Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO) introduces a new, harmonized framework for the safety and quality of substances of human origin used for human application. It was adopted in July 2024 and will take full effect on 7 August 2027 across all EU Member States.

This landmark regulation will reshape how organizations handle blood, tissues, cells, and other SoHO materials — and one of the key operational areas it touches is temperature monitoring.

The Rising Importance of Temperature Control Under the SoHO Regulation

SoHO materials are highly sensitive to environmental conditions. Any deviation from defined storage or transport temperatures can compromise their integrity, safety, and clinical effectiveness.

Under the new SoHO Regulation, organizations must implement robust quality and safety systems. This includes:

• Ensuring that SoHO are stored, processed, transported and distributed under validated conditions.
• Maintaining complete traceability from donor to recipient, including environmental data during handling.
• Implementing risk management measures to prevent or respond to adverse events such as temperature excursions.
• Demonstrating compliance during audits and inspections by competent authorities.

While the regulation doesn’t list exact temperature ranges (as these depend on the specific SoHO), it clearly requires continuous monitoring, data logging, and rapid response capabilities to ensure product quality and patient safety.

The Compliance Challenges Ahead

Meeting these obligations will require more than basic data loggers or manual checks. Common challenges include:

• Real-time visibility: detecting and responding immediately to temperature deviations.
• Reliable recordkeeping: maintaining long-term, tamper-proof temperature logs for audits.
• Multi-site consistency: ensuring uniform monitoring standards across multiple facilities or transport stages.
• Validation and maintenance: proving that monitoring systems are accurate, calibrated, and fit for purpose.
• Audit readiness: being able to instantly provide authorities with clear evidence of compliance.

Organizations that do not address these gaps ahead of 2027 may face compliance risks, operational disruptions, or even loss of authorization to handle SoHO.

How the ViGIE Monitoring System Supports SoHO Compliance

To meet the demanding quality and safety obligations of the EU SoHO Regulation, organizations need more than basic temperature loggers: they need a smart, reliable, and auditable system. The ViGIE Monitoring System offers exactly that: a comprehensive platform designed to safeguard substances of human origin throughout their entire lifecycle.

Here’s how ViGIE helps ensure SoHO compliance:

• Real-time monitoring
  ViGIE provides continuous, 24/7 monitoring of temperature and other critical conditions across storage areas, laboratories, and distribution points.
• Multi-channel alerts (email, SMS, app, voice call)
  When temperature thresholds are breached, ViGIE sends alerts via email, SMS, mobile app notifications and voice calls. Ensuring that critical alarms reach the right people at the right time.
• Omnichannel access
  Users can view real-time data, alarms, and historical logs from any device, whether on a computer, tablet, or mobile phone.
• Transport module for in-transit monitoring
  ViGIE’s transport module allows organizations to continuously track and record temperature conditions while SoHO materials are in transit.
• Compliance-ready documentation
  Every measurement, alarm and user action is securely logged and timestamped, creating a full audit trail. ViGIE also generates automated compliance reports, simplifying inspections and demonstrating adherence to the SoHO Regulation.

With its real-time visibility, proactive alerts, full mobility, and end-to-end traceability, the ViGIE Monitoring System provides everything SoHO entities need to stay compliant, protect patient safety, and build trust with regulators.

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Why Early Action Matters

The SoHO Regulation sets a clear deadline of 7 August 2027. Building a compliant monitoring framework takes time: selecting technology, validating systems, updating standard operating procedures, training staff, and integrating documentation workflows.

Organizations that start early will not only ensure compliance but also strengthen patient safety, operational efficiency and public trust in their services.

Conclusion

The EU SoHO Regulation 2024/1938 raises the bar on quality and safety for all substances of human origin. One of its core implications is the need for reliable, continuous temperature monitoring across every stage of SoHO handling.

Deploying a robust system like the ViGIE Monitoring System can help organizations stay ahead of these requirements, safeguarding both their regulatory standing and the health of the patients they serve.

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