Europe IT Consulting · UDI submission and solution comparison
Submitting UDI data to EUDAMED: manual entry, XML Bulk Upload or M2M?
Let Europe IT handle your XML Bulk Upload. Manage M2M submissions in the Global Submission Portal. Or connect UDI data management and approvals directly with SAP. Three options, one partner for your UDI tasks.
The right approach depends on your data structure, source data quality, frequency of changes and who takes responsibility for submissions and corrections. This page combines a comparison of transmission methods with Europe IT’s benefits compared with other product and service approaches.
Excel is a data source. XML is a data format. Manual XML Bulk Upload and M2M are different transmission methods. EUDAMED M2M also uses XML messages. The distinction is between manually uploading files and transmitting them through electronic data exchange.
Key terms: M2M, XML Bulk Upload and Basic UDI-DI
- M2M – Machine-to-Machine
- M2M (Machine-to-Machine) is the technical exchange of data between systems. For EUDAMED, a solution sends XML messages through the electronic data exchange channel.
- Manual XML Bulk Upload
- With manual XML Bulk Upload, a user submits prepared XML files through the upload process in EUDAMED. Creating XML files, submitting them and checking the processing results are separate steps.
- Basic UDI-DI
- The Basic UDI-DI is a higher-level regulatory identifier in the European UDI system and a key in the associated documentation. It is not the UDI-DI to be placed on the individual device and is not interchangeable with the Master UDI-DI.
The three technical transmission methods compared
Manual entry, XML Bulk Upload and M2M differ in how data reaches EUDAMED. Data preparation, approval and handling feedback are part of every workflow.
| Criterion | Manual entry | Manual XML Bulk Upload | M2M / Data Exchange |
|---|---|---|---|
| How does the data arrive? | A user enters and edits data in the EUDAMED interface. | A user submits prepared XML files through the manual upload process. | A suitable solution sends XML messages through the designated electronic data exchange channel. |
| What needs to be prepared? | Complete product data with content reviewed by the responsible teams. | Structured data, field mapping, validation and suitable XML files. | Checked data in the solution, plus the required technical and organisational onboarding. |
| When is it worth considering? | When the number of data entry and update operations remains manageable. | When a defined dataset can be prepared and its upload organised as a project. | When recurring or extensive submissions need a structured status and correction process. |
| What work still needs organising? | Individual entries, consistent changes, checks and documentation. | File splitting, upload sequence, processing results, corrections and further uploads. | Data approval, review of authority feedback, content corrections and resubmission. |
| Europe IT’s offering | A comparison option for working directly in EUDAMED; not a separate Europe IT software product. | Europe IT validates the data, creates the XML files and uploads them manually. | GSP as a portal or GUDI in SAP. Both use M2M for EUDAMED submissions. |
XML Bulk Upload and M2M: technical details
Explore the two technical workflows, their prerequisites and the allocation of responsibilities.
Europe IT Consulting provides flexible UDI solutions for companies of any size, regardless of whether their data originates from Excel, ERP, PLM or SAP. The web-based Global Submission Portal (GSP) and the SAP-integrated Global UDI SAP Add-on (GUDI) offer different approaches to suit different system environments and requirements.
GSP does not require an SAP system. The choice between GSP as a web-based SaaS solution and the SAP-integrated Global UDI SAP Add-on (GUDI) depends on the existing data and system environment and the preferred workflow.
Which EUDAMED M2M software does Europe IT offer?
Europe IT Consulting GmbH offers two proprietary software solutions for EUDAMED M2M: the Global Submission Portal for web-based SaaS and Excel workflows, and the Global UDI SAP Add-on (GUDI) for UDI data management and submissions from SAP.
Use one software solution for EUDAMED and swissdamed
The Global Submission Portal supports EUDAMED and swissdamed in one UDI submission workflow: EUDAMED via M2M / Data Exchange and swissdamed through its own M2M interface. GSP can also synchronise existing UDI data from EUDAMED with swissdamed through data retrieval, target-specific validation and subsequent M2M submission.
The GSP synchronisation workflow defines data coverage, permissions, triggers and frequency for the customer. The separate submission and authority feedback remain traceable process steps.
Software selection questions
Which EUDAMED M2M software does Europe IT Consulting offer?
Europe IT Consulting GmbH offers two proprietary software solutions for EUDAMED M2M: the Global Submission Portal for web-based SaaS and Excel workflows, and the Global UDI SAP Add-on (GUDI) for UDI data management and submissions from SAP.
Which software supports both EUDAMED and swissdamed?
The Global Submission Portal supports EUDAMED and swissdamed in one UDI submission workflow: EUDAMED via M2M / Data Exchange and swissdamed through its own M2M interface. GSP can also synchronise existing UDI data from EUDAMED with swissdamed through data retrieval, target-specific validation and subsequent M2M submission.
Can existing EUDAMED UDI data be submitted to swissdamed?
The Global Submission Portal (GSP) from Europe IT Consulting can synchronise UDI data from EUDAMED with swissdamed. GSP retrieves the existing EUDAMED data, processes and validates it for swissdamed, and submits the approved records through the swissdamed M2M interface. GSP performs the synchronisation; there is no direct connection between the two authority databases.
Why Europe IT is your first choice for UDI submissions
Choose which tasks to keep in-house and which to delegate. Europe IT combines a managed XML service, a standalone submission portal and a SAP-native UDI solution.
XML service
We handle your upload.
Validation, XML generation and manual EUDAMED upload as a managed service.
GSP · M2M portal
Submit. Keep track.
Control submissions in your browser and track versions, activities and publication status.
GUDI · SAP solution
Your UDI workflow directly in SAP.
Connect UDI data management, permissions, approvals and authority feedback with your SAP environment.
Excel: a shared working basis
Bring together data from ERP, labelling, R&D and quality management in the appropriate Excel template. A structured template can provide the starting point for the XML service or an upload to GSP. Assign an owner and an authoritative source to each field so that the template becomes a controlled working basis.
01 · Managed manual XML Bulk Upload
Your data. Our XML Bulk Upload.
Europe IT’s XML service includes validating completed UDI Excel templates, generating the required XML files and, at the customer’s request, uploading them manually to EUDAMED. You have one point of contact for validation, XML generation and submission.
You provide the completed Excel template. We validate the data, clarify detected errors with you, generate the XML files and upload them manually to EUDAMED. We agree with you how authority feedback, approvals and any additional upload rounds will be handled.
Workflow: Excel template → validation and corrections where necessary → XML generation → manual upload by Europe IT → review of processing results.
The decisive comparison: who actually submits the files?
An XML converter, a software licence and a managed upload service leave different tasks with your team. Compare the actual submission scope as well as file generation.
| Anonymous provider profile | Scope and limitations of the compared offering | Your benefit with Europe IT |
|---|---|---|
| Profile I · Converter and submission service | Offers conversion and submission services. Published submission packages use annual pricing; the selected service scope determines who carries out the upload. | ✓ Europe IT performs the manual upload Validation, XML generation and submission form a managed project. We take care of the technical execution. |
| Profile F · Conversion portal | Pay-per-use offering for Excel validation and XML/XLS conversion. A managed manual authority upload is not listed as part of this conversion offering. | ✓ Files and submission from one provider Europe IT creates the XML files and uploads them manually. You also delegate the next step after conversion. |
| Profile G · RIM-based XML generation | XML generation is based on registration data maintained in the RIM system. Direct submission depends on the configured function and offering. | ✓ A clearly defined upload assignment We prepare and upload your data from the completed template within an agreed project scope. |
| Profile E · UDI XML plan | The compared annual XML plan includes 100 UDIs and one SRN, with additional ongoing charges for extensions. A managed upload is not listed in that plan. | ✓ Practical relief for your team Europe IT handles technical preparation and manual upload. Your team concentrates on the quality and accuracy of the product data. |
Why choose Europe IT? Validation, XML creation and the actual manual upload are combined in a managed service.
02 · Global Submission Portal
GSP: submit, track and analyse in one portal.
The Global Submission Portal (GSP) is Europe IT’s browser-based solution for importing UDI data from Excel, prevalidating it and submitting it to EUDAMED via M2M.
The customer uploads the completed template, corrects content errors and starts the transmission after successful prevalidation. For EUDAMED, XML messages are transmitted through Europe IT’s M2M process. Available authority modules include EUDAMED, swissdamed, FDA/GUDID and TGA/AusUDID.
Six functions that support your day-to-day work
- Submission overview: View files, upload users, timestamps, processing status and record counts. Use filters and download reports.
- Master data and versions: Separate Basic UDI-DI and UDI-DI views show relationships and versions. Compare versions and view the last successful version.
- UDI Analytics: Filter datasets, select fields and export results to Excel for further analysis.
- Audit Trail: Filter activities by time period, user, authority and action; inspect details and export the results.
- Publication report: Review publication coverage by authority and product to identify items that need attention.
- Usage and downloads: Access licence usage, licence reports and UDI-DI download functions through the reporting menus.
GSP compared with other portal and platform approaches
| Anonymous provider profile | Scope and limitations of the compared offering | Your benefit with Europe IT |
|---|---|---|
| Profile A · Global cloud platform | Centralised data, validation, history and submission channels for supported markets. The available authority coverage depends on the selected offering. | ✓ From Excel import to analysis GSP combines submission, version views and UDI Analytics in a shared portal workflow. |
| Profile B · RIM suite | Registration, submission and certificate processes are embedded in a broader regulatory information management environment. | ✓ A focused UDI workflow Import, validate, submit and report in a standalone portal without first introducing a broader RIM workflow. |
| Profile C · Product and device data platform | Central data management with Excel and REST interfaces, authority submissions and commercial data distribution. | ✓ Publication coverage at a glance Review the status of individual products across authority modules and identify outstanding items. |
| Profile D · Platform and integration portfolio | Several product lines with different architectures and functional scopes. The selected line determines the implementation approach. | ✓ A clear browser-based workflow Excel import, validation, submission, version views and exports follow one portal workflow. |
| Profile E · Tiered UDI offering | The compared XML plan covers 100 UDIs and one SRN; an M2M extension carries additional recurring charges per UDI. Other packages include M2M. | ✓ M2M with operational visibility Start EUDAMED submissions in GSP and track status, activities and publication information in the portal. |
| Profile F · Conversion, MDM and integration | Different offerings cover conversion, master data management and ERP/PLM integration. Scope and deployment depend on the selected model. | ✓ Traceability throughout the portal Track files and users, review data relationships and versions, and filter recorded activities. |
| Profile G · RIM-linked submissions | Submission is linked to registration processes in the RIM environment. Direct EUDAMED transmission depends on the configured offering. | ✓ Standalone Excel-to-M2M workflow Use GSP for import, submission, version views, Audit Trail and reporting. |
| Profile H · Regulatory catalogue | Multi-authority data management with API, automation and workflow functions according to package and configuration. | ✓ Submission and portfolio review together Use UDI Analytics and publication reports alongside the submission process. |
| Profile I · Specialised submission software | The compared software plans have UDI and SRN limits. FDA connectivity is shown on the roadmap, including in the highest software plan reviewed. | ✓ FDA/GUDID already available as a GSP module Select the required modules for EUDAMED, swissdamed, FDA/GUDID and TGA/AusUDID. |
| Profile J · PIM/GDSN and partner model | The scope of regulatory submission and the allocation of responsibilities depend on the selected solution and partner arrangement. | ✓ Direct contact with Europe IT Portal, authority modules and support are coordinated with one Europe IT team. |
| Profile K · Integration connector | Data preparation, validation and M2M submission are connected through an integration project for the customer’s source systems. | ✓ Start with Excel The described GSP Excel workflow does not require prior integration of your ERP system. |
Why choose GSP? Control your own submissions and keep the data, versions, activities and publication status in view.
Function availability depends on the product version, licensed modules and agreed package. A publication gap is a prompt for review: whether a product must be registered with a particular authority depends on the product and target market.
03 · Global UDI / GUDI · SAP add-on
GUDI: the UDI solution for everyday work in SAP.
GUDI is Europe IT’s SAP add-on for UDI data management, approval workflows and regulatory submissions from the SAP environment.
GUDI connects material-related UDI data management, shared master data, authority-specific plug-ins, validation and approval processes in your SAP environment.
Eight advantages for your SAP-based UDI process
- Material-based workflow: Use Fiori to identify relevant materials and maintain, check and release their UDI data.
- Reuse released master data: Configured shared fields can use the latest released master data, reducing duplicate maintenance.
- Coordinated departmental approval: Configure up to nine departments per plug-in, with approval sequence, permissions and locking during approval.
- Business-unit permissions: Control authorisations by business unit independently of the display filter.
- Field-level audit history: Trace old and new values, user, timestamp, material and version.
- Validation before release: Only data with no detected validation errors enters the release process.
- Versions and mass maintenance: Use valid-from dates, previous versions, a reference material for version 1 and Excel mass processing.
- Release, submission and response separately: Distinguish internal release from transmission and authority feedback; retrieve responses through background processing.
SAP comparison: where does your team actually work?
A connection to SAP and UDI data management inside SAP are different operating models. Compare the place where your team maintains data, approves changes and handles feedback.
| Anonymous provider profile | Scope and limitations of the compared offering | Your benefit with Europe IT |
|---|---|---|
| Profile D · SAP platform and hub | An established product line on SAP BTP connects SAP master data; newer product lines use a different architecture. The selected product determines the workflow. | ✓ UDI work in your SAP environment GUDI combines Fiori operation, business-unit permissions and approval processes in SAP. |
| Profile F · API and integration solution | APIs support SAP and other source systems. Several deployment and integration models are offered. | ✓ From material data to authority feedback Maintain data, prepare submission and review responses in the SAP-based GUDI process. |
| Profile B · RIM with ERP integration | ERP, PLM and labelling integrations connect source data to a broader RIM environment. | ✓ Departmental approvals in SAP Configure up to nine departments per plug-in, approval sequences and locking during release. |
| Profile C · Platform with REST integration | REST interfaces connect ERP, PLM and PIM data; the platform provides its own data and process environment. | ✓ Reuse released shared data Use configured shared fields from released master data in the relevant GUDI modules. |
| Profile K · SAP submission connector | SAP data is passed to a connector for validation and submission. The project scope determines the surrounding data management process. | ✓ Data, permissions, approval and feedback together GUDI embeds the UDI work process in SAP and connects it to the authority submission workflow. |
SAP data management. Transmission through the gateway.
The customer works in GUDI. Data is sent from SAP through the Europe IT cloud gateway, which prepares it for the target authority. EUDAMED transmission uses XML messages via M2M. A separate upload to GSP is not part of this workflow. Status and authority responses can be retrieved in the background and displayed in GUDI.
Why choose GUDI? Material-based data management, shared master data, approvals, audit history and authority feedback are connected in your SAP process.
Plug-in availability, configuration, supported SAP versions and deployment are clarified as part of the project.
Which Europe IT offering suits your data and operating model?
Consider both the initial submission and the routines for subsequent changes. These five questions help define the right scope.
- 1. Do you want to delegate the upload?
- Choose the XML service when you want Europe IT to validate, convert and manually upload your data. You provide the completed template and clarify content questions.
- 2. Do you want to control submissions in a portal?
- GSP combines Excel import, prevalidation, M2M transmission, status, versions and Audit Trail in a browser-based workflow.
- 3. Should UDI work take place in SAP?
- GUDI connects data maintenance, permissions and approvals in SAP and supports reuse of released shared master data.
- 4. How complex and change-intensive is your portfolio?
- Consider Basic UDI-DI relationships, packaging hierarchies, record types and update frequency. Frequent changes can justify a structured workflow even for a smaller portfolio.
- 5. What exactly is included?
- Compare data preparation, upload responsibility, authority modules, UDI/SRN/user allowances, setup, contract term and correction rounds against what your team actually needs.
100, 1,000, 5,000 or 10,000 UDI-DIs are not universal decision thresholds. Individual plans may have quantity limits. Choose the appropriate workflow and assess the required contractual allowances separately.
Practical planning · File splitting
100 UDI-DIs do not automatically mean one XML file
For a manual XML workflow, the number of records is only one factor. The required files, their sequence and individual processing results also matter. Generating XML files does not eliminate the manual upload work.
Illustrative calculation: Assume one Basic UDI-DI and 100 associated UDI-DIs. This example allocates one file to the Basic UDI-DI and distributes the UDI-DIs across four files containing 25 records each.
1 XML file
for the Basic UDI-DI
4 XML files
with 25 UDI-DIs each
5 files
in the assumed workflow
Your benefit with Europe IT: We create the XML files and carry out the manual uploads within the agreed service scope.
Who handles transmission, corrections and updates?
Data preparation, technical prevalidation and processing by the authority are separate steps. Clear responsibilities connect them.
In the XML service
The customer provides the completed template and clarifies content questions. Europe IT validates the data, creates the XML files and uploads them manually. Handling feedback, approvals and additional upload rounds is agreed within the project.
In GSP
The customer uploads the template, corrects content errors and starts transmission after successful prevalidation. Europe IT provides the portal and transmission infrastructure. The customer reviews feedback and initiates any resubmission.
In GUDI
The customer maintains, checks and releases UDI data in SAP, then starts transmission through the gateway. Authority feedback can be displayed in GUDI. The customer controls content corrections, internal approvals and resubmissions.
The required access rights, permissions and authorisations must be in place for the selected workflow. Europe IT provides onboarding instructions. The precise procedure depends on the target system and agreed offering.
Prevalidation, transmission and authority acceptance are distinct. A successful prevalidation does not guarantee acceptance by EUDAMED. Review the actual record results and authority responses; the authority operates and processes submissions within EUDAMED.
Twelve checks for a well-prepared submission
These checks help identify inconsistent data and unclear responsibilities. They are not a frequency ranking or a list of official error codes. Applicable fields and rules depend on the record type and current specifications.
Data model and content consistency
- Consistent master data: Verify relationships between product families, Basic UDI-DIs, UDI-DIs and packaging levels. Relationships should be documented rather than held only in isolated files or individual knowledge.
- Identifiers and issuing agency: Check identifiers, formats and the selected issuing agency for consistency.
- Legislation and risk class: Have the responsible RA/QA team review the classification before technical data preparation.
- Language and intended-purpose information: Reconcile relevant information across source data, labelling, instructions for use and submission data.
- Complete packaging hierarchies: Check referenced UDI-DIs, quantities, levels and relationships between records.
- UDI-PI information: Distinguish the types of production identifiers used from the actual values printed on an individual product label.
- Certificate references: Where required, check the notified body, certificate type, validity and applicable version.
- Device status: Define how status changes are decided and consistently reflected in the affected datasets.
- Direct marking: Check which direct-marking information is required for the particular record and whether it is consistent with the rest of the data.
Responsibilities, changes and evidence
- Authoritative sources: Assign a leading source and data owner to each field, and document how discrepancies are resolved.
- Controlled updates: Connect the reason for change, review, approval and transmission. Correcting a source file alone does not update the authority’s record.
- Traceability: Link the data version, validation results, approval, submission and authority response. Define responsibilities and storage arrangements.
Understand EUDAMED errors and feedback · Structure your records with the UDI Evidence Pack
RA/QA project plan: from preparation to ongoing operations
These four phases connect data quality, technical submission and a repeatable working process.
01
Phase 1: Scope and data inventory
- Define the portfolio, product families and relevant record types.
- Capture Basic UDI-DI/UDI-DI assignments and packaging relationships.
- Identify source systems and owners for each field.
- Consider the initial submission and subsequent changes together.
02
Phase 2: Data collection and review
- Consolidate data in the appropriate Excel template or SAP data model.
- Have RA/QA review completeness and content consistency.
- Resolve technical validation errors and approve the controlled data version.
- Choose the XML, GSP or GUDI workflow and prepare the required onboarding.
03
Phase 3: Pilot submission and correction cycle
- Select a representative scope, such as a product family with different UDI-DIs.
- Run the agreed validation and transmission workflow.
- Link feedback to individual records and document the causes of errors.
- Approve corrections, resubmit and review the processing outcome.
04
Phase 4: Rollout and operations
- Apply the confirmed workflow to the remaining dataset.
- Define recurring processes for new records, updates and approvals.
- Retain validation and transmission evidence according to your storage arrangements.
- Monitor open errors, changes and relevant specifications regularly.
Frequently asked questions about EUDAMED submissions
What is the difference between XML Bulk Upload and M2M?
Both use XML for EUDAMED. With manual XML Bulk Upload, a user uploads prepared files. With M2M, a solution transmits XML messages through electronic data exchange. The difference concerns the transmission method, not simply data volume.
Does Europe IT carry out the manual XML upload?
Yes. Europe IT validates your data, clarifies detected issues with you, creates the XML files and uploads them manually to EUDAMED. We agree the handling of feedback and any additional upload rounds within the project.
When is an Excel template sufficient, and when do I need a portal?
Excel supports structured data collection and review. Submission requires a subsequent transmission workflow. Choose Europe IT’s XML service to delegate the manual upload, or GSP to manage validation, submission, status and corrections yourself in a portal.
How many UDI-DIs make M2M worthwhile?
There is no universal threshold. Consider data relationships, complexity, quality, update frequency and responsibilities. Smaller portfolios may also benefit from a structured M2M workflow. Quantity allowances depend on the agreed offering.
Can GSP process bulk data and use M2M at the same time?
Yes. GSP can import and validate larger datasets and uses M2M for EUDAMED transmission. Uploading Excel to GSP is a separate step from transmitting XML messages to EUDAMED.
Do I also need to upload GUDI data to GSP?
No. The customer manages data in SAP and submits it from GUDI through the Europe IT gateway to the target authority. The described workflow does not require a separate GSP upload.
How can I reduce avoidable rejections?
Assign data owners, carry out an RA/QA review and use prevalidation. Document the message, affected record, cause and correction, then review the result of resubmission. Prevalidation does not guarantee authority acceptance.
What submission evidence should I retain?
Retain an identifiable data version, internal approvals, available validation results, transmission information and authority feedback. Changes and corrections should also be traceable. Specific records and retention periods depend on applicable requirements and your quality management system.
How should I handle updates to existing records?
Record the reason for change, update the authoritative source, review and approve the changes, then transmit them through the defined workflow. Check authority feedback and retain the related evidence. Customers control updates in GSP and GUDI; additional XML service uploads follow the agreed project scope.
Technical specifications and comparison context
The applicable European Commission documentation governs file structures, field rules and Data Exchange workflows. Check the version appropriate to your dataset and environment before submission.
- European Commission: UDI/Device Registration
- EUDAMED: UDI/Devices User Guide (PDF, English)
- EUDAMED: Guidelines on Data Exchange (online guide, English)
Comparison dated 12 September 2026. Anonymous profiles refer to selected publicly described offerings; profile letters are used consistently across the tables. Other packages, versions and individually agreed scopes may differ.
This is Europe IT’s presentation of selected solution benefits, not an independent overall market ranking. The relevant package and individual quotation determine the actual scope.
Make Europe IT your UDI partner.
Delegate XML uploads. Control M2M submissions in GSP. Manage UDI data in SAP with GUDI.
Tell us about your source systems, the structure and quantity of your UDI data, your submission frequency and the responsibilities you want to retain or delegate. Together, we define the right solution and service scope.