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Regulation (EU) 2024/1938 · enforced August 2027
EU SoHO compliance software for donor human milk banks and hospitals
One platform handles traceability, donor eligibility, and audit-ready records. Because it is built for the Substance of Human Origin standard, your milk bank stays compliant with confidence.
Trusted & compliant
SOC 2 / AICPA
GDPR · EU data residency
Operating in EU NICUs
Outcomes data published in
The European Society of Medicine
Trace donor → infant
in seconds
What changes under the regulation
Human milk is now a Substance of Human Origin
Regulation (EU) 2024/1938 places donor human milk in the same legal category as blood, tissues and cells. As a result, the same strict rules for records and traceability now apply to every milk bank.
August 2027 deadline
This is the full enforcement date. By then, every EU milk bank must show SoHO-compliant operations and software traceability.
Reclassified substance
Donor human milk now leaves food regulation and enters the SoHO framework. Therefore, a hospital-grade chain of custody is no longer optional — it is the law.
End-to-end traceability
You can trace each unit from donor collection to the recipient infant, in both directions. Every step is documented and ready for audit.
Paper logs and spreadsheets no longer meet the standard
Paper & spreadsheets
Breakable chain of custody from donor to infant
Manual donor screening with no eligibility lock
Slow, error-prone recall across batches
No structured GDPR data handling
Timeless Medical Nutrition Platform™ delivers — today
Unbroken bi-directional chain of custody
Donor eligibility enforced in the workflow
Rapid recall in both directions, in seconds
GDPR-compliant data handling across all records
The evidence
Digital safety barriers measurably reduce risk
Peer-reviewed research shows that centralized preparation and bar code scanning dramatically cut contamination and administration errors — the same safeguards built into Timeless Medical Nutrition Platform™.
24×
More contamination at the bedside
Feeds prepared at the bedside were 24 times more likely to show microbial growth than those prepared in a centralized space with dedicated technicians.
up to 87%
Fewer preparation errors
Bar code scanning with dedicated technicians reduced the risk of feeding errors by 82–87% across multiple hospital studies.
60% → 100%
Documentation accuracy
After bar code scanning was introduced, correctly documented feedings rose from 60% to 100% — a complete, auditable record.
Source: Steele, C. & Smith, S. (2026). Enhancing Enteral Nutrition Safety: A Review of Current Practices and Research Opportunities. Medical Research Archives, 14(2). Findings reflect studies of centralized preparation and bar code scanning.
Article-by-article
How Timeless Medical Nutrition Platform™ maps to the SoHO standard
Traceability
Bi-directional traceability
Links every unit from collection label through processing and dispensing to the specific infant. Trace forward or backward in seconds.
Donor eligibility
Donor eligibility management
Intake captures history, consent, and serology. Timeless Medical Nutrition Platform™ flags expired screenings and blocks ineligible donors from the workflow.
Processing
Pasteurisation & batch records
Every run logged with timestamp, temperature profile, batch composition, and operator ID. Immutable and audit-ready.
Recall
Rapid recall management
Identifies every affected unit from a compromised donor or batch in seconds, with automated alerting and a documented response workflow.
Vigilance
Adverse event & deviation tracking
Log, investigate, and resolve deviations directly in Timeless Medical Nutrition Platform™. Every event timestamped and stored — the vigilance trail the regulation requires.
Data protection
GDPR-compliant data handling
Operated by a GDPR-compliant organisation with data minimisation, access control, and a Data Processing Agreement for EU procurement.
Operational return on investment
Compliance that pays for itself
Automating verification and documentation doesn't just reduce risk — it returns clinical hours, cuts product waste, and lowers the cost of adverse events.
1,340
nursing hours saved per year at one hospital — plus a half-time position eliminated
33–50%
less time on verification tasks for milk and formula preparation
32 → 19
days to full feeds for preterm infants with centralized, dedicated preparation
Source: Steele, C. & Smith, S. (2026), Medical Research Archives, 14(2). Figures reflect published studies of centralized preparation and bar code scanning; results vary by setting.
Common questions from European milk banks
Is Timeless Medical Nutrition Platform™ available in German and other European languages?
Yes. Timeless Medical Nutrition Platform™ supports multilingual interface configurations. Our DACH implementation includes a full German-language interface and documentation, making EU SoHO compliance straightforward for German, Austrian and Swiss milk banks.
Does Timeless Medical Nutrition Platform™ store data within the EU?
Data residency options are available for European deployments. Our team provides a GDPR-aligned Data Processing Agreement as part of any procurement — a mandatory consideration for EU hospitals evaluating SoHO compliance software.
Does Timeless Medical Nutrition Platform™ support competent authority reporting under EU SoHO?
Timeless Medical Nutrition Platform™'s reporting module generates structured documentation that supports competent authority submissions under Regulation (EU) 2024/1938, aligned to your member-state requirements and SoHO entity obligations.
We're on paper records — how complex is the transition?
Our implementation team specialises in onboarding milk banks from paper-based or legacy systems. A structured migration plan, staff training, and go-live support are included in every deployment — most milk banks are fully operational within weeks.
Does Timeless Medical Nutrition Platform™ integrate with our EHR or hospital information system?
Yes. Timeless Medical Nutrition Platform™ integrates with major EHR and HIS platforms — including Epic, Oracle Health (Cerner), and MEDITECH — using industry-standard HL7 and FHIR interfaces, so patient, order, and feeding data stay synchronised across your systems without duplicate entry. For interface specifications and supported message types, see our technical information.
See Timeless Medical Nutrition Platform™ SoHO compliance capabilities in action
Book a live demo with our team. We'll walk you through traceability, recall, and documentation workflows — and show exactly how your milk bank meets the August 2027 deadline.
No pressure, no generic slides
A real system already operating in European NICUs
Tailored to your member-state obligations
GDPR-compliant. We'll never share your details.
