Data exists, but is not submission-ready
Required fields, relationships, and authority-specific structures are not yet complete or consistent.
UDI submission for medical devices and IVDs
Submit UDI data securely to EUDAMED, swissdamed, GUDID & AusUDID
Import structured UDI data from Excel, identify errors before submission, approve the transmission yourself, and track status and authority feedback in one central portal.
No in-house M2M development. No SAP requirement. With personal technical onboarding by Europe IT Consulting.
Non-binding initial assessment based on your target systems, data source, UDI volume, and mandates.
- Web-based SaaS solution
- Customer-controlled approval
- Multi-authority workflow
248Records
241validated
7to review
RecordValidationSubmission
Basic UDI-DI 001ValidReady
UDI-DI 00487ValidProcessed
UDI-DI 00488ReviewBlocked
Customer approvalYou decide when the data is submitted.
Schematic process view – functions and statuses depend on the agreed authority module.
500.000UDI records have been submitted to authorities via M2M using Europe IT UDI solutions
4key UDI target systems in one modular solution
Browserno SAP installation required for GSP
Controlfinal approval and submission by the customer
Your starting point
Your UDI data needs to reach the authority – not become another IT project
The challenge is rarely just the upload. What matters is complete data, traceable checks, controlled approvals, and clear feedback for every record.
Manual entry consumes Regulatory Affairs resources
Entering many UDI-DIs individually in authority portals is time-consuming and difficult to reproduce.
XML and M2M create technical complexity
Formats, interfaces, access credentials, and responses must be aligned from both a regulatory and technical perspective.
Multiple target systems create duplicate work
Similar product data must be processed differently for EUDAMED, swissdamed, GUDID, or AusUDID.
The GSP answer:Data import, pre-validation, approval, electronic submission, error handling, and status tracking in one controlled workflow.
UDI Submission Readiness Check
Does the Global Submission Portal fit your UDI project?
Answer five short questions. You will receive an immediate non-binding assessment and can transfer the information directly into a quote request.
- identify the appropriate solution path
- identify the authority modules you need
- structure data source, volume, and mandates
- prepare your request without entering the same data twice
From source data to authority feedback
Do more than upload. Know what happens to every record.
The operational process remains under control: prepare data, validate it, approve it, submit it, and handle feedback in a targeted way.
- 1
Prepare data
Use the appropriate authority-specific Europe IT template and provide UDI data in a structured format.
- 2
Import the file
Upload the Excel file in the licensed GSP module and process it for the intended workflow.
- 3
Identify errors in advance
Review missing, formally invalid, or visibly inconsistent information at record level.
- 4
Approve submission
The authorized customer confirms the validated data set and starts the electronic submission.
- 5
Track the result
Review file, record, and available authority statuses, correct errors, and resubmit when required.
Clear responsibilities: Europe IT provides the portal and the validation and transmission process. The customer is responsible for the regulatory content of its data and starts the final submission. The respective target system processes the submitted data.
Concrete value for Switzerland
Reuse EUDAMED data for swissdamed
Is your UDI data already available in EUDAMED? The Global Submission Portal can take over this data, process it for swissdamed, and submit it through the swissdamed M2M interface after your approval.
Important: Data reuse and synchronization take place through the Europe IT workflow. There is no direct database connection between EUDAMED and swissdamed.
Check an EUDAMED-to-swissdamed project1EUDAMED datareuse the existing data set
2GSP processingmapping, validation, and approval
3swissdamed M2Msubmit the approved data set
Choose the right submission route
Manual entry, XML, your own M2M connection, or GSP?
The right solution depends on data structure, frequency, target systems, and the level of process control you need – not just on a fixed record threshold.
| Criterion | Manual entry | XML bulk upload | Own M2M connection | Global Submission Portal |
|---|---|---|---|---|
| Data preparation | Individual entry in the portal | XML files per process | customer-owned systems | structured Excel template |
| Technical infrastructure | none required | XML generation required | develop and operate yourself | Europe IT transmission service |
| Pre-validation | depends on the authority portal | depends on the generation process | must be implemented by the customer | integrated into the GSP workflow |
| Status and errors | in the respective portal | spread across several steps | must be implemented by the customer | centrally traceable in the portal |
| Multiple target systems | separate portals | separate file processes | separate integration for each system | modular authority modules |
| Suitable when … | a small number of infrequent records are maintained manually | a clearly defined upload project is planned | an in-house integration platform is operated strategically | a controlled web-based submission workflow is required |
Practical assessment: GSP is particularly relevant when Excel or structured exports are the data source, multiple or recurring submissions need to be controlled, and no in-house M2M infrastructure should be built. For permanent UDI master data management in SAP, the Global UDI SAP Add-on should also be evaluated.
Product demo
See the controlled submission process in action
The demo shows how an authority-specific Excel file is imported, validated, approved by the customer, and tracked through record and authority status.
- Select a module and upload the Excel file
- Review errors and affected records
- Distinguish file, record, and authority status
- Evaluate feedback and prepare corrections
Experience from real projects
What customers say about working with us
The statements refer to the GSP, EUDAMED, or SAP UDI solution and collaboration described in each quote.
From interest to a concrete solution
You receive a project assessment – not a generic standard presentation
Based on your information, we assess target systems, data source, data volume, mandates, and operating model. You then receive the remaining information required and an individual quotation.
01Target systems and modulesWhich authority processes are required?
02Data source and structureExcel, ERP/PLM export, SAP, or existing EUDAMED data?
03Volume and mandatesUDI-DIs, Basic UDI-DIs, SRN, CHRN, DUNS, or sponsor.
04Concrete scope of servicesOnboarding, license, submission, and optional additional services.
Frequently asked questions
Key questions about UDI data submission with GSP
Short answers for Regulatory Affairs, Quality Management, and IT.
Go to the detailed technical GSP page →What is the Global Submission Portal?
The Global Submission Portal is Europe IT Consulting’s web-based UDI submission software. It combines structured data import, pre-validation, customer-controlled approval, electronic submission, and status and error tracking.
Do I need SAP for the Global Submission Portal?
No. GSP is used in the browser. No SAP installation or self-developed M2M infrastructure is required. For permanent UDI master data management within SAP, Europe IT also offers the Global UDI SAP Add-on.
Which target systems does GSP support?
Depending on the agreed product scope, modules for EUDAMED, swissdamed, FDA GUDID, and TGA AusUDID can be used. Exact availability, functions, and technical connectivity are confirmed in the quotation and onboarding.
How is Excel data submitted?
The customer uses the Europe IT template that matches the authority module and uploads it to the portal. After pre-validation, an authorized user confirms the valid data set and starts further processing and submission.
Can existing EUDAMED data be reused for swissdamed?
Yes. Within the Europe IT workflow, existing EUDAMED data can be reused, processed for swissdamed, and submitted through swissdamed M2M after customer approval. There is no direct database connection between EUDAMED and swissdamed.
Who starts the final submission?
The customer does. A file is first imported and pre-validated. When no blocking errors remain, the authorized user confirms the data set and starts the submission in GSP.
Is GSP suitable for one-time and recurring submissions?
Both can be possible. For recurring updates, the central workflow offers particular advantages. For a one-time, clearly defined project, it can also be assessed whether a project-based XML service is more economical.
How is the price determined?
Pricing depends on the required modules, UDI volumes, number of manufacturers or mandates, setup scope, and optional additional services. You receive a specific individual quotation before commissioning.
Check your UDI project
Request an individual quote for your target systems and data
Tell us the key facts. We will assess which workflow, modules, and setup scope fit your project.
- assessment of GSP, GUDI, or a project-based upload service
- concrete scope for modules, UDI-DIs, and mandates
- technical onboarding and next steps
- transparent individual quotation
No demo required.You can request a quote directly or arrange a live demo first.