udi-labeling-generator

name	udi-labeling-generator
description	Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers
allowed-tools	["Read","Write","Glob","Grep","Edit","Bash"]
metadata	{"specialization":"biomedical-engineering","domain":"science","category":"Regulatory Compliance","skill-id":"BME-SK-004"}

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