UDI & EUDAMED Management
From Technical Documentation Straight into EUDAMED
Because UDI data is TD data. Maintain Basic UDI-DIs and UDI-DIs once in your electronic Technical Documentation, sync them with EUDAMED and export registration-ready XML. No redundant EUDAMED database.
Single Source of Truth
One centralized UDI database integrated with your technical documentation
Audit Trail
Complete traceability with versioned snapshots and sync history
EUDAMED Ready
API sync and XSD-validated XML export for EUDAMED. MDR and IVDR.
No Redundant EUDAMED Database
Do not maintain a redundant EUDAMED UDI database. Because UDI data is already part of your digital technical documentation.
With meddevo, your UDI data is seamlessly integrated into your electronic Technical Documentation (eTD), eliminating the need for separate management.
- Single source of truth for all UDI data
- Complete audit trail for regulatory compliance
- Excel import/export and EUDAMED XML export
Reuse UDI Data Across Your Portfolio
meddevo keeps a single source of truth. You can use your UDI data anywhere you want to automate processes and documents. All data is managed in compliance with EUDAMED requirements.
Leverage your UDI data for automated document generation, including Declarations of Conformity, labels, and more.
What is UDI?
A Unique Device Identifier (UDI) is a system that uniquely identifies medical devices within the healthcare supply chain. It's a global initiative aimed at improving patient safety, modernizing device post-market surveillance, and facilitating medical device innovation.
UDI-DI
The Device Identifier (DI) is a fixed portion that identifies the specific version or model of a device and the labeler.
UDI-PI
The Production Identifier (PI) is a variable portion that identifies the unit of device production including serial number, lot, and expiration date.
Global Standards
UDI follows international standards (GS1, HIBCC, ICCBBA) to ensure global interoperability and traceability.
Why is UDI Important?
The implementation of UDI is a significant step towards more transparent and efficient healthcare systems. It allows for better traceability of medical devices, improved patient safety, and more effective post-market surveillance.
UDI helps healthcare providers and regulators in their decision-making processes, enabling faster identification of device-related issues and more efficient recalls when necessary.
Patient Safety
Unique identification enables rapid response to safety concerns
Supply Chain Efficiency
Streamlined logistics and inventory management
Regulatory Compliance
Meet MDR, IVDR, and FDA UDI requirements
Post-Market Surveillance
Efficient tracking and monitoring of devices in the field
Our UDI Management Solution
At meddevo, we understand the complexities of UDI (Unique Device Identifier) management in the medical device industry. Our UDI Management solution is designed to simplify this process, ensuring compliance with international regulations while enhancing traceability and patient safety.
Integrated Data Management
Our solution integrates UDI data directly into your electronic Technical Documentation (eTD), eliminating data duplication and ensuring consistency across all your regulatory documentation.
Manage UDI data with full version control and change history for complete audit compliance.
Automation & Efficiency
Leverage your data across and create regulatory documents automatically.
The export validation reports every issue with a code and lists every skipped entry with its reason, so nothing reaches EUDAMED unchecked.
Everything You Need for UDI Compliance
A comprehensive digital platform for medical device UDI management, connected to EUDAMED
Single Source of Truth
Centralized UDI database integrated with your technical documentation for consistency.
Complete Audit Trail
Full version history, sync jobs and snapshots for regulatory compliance and audits.
Multi-Product Support
Manage UDI data across your entire product portfolio from one platform.
Document Automation
Automatically populate Declarations of Conformity and other documents with UDI data.
EUDAMED Integration
Coming SoonExport UDI data in EUDAMED-compatible formats for seamless submission.
Intelligent Validation
Built-in validation against the EUDAMED business rules, with error codes, before anything leaves your system.
Ready to Transform Your UDI Process?
Want to learn more about automation of regulatory processes and technical documentation? Get started with meddevo today.
Schedule a demo to see UDI Management in action
Discuss your UDI requirements with our team
Import your existing UDI data and connect your SRN
Register and update devices in EUDAMED from your eTD
Ready to simplify your UDI management?
meddevo UDI Management is the single source of truth for your UDI data, integrated directly into your electronic Technical Documentation and connected to EUDAMED.
MDR and IVDR ready. EUDAMED sync and XML export included.
No credit card required. See the demo or contact us to learn more.