Global UDI Regulatory Submission
Automate submissions to GUDID, EUDAMED, ausUDID, swissdamed and other UDI registries through a single, validated global UDI solution. Ensure FDA & EU MDR compliance while streamlining device submissions to multiple UDI databases worldwide through an audit-ready framework.
Understanding UDI
A quick overview of UDI fundamentals, regulatory requirements and benefits.
What is UDI?
Unique Device Identification (UDI) is a global regulatory framework designed to unambiguously identify medical devices from manufacturing through clinical use.
Core Components of UDI
A compliant UDI consists of a Device Identifier (DI) for the model and manufacturer, and Production Identifiers (PI) for variable data like lot numbers, serial numbers, manufacturing dates and expiration dates.
Global UDI Regulations
Major regulators including the FDA (USA), EU Commission, TGA (Australia) and Swissmedic (Switzerland) mandate UDI to strengthen post-market surveillance, streamline recalls, and improve global healthcare supply chain traceability and patient safety.
Device Submission Requirements
Beyond labeling, regulations mandate the submission of key device attributes to their registries such as GUDID, EUDAMED, ausUDID, and swissdamed. Critical data including packaging levels, sterilization status, and market authorization must be accurately maintained throughout the product lifecycle.
Benefits of UDI
Improved Patient Safety
UDI ensures unambiguous device identification at the point of care, enabling faster recalls and precise field safety corrective actions (FSCA).
Stronger Post-Market Surveillance
Standardized UDI supports regulatory vigilance to proactively monitor device performance, detect safety trends, and take timely, data-driven action.
End-to-End Device Traceability
UDI provides a consistent way to identify devices across the global supply chain, improving real-time transparency and reducing errors throughout the device lifecycle.
Regions with Advanced UDI Regulations
Device registration to GUDID is already mandatory for devices across all risk classes.
Learn MoreDevice registration to IMDIS is already mandatory for devices across all risk classes.
Device registration to J-Med Net is already mandatory for devices across all risk classes.
The UDI framework is still evolving post-Brexit with expected future alignment to EU MDR and other international standards.
UDI Devices module in swissdamed is now live with device registration becoming mandatory on 1 July 2026.
Learn MoreNMPA UDID rules already apply to high-risk devices with third-batch devices (including many Class II) required to be submitted from 1 June 2024.
Device submission to Saudi-DI is already mandatory for devices across all risk classes.
Device registration in AusUDID for Class III and Class IIb starts on 1 July 2026.
Learn MoreDevice registration to TUDID is already mandatory for all high-risk and moderate-risk devices.
Device submission to SMDR is in effect for Class D devices as of 1 November 2024, with Class C devices starting on 1 November 2026.
UDI data submission timelines to the SIUD is based on risk class with Class IV devices becoming mandatory on 1 September 2029.
The Complexity of Global UDI Regulatory Compliance
Navigating fragmented requirements, product data silos, and evolving submission standards across international markets.
Fragmented UDI Regulatory Requirements
Every region from the FDA (USA) and EU MDR (Europe) to TGA (Australia) and Swissmedic (Switzerland) has unique data attributes, formats, and submission deadlines. Manually tracking these evolving rules increases the risk of non-compliance and delayed market access.
Siloed Medical Device Data
Critical UDI attributes are often trapped in disconnected ERP, PLM, Excel or other applications. Without a single, centralized application to aggregate this product data, device manufacturers lack the unified environment needed to manage global UDI submissions.
Inefficient Manual Submission Processes
Relying on manual portal uploads is slow, error-prone, and unscalable. As device volume grows, the lack of automated Machine-to-Machine (M2M) connectivity creates a massive administrative burden and creates potential data quality issues.
Lack of Audit Trails and Version Control
UDI regulation requires a time-stamped history of every record change. Without a robust audit trail (compliant with 21 CFR Part 11 & Annex 11), manufacturers face significant liability when presenting digital evidence for device updates to global regulators.
Streamline Global Regulatory Compliance with a Unified UDI Solution
Centrally manage UDI data and automate submissions to global registries like GUDID, EUDAMED, ausUDID, swissdamed and more.
Centralized UDI Data Repository
Centralize global UDI device data coming from your PLM, ERP, Excel and other systems into a single authoritative repository.
Native UDI Data Validation
Validate UDI data natively against FDA, EU, TGA, Swissmedic and other global regulatory rules to ensure submission-ready data for UDI compliance.
Automated M2M Submissions
Automate secure machine-to-machine UDI data submissions and updates to global regulatory registries in their respective HL7 SPL, SOAP XML, and other formats.
Comprehensive Audit Trail & Submission History
Track every UDI data change and submission with time-stamped audit trails that support regulatory review and compliance with 21 CFR Part 11 & Annex 11 requirements.
How It Works
Best practice workflow for global UDI data management and submissions
Aggregate Device Data From Source Systems
Consolidate disparate device attributes from ERP, PLM, Excel and others into a single, centralized application for UDI data.
Maintain & Validate Data Against UDI Database Rules
Ensure submission-ready data by validating records against FDA (GUDID), EU (EUDAMED), TGA (ausUDID), Swissmedic (swissdamed), and other regulatory rules.
Automate Submission to UDI Databases
Streamline device submissions to UDI databases with secure, automated M2M submissions in their respective HL7 SPL, SOAP XML and other formats.
Monitor Status & Track Submission History
Maintain a full audit trail of UDI data changes and time-stamped submission history to support 21 CFR Part 11 and Annex 11 compliance.
Built for Every Stakeholder
Different teams, different priorities – one enterprise UDI solution that delivers value across your organization.
Regulatory Affairs (RA)
Accelerate global market access with submission-ready UDI Data
Global UDI Data Management
Global UDI Data Management – Manage GUDID, EUDAMED, ausUDID, swissdamed, and other UDI database attributes within a single, unified interface.
Native UDI Data Validation
Utilize a built-in rules engine to catch UDI data errors before they reach regulators, significantly reducing submission rejection rates.
Direct M2M Connectivity
Submit device data instantly to regulators via HL7 SPL, SOAP XML, or other native formats, eliminating manual, error-prone portal entries.
Supply Chain & Operations
Simplify UDI data management and workflow
Streamlined Data Collection
Automatically aggregate UDI attributes from ERP, PLM, and Excel to eliminate manual data entry and reduce clerical errors across the supply chain.
Flexible Approval Workflows
Configure review and approval routings that adapt to your internal SOPs, ensuring data accuracy before it reaches UDI regulators or the production floor.
Centralized UDI Data Repository
Establish a single, authoritative repository for all device identifiers and UDI attributes to drive alignment between UDI regulatory databases and physical labels.
MDM/PIM
Leverage your golden product record for UDI without rework or data duplication
Seamless UDI Data Onboarding
Ingest standardized product data directly from your MDM/PIM systems to eliminate redundant data entry and preserve your existing data investments.
Flexible Attribute Mapping
Map and transform product attributes from MDM/PIM systems to UDI fields, ensuring alignment with enterprise data models and regulatory requirements
Bi-Directional Data Synchronization
Sync relevant UDI-enriched product data back to your MDM/PIM system to continuously enhance and maintain the integrity of your product’s golden record.
Information Technology (IT)
Establish secure & scalable infrastructure for global UDI compliance
Seamless System Integration
Connect via flat-file transfers (CSV/Excel/XML), or APIs to consolidate device data from your PLM, ERP, Excel and other systems.
Enterprise-Grade Security & RBAC
Protect sensitive product data with Role-Based Access Controls (RBAC), Single Sign-On (SSO), and advanced security protocols.
Flexible Hosting Models
Choose the deployment that fits your IT strategy with options for Public Cloud, Private Cloud, or Hybrid hosting to balance scalability with control.
Quality Assurance (QA)
Ensure quality standard compliance & audit readiness
Validation-Ready Software Environment
Deploy a solution that supports GAMP 5 system validation requirements for the highest levels of system quality and reliability.
Immutable Audit Trails and eSignature
Maintain complete, time-stamped records and electronic signatures that fully satisfy 21 CFR Part 11 and EU Annex 11 requirements for data integrity.
Compliance with Quality and Security Standards
Ensure alignment with global benchmarks including GAMP (Software Quality), ISO 27001 (Information Security), and SOC 2 Type II standards.
Why Medical Device Manufacturers Choose Innovit
Industry expertise, proven solution, and strategic focus on bringing quality to healthcare master data
Deep Medical Device & Healthcare Specialization
Leverage 25 years of experience in healthcare master data management, supported by strategic memberships & partnerships with key industry players including MedTech Europe, GS1 Healthcare, HTG, and USDM Life Sciences.
Proven & Scalable Enterprise Solution
Trust a battle-tested UDI compliance software used by the world’s leading medical device manufacturers to manage millions of device records & automate high-volume submissions to GUDID, EUDAMED, and other global registries.
Rapid Deployment & Time-to-Value
Deploy faster with a structured implementation methodology, an easy-to-use interface, and an embedded knowledge center. Our on-hand expert support ensures your team is confident from initial deployment through daily use.
Uncompromising Security & Quality Standards
Protect your data integrity with a platform designed for the most rigorous requirements, including GAMP 5 system validation, ISO 27001, SOC 2, 21 CFR Part 11, and EU Annex 11 compliance standards.
Trusted By
Industry Leaders
We’re proud to work alongside industry-leading healthcare brands that trust us to drive innovation and success.
What Our Customers Say
Reliable Data
Quality
Increased
Efficiency
Accelerated
Compliance
Customer Success Story
B. Braun Streamlines UDI Data Submission to EUDAMED with Innovit EUDAMED Connector
The Problem
B. Braun, a global medical leader, faced challenges submitting high-volume UDI data to EUDAMED. Relying on SAP ERP data, they required a robust solution to ensure data quality, manage complex attribute mapping, and eliminate risks from manual entry and inconsistent submissions across their global product portfolio.
The Solution
B. Braun implemented Innovit’s EUDAMED Connector to create an automated UDI compliance workflow. The solution onboards SAP data, validates it against EUDAMED rules, and utilizes M2M technology via AS4 for secure submissions. This GAMP 5-ready environment provides real-time monitoring, ensuring 100% transparency and accountability.
Reliable Data
Quality
Increased
Efficiency
Accelerated
Compliance
Ready to Streamline Your Global UDI Compliance?
Simplify global UDI data submissions, ensuring quality & security, and accelerating market access.
Ready to Streamline Your Global UDI Compliance?
Simplify global UDI data submissions, ensuring quality & security, and accelerating market access.