EUROPE IT CONSULTING · SYSTEM-TO-SYSTEM UDI SUBMISSION
EUDAMED M2M / Data Exchange for UDI data
Submit UDI data from Excel or SAP. Control the process. Keep track of authority feedback.
EUDAMED M2M (Machine-to-Machine) means system-to-system exchange with EUDAMED. Structured data is transmitted through connected systems instead of manually uploading individual XML files through the authority’s interface. M2M also uses XML data: file format alone does not distinguish the submission methods. The European Commission explains the different methods.
Europe IT Consulting offers this submission process through the Global Submission Portal (GSP) and GUDI, the UDI solution for SAP. In GSP, you upload your completed Excel template, have the data validated automatically and then initiate submission. With GUDI, you maintain and validate UDI data in SAP and trigger submission directly from GUDI. Europe IT operates the access point or gateway used for this purpose.
You retain control of when submissions start and how content errors are corrected. Status and authority feedback are available in the relevant solution. This page explains the workflow that fits your data source, the prerequisites to clarify and how M2M differs from manual XML upload.
When is EUDAMED M2M worthwhile?
When a single submission becomes a recurring data process, M2M deserves a closer look. It is particularly relevant if you regularly update product data, provide it from a central system or want to process feedback systematically.
01
Recurring submissions
New products, updates and corrections need to follow a defined workflow.
02
Structured source data
Your data resides in Excel or SAP. Relationships between Basic UDI-DIs and UDI-DIs also matter.
03
Traceable processing
Your team needs an overview of submissions, responses and records still requiring correction.
A particular number of UDI-DIs alone is not a sufficient selection criterion. Data quality, structure, submission frequency and the intended operating model also influence the decision. For an overall comparison, see our guide to EUDAMED data submission.
Two working environments. One clear submission process.
You work in the solution that fits your data source. Technical exchange with EUDAMED uses the submission infrastructure provided by Europe IT.
EXCEL → GSP
From Excel template to submission
For customers who want to submit data through a portal.
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Prepare data
Complete the Excel template for the required module with your UDI data.
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Upload and validate
Upload the template to GSP. Automatic pre-validation identifies errors to correct before sending.
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Initiate submission
Once no validation errors remain, initiate submission in the portal.
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Handle feedback
Track status, review authority feedback and correct your data if necessary.
SAP → GUDI
Directly from GUDI to EUDAMED
For customers who manage UDI data in SAP.
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Maintain data
Shared data is maintained in the GUDI master; authority-specific information is maintained in the EUDAMED plug-in.
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Validate and approve
Check the data and complete the required approvals within the GUDI process.
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Trigger submission
Initiate submission directly from GUDI. There is no need to switch manually to a separate upload portal.
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Review feedback in GUDI
GUDI can retrieve and display submission status and authority feedback. You control corrections and resubmission yourself.
TECHNICAL SUBMISSION PATH
GSP or GUDI → Europe IT gateway / access point → EUDAMED
Return path: authority feedback → processing in the Europe IT solution → customer review.
What “directly from GUDI” means: You initiate submission in GUDI and handle feedback there as well. This does not mean that technical data traffic bypasses the Europe IT transmission infrastructure.
The official EUDAMED M2M architecture provides data exchange through access points based on eDelivery and AS4. XML describes the data; AS4 handles technical message transport. European Commission architecture.
Keep data source, solution and submission method separate
| Layer | With GSP | With GUDI |
|---|---|---|
| Data source | Completed Excel template containing structured source data | UDI data in SAP |
| Europe IT solution | Global Submission Portal: import, pre-validation and submission workflow | GUDI: data maintenance, validation, approval and submission |
| Submission method to EUDAMED | M2M / Data Exchange through Europe IT infrastructure | M2M / Data Exchange through Europe IT infrastructure |
| Operating model | Customer-controlled portal process, according to the agreed service scope | Customer-controlled process in the SAP/GUDI environment |
At Europe IT, M2M is not an additional product competing with GSP and GUDI. It is the technical submission method each solution uses for EUDAMED.
Before the first production submission
A working M2M process requires appropriate permissions and coordinated onboarding. Europe IT provides instructions and the necessary authorisation documents. The specific procedure depends on the current registration status, the access point used and the EUDAMED services requested.
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Clarify actor registration and permissions
Check Actor Registration and the responsible Local Actor Administrator (LAA). The European Commission lists a registered actor and an active LAA as prerequisites. Official prerequisites.
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Authorise Europe IT as your transmission partner
EUDAMED provides for a Third Party Agreement when using an existing third-party access point. Europe IT gives you appropriate onboarding instructions and authorisation documents. A newly developed customer-specific interface is not the standard model of this offering.
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Coordinate services, tests and production access
Playground and production environments must be treated separately. When applying for production access through an existing access point, the Commission requires evidence of successful tests. EUDAMED is responsible for review and activation. Official process for using an access point.
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Prepare access and the data process
Following the necessary approval, module-specific access permissions must be configured. Data preparation, validation and responsibilities for error correction are coordinated at the same time. Information on security keys.
The evidence required for your case is clarified during onboarding. This does not imply a blanket activation-time commitment or a guarantee that every record will be accepted after passing pre-validation.
M2M and XML Bulk Upload: what is the difference?
Bulk describes the processing of larger data volumes; M2M describes the transmission method. GSP can therefore process bulk data and transmit it via M2M. An XML document in the process does not automatically mean that someone uploads a file manually.
| Aspect | M2M with GSP or GUDI | Manual XML Bulk Upload |
|---|---|---|
| Submission initiation | The customer initiates submission in GSP or GUDI. | A user uploads prepared XML files to EUDAMED. |
| Transmission | System-to-system exchange through the access point. | Manual file upload in the authority’s interface. |
| Preparation | Data is prepared and validated within the relevant solution workflow. | Source data is validated and converted into suitable XML files. |
| Feedback | Status and authority feedback are processed in the relevant solution. | Feedback must be checked within the manual upload workflow. |
| Europe IT offering | Portal- or SAP-based submission process. | On request: validation, XML generation and manual upload on the customer’s behalf. |
The European Commission also distinguishes manual XML file upload from M2M. Official explanation of submission methods.
The required division into XML files depends on record types, relationships and applicable structures. Consider the entire workflow when choosing, not just XML file generation. More about UDI data submission with Europe IT.
Sent does not mean successfully submitted
Pre-validation, technical transmission and authority processing are separate steps. Successful sending alone does not confirm acceptance of the content or publication of a record. The official EUDAMED message structure distinguishes, among other things, message acknowledgements from processing reports. Message exchange documentation.
Three checks for a reliable conclusion
1. Before sending: Is the data free from validation errors detected in the GSP or GUDI process?
2. After initiation: What transmission and processing status does the solution show?
3. After authority feedback: Which individual records were accepted, and which require correction?
GSP and GUDI support the handling of status and authority feedback. The customer corrects content errors and also initiates resubmission. In GSP, a completed file-processing status must not be interpreted without checking as successful publication of every record in that file.
| Participant | Role in the process |
|---|---|
| Customer | Provide and maintain data; grant necessary authorisations; initiate submission; correct content errors; trigger resubmission. |
| Europe IT Consulting | Provide GSP or GUDI and the agreed submission process; operate the access point/gateway used; guide customers through onboarding. |
| EUDAMED / European Commission | Operate EUDAMED; review required access requests; process submissions under EUDAMED rules and generate feedback. |
For help interpreting specific responses: EUDAMED error library.
Frequently asked questions about EUDAMED M2M
Do I have to use SAP for EUDAMED M2M?
No. Europe IT offers an Excel-based portal process through the Global Submission Portal. GUDI is the solution for companies that want to manage UDI data in SAP and submit it from there.
Can I submit directly from GUDI to EUDAMED?
Yes. You initiate submission in GUDI. The technical transfer uses the connected Europe IT infrastructure. Status and authority feedback can be retrieved and displayed in GUDI.
Does GSP submit immediately after an Excel upload?
Uploading first starts automatic pre-validation. If no validation errors are present, the customer initiates the actual submission. Uploading, validating and submitting are therefore separate steps.
Is M2M a different file format from XML?
No. XML is a data format; M2M is a transmission method. EUDAMED system-to-system exchange also uses XML data. This is different from manually uploading an XML file to EUDAMED.
Does Europe IT need to build a custom EUDAMED interface at our site?
That is not the primary role of this offering. Europe IT uses M2M within GSP or GUDI and operates the transmission infrastructure. Necessary setup and authorisation are agreed during onboarding.
Does validation guarantee acceptance by EUDAMED?
No. Pre-validation helps detect errors before sending. Subsequent processing and authority feedback still need separate review. Official technical foundations include XML schemas and business rules. European Commission technical foundations.
Who corrects data and initiates resubmission?
The customer corrects content errors and initiates resubmission themselves. Europe IT provides the relevant solution and submission process.
From how many UDI-DIs does M2M make sense?
There is no universal selection threshold based solely on record count. Data relationships, update frequency, quality, source system and operating model are equally important. The assessment is based on your specific data process.
How do your UDI data reach EUDAMED today?
Tell us about your starting point: is the data in Excel or SAP? Is this an initial submission or regular updating? How are your Basic UDI-DIs and UDI-DIs structured?
Together, we clarify whether GSP, GUDI or an XML-based project process fits your task and which onboarding steps are needed.
Official sources and further information
The linked technical primary sources are published by the European Commission and are in English. The descriptions of Europe IT workflows refer to GSP and GUDI; they are not service commitments by the Commission.
- Submission methods and purpose (European Commission)
- M2M Data Exchange Architecture (European Commission)
- M2M prerequisites (European Commission)
- Using an existing access point (European Commission)
- Technical documentation and validation foundations (European Commission)
- Message exchange and feedback (European Commission)
- Module-specific security keys (European Commission)
More official EUDAMED links · General EUDAMED FAQ
Editorial source check: . Technical specifications and onboarding procedures may change; the official documents current for your process are authoritative.
