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GUDID · EUDAMED · UDI · Data Management

UDI Compliance —
US, EU, and Beyond.

End-to-end Unique Device Identification compliance for both FDA GUDID and EU EUDAMED — from initial setup and data management to bulk submissions and ongoing maintenance.

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Overview

UDI compliance is mandatory, multi-jurisdictional, and technically demanding. It intersects with labeling, quality systems, manufacturing, and postmarket surveillance — and errors in GUDID or EUDAMED can trigger FDA or competent authority inquiries. Mansour Consulting has executed large-scale UDI programs, including bulk EUDAMED submissions involving hundreds of devices.

FDA GUDID Compliance

We manage the complete GUDID submission process for your device portfolio — from initial account setup through ongoing data maintenance.

  • GUDID account setup and user administration
  • Device identifier (DI) and production identifier (PI) strategy
  • GUDID data element review and population
  • Bulk submission file preparation and upload
  • Label review for UDI marking requirements
  • Direct Mark exemption analysis
  • DSCSA compliance coordination for combination products

EU EUDAMED Registration

The European EUDAMED database imposes distinct requirements under EU MDR 2017/745 and IVDR 2017/746. We have hands-on experience with large-scale EUDAMED submissions, including complex batch upload projects.

  • EUDAMED actor registration and economic operator setup
  • UDI-DI and UDI-PI data preparation per EUDAMED schema
  • XML batch file preparation and validation
  • Business rule violation analysis and remediation
  • Class I, IIa, IIb, and III device registration
  • Legacy MDD device migration to MDR

We recently completed a 804-device EUDAMED bulk registration project across 34 XML batch files — resolving complex business rules.

UDI Labeling Review

UDI requirements extend to the physical label and packaging. We review labeling for full compliance across US and EU requirements.

  • UDI carrier format review (GS1, HIBCC)
  • Human-readable interpretation (HRI) requirements
  • Package level UDI applicability
  • Label change management within your QMS

Ongoing Data Management & Maintenance

UDI compliance is not a one-time event. Device changes, new product introductions, and annual reviews all require ongoing data management.

  • Annual GUDID and EUDAMED data review
  • Change management for device modifications
  • New product UDI integration
  • Training for internal UDI coordinators