US FDA regulations require medical device manufacturers to submit Unique Device Identification (UDI) data for medical devices to the Global Unique Device Identification Database (GUDID) in a complex XML format. RIM Registrations allows users to generate XML files for US marketed device product registrations.
Vault generates submission XML using the HL7 SPL XML file format.
Note: This feature is only available on RIM Registrations Vaults and requires configuration by a Vault Admin. See additional details about generating UDI data for EUDAMED.
Generating UDI Data for GUDID
To generate unique device identification (UDI) data for GUDID:
- Navigate to a Registration record with a Registration Type field value of Marketed Device Product Registration and Country field value of United States.
- In the Registration record’s Actions menu, select Generate UDI Submission.
- Optional: Select a Regulatory Objective to limit the submission to only include devices that were impacted by that Regulatory Objective.
- Click Continue.
- Vault generates UDI data via the Create UDI Submission job. When finished, you’ll receive a Vault notification and email with a CSV file of successes, warnings, and errors. You can download the file from the in-Vault notification or email notification.
Repeat these steps for all Medical Device Types on the selected Marketed Device Product Registration, as applicable.
How Vault Generates UDI Data for GUDID
Vault determines the data it includes in a GUDID submission based on whether you selected a Regulatory Objective when running the Generate UDI Submission action:
- When you do not select a Regulatory Objective, Vault includes all Packaging records with a corresponding Registered Packaging Characteristic related to the registration, and the packaging characteristic record’s Use for UDI and Smallest Unit (
smallest_salable_unit__v) fields are both “Yes”. - When you select a Regulatory Objective, Vault locates Packaging records based on related registered details (where both Use for UDI and Smallest Unit are “Yes”) in the order listed in the table below. The Path to Packaging represents that record’s field(s) Vault uses to locate the Packaging record where the Smallest Unit field is “Yes”.
Vault additionally checks whether an active Registered Device Identifier record exists for the registration and the Device Identifier for the packaging being evaluated.
| Object | Object Type(s) | Path to Packaging |
|---|---|---|
| Registered Packaging Characteristic | UDI Attributes | Packaging |
| Registered Packaged Product | All standard types, custom types are ignored. | Packaging |
| Registered Regulatory Text | Device Trade Name | Packaging |
| Registered Regulatory Text | Device Description | Packaging |
| Registered Nomenclature Code | N/A | Packaging, if populated Product Variant, if populated Product |
| Registered Authorization | Device Premarket Submission | Packaging, if populated Product Variant, if populated Product |
| Registered Authorization | Device Listing | Packaging |
| Registered Packaging Characteristic | UDI Clinical Size | Packaging |
| Registered Shelf Life or Condition | Device Storage and Handling Condition | Packaging |
Create UDI Submission Job Results
Each time you run the Generate UDI Submission action, the asynchronous Create UDI Submission job evaluates all active source records, then creates documents and object records per the table and limitations below.
| Scope | Lifecycle State(s) | |
|---|---|---|
| UDI Submission XML document | One per device identifier in the selected registration | Ready to Review |
| UDI Submission Group record | One per 300 UDI Submission records | Generated (or Failed to Generate), then Ready to Review once related submissions are successfully created. |
| UDI Submission record | One per XML document | |
| Registered Device Identifier record | One per Device Identifier related to the registration's included packagings |
When complete, Vault sends a notification and email with a CSV file summarizing the job run. You can use this data to locate the XML documents and related object records in your Vault to resolve any errors and regenerate the submission.
See additional details about UDI Submission Viewer-specific lifecycle states for these records, including when submitting to a Health Authority directly from Vault.
Viewing GUDID Data
When the Create UDI Submission job completes successfully, Vault creates one or more UDI Submission records and relates them to the Registration from which the job was started. Each record contains details about the Device Identifiers included in that UDI Submission (for example, Basic UDI DIs and UDI DIs).
Vault also stores an XML file in the Library under the UDI Submission document subtype for each UDI Submission record. By default, you can view the XML from the document’s viewable rendition, or download the source XML file and open it in an XML viewer. When configured, you can also launch the UDI Submission Viewer to display the XML in a readable format.
If there are any XML validation errors, a CSV file with the validation errors will be attached to the XML file.
About the UDI Submission Viewer
When the UDI Submission Viewer is configured in your Vault, you can:
- View XML UDI data in a human-readable format.
- Submit a UDI submission to EUDAMED directly from Vault.
Resolving Source Data Errors
You can use the information in the results files as well as any responses from GUDID to identify and troubleshoot source data errors. Once you’ve made corrections, you can create, review, and submit a new UDI submission.
To correct source registration data errors, we recommend using the Manage Registered Details wizard to withdraw the incorrect registered join record (for example, Registered Nomenclature Code) and replace it with a new record. If the root cause of a UDI submission error is in the core source data (for example, Nomenclature Code), you may need to correct the source record directly.
About GUDID UDI Submissions for Master UDI-DI
Master UDI-DI supports capturing an identifier of a group of highly individualized products or devices, primarily for managing UDI submissions for products such as contact lenses: As these products are available in so many variants due to the high number of clinical parameters that characterize them, a UDI-DI would need to be assigned to each variant. This results in a proliferation of UDI-DIs to be assigned, which overwhelms GUDID disproportionately compared to the safety risk associated with contact lenses.
To support this use case, Vault’s Master UDI-DI can be used to group contact lenses with the same clinical and design parameter combinations, including base curve and diameter. This reduces the number of data records in GUDID and prevents different identifiers from being assigned to similar lenses.
In Vaults where the Identifier Type picklist value Master UDI-DI (master_udidi__v) is active and set on Data Carrier object records, Vault validates this parameter upon submission generation.
UDI Submissions for Multiple Products with the Same Basic UDI
Vault supports defining multiple Products sharing the same Basic UDI within a single UDI submission. Along with related configuration, users with the appropriate permissions can generate this type of UDI data when:
- Marketed Device Product Registrations for the United States have a Registration Scope of “Marketed Product Group”.
- All Products sharing the same Basic UDI are included within the same US registration.
Note: Registrations exceeding 300 Basic UDI-DIs may contain inconsistencies when products with the same Basic UDI-DI are split across multiple UDI submissions.
Limitations
To facilitate viewing and submitting capabilities, Vault generates UDI Submissions in groups of 300 within a single UDI Submission Group record.
In the event one submission within a group fails to generate, Vault marks the UDI Submission Group and all included UDI Submission records as Failed to Generate, and you must use the Create UDI Submission job log to locate the XML documents and related object records in your Vault to resolve any errors and regenerate the submission.