI Container Packages Submission”.
2. Within the Registered Device Identifier object, activate the Container Packages Version field.

This capability also uses the Registered DI Container Package object, which is active by default.

Market Information Submission Support

Vault can generate compliant EUDAMED UDI submissions for marketing information updates, incorporating the relevant market information. This includes new markets and changes to the start and stop dates for existing markets, based on related registrations.

To configure your Vault to support this capability:

1. Within the UDI Submission object:
   • Activate the UDI-DI / EUDAMED ID Market Information object type (udi_submission_market_information__v)
   • Create a corresponding object page layout for the newly-activated object type. We recommend labeling the layout “UDI Market Information Submission”.
2. Within the Registered Device Identifier object, activate the Container Packages Version and Market Information Version fields.
3. For the Registered Device Identifier object’s EUDAMED ID object type, create a custom object page layout, or otherwise ensure your Vault’s existing custom layout for this type includes:
   • The Market Information Version field
   • Related object sections for the Registered DI Country and Registered DI Container Package objects.
4. For the Registered Device Identifier object’s UDI DI object type, create a custom object page layout, or otherwise ensure your Vault’s existing custom layout for this type includes:
   • The Container Packages Version and Market Information Version fields
   • Related object sections for the Registered DI Country and Registered DI Container Package objects

Enabling Enhanced UDI Attribute Locations

When the Enable enhanced UDI attribute locations setting is enabledin Admin > Settings > Application Settings, 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.

UDI Submissions for Multiple Products with the Same Basic UDI

The Enable enhanced UDI attribute locations setting additionally supports defining multiple Products sharing the same Basic UDI within a single UDI submission.

To do this:

1. Navigate to Admin > Settings > Application Settings and enable the Enable enhanced UDI attribute locations setting.
2. Within the Device Identifier object:
   • Activate the Autoname Calculation field (autoname_calculation__v).
   • Update the DI Name (name__v) field’s default value format to {object_type__vr.name__v} - {device_identifier__vr.identifier__rim} - {autoname_calculation__v}.
3. Review your Vault’s security configuration and ensure that any users granted access to generate a UDI submission for one Product have the necessary access to all other Products sharing the same Basic UDI, as well as any associated packagings with related UDI-DIs that must be registered. Without these permissions, users risk registering only a subset of the data for a Basic UDI.

Once configured, additionally ensure related records are set up to support this feature.

Object Configuration

The RIM data model is periodically updated to better support evolving UDI needs and new feature functionality.

For the 24R3 release and earlier, many of these changes were incorporated into a configuration workbook as a resource for aligning RIM Vaults to the UDI data model. This workbook and its instructions are preserved below.

As of 25R1, this workbook is no longer maintained. Instead, RIM Vault Admins should consult that release’s Data Model Documentation workbook in Veeva Connect to assess any UDI-specific RIM data model updates.

24R3 General Release & Earlier

The UDI Objects and Fields workbook contains an inventory of the objects, object types, and fields available to manage UDI data in your Vault through the 24R3 release.

1. Use the Objects & Object Types tab to confirm the UDI objects and/or object types, as applicable, are active.
2. Use the Object Fields tab to confirm the UDI fields are active and assigned to the indicated objects and/or object types, as applicable. Object fields added to the workbook after 22R2 are labeled as such in the Release column.
3. Review your Vault’s object page layouts. Create new layouts as required, and/or update existing layouts to add the active fields configured in Step 2.

The workbook references components by their Veeva-recommended Label, which may differ in your Vault. To aid in locating some of these components, their Names are included in the Notes column for when the Veeva label and name do not reasonably match. (For example, the object named classification__v is now known by its Nomenclature Code label.)

See also Object Configuration Guidelines.

Object Configuration Guidelines

The attributes collected within a UDI submission come from specific fields on specific objects or object types. As such, there is limited flexibility when modifying certain components, and updates to the Veeva-recommended object configuration should be completed with caution.

The types of configurations that can be made safely include:

• Updating the label of an object, object type, or field.
• Making UDI source fields required or adding validation rules.
• Adding custom fields for reporting or other non-UDI purposes.

The following types of configuration changes are generally “safe”, but must still allow Vault to populate required UDI source fields for certain UDI submissions:

• Removing from page layouts any fields which are not applicable to your organization. For example, IVD-related fields can be removed from page layouts in a non-IVD manufacturer’s Vault.
• Inactivating object reference records which are not applicable to your organization. For example, if GS1 is your organization’s only issuing agency, you can inactivate the Organization record for HIBCC.
• Modifying Veeva-provided custom object types or creating additional custom object types.
• Changing Veeva-provided page layouts or page layout rules.
• Updating the Name of a Veeva-provided record, with respect to existing page layout rules. For example, Controlled Vocabulary records where the Controlled Vocabulary Type is “Product Characteristic Type” are used to show and hide fields within the Submission Product Characteristic object page layouts.

Never make the following types of configuration changes:

• Moving UDI source fields from one standard object type to another.
• Configuring Yes/No object fields as checkboxes, which introduces compliance risk. Yes/No object fields for UDI should adhere to the default Yes and No radio button configuration.

Controlled Vocabularies

Vault references Controlled Vocabulary records to populate many of the values included in a UDI submission.

Review the Controlled Vocabulary records in your Vault and verify there are active records for each of the below UDI-related types, as identified by the Controlled Vocabulary Type (controlled_vocabulary_type__rim) field and picklist.

• Applicable Device Legislation (applicable_device_legislation__v)
• Certificate Type (certificate_type__v)
• Clinical Size Precision (clinical_size_precision__v)
• Clinically Relevant Size (clinically_relevant_size__v)
• Critical Warning (critical_warning__v) ¹
• Device Unit of Measure (device_unit_of_measure__v)
• DTD XSD Version (dtd_xsd_version__v) ¹
• Organization Role (manufacturing_site_organization_role__v)
• Marketing Status (marketing_status__v)
• Marketing Substatus (marketing_substatus__v)
• Marketing Substatus Scope (marketing_substatus_scope__v)
• Medical Device Type (medical_device_type__v) ¹
• Non-Medical Purpose (nonmedical_purpose__v)
• Packaging Characteristic Type (packaging_characteristic_type__v)
• Product Characteristic Type (product_characteristic_type__v)
• Production Identification Method (production_identification_method__v)
• Special Device Type (special_device_type__v)
• Storage and Handling Type (storage_and_handling_type__v) ¹
• Substance Classification (substance_classification__v)

1. Additional requirements apply. See Additional CV Requirements for Validation. ↩

Additional CV Requirements for Validation

Vault references values in certain Controlled Vocabulary records when validating and reporting errors in UDI data which may cause a submission to be rejected.

To ensure Vault can evaluate records against EUDAMED UDI/Device Business Rules:

1. Populate the Requires Description field on any Critical Warning and Storage and Handling Type records that require a description. These records are typically denoted with an asterisk (*) at the end of the record’s Name value.
2. Populate the UDI Validation Criteria Version field on any Medical Device Type records.
3. Create a Controlled Vocabulary record for the EUDAMED validation criteria version with the following minimum requirements:
   • Controlled Vocabulary Name: EUDAMED UDI Business Rules v2.7
   • Controlled Vocabulary Type: DTD XSD Version
   • HA Code Source: European Commission
   • CV Value Filter: Validation Criteria Version
   • Vault RIM UUID: 58ea2aca-e3a0-4e34-8e88-cd63847daefe

Constraints

Vault uses reference constraints to limit selectable options to the appropriate records, based on the context of the current record. When generating UDI data, Vault uses Constraints of the Product Type Jurisdiction object type to determine EU countries for the purposes of medical device regulations.

Review the Constraint records in your Vault and verify or create active Product Type Jurisdiction records. You can also use the Product Type Jurisdiction Constraints sample file to gather your organization’s data and build files for record creation or update via Vault Loader.

The above sample file also includes the appropriate Vault RIM UUID values required for the constraints’ underlying Country and Region records. For European Union records, these values are:

• Country: ba930019-631a-4301-83d5-d1e5880c50ba
• Region: 21e638f7-be7b-4797-85a5-236c76eab80b

Optional Constraints for UDI

Though not required for use, Veeva recommends creating and maintaining additional Constraint records for the below object types to help ensure data integrity for UDI submissions:

• Organization Role
• Packaging Characteristic
• Product Characteristic
• Risk Class
• UDI Constraint

Publishing Validation Criteria

The Publishing Validation Criteria object stores the individual rules defined in Health Authority business rules, which Vault references when validating UDI data.

To set up your Vault’s Publishing Validation Criteria:

1. Complete the required object configuration steps, including adding the Validation Criteria Version and Validation Errors fields to all UDI Submission object types.
2. Address all Controlled Vocabulary requirements.
3. Download the EUDAMED UDI Publishing Criteria and use Vault Loader to create Publishing Validation Criteria records.

Related Permissions

To generate GUDID submissions, users require Read, Create, and Edit permission for the UDI Submission object, as well as its UDI Submission and UDI Submission Group object types.

When the Enable enhanced UDI attribute locations subsetting 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.