EUROPE IT CONSULTING · EUDAMED XML SERVICE
EUDAMED XML Bulk Upload: turn Excel data into a planned upload process
EUDAMED XML Bulk Upload is the transfer of structured data through XML files uploaded manually to EUDAMED. File generation can be automated; uploading remains a separate task. This distinguishes it from system-to-system exchange via M2M. Official European Commission explanation.
Europe IT Consulting supports you with a clear workflow: you complete our Excel template. We validate the UDI data and, once identified errors have been resolved, convert it into EUDAMED-compliant XML files. On request, we also upload the XML files manually to EUDAMED on your behalf.
Product count is not the only factor. Basic UDI-DIs, their associated UDI-DIs, existing registrations and the operations required also influence how files are split. We therefore consider data preparation, XML generation and upload together, turning an Excel list into a traceable submission process.
From your Excel template to manual upload
-
Structure data
Enter the required information in the appropriate Excel template. We first clarify whether new products will be registered or existing records supplemented or updated.
Customer -
Validate UDI data
Europe IT checks the supplied data. Identified content errors are clarified and corrected by the customer before conversion.
Europe IT + customer -
Generate XML files
Once the identified validation errors have been resolved, the data is mapped to the intended EUDAMED structures and converted into XML files.
Europe IT -
Upload XML manually
Within the agreed service scope, we upload the XML files to EUDAMED for you. The necessary permissions and specific upload procedure must be clarified in advance.
Europe IT – on request -
Clarify results and further work
Authority feedback determines the processing result. If follow-up work is needed, content corrections and any resubmission are coordinated.
Completion of the upload workflow
Excel is the data source, the XML service is the Europe IT project process, and manual XML upload is the technical submission method. More about the MDR/IVDR Excel template.
Why one Excel file does not automatically mean one XML file
A spreadsheet can contain different record types and operations. XML generation requires clarity about which information belongs together and which EUDAMED service will be used. Initial registration is not the same as adding further UDI-DIs or updating existing data.
- Relationships: Which UDI-DIs belong to which Basic UDI-DI?
- Existing records: Which identifiers and records are already registered in EUDAMED?
- Operation: Is this registration, an addition or an update?
- Technical structure: Which XML structure, schema version and service-specific rules apply?
Registering a new Basic UDI-DI includes a UDI-DI with the required information. A new Basic UDI-DI is not registered in isolation without a UDI-DI. This is confirmed by the official registration guide.
Within a Device object, the UDI-DIs must correspond to its Basic UDI-DI. These relationships form part of the UDI/Devices Business Rules. Multiple Device objects within an XML request are not categorically excluded; the Bulk Upload guide explicitly describes such requests.
UNDERSTANDING FILE SPLITTING
1 new Basic UDI-DI and 100 UDI-DIs in total
The following example shows one possible staged workflow: the first XML file contains the new Basic UDI-DI and the first UDI-DI. The remaining 99 UDI-DIs are then divided into four subsequent files.
File 1
Basic + 1
New Basic UDI-DI and UDI-DI no. 1
File 2
25
UDI-DIs nos. 2–26
File 3
25
UDI-DIs nos. 27–51
File 4
25
UDI-DIs nos. 52–76
File 5
24
UDI-DIs nos. 77–100
Check the total: 1 + 25 + 25 + 25 + 24 = 100 UDI-DIs. The first UDI-DI is not counted again in subsequent files.
If the Basic UDI-DI is already registered appropriately and 100 more UDI-DIs are to be added, the starting situation is different: the same grouping into batches of 25 results in four subsequent files. Existing EUDAMED records therefore matter for planning.
Validation before conversion: data first, then the file
An XML document may be technically readable yet contain incomplete or contradictory product information. Conversely, correct content can fail because of an unsuitable format or incorrect mapping. Validation is therefore a separate step before XML generation.
| Validation layer | Typical questions |
|---|---|
| Data content | Are required details complete? Are identifiers, values and manufacturer assignments correct? |
| Relationships | Are Basic UDI-DI, UDI-DI and associated information consistent? |
| XML structure | Do structure, data types, values and version match the intended EUDAMED service? |
| Processing | What does EUDAMED report for the individual objects after upload? |
The European Commission provides XML schemas, sample files, business rules and data definitions, among other resources. Technical documentation.
Europe IT validates customer data before conversion. Passing pre-validation does not guarantee that EUDAMED will accept every record. For specific error patterns, see the EUDAMED error library.
After upload: read responses and respect dependencies
Uploading a file and processing its contents are separate steps. Once processing is complete, EUDAMED provides an XML response. If a request contains multiple objects, some may succeed while others contain errors. The official Bulk Upload guide recommends correcting and resubmitting only the objects that failed.
- Check each object’s result: A mixed result does not mean that the entire file has been rejected.
- Do not repeat blindly: Objects already created successfully should not be included unchanged in a new registration request.
- Plan dependent steps: Before further data builds on a new registration, its result must be checked.
- Allow for processing time: File generation, individual uploads and authority processing are separate workload components.
This page does not promise fixed waiting times or assert a universal limit of exactly one file being processed at a time. What matters is the dependency structure of your data and the current behaviour of the EUDAMED services used.
Assess MDD and other legacy data separately
MDD, AIMDD or IVDD legacy records must not simply be treated like MDR/IVDR product families when planning. EUDAMED defines its own identification rules for legacy devices: EUDAMED DI and, where no UDI-DI has been assigned, EUDAMED ID. Official explanation of legacy identifiers.
Before generating XML, clarify which identifiers already exist, which legacy records are registered and which operation will be performed. The number of Excel rows alone cannot provide a reliable estimate of files or time needed.
Europe IT takes the relevant record type into account during data preparation. The example of a new Basic UDI-DI with 100 UDI-DIs is not a general template for MDD or legacy registrations.
When does XML Bulk Upload fit, and when is M2M worth considering?
A project-based XML process may fit if you want a defined dataset prepared and submitted for you. For frequent changes or an ongoing integrated workflow, GSP and GUDI should also be considered. The overall operating process, not a rigid volume category, determines the choice.
| Your need | What to assess |
|---|---|
| Have a completed Excel template converted to XML | XML service: data validation and file generation. |
| Have files uploaded for a specific project | Manual XML upload by Europe IT within the agreed scope. |
| Submit regularly from Excel yourself | GSP: portal, automatic pre-validation, customer-initiated sending and M2M submission to EUDAMED. |
| Maintain and submit UDI data in SAP | GUDI: data management, approvals, submission and authority feedback in the SAP/GUDI environment. |
Important: M2M can also process XML data and large data volumes. An XML export inside software does not make its submission process a manual XML Bulk Upload.
Frequently asked questions about EUDAMED XML Bulk Upload
Can Europe IT convert our Excel data into EUDAMED XML?
Yes. You complete the Europe IT Excel template. Europe IT validates the data and, after the identified errors have been resolved, generates XML files for the agreed EUDAMED operation.
Does Europe IT also handle the actual XML upload?
Yes. On request, Europe IT uploads XML files manually to EUDAMED on the customer’s behalf. Scope, permissions and handling of any follow-up work are agreed for each project.
Can I upload the Excel file directly to EUDAMED?
The EUDAMED Bulk Upload described here uses XML. The completed Excel template is the data source for validation and conversion by Europe IT, not the finished EUDAMED upload file.
Are no more than 25 UDI-DIs always permitted per XML file?
No such universal claim is made here. The grouping into batches of 25 on this page is a calculation assumption for subsequent files in a specific example. The service used, data structure and current technical specifications are authoritative.
Why does a new Basic UDI-DI also require a UDI-DI?
EUDAMED registration of a new Basic UDI-DI requires an associated UDI-DI with the necessary information. The example’s first file therefore contains both levels. The EU registration guide explains this requirement.
Does Bulk Upload mean everything is sent in a single file?
No. Bulk Upload is the file-based method for structured data. Which objects are submitted together and how many files are appropriate or required depend on the specific operation.
Is XML Bulk Upload the same as M2M?
No. XML Bulk Upload involves manually uploading a file in the EUDAMED interface. With M2M, exchange takes place between systems. That exchange can also use XML.
What information helps estimate the workload?
Useful information includes the data source, record types, number and relationships of Basic UDI-DIs and UDI-DIs, existing registration status and the service required: XML generation, manual upload or both.
Assess the upload effort based on your data
Have an Excel list but no reliable plan for XML files and EUDAMED uploads? Tell us about your data structure and intended outcome. Together, we clarify the appropriate scope for data validation, XML generation and manual upload.
Sources and technical context
The following English-language primary sources are published by the European Commission. They explain EUDAMED requirements; the Europe IT service described is separate from them.
- XML upload and M2M: official explanation
- Bulk Upload: workflow and responses
- UDI/Devices: Business Rules (PDF)
- Registration of MDR/IVDR devices
- Technical documentation: schemas and data definitions
- Identifiers for legacy devices (PDF)
Sources checked: . Technical rules and versions may change. The numerical example is explicitly a model calculation based on the stated assumptions.
