UDI Labeling Generator Skill

Purpose

The UDI Labeling Generator Skill creates compliant Unique Device Identification labels and manages device identifier assignments for FDA GUDID and EU EUDAMED submissions.

Capabilities

• •UDI-DI and UDI-PI generation
• •GUDID data submission preparation
• •Label content validation
• •IFU (Instructions for Use) template generation
• •Multi-language labeling support
• •Symbol compliance verification (ISO 15223-1)
• •Barcode generation (GS1, HIBCC, ICCBBA)
• •Label artwork review assistance
• •EUDAMED UDI registration support
• •Package hierarchy management
• •Date format standardization

Usage Guidelines

When to Use

• •Creating device labeling for regulatory submission
• •Registering devices in GUDID or EUDAMED
• •Designing label artwork and content
• •Validating labeling compliance

Prerequisites

• •Device identification information finalized
• •Issuing agency account established
• •Package configuration defined
• •Regulatory requirements identified

Best Practices

• •Establish UDI strategy early in development
• •Validate barcode readability across packaging
• •Ensure symbol usage meets ISO 15223-1
• •Maintain consistency across label variants

Process Integration

This skill integrates with the following processes:

• •510(k) Premarket Submission Preparation
• •EU MDR Technical Documentation
• •Design Control Process Implementation
• •Sterile Barrier System Validation

Dependencies

• •FDA GUDID API
• •GS1 standards and databases
• •EUDAMED system
• •ISO 15223-1 symbol library
• •Issuing agency interfaces

Configuration

udi-labeling-generator:
  issuing-agencies:
    - GS1
    - HIBCC
    - ICCBBA
  label-types:
    - device-label
    - package-label
    - shipping-label
  barcode-formats:
    - GS1-128
    - DataMatrix
    - QR-Code
  regulatory-regions:
    - FDA
    - EU-MDR
    - Health-Canada

Output Artifacts

• •UDI-DI assignments
• •UDI-PI format specifications
• •GUDID submission files
• •Label content templates
• •IFU drafts
• •Barcode specifications
• •Symbol usage guides
• •Multi-language label sets

Quality Criteria

• •UDI format complies with issuing agency requirements
• •Labels meet FDA 21 CFR 801 requirements
• •EU MDR Annex VI requirements satisfied
• •Symbols conform to ISO 15223-1
• •Barcodes meet readability specifications
• •Package hierarchy accurately represented