Udi Labeling Generator

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