Configuration for Generating UDI Data

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 and view 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).

Configuration Overview

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. 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. Recommended: Configure the UDI Submission Viewer to allow users to review UDI XML files in a user-friendly format and, optionally, submit UDI data to EUDAMED directly from your Vault.

Object Configuration

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

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 EUDAMED UDI/Device 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.