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. RIM Registrations allows users to generate 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).
Vault generates submission XML using the EUDAMED XML Schema v3.0.30, or an XML version specified by a Vault Admin.
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 US GUDID.
Generating UDI Data for EUDAMED
To generate unique device identification (UDI) data for EUDAMED:
- Navigate to a Registration record with a Registration Type field value of Marketed Device Product Registration and Country field value of European Union.
- In the Registration record’s Actions menu, select Generate UDI Submission.
- Select a Medical Device Type and a UDI Submission Type.
- Optional: Override the pre-populated EUDAMED XML Version if, for example, you are creating a submission for the EUDAMED Playground using a test version. This step may not be required in Vaults using a related Application Setting which defaults a specific XML version.
- Optional: Select a Regulatory Objective to limit the submission to only include devices that were impacted by that Regulatory Objective. This drop-down is pre-filtered based on the Medical Device Type and UDI Submission Type values you selected above.
- Click Continue.
- Vault generates UDI data based on the UDI submission type and other criteria 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 EUDAMED
Vault uses three criteria to determine the data it includes in EUDAMED submissions:
- The selected UDI Submission Type.
- The Regulatory Objective record’s related records and metadata.
- Whether the Vault’s Enable enhanced UDI attribute locations Application Setting is enabled or disabled.
These criteria are listed in the table below, according to UDI Submission Type.
Vault additionally enforces language and maximum object limits to ensure all XML files comply with EUDAMED Production registration requirements.
| UDI Submission Type | Setting Enabled | Setting Disabled |
|---|---|---|
| New Device / SPP Registration | Registered Product Characteristics Registered Packaging Characteristics |
Registered Products Registered Packaged Products |
| Additional UDI-DI Registration | Registered Packaging Characteristics | Registered Packaged Products |
| Basic UDI / EUDAMED DI Update | All relevant joins are evaluated to identify a unique list of Products. | All relevant joins are evaluated to identify a unique list of Products. |
| UDI-DI / EUDAMED ID Update | All relevant joins are evaluated to identify a unique list of Packagings, Product Variants, and/or Products. | All relevant joins are evaluated to identify a unique list of Packagings, Product Variants, and/or Products. |
| UDI-DI / EUDAMED ID Market Information | Registered Packaging Characteristics Registered Packaged Products |
Registered Packaged Products |
| UDI-DI Container Packages | Registered Packaging Characteristics Registered Packaged Products |
Registered Packaged Products |
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 every 40 device identifiers in the selected registration. | Ready to Review |
| UDI Submission record | One per XML document | Ready to Review once related UDI Submissions are successfully created, or Failed to Generate. |
| 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.
See additional details about UDI Submission Viewer-specific lifecycle states for these records, including when submitting to a Health Authority directly from Vault.
Viewing EUDAMED 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 human-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 UDI data to EUDAMED directly from Vault.
Resolving Source Data Errors
You can use the information in the results files as well as any responses from EUDAMED 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 EUDAMED 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 EUDAMED 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 EUDAMED 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 European Union have a Registration Scope of “Marketed Product Group”.
- All Products sharing the same Basic UDI are included within the same European Union registration and related country registrations.
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
This feature only supports UDI submission generation in all official EU languages, as well as Icelandic (IS), Norwegian (NB), and Turkish (TR).
When generating a submission, Vault automatically filters out any UDI data model properties with translations in unsupported languages, including:
- Medical Purpose
- Description
- Trade Name
- Clinical Size Description
- Unit of Measure Description
- Substance Name
- Storage and Handling Description
- Critical Warning Text
Additionally, Vault enforces a maximum object limit to ensure all XML files comply with EUDAMED Production registration requirements. This limitation is designed to evolve with EUDAMED requirements and will be adjusted accordingly in future releases.
- Currently, EUDAMED requires that each submission contains up to 40 total objects (device identifiers) for all UDI Submission Types, including Basic UDI / EUDAMED DI Updates, UDI-DI / EUDAMED ID Market Information, and UDI-DI Container Packages.
- For New Device/SPP Registration submissions, Vault also enforces a limit of only one UDI-DI per Basic UDI-DI.
- When a registration exceeds this limit, Vault automatically splits the data into multiple compliant XML submissions and includes the details in the CSV results file.