FDA · UDI · GUDID
FDA UDI and GUDID: prepare, submit and maintain device data
Europe IT Consulting supports medical device companies with FDA UDI projects, from master data and labelling to submission to the Global Unique Device Identification Database (GUDID).
UDI identifies a medical device. GUDID is the FDA database for associated device information. Implementation requires device data, labelling and the submission process to fit together. Whether you start with Excel or already manage UDI data in SAP, reliable sources, clear responsibilities and an appropriate transfer method are essential.
Find the fundamentals and the route to a suitable Europe IT solution here. For incident reporting rather than device data, the separate FDA eMDR page takes you to the correct process.
UDI, DI and PI explained
The FDA UDI rule applies to the device labeler — often, but not always, the manufacturer. Responsibilities generally include UDI labelling and providing device information in GUDID, taking account of exemptions and alternative provisions.
- Device Identifier (DI): the fixed identification component for the labeler and a specific device version or model.
- Production Identifier (PI): the variable component, such as lot, serial number or expiry date, where included on the label.
The UDI is represented in human-readable and machine-readable form. Source: FDA UDI Basics.
Important for your data structure: GUDID does not store individual lot or serial numbers as PI values. It does record which PI types are part of the UDI. Source: FDA GUDID overview.
Which requirements apply to your devices?
A generic Class I, II and III deadline table is not enough for a reliable assessment. Labelling, direct marking and GUDID submission must be considered separately. Device type, exemptions and relevant FDA policies can affect the assessment.
Use the current FDA Compliance Policies and UDI Rule Compliance Dates. Historic implementation dates are not a general future schedule for a new project.
When scoping your project, we clarify:
- Which devices and packaging levels are in scope?
- Who is responsible for labeler data and device labelling?
- Which information is in the ERP, and what needs to be added?
- How are changes reviewed, approved and resubmitted?
How does data reach GUDID?
The FDA distinguishes manual entry in the GUDID web application from submission of HL7 SPL XML through its Electronic Submissions Gateway. For the file-based route, required accounts and tests form part of preparation. Official guide: Submit Data to GUDID.
An Excel file is the data source, not the authority’s XML format. Conversion, validation and sending are separate steps. The right solution depends on data quality, change frequency and operating model as well as record volume.
Find current gateway guidance at ESG NextGen. Do not use old WebTrader or WTHS instructions for new onboarding without checking them.
From Excel to SAP: Europe IT supports your GUDID process
Prepare data with Excel
Structure device information, packaging details and other required attributes. The template supports data entry; conversion and transfer are selected separately.
Work in the GSP portal
In the Global Submission Portal, the customer uploads the completed module template. Following automatic validation and error correction, the customer initiates transfer. Status and feedback support subsequent processing.
Use GUDI in SAP
GUDI connects UDI data management in SAP with authority modules. The customer submits from GUDI and can track submission status and authority feedback.
Want to discuss data preparation, submission scope or a defined project first? Our UDI data submission overview helps you choose. Information on the existing FDA module is also available under UDI solution for the FDA.
Consulting, labelling and technical implementation
A successful data process starts before sending. Europe IT supports you in these established areas:
- Gap analysis: align master data, labelling systems and GTIN management.
- UDI attributes: map existing data and identify content gaps.
- Labelling and print management: implement device information and labelling consistently.
- GS1 barcode consulting: for example GS1-128 and GS1 DataMatrix in SAP.
- GUDID transfer: prepare data for the agreed HL7 SPL process.
- Onboarding support: prepare accounts, permissions, required testing and production setup using current FDA guidance.
Scope and responsibilities are defined for your project. FDA review or approval remains an authority step. Further support: MedTech consulting and GS1 barcode generator for SAP.
A look at the existing solution
FDA UDI and GUDID FAQ
Can I register devices in AccessGUDID?
AccessGUDID is the public search service. You can search and retrieve device data there; use the designated GUDID process for submission. Open AccessGUDID.
Do I need SAP to use GUDID?
No. In addition to the SAP-based GUDI route, Europe IT offers Excel and portal processes. The choice depends on where your data is maintained and how you want to operate the process.
Are GUDID and eMDR the same?
No. GUDID concerns device information; eMDR concerns electronic incident reports. Each requires its own data and checks. For case reports, use the eMDR page.
Does Europe IT make all substantive corrections?
In the described GSP/GUDI process, the customer corrects content errors and initiates resubmission. Additional support is agreed as a separate service scope.
Define your FDA UDI project
Tell us which source data you have and whether you need an Excel, portal or SAP process. We help you identify the next steps.
Get in contact with usOfficial FDA sources, guides and support
Regulatory sources checked on . Individual requirements must be checked for the device and process.
