Regulatory posture

Built for the EU AI Act.

The AI Act classifies AI for diagnosis and clinical decision support as high-risk, and mandates logging, transparency, human oversight, and demonstrable accuracy. Most tools will retrofit those. Axiisium started there.

The Act is not a threat to an audit-grade product. It is a tailwind. Every requirement it places on high-risk clinical AI, Axiisium already treats as the point of the product, not a compliance tax bolted on afterward.

Art. 12 & 19 · Record-keeping

Automatic, durable logs

High-risk systems must automatically log events and retain them for at least six months.
Axiisium binds every decision to a signed, tamper-evident record, anchored to an external append-only log. Not just retained: independently verifiable, by anyone, without trusting us.
Art. 13 · Transparency

Legible capabilities and limits

Operation must be transparent: intended purpose, accuracy level, and limitations disclosed to the deployer.
Each call shows which signal drove it, a calibrated confidence, the WHO 2022 / ICC 2022 rationale, and states plainly what is assumed and what is deferred.
Art. 14 · Human oversight

The clinician decides

Systems must let a competent human monitor operation, catch anomalies, and intervene.
A qualified clinician makes the diagnosis; a confirmatory assay gates any decision; the model ranks who to sequence but never makes the genetics call. Fail-safe by architecture, not by policy.
Art. 15 · Accuracy & robustness

Measured, not asserted

Appropriate accuracy, robustness, and cybersecurity, declared and evidenced.
Morphology validated at literature level (0.894 ±0.066 AUROC, patient-grouped, leakage-free), calibrated confidence bands, and a configurable recall-floor that bounds the false-negative rate.
Art. 9 · Risk management

Safe by construction

A continuous risk-management process across the lifecycle.
The ranking cannot itself drive an unconfirmed clinical action: mandatory confirmatory gating and the recall-floor are properties of the pipeline, and it defers hard markers to the assay.
Art. 10 · Data governance

Provenance of the inputs

Training and evaluation data governed for quality and representativeness.
Validation is patient-grouped and leakage-free, and each signed record carries a digest of the exact inputs that produced the call.
Timeline

When it applies.

Aug 2026Core high-risk obligations apply in full: conformity assessment, technical documentation, and human oversight.
Aug 2027Extended transition for AI already regulated as a medical device under the MDR / IVDR that requires Notified Body assessment.
In fluxThe Commission's Digital Omnibus may adjust the high-risk timeline as harmonised standards mature; we track it.Update · Jun 2026The European Parliament approved Omnibus amendments shifting the deadline for AI embedded as safety components in medical devices to August 2, 2028.
⚖️ Regulatory Status & Compliance Philosophy

Axiisium is Research Use Only (RUO) today. It is not yet conformity-assessed as an in vitro diagnostic or medical device.

What we are claiming is narrow and true: the core architecture is already natively shaped around high-risk regulatory requirements. Transitioning Axiisium from RUO to a fully regulated clinical product is strictly a matter of execution, conformity assessment, and rigorous documentation, not an architectural rebuild. The auditable, human-gated, meticulously logged core is not a superficial feature we add later to pass the EU AI Act or IVDR. It is the fundamental foundation we started from.