The EU SoHO (Substances of Human Origin) Regulation*, coming into force on 7 July 2027, strengthens safety, traceability, and quality requirements for human-derived substances such as blood products, tissues, and cells across Europe. Its purpose is to ensure that every step — from donation through processing, storage, transport, and clinical use — is transparent, controlled, and fully compliant. This reduces risks for patients, enhances oversight, and supports harmonized standards across EU Member States.

 

How Tridentify supports compliance with the QTA Tracer System®

 

End-to-end traceability
Tridentify enables secure identification and continuous tracking of SoHO
materials throughout the entire cold-chain and custody process,
supporting the Regulation’s strict traceability obligations.

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Digitalized and auditable documentation
Through integration with the QTA Tracer System®, Tridentify reduces
manual paperwork and ensures accurate, standardized, and inspection-ready
records.

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Regulatory-grade data integrity
Tridentify helps ensure that critical donor and product information remains securely linked, protected, and accessible, enabling full transparency and readiness for regulatory audits.

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Interoperability and workflow assurance
By eliminating uncertainties in cold-chain workflows through standardized identification, monitoring, and connectivity, Tridentify supports blood banks, healthcare organizations, and industry partners in meeting EU-wide SoHO requirements efficiently.

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Certified medical technology supporting compliance

Tridentify’s QTA Tracer System® is a MedTech MDD Class IIa device (with MDR certification planned for 2026). It is designed to be easy to use while delivering:

1. Quality, Traceability, and Accessibility/Audit Readiness of digital data across the full cold-chain process

2. Robust compliance support aligned with the upcoming SoHO regulatory framework, including Risk Management

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* specifically Regulation (EU) 2024/1938