CASE STUDY · MEDTECH · EXCEL AND PROJECT SUPPORT

Prepare UDI data for EUDAMED with Excel: structure without another major IT project

A specialised MedTech company needs a clear route from its device data to submission with limited internal resources.

This anonymised Europe IT Consulting case combines the MDR/IVDR Excel template, data checks and supported submission. The company has no SAP system for UDI and uses its existing Office and ERP environment.

The lesson is not “small portfolio means Excel”. The relevant factors are available data, responsibilities, change effort and the desired operating model. The template supplies the data basis; submission remains a separate process.

Limited capacity, many data questions

The existing report describes a Polish MedTech company specialising in minimally invasive diagnostic devices for cardiology. A small Regulatory Affairs team had to prepare EUDAMED device information without introducing extensive new IT infrastructure.

Challenges included data structure, XML expertise, content questions and a tight schedule. Information had to be gathered from existing sources. Choosing a spreadsheet did not automatically solve those tasks.

Three components with different responsibilities

The Excel template

Defined fields, structure and entry aids help collect the required information. The workbook does not replace a full substantive review.

Review and clarification

Europe IT checks the supplied data within the agreed scope. Open questions and content corrections are addressed with the customer.

The submission process

Technical preparation and transfer follow the selected route. Generating XML and uploading it manually is different from M2M.

MDR/IVDR Excel template in detail · Distinguish XML and M2M correctly

How data preparation was organised

1. Discuss requirements and explain the structure

Initial consulting clarified device structure and specific data characteristics. The customer received the appropriate template and an introduction to worksheets, field formats and working principles. The aim was to make the required information understandable.

2. Collect data and resolve questions

The customer entered information in Excel using the available entry aids. Europe IT supported preparation and checked the supplied data. Unclear or contradictory information was discussed before further processing.

3. Prepare processing and submission

The report describes delivery of the completed workbook, checks before conversion, creation of the required format and connection to a transfer process. Validation and processing results were to be associated with the supplied data version.

4. Review results and future changes

Available feedback must be evaluated after submission. This includes deciding who maintains changes and initiates corrections or retransmission. The first upload is therefore not the end of the collaboration.

Which transfer route belongs in your project?

The case does not establish that every Excel request follows the same technical route. For current projects, distinguish two confirmed Europe IT processes:

XML project for EUDAMED

On request, Europe IT validates the completed template data, generates the necessary XML files after error-free validation and uploads them for the customer through EUDAMED’s manual upload process. File splitting and upload steps matter.

Global Submission Portal

The customer uploads the completed template to GSP and initiates transfer after successful automatic validation. GSP uses M2M/Data Exchange for EUDAMED.

Without project evidence, the historical route in this anonymised case must not be equated with either current operating model. For solution selection: UDI Data Submission and Global Submission Portal.

Practical benefits of the approach

  • Use the existing working environment: data collection can begin in a familiar Excel structure.
  • Identify questions earlier: clarify field mappings and data relationships before transfer.
  • Add targeted technical support: the customer team need not develop its own XML project solely for a submission.
  • Retain responsibility for data content: support with validation and processing does not replace the accuracy of the customer’s device information.
  • Plan evidence: keep data versions, checks and results traceable together.

The approach aims to reduce avoidable rework. It cannot generally promise fixed cost savings, error-free acceptance or a specific project duration. Effort and outcome depend on data quality, relationships, permissions and feedback, among other factors.

When is an Excel-based starting point appropriate?

Excel can fit when structured source data is available, the team can control maintenance and the transfer needs fit the selected workflow. Device count alone does not decide this.

For frequent changes, multiple authorities and growing coordination needs, a portal or integrated data management may provide greater relief. Assess GUDI particularly when SAP is the appropriate environment; it is not an automatic growth step for every company.

Five working principles follow from the case: Structure data early, clarify responsibilities, consolidate questions, document results and plan updates from the start. A personal contact helps with the process, but fixed response times or priority support must be agreed separately.

Expansion to further markets mentioned in the original report remains an outlook. This page does not claim additional authority modules have already been implemented.

Want to start without a major IT project?

Describe your data source, target authorities and planned change frequency. Europe IT helps identify an appropriate preparation and transfer process.

View the template · Structure submission evidence · UDI guide

Editorial status: 4 September 2026. Anonymised case based on the existing Europe IT publication; no guaranteed outcomes for subsequent projects.