Europe IT knowledge portal · Unique Device Identification
UDI guide for medical devices: fundamentals, authorities and data transmission
Unique Device Identification (UDI) connects the unique identification of medical devices with structured product and labelling data. The data maintained and the database to which it is submitted depend on the market and applicable regulatory framework.
This guide helps Regulatory Affairs, Quality, Master Data and IT teams find the right specialist page: from UDI-DI, UDI-PI and Basic UDI-DI through EUDAMED, FDA GUDID, swissdamed and TGA AusUDID to data validation, XML bulk upload, M2M, GSP and GUDI. First select your question. The linked detail pages then explain the relevant process.
Quick start for your situation
Which topic path leads to the right answer?
Start with the problem you need to solve. The guide assigns each question to a specialist page instead of mixing every topic on one page.
I want to understand UDI terminology
Start with the glossary, then explore identifiers, labelling and barcodes on the specialist pages.
I need to register for a specific market
First select the EU, USA, Switzerland or Australia. For other markets, the global UDI overview links to the available information.
I need to prepare or validate data
Clarify the data source, responsibilities, data model and checks before selecting a transmission method.
I am comparing EUDAMED transmission methods
Manual entry, XML bulk upload and M2M are technical methods. Excel, GSP and GUDI fulfil different roles in the overall process.
I have an error or authority feedback
First identify the message and affected record. Then correct, check and document the resubmission.
I am looking for a solution or specialist support
Compare project-based support, the web-based GSP and SAP-integrated UDI data management with GUDI.
UDI fundamentals for medical device manufacturers
In brief: UDI is a system for uniquely identifying medical devices. In practice, labelling, internal master data and database information required for the target market must work together consistently. Specific information requirements are explored on the relevant market and authority pages.
UDI-DI
The Device Identifier identifies the relevant product or product model in its UDI context. Its relationships to other records must be unambiguous in the data model.
UDI-PI
The Production Identifier denotes the production-related components of the UDI. Data maintenance and labelling must distinguish the intended PI types from the actual information on the product.
Basic UDI-DI
In the European context, Basic UDI-DI is a higher-level regulatory identifier. It is not the same as the UDI-DI of an individual product record; its assignment requires a substantive decision.
Read more: UDI/MDR/IVDR terminology · UDI barcodes and labelling · UDI compliance, audit trail and software
Clarify the target market first
UDI by market and authority
The fundamental UDI concept is internationally compatible, but data models, processes and technical transmission methods are market- and authority-specific. For each region, use the relevant specialist page and current primary documentation from the responsible authority.
| Market | Database / context | Where to start | Further detail |
|---|---|---|---|
| European Union | EUDAMED / UDI and product data | EUDAMED overview | Transmission methods Excel template |
| USA | FDA GUDID | The FDA UDI system | FDA GUDID Excel template |
| Switzerland | swissdamed | swissdamed overview | swissdamed Excel template EUDAMED → swissdamed |
| Australia | TGA AusUDID | TGA AusUDID overview | AusUDID Excel template |
| Other markets | Market- and authority-specific UDI systems | UDI worldwide overview | Check the specific market and current technical/regulatory position separately. |
Prepare, validate and transmit UDI data
A reliable UDI process starts before upload. Separate the data source, Europe IT solution, technical transmission method and operating model. This makes the actual role of an Excel file, portal, SAP solution or service clear.
Level 1
Data source
Excel, SAP, ERP, existing database or other structured source data.
Level 2
Solution
GSP, GUDI, XML project process, data preparation or consulting.
Level 3
Transmission method
Manual entry, manual XML upload or M2M / Data Exchange.
Level 4
Operating model
One-off or regular transmission, software operation or project support.
Validation is not transmission. Data checks can reveal detectable errors before submission. Only the subsequent submission process transmits the data. Successful pre-validation is not yet final acceptance by the authority.
Relevant specialist pages: UDI Data Submission · EUDAMED transmission methods · EUDAMED error library
EUDAMED workflow for RA/QA
From the decision to documented feedback
The three existing core guides remain part of this resource. Together with the overview and FAQ, they form a traceable EUDAMED path.
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Understand EUDAMED and its data context
Start with the Europe IT overview, then verify regulatory details in the European Commission’s current documentation.
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Select the transmission method and operating model
Compare manual entry, XML bulk upload and M2M, alongside the roles of Excel, GSP, GUDI and the Europe IT XML service.
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Handle data errors and authority feedback
Assign messages to the correct record, establish the cause and check the result of retransmission after correction.
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Traceably link the data version, checks and feedback
Connect internal data versions, approval, available validation results, submission and authority feedback. The Evidence Pack guide helps organise this structure without guaranteeing an audit outcome.
Further questions: EUDAMED FAQ
Europe IT solutions for operational UDI processes
The guide provides specialist orientation. For operations, we distinguish data preparation, project-based support and software solutions. The appropriate role must be clear before a project begins.
Data source
Excel templates
Authority-specific templates support structured data provision and internal checks. A completed template is not yet a transmission to an authority.
Project support
XML and UDI Data Submission
Europe IT can validate customer data, generate the agreed XML files and manually upload them on request within the confirmed EUDAMED process.
Web portal
Global Submission Portal
GSP connects Excel import, pre-validation, customer-controlled transmission, status and authority feedback. It uses M2M / Data Exchange for EUDAMED.
SAP-integrated
Global UDI / GUDI
GUDI supports UDI data management and transmission to authorities in SAP. The customer maintains, checks and transmits data from GUDI.
Important: GSP and GUDI are two different Europe IT solutions. M2M is the technical transmission method to EUDAMED within each process — not a generic standard interface installed at the customer’s premises.
Practical knowledge: evidence, case studies and training
A guide explains a working method, a case study describes a specific context and a webinar documents the position at the event date. These resources complement the authority and product pages.
Work with SAP
How data transfer, roles and approvals work together in an SAP-based UDI project.
Prepare with Excel
How structured templates, data checks and supported transmission facilitate a project-based start.
Structure submission evidence · Find webinars and training · Look up terms in the glossary
UDI consulting, webinars and further learning
Not every question starts with a software decision. Europe IT also helps assess requirements, prepare data and plan an appropriate UDI process. Consulting, existing webinars and the global market overview offer a structured starting point.
Frequently asked questions about the UDI guide
Who is the UDI guide for?
It is intended particularly for medical device manufacturers and Regulatory Affairs, Quality, Master Data and IT teams. It provides a starting point and links to Europe IT’s detailed specialist and solution pages.
Where do I start when introducing UDI?
First clarify target markets, product portfolio, responsible parties and data sources. Then define identifiers and record relationships. Only then select validation, transmission method and operating model.
Which UDI database is relevant for my market?
The market determines the relevant database or authority. This guide links to EUDAMED for the EU, FDA GUDID for the USA, swissdamed for Switzerland and TGA AusUDID for Australia. For other markets, use the global UDI overview and check current primary sources.
Can I transmit UDI data from Excel?
Excel can serve as a structured data source. The file itself is not automatically a transmission to an authority. Depending on the target system and operating model, it is followed by manual entry, an XML process, upload to GSP or another confirmed submission option.
How does data validation differ from UDI Data Submission?
Validation checks data before transmission against the rules and structures implemented in the process. Submission means the subsequent filing or transmission. After submission, the authority’s processing result must also be checked.
When do I need GSP and when GUDI?
GSP is the web portal solution for structured upload, validation, submission and status processes without requiring SAP-integrated UDI master data management. GUDI is designed for maintaining and transmitting UDI data in SAP. The choice depends on data sources, organisation and desired operations.
Is the regulatory information in this guide always up to date?
Europe IT can update specialist pages, but authorities may change rules, technical documents and dates. Before making a decision, verify changeable regulatory and technical statements in the responsible authority’s current primary documentation. Each detail page should show its information date.
Primary sources and currency
This UDI guide provides orientation. For changeable regulatory or technical information, the responsible authorities’ publications govern. The following links are starting points; check document versions and scope before use.
Would you like to assess your specific UDI process?
Tell us your target markets, data sources, UDI data volume and structure, and planned transmission frequency. Together, we can establish whether consulting, a project-based submission process, GSP or GUDI fits your situation.
