# Generating UDI Data for EUDAMED 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 v3.0.25, or an XML version specified by a Vault Admin.
## Generating UDI Data {#generate-udi-data} To generate unique device identification (UDI) data for EUDAMED: 1. Navigate to a _Registration_ record with a _Registration Type_ field value of _Marketed Device Product Registration_ and _Country_ field value of _European Union_. 2. In the _Registration_ record's **Actions** menu, select **Generate UDI Submission**. 3. Select a **Medical Device Type** and a **UDI Submission Type**. 4. 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. 5. 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. 6. Click **Continue**. 7. Vault generates UDI data based on the UDI submission type and [other criteria][2] via the [_Create UDI Submission_ job][1]. 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 {#how-vault-generates-udi-data} Vault uses three criteria to determine the data it includes in UDI submissions: 1. The selected UDI Submission Type. 2. The *Regulatory Objective* record's related records and metadata. 3. Whether the Vault's *Enable enhanced UDI attribute locations* Application Setting is enabled or disabled. Vault additionally enforces a maximum [object limit][3] to ensure all XML files comply with EUDAMED Production registration requirements. These criteria are listed in the table below, according to *UDI Submission Type*. | 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 | ## Viewing UDI Data When the [_Create UDI Submission_][1] 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. 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 in your Vault, you can also launch the UDI Submission Viewer to display the XML in a readable format. If there are any XML validation errors based on the EUDAMED XML schema, a CSV file with the validation errors will be attached to the XML file. ### About the UDI Submission Viewer When configured by an Admin, you can view XML in a readable format in the UDI Submission Viewer. The viewer also allows your organization to submit UDI data to EUDAMED directly from a Registrations Vault. See Using the UDI Submission Viewer. ## 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, Veeva recommends 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 the Create UDI Submission Job {#about-create-udi-submission-job} When you run the _Generate UDI Submission_ action, the asynchronous _Create UDI Submission_ job evaluates all active source records where the _Use for UDI_ field value is "Yes". The job only evaluates _Registered Product_ and _Registered Packaged Device Product_ records that match the selected _Medical Device Type_ as well as any other registered details related to those products and packaging. As the job runs, Vault creates one _UDI Submission_ XML document in the Library for every [40 device identifiers][3] in the selected registration. These documents correspond to _UDI Submission_ and _UDI Submission DI_ object records, which Vault also creates during the job run to map UDI data to corresponding submissions and registrations. For New Device/SPP Registration submissions, Vault also enforces a limit of only one UDI-DI per Basic UDI-DI. 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. If the UDI Submission Viewer is enabled, Vault updates the _UDI Submission_ object record, _Registered Device Identifier_ object records, and _UDI Submission_ XML document lifecycle states to either _Ready to Review_ or _Failed to Generate_. ## 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 {#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.
## Limitations {#limitations} 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. [1]: #about-create-udi-submission-job [2]: #how-vault-generates-udi-data [3]: #limitations