UDI Data Submission: transmit UDI data to authorities
Validate UDI data from Excel, SAP, ERP or other structured sources, approve it under controlled conditions and transmit it to regulatory target systems through the appropriate process.
Europe IT Consulting supports medical device manufacturers with submission processes for EUDAMED, swissdamed, FDA GUDID, TGA AusUDID, NMPA China and ÜTS. Options include Global Submission Portal, the GUDI SAP UDI add-on, EUDAMED XML bulk upload and project-based support.
Example of direct UDI data transfer from SAP
What does UDI Data Submission mean?
UDI Data Submission is the controlled process of preparing, checking, approving and transmitting UDI-related product data to a regulatory system, then processing its feedback. Submission therefore begins before sending.
Provide data
Collect UDI and product data from Excel, SAP, ERP or a database.
Mapping
Map source fields to the required authority-specific structures.
Validation
Check required fields, formats, values, rules and relationships.
Approval
Correct errors and have the responsible roles approve records.
Transmission
Execute the intended manual, XML or M2M process.
Status and feedback
Assess responses and return errors to the correction process.
Your data source is the starting point
The appropriate submission method is not determined solely by UDI-DI count. Structure, relationships, quality, transmission frequency, source system and operating model also matter.
Excel
Prepared UDI spreadsheets for validation, data preparation or an agreed submission process.
SAP
Product and material data as the basis for GUDI or an agreed export and mapping process.
ERP and database
Structured source data whose fields and relationships are mapped to the required authority model.
Existing XML data
Existing files as the starting point for checks, adaptation or a defined XML process.
Four paths to the right UDI submission
These offerings are not competing names for the same process. They solve different tasks and are used according to the starting situation.
Global Submission Portal
For structured or larger datasets and recurring submissions — without requiring UDI data to be maintained in SAP.
- Import from agreed structured sources
- Mapping and validation
- Submission workflows
- Status and authority feedback
- EUDAMED through M2M/Data Exchange
GUDI SAP UDI Add-on
For manufacturers maintaining UDI data in SAP who want authority-specific additions, validation, approval and direct transmission.
- Shared data in the GUDI master
- Authority-specific plug-ins
- Validation, roles and approvals
- Audit trail
- Direct M2M transmission from GUDI
EUDAMED XML Bulk Upload
For structured source data converted into EUDAMED-compliant XML after mapping and validation.
- Source-data analysis
- Mapping to EUDAMED structures
- Data validation and correction cycles
- Generation of compliant XML files
- Manual XML upload as a separate step
Excel-based submission process
For companies providing UDI data in a defined template for preparation through an agreed project process.
- EUDAMED or FDA GUDID Excel templates
- Checks and correction cycles
- Mapping and submission preparation
- Agreed roles and handovers
- Follow-on process depends on the target system
Four layers that must stay distinct
This distinction makes the roles of input data, Europe IT solutions, technical transmission and operations visible.
Data source
Product and UDI source data originates or resides here: Excel, SAP, ERP, database or structured export file.
Europe IT solution
GSP, GUDI, validator or project process handles maintenance, import, validation, approval or workflow control according to the model.
Technical transmission method
Approved data reaches the target system through manual entry, XML upload or M2M; EUDAMED calls its M2M method M2M/Data Exchange.
Operating model
The process is organised as one-off transmission, regular submission, software operation or project-based support.
Direct comparison of solutions and transmission methods
This table summarises inputs, tasks and outcomes. Final selection depends on the specific data and operating model.
| Solution or process | Typical input | Task | Transmission or result |
|---|---|---|---|
| Global Submission Portal | Structured bulk data from Excel, ERP, SAP or other sources | Import, mapping, validation, submission workflow, status and feedback processing | EUDAMED through M2M/Data Exchange; other systems depend on the configured module |
| GUDI SAP UDI Add-on | Product and UDI data in SAP | Central maintenance, authority plug-ins, validation, roles, approval and audit trail | Direct customer-triggered M2M transmission from GUDI; M2M/Data Exchange for EUDAMED |
| EUDAMED XML Bulk Upload | Agreed structured source data | Mapping, validation and generation of EUDAMED-compliant XML | File-based XML upload; responsibility for manual upload agreed per project |
| Excel/project process | Completed EUDAMED or FDA GUDID Excel templates | Data checks, correction cycles, mapping and agreed submission preparation | Depends on the agreed target system and operating model |
| UDI Excel Cloud Validator | Prepared Excel file for EUDAMED or FDA GUDID | Automated checks with errors, warnings and correction guidance | Excel/CSV validation report; no submission by the validator |
Direct submission from GUDI
With the GUDI SAP UDI Add-on , customers maintain shared UDI data and authority-specific additions in SAP. Records are checked against the relevant module’s rules and approved through defined roles.
The customer then transmits data directly from GUDI to the authority via M2M. No additional submission portal or manual handover between GUDI and the target system is required.
GUDI process:
SAP product data → UDI data maintenance → authority-specific validation → approval → direct M2M transmission → regulatory target system
EUDAMED XML Bulk Upload
Europe IT offers XML-based bulk upload processes for EUDAMED. This method is functionally and technically distinct from M2M/Data Exchange.
Typical XML process:
Structured source data → mapping → validation → EUDAMED-compliant XML files → XML upload process
Each project defines the data supplied, mapping and correction cycles, substantive file approval and who performs manual upload. Creating an XML file alone does not mean it has been uploaded to or accepted by EUDAMED.
Excel-based project support
Dedicated templates for prepared Excel data are available for EUDAMED and FDA GUDID . They provide a defined starting structure for data preparation, validation and the agreed follow-on process.
Depending on the project, support can include correction cycles, mapping and submission assistance. Suitability depends on record relationships, quality, transmission frequency, source system and operating model — not volume alone.
Supported authorities and UDI modules
Europe IT solutions support UDI and regulatory modules for different markets. The solution and transmission process are defined per authority and use case.
Availability and features are confirmed for the required solution, version and project. Regulatory requirements and technical specifications may change.
From data analysis to authority feedback
1. Define target systems, scope and operating model
Define markets, products, UDI structures, transmission frequency and responsibilities. This reveals whether you need a one-off project, recurring portal operation or an SAP-integrated model.
2. Check source data and mapping
Compare existing fields, formats and record relationships with the target model. Identify missing or contradictory information before production transmission.
3. Validate and correct data
Check data against the structures and rules of the agreed solution. Technical checks do not replace the manufacturer’s substantive assessment and approval.
4. Approve and transmit the submission
After correction and approval, transmit via the defined manual, XML or M2M method. GUDI customers send directly from the SAP UDI add-on; GSP transmission takes place in the configured portal workflow.
5. Process status and feedback
Where supported by the solution, technical status messages and authority feedback are linked to the transaction. Errors can return to correction and renewed approval cycles.
FDA GUDID and HL7 SPL
For FDA GUDID, UDI data can be converted into the required HL7 SPL XML structures and processed through the agreed transmission workflow. This applies to FDA GUDID and must not be interpreted as a universal format for EUDAMED, swissdamed or other UDI systems.
Depending on the starting situation, data comes from a FDA GUDID Excel template, SAP/ERP export or GUDI. Mapping, validation, approval, transmission and status handling are defined for the selected solution and operating model.
Which submission path fits your needs?
- GUDI: when SAP is the central working environment and customers want to transmit directly from GUDI to authorities via M2M.
- Global Submission Portal: when structured imports, larger or recurring volumes, validation and multiple target systems are needed.
- EUDAMED XML bulk upload: when a file-based process with mapping, validation and XML generation fits.
- Excel/project process: when data is supplied in a controlled template and prepared per project.
- UDI Excel Cloud Validator: when the initial need is only to check prepared Excel data quality.
- UDI consulting: when scope, data ownership or target process is not sufficiently clear. Go to UDI consulting.
No fixed volume threshold: Data models, relationships, errors, recurrence, source systems and responsibilities matter as much as UDI-DI count.
Frequently asked questions about UDI Data Submission
No. XML bulk upload uses generated EUDAMED-compliant files in a file-based upload process. M2M/Data Exchange transmits through a suitable solution. XML generation and manual upload must therefore be distinguished from M2M transmission.
Yes. After maintenance, validation and approval, the customer transmits UDI data directly from GUDI through the integrated M2M connection. GUDI is the SAP UDI add-on and user interface; M2M is the technical transport method.
No. It checks prepared Excel data and creates a report with errors, warnings and guidance. Correction, approval and submission take place in subsequent steps.
There is no universal hard threshold beyond which M2M is always right. In addition to volume, structure, Basic UDI-DI/UDI-DI relationships, quality, frequency, source systems, automation needs and operating model are decisive.
No. Validation can reveal formal, structural and implemented business-rule errors before transmission. It replaces neither the manufacturer’s data responsibility nor final processing and feedback by the regulatory system.
Enquire about your UDI submission project
Describe your data source, authorities or target systems, approximate structure, current quality, planned transmission frequency and timeframe. Europe IT Consulting can use this to identify the appropriate next step.
