MDR CE-marked Class IIa Temperature Monitoring Solution with Shelf-Life Management for Blood and Transfusion Medicine
- Ann-Christine Jungmar
- 4 days ago
- 2 min read
Tridentify Achieves Historic Milestone: QTA Tracer System® Becomes World’s First and Only MDR CE-marked Class IIa Temperature Monitoring Solution with Shelf-Life Management for Blood and Transfusion Medicine
Stockholm, SWEDEN — Tridentify, a pioneer in advanced health tech solutions, proudly announces that its patented QTA Tracer System® has successfully transitioned from the Medical Device Directive (MDD) to achieve formal MDR CE-marking as a Class IIa medical device under the European Union’s rigorous Medical Device Regulation (EU 2017/745).
With this achievement, the QTA Tracer System® secures its position as the first and only temperature monitoring medical solution with shelf-life management worldwide to receive CE-marking according to MDR specifically indicated for transfusion medicine and blood products.
Unmatched Innovation in Blood Safety and Cold Chain Logistics
Unlike traditional data loggers, the QTA Tracer System® acts as an intelligent, real-time Internet of Medical Things (IoMT) solution. By applying custom biological profiles directly to individual blood bags, the system dynamically calculates the actual remaining shelf-life based on real-time exposure to temperature, light, and movement.
This historic MDR CE-marking as a Class IIa guarantees that healthcare providers, blood banks, and laboratories can fully trust the system's automated quality decisions - safeguarding blood components from donor to patient, or "vein to vein".
Regulatory Excellence Ahead of the SoHO Mandate
The transition from MDD to MDR CE-marking demonstrates the robustness of Tridentify's clinical evidence, cybersecurity, and stringent quality management. This breakthrough aligns perfectly with the upcoming EU Substances of Human Origin (SoHO) Regulation, that will come into effect in August 2027, establishing Tridentify as the definitive global standard for audit-readiness and compliance.
"Achieving MDR CE-marking as a Class IIa medical device is an incredible validation of our team's vision to eliminate cold chain uncertainties entirely," said Ann-Christine Jungmar, CEO, at Tridentify.
"Being the world's only MDR CE-marked Class IIa temperature monitoring solution with shelf-life management for transfusion medicine allows us to uniquely empower hospitals to minimize blood waste, drastically reduce costs, and, most importantly, maximize patient safety", Ann-Christine continues.
Key Benefits of the MDR CE-marked QTA Tracer System®:
Dynamic Shelf-Life Management: Automatically calculates the remaining shelf-life and continuously displays the status. The evidence-based display eliminates uncertainties. (Green=OK to use. Red=Not OK).
Waste Reduction: Safely recover blood bags and reduce waste.
Traceability: Cloud-based data tracking that meets absolute traceability and compliance requirements.
About Tridentify ABTridentify is a Swedish medical technology company dedicated to "Safeguarding Medicines for Life®". Through its proprietary SaaS platform and intelligent QTA Tracers, Tridentify delivers real-time quality control and traceability for temperature-sensitive blood products, biologicals, and pharmaceuticals globally by "Safeguarding as Service®".
Media Contact:Ann-Christine Jungmar, CEO
Mobile: +46 (0) 708 71 46 76
Comments