EUDAMED · Decision guide for Regulatory Affairs & Quality

Transmit UDI data to EUDAMED: manually, by XML bulk upload or M2M?

UDI data can be transmitted to EUDAMED through manual entry, manual XML bulk upload or M2M / Data Exchange. The right method depends on more than UDI-DI count. Data structure, source-data quality, transmission frequency and who handles submissions and corrections in daily operations also matter.

Excel is a data source, not a transmission method in its own right. Europe IT supports different workflows: in our XML service, we validate the completed Excel template, generate XML files and manually upload them to EUDAMED on request. In Global Submission Portal (GSP), the customer uploads the template and starts M2M transmission after successful pre-validation. With GUDI, the customer manages UDI data in SAP and transmits it from there to the authority.

This guide compares technical methods, explains Europe IT solutions and shows how preparation, approvals, authority feedback and updates fit into a traceable RA/QA process. Choose a workflow that suits your data and team.

Comparing the three technical transmission methods

Manual entry, XML bulk upload and M2M differ in how data reaches EUDAMED. They replace neither substantive data maintenance nor feedback handling.

Comparison by workflow and operating model — no fixed volume categories. Scroll horizontally on narrow screens.
Criterion	Manual entry	Manual XML bulk upload	M2M / Data Exchange
How does data arrive?	A user enters and edits data in EUDAMED’s interface.	Prepared XML files are submitted through the manual upload process.	A suitable solution transmits through the designated electronic data exchange.
What is prepared?	Required product data with substantively checked information.	Structured data, mapping, validation and suitable XML files.	Checked data in the solution and required technical and organisational onboarding.
When to consider it?	When entry and change operations remain manageable.	When a defined dataset can be prepared and manual file and feedback handling fits the organisation.	When recurring or extensive submissions need structured status and correction handling.
What still needs organising?	Consistent entries, changes and documentation of processing.	File splitting, upload order, results, corrections and further uploads.	Data approval, substantive correction and retransmission by responsible users.
Europe IT context	Comparison option for working directly in EUDAMED; not a separate software product.	Project-based XML service: validation, XML generation and manual upload on request.	GSP portal or GUDI in SAP, each transmitting to EUDAMED via M2M.

Manual entry

Data is entered directly in EUDAMED, which can be practical for individual tasks. Consider later changes, product relationships and repeated checks as well as initial entry.

Manual XML bulk upload

Data is prepared, checked and converted into appropriate XML structures. A user then uploads the files and checks processing. XML generation and actual upload are two separate tasks.

M2M / Data Exchange

M2M means Machine-to-Machine: the solution uses electronic transmission to EUDAMED. At Europe IT it forms part of the GSP or GUDI process. It does not replace the customer’s substantive data responsibility.

What roles do Excel, GSP and GUDI play?

The data source does not automatically determine the transmission method. The same structured Excel template can feed an XML service or a GSP upload. GUDI instead combines UDI data management and submission in SAP.

Data source: Where does information come from — Excel, SAP, ERP, labelling, R&D or quality management?

Solution: Where is data prepared and processed — an XML project, GSP or GUDI?

Transmission method: How does it reach EUDAMED — manual entry, XML upload or M2M?

Operating model: Who operates the process — and is transmission one-off, project-based or regular?

Excel: consolidate and check data

An Excel template helps structure information from different sources for internal review. Assign an owner and authoritative source to each field. This makes it a controlled working basis rather than another contradictory file version.

A completed file is not itself an EUDAMED submission. The agreed validation and transmission process follows. More about the EUDAMED Excel template

Portal-based process

Global Submission Portal

GSP supports import, automatic pre-validation, transmission and status tracking. The customer uploads the completed Excel template. Once displayed errors are resolved, the customer starts transmission. GSP uses M2M / Data Exchange for EUDAMED.

The portal can also process larger datasets. Bulk processing and M2M are therefore not competing products. Customers correct substantive errors and trigger retransmission themselves.

Consider this when: You want to control submissions without SAP-integrated UDI master data management and track status and authority feedback in a portal.

Explore GSP and its submission process →

SAP-integrated process

Global UDI / GUDI

GUDI combines UDI data maintenance, authority-specific modules and transmission in SAP. Customers manage data in GUDI and transmit directly to authorities. EUDAMED transmission uses M2M.

Transmission status and authority feedback can be retrieved and displayed in GUDI. Customers remain responsible for corrections and retransmission. A separate GSP upload is not part of this GUDI workflow.

Consider this when: You want to anchor data maintenance, roles, approvals and changes in SAP and reuse common data across authority modules.

Explore GUDI for UDI data management in SAP →

XML service: Europe IT prepares and manually uploads

You can engage Europe IT for preparation and upload when using manual XML. Supply the completed Excel template; we validate data, clarify detected errors with you, generate XML after error-free validation and manually upload to EUDAMED on request.

Workflow: Excel template → validation and corrections as needed → XML generation → manual upload → check processing results.

This is a project-based submission process, not an M2M upload. View UDI transmission support

Which method fits your data and operating model?

A one-off, well-prepared dataset has different requirements from a continually changing portfolio. Assess the whole workflow, not just the first transmission.

1. Data structure, not just record count: How are UDI-DIs distributed across Basic UDI-DIs? Which product and packaging relationships, record types and XML structures are needed? These affect preparation, file splitting and error handling.
2. One-off submission or ongoing changes?: A supported XML process may suit a defined project. For regular creations, changes or corrections, also assess GSP/GUDI and M2M. Frequent updates can matter even for a small portfolio.
3. Data quality and internal approval: Is data complete, consistent and internally approved? If not, start with consolidation, substantive review and validation. Fast transmission does not resolve contradictory source data.
4. Source system and preferred operation: For data from different sources supplied through Excel, consider XML service or GSP. If UDI data management itself belongs in SAP, assess GUDI.
5. Responsibilities and tracking: Who starts submissions, evaluates feedback, corrects data and approves updates? Compare file management, manual uploads, status checks and documentation with the desired portal or SAP workflow.

100, 1,000, 5,000 or 10,000 UDI-DIs are not fixed product boundaries. The right solution follows from structure, recurrence, quality and operating model. Volume-only recommendations fall short.

Practical planning · File splitting

100 UDI-DIs do not automatically mean one XML file

Manual XML planning involves more than UDI-DI count. Required files, their order and individual processing steps also matter. Generating XML does not remove this manual work.

Example calculation: Assume one Basic UDI-DI with 100 associated UDI-DIs. This example uses a separate Basic UDI-DI file and splits the UDI-DIs into four files of 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

Context: Splitting into groups of 25 is a calculation assumption here, not a universal technical limit. Permitted file structure, record counts, order and processing for a specific upload must be checked against applicable EUDAMED requirements.

Multiple files mean multiple upload and check steps to coordinate. Depending on processing, feedback may need to arrive before the next step. Include this effort when choosing manual XML or M2M.

Assess legacy/MDD data separately: Do not apply the example to other record types without checking. First clarify the applicable model and relationships.

Who handles transmission, corrections and updates?

A suitable solution needs clear responsibilities. Technical pre-validation, transmission and EUDAMED processing are distinct steps.

In the XML service

The customer supplies the completed template and resolves substantive data questions. Europe IT validates, generates XML after error-free checks and manually uploads on request. Also agree how feedback, approvals and further uploads are handled.

In GSP

The customer uploads the template and starts transmission after successful pre-validation. Europe IT provides the portal and transmission process and operates the EUDAMED access point/gateway used. The customer reviews feedback, corrects content errors and starts retransmission.

In GUDI

The customer maintains UDI data in SAP and starts transmission from GUDI, which can display status and authority feedback. The customer remains responsible for substantive corrections, internal approvals and resubmissions.

Required access, permissions and authorisations must be in place. Europe IT provides onboarding instructions, such as authorisation for M2M transmission on the customer’s behalf. The specific workflow depends on the target system.

Pre-validated does not automatically mean accepted by EUDAMED. Successful pre-transmission checks are not final authority processing. Check actual record and authority responses. EUDAMED’s operation and internal processing belong to the authority.

Check twelve data and process risks before submission

These checks help identify inconsistencies and unclear workflows. They are neither a frequency ranking nor official EUDAMED error codes. Applicable fields and rules depend on the record and rule version.

Data model and substantive consistency

Contradictory master data: Clarify links between product family, Basic UDI-DI, UDI-DI and packaging levels. Relationships must not exist only in isolated files or individual knowledge.
Incorrect codes or issuing agency details: Check identifiers, formats and Issuing Agency for consistency.
Unclear legislation and risk class assignment: Have responsible RA/QA teams check the classification before technical preparation.
Missing or contradictory language and purpose information: Reconcile relevant source data, labelling, instructions for use and submission data.
Incomplete packaging hierarchies: Check referenced UDI-DIs, quantities, packaging levels and record relationships.
Misunderstood UDI-PI information: Separate production identifier types from actual entries on individual product labels.
Incomplete certificate references: Where required, check the notified body, certificate type, validity and relevant revision.
Contradictory device status: Define how status changes are decided and reflected in affected datasets.
Unclear direct marking information: Check which direct marking entries the record requires and how they align with the rest of the UDI record.

Responsibility, changes and evidence

Multiple contradictory sources: Define an authoritative source and owner per field. Document how discrepancies are resolved.
Changes without controlled updates: Connect change reason, review, approval and transmission. Correcting a source file does not itself update an authority record.
Missing traceability: Link data version, check result, approval, submission and authority response. Define responsibilities and filing.

Further reading: Understand EUDAMED errors and responses · Structure evidence with the UDI Evidence Pack

RA/QA project plan: from data preparation to operations

Transmission is one part of the project. These four phases connect quality, technical submission and repeatable working processes.

Phase 1: scope and data inventory

Define portfolio, product families and relevant record types.
Record Basic UDI-DI/UDI-DI mappings and packaging relationships.
Define source systems and owners per field.
Consider initial transmission and later changes together.

Phase 2: data collection and review

Consolidate data in the appropriate Excel template or SAP model.
Have RA/QA check completeness and substantive consistency.
Resolve technical validation errors and approve the data version under control.
Select the transmission method and users; prepare required onboarding.

Phase 3: pilot submission and correction cycle

Choose a representative scope, such as a product family with varied UDI-DIs.
Run the agreed validation and transmission workflow.
Link feedback to individual records and document causes.
Approve corrections, retransmit and check processing results.

Phase 4: rollout and operations

Apply the confirmed workflow to the remaining data.
Define record creation, updates, approvals and responsibilities as a recurring process.
Save validation and transmission evidence per transaction or under the internal filing scheme.
Regularly track open errors, changes and relevant requirements.

Frequently asked questions about EUDAMED transmission

What is the difference between XML bulk upload and M2M?

Manual XML bulk upload generates suitable XML files and uploads them through EUDAMED’s upload process. M2M uses electronic data exchange through a solution. The distinction concerns transmission, not volume alone; M2M can also process large datasets.

When is an Excel template enough, and when do I need a portal?

Excel is sufficient as a tool for structured collection and internal checks. Actual EUDAMED submission requires a subsequent transmission process. Consider GSP if you want to control validation, submission, status and corrections in a portal. Alternatively, Europe IT can prepare and manually upload through its XML service.

From how many UDI-DIs should I use M2M?

A universal threshold is not a sound decision basis. Consider Basic UDI-DI/UDI-DI structure, relationships, file splitting, quality, frequency and operating model. Frequent changes can justify a structured M2M process even for small portfolios.

Does Europe IT offer manual XML upload?

Yes. On request, Europe IT validates the completed Excel data, generates XML after error-free validation and manually uploads it to EUDAMED. Customers retain responsibility for substantive accuracy. Support scope and feedback handling are agreed per project.

Can GSP process bulk data while using M2M?

Yes. GSP can import and validate larger volumes and uses M2M / Data Exchange for EUDAMED. Excel upload to GSP is therefore not the same as manual XML upload to EUDAMED.

Do I also need to upload GUDI data to GSP?

No. In GUDI, customers manage data in SAP and transmit directly to authorities, using M2M for EUDAMED. GSP is an independent portal solution, not a necessary intermediate step in this GUDI workflow.

How do I reduce avoidable rejections?

Assign data owners, carry out substantive RA/QA review and use pre-validation. Document the message, record, cause and correction for each error, then check retransmission results. Pre-validation does not guarantee EUDAMED acceptance.

Which submission evidence should I retain?

Useful evidence includes identifiable data versions, internal approvals, available validation results, transmission information and authority feedback. Corrections and changes should also be traceable. Required documents and retention depend on applicable requirements and your QMS. Software features or evidence packages alone do not guarantee a successful audit.

How do I update existing records?

Record the reason and affected fields, update the authoritative source, then review and approve. Transmit through the defined process, check feedback and file the evidence. In GSP and GUDI, customers control substantive corrections and retransmissions.

Further information and technical requirements

The applicable European Commission documentation governs file structures, field rules and data-exchange workflows. Before submission, check the version appropriate to your record and environment.

For specialist orientation: EUDAMED overview · UDI guide

Which EUDAMED method fits your business?

Europe IT supports selection and implementation, from structured Excel preparation and manual XML services to GSP or GUDI processes.

For a concrete discussion, tell us your source system, Basic UDI-DI and UDI-DI count and structure, planned transmission frequency and desired task allocation.

Discuss the right EUDAMED transmission method →

Would you like to view the solutions first? Global Submission Portal · GUDI for SAP