SystemAIS-001Medical device and SaMD

Retinal Screening Assistant

Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.

Device class

Class IIa (MDR)

FDA

Class II, 510(k)

EU AI Act

High-risk (Annex I)

Status

In operation

State

Deployed

Owner

Cirocco Jones

Record completeness

100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.

The system is in operation while its record stands below the floor of 70. That contradiction is raised as blocker STATE-01.

Blockers

Findings are computed from record state on every read, evaluated on 2026-07-30. Nothing here is stored on a record.

Where this AI System stands

14 blockers hold this AI System back. Each names the record and the action that clears it.

Blockers

A blocker stops a governance gate from passing.

BlockerUDI-02UDI-DI (01)05412345000041 is not registered
Threshold recalibration for the northern sites. Performance changes, so registration is required before release. A change that affects performance or safety carries a new UDI-DI, and that UDI-DI is registered before the version is placed on the market.
Affects
(01)05412345000041
Effect
Blocks release of this version.
Register the UDI-DI
BlockerAIACT-49Not registered in the EU database
A high-risk system listed in Annex III is registered under Article 49(1) before it is placed on the market or put into service.
Affects
SystemAIS-001
Effect
Blocks placing on the market.
Record the registration
BlockerMON-01Monitoring threshold breached: Sensitivity, northern sites
Observed 0.88 against threshold "Not below 0.92" on 2026-07-01.
Affects
SystemAIS-001
Effect
Requires an AI Risk assessment and a change or restriction decision.
Review monitoring response
BlockerMON-01Monitoring threshold breached: Image statistics drift
Observed 0.21 against threshold "Not above 0.15" on 2026-07-01.
Affects
SystemAIS-001
Effect
Requires an AI Risk assessment and a change or restriction decision.
Review monitoring response
BlockerSIG-01Performance signal not acknowledged: Sensitivity below threshold, northern sites
Sensitivity 0.88 against a floor of 0.92 across four northern sites over the July window. Observed 2026-07-01.
Affects
SystemAIS-001
Effect
Restriction is proposed. Blocks continued operation until answered.
Open the signal inbox

Warnings

A warning lowers readiness but does not stop a gate.

WarningREPO-01Repository event main has no governance response
Site-level threshold recalibration, northern cohort, Performance changes. Freeze a new AI Model Version, open a change authorisation review, and assign a new UDI-DI.
Affects
4de90c1
Effect
Change is happening in the repository ahead of the record set.
Answer the event
WarningREPO-01Repository event #412 has no governance response
Add second input modality: OCT volumes, Outside the declared Controlled Evolution boundary. Requires a new authorisation and a new Basic UDI-DI.
Affects
77b0aa3
Effect
Change is happening in the repository ahead of the record set.
Answer the event
WarningEVID-01DHF-2291-RMR-003 is stale
Approved 2025-02-06. Review interval is 12 months.
Affects
DHF-2291-RMR-003
Effect
Weakens the mapping that depends on it.
Review the mapping
WarningTRACE-02Model versionMV-001 has no testing suitability record
Performance cannot be traced to a specific, immutable Dataset Version.
Affects
Model versionMV-001
Effect
Blocks model approval.
Record testing suitability
WarningTRACE-01Model versionMV-003 has no training suitability record
No Dataset Model record states which Dataset Version was used for training or why it is suitable.
Affects
Model versionMV-003
Effect
Blocks model approval.
Record dataset suitability

For information

Recorded so nothing is silently dropped.

No findings. Every rule in scope passes.

Nothing to note.