Regulatory software creates the greatest value not by offering as many functions as possible, but by supporting a specific process reliably, transparently and with clear responsibilities.
A recent article by VDE Health, published on 26 August 2026, “Compliance software for Regulatory Affairs in medical devices: an overview of tools and services”, categorises compliance software for medical devices along the entire product lifecycle: from eQMS, development and risk management to Regulatory Information Management, UDI, registration and labelling. Its central point is highly relevant in practice: it is not the broadest functional scope that matters, but the fit with products, target markets, data and the actual regulatory processes.
For many manufacturers, the immediate digitalisation need does not begin with a full RIM or eQMS project, but with a clear question: How can UDI data from existing sources be checked, approved, submitted to the relevant authorities and traceably updated when changes occur?
Regulatory software: different tasks, different tools
eQMS and development
These systems manage, for example, documents, CAPA, changes, training, risks and development evidence. They support the quality management system, but do not replace expert assessment.
RIM and market access
Regulatory Information Management systems support international product, registration, certificate and country data, as well as deadlines and portfolio analyses.
UDI, registration and submission
This area focuses on structured product data, validation, labelling, approval and submission to authorities such as EUDAMED, swissdamed, FDA GUDID or AusUDID.
What Europe IT specifically covers in this area
In this context, Europe IT is not a complete eQMS or a comprehensive RIM system. The focus is on the operational UDI layer: preparing product data for authority processes, technically validating it, submitting it within the agreed process and making the processing status traceable.
The practical difference lies in connecting the data source with the submission route. Manufacturers can start with Excel data or manage UDI data in an SAP environment. Rather than introducing a new end-to-end system for every case, the process is selected according to whether it concerns a defined data set, a recurring portal process or SAP-integrated data management.
This scope is intentionally focused: regulatory decisions, data content, approvals and the assessment of authority feedback remain with the manufacturer. The solution supports the controlled process, but does not replace Regulatory Affairs responsibility.
Which UDI process fits which starting point?
The three routes do not differ solely by the number of UDI-DIs. The data source, frequency, preferred way of working and day-to-day division of responsibilities are all decisive.
| Starting point | Relevant consideration | Further information |
|---|---|---|
| A defined data set to be prepared as XML files | XML project: structure and validate data, generate suitable XML files, and define responsibility for upload and feedback within the project. | EUDAMED XML Bulk Upload |
| Recurring UDI submissions based on structured Excel data | Portal process with import, pre-validation, customer-controlled submission, and status and error handling in the agreed process. | Global Submission Portal |
| UDI data is to be maintained, approved and reused in SAP | SAP-integrated process with UDI data management, authority-specific information, approvals and submission from the GUDI environment. | Global UDI Add-on for SAP |
Determine the right route based on your own process
A decision based only on data-volume tiers is too limited. First clarify where the authoritative product data is held, whether the process is one-off or recurring, and who checks and approves data and handles authority feedback. On this basis, the appropriate submission route can be selected transparently.
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