Traceability

Traceability is a critical regulatory requirement that ensures medical devices can be tracked throughout their lifecycle—from raw materials and components through manufacturing, distribution, clinical use, and eventual disposal or return. This capability is essential for patient safety, recall management, and post-market surveillance.

Why Traceability Matters:
- Rapid and effective product recalls
- Adverse event investigation
- Counterfeit device prevention
- Supply chain security and verification
- Post-market surveillance data collection
- Inventory and expiration management
- Regulatory compliance demonstration

Unique Device Identification (UDI) System:

The UDI is a global system that provides unique numeric or alphanumeric codes for medical devices:

UDI Components:
- Device Identifier (UDI-DI) - Specific to device model and version
- Production Identifier (UDI-PI) - Lot/batch number, serial number, expiration date, manufacturing date

UDI Implementation by Region:
- USA (FDA) - Mandatory since 2013-2022 (phased by class)
- EU (EU MDR) - Required under EU MDR Article 27
- China (NMPA) - Implemented since 2021
- Australia, Brazil, Saudi Arabia - Following similar UDI requirements

UDI Issuing Agencies:
- GS1 (most common globally)
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (International Council for Commonality in Blood Banking Automation)

Traceability Throughout Supply Chain:

Manufacturing Level:
- Raw material and component tracking
- Lot and batch control
- Process validation and equipment logs
- Environmental monitoring records

Distribution Level:
- Wholesale and distributor records
- Import/export documentation
- Storage condition monitoring
- Chain of custody documentation

Clinical Level:
- Patient implant registries
- Hospital inventory systems
- Surgical logs and documentation
- Electronic health records integration

Recall and Field Actions:
Effective traceability enables manufacturers to quickly identify affected devices, notify customers, and remove products from the market when safety issues arise.

Quality Management Integration: Traceability requirements are integrated into ISO 13485 Quality Management Systems, ensuring documented procedures for device identification and tracking.