Global UDI & EUDAMED: Preparing for Traceability

Unique Device Identification (UDI) is transforming how medical devices are tracked and monitored across their lifecycle. The system is simple in concept: assign a globally unique identifier to every device and link it to key information in regulatory databases. In practice, however, implementing UDI across multiple markets is complex, resource-intensive, and increasingly non-negotiable.

As of 2025, the U.S., EU, China, Brazil, Japan, South Korea, and other jurisdictions have all introduced UDI systems. Europe’s EUDAMED database is moving toward full functionality, with mandatory use expected in 2026. Manufacturers that are not already prepared risk market disruption.

Regulatory Landscape

United States

The FDA’s UDI rule is fully in effect. All device classes must carry UDIs on labels and packaging, and data must be submitted to the FDA’s Global UDI Database (GUDID). Enforcement actions now focus on data quality, with FDA warning firms for incorrect or incomplete entries.

European Union

Under MDR and IVDR, UDI requirements are phased in by risk class. Basic UDI-DIs must be assigned, and device identifiers uploaded to EUDAMED. While some modules of EUDAMED remain voluntary, the European Commission has confirmed full functionality will trigger mandatory use, expected in 2026. Manufacturers should not wait.

China

NMPA has rolled out UDI requirements in stages. Class III devices and many Class II devices must now carry UDIs and be registered in China’s UDI database. Enforcement is strict, with customs inspections checking for UDI compliance.

Other Markets

Brazil (ANVISA), Japan, South Korea, Australia, and Saudi Arabia are at various stages of UDI implementation. Many align with IMDRF UDI standards, but local differences remain.

Why UDI Matters

Regulators and healthcare systems view UDI as critical for:

• Traceability: Rapid identification of affected products in recalls.

  
  

• Patient Safety: Linking devices to patients and outcomes.

  
  

• Data Quality: Enhancing PMS and vigilance by tying incidents to specific device versions.

  
  

• Procurement and Inventory: Hospitals increasingly require UDI for supply chain management.

  
  

For manufacturers, UDI is both a compliance requirement and a commercial necessity.

Practical Implementation Steps

1. Assign UDIs via Accredited Agencies: Use GS1, HIBCC, or ICCBBA depending on product type and market. Ensure consistent assignment across geographies.

   
   

2. Update Labeling Systems: Integrate UDI into artwork and packaging processes. Barcodes must be scannable and compliant with issuing agency standards.

   
   

3. Submit to Databases: Prepare data submissions for FDA GUDID, EU EUDAMED, and China NMPA’s system. Ensure accuracy and consistency.

   
   

4. Integrate with ERP and QMS: UDI data should flow seamlessly into manufacturing, distribution, and complaint handling systems. This supports PMS and recalls.

   
   

5. Train Staff: Ensure regulatory, quality, supply chain, and IT teams understand their roles in maintaining UDI compliance.

   
   

Challenges and Case Examples

• Data Quality Issues: FDA has cited firms for incomplete or inaccurate GUDID entries. Errors in device description or identifier fields can result in compliance findings.

  
  

• Global Complexity: A manufacturer discovered its UDI assignment was inconsistent between U.S. and EU markets, creating confusion and requiring re-labeling.

  
  

• Supplier Dependencies: Some companies rely on contract manufacturers for labeling but failed to provide clear UDI requirements, leading to noncompliance.

  
  

Strategic Implications for Leadership

For executives, UDI and EUDAMED are more than regulatory hurdles. They are strategic enablers of supply chain efficiency and market credibility. Hospitals prefer suppliers with robust traceability. Regulators expect transparency.

QA/RA leaders must ensure UDI is integrated into the quality system. Operations leaders must coordinate labeling and data management. IT teams must support database integration and data quality monitoring.

Final Thoughts

Global UDI and EUDAMED requirements are reshaping device compliance and market access. Companies that implement strong UDI systems will not only avoid disruptions but also gain efficiencies and credibility.

How PRP Compliance Can Help: We help clients design global UDI strategies, manage labeling and database submissions, and ensure end-to-end traceability. Contact PRP Compliance to get your UDI systems ready before deadlines close.