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SystemAIS-002Medical device and SaMD

Triage Note Summariser

Summarise free-text triage notes for the reviewing nurse. Non-diagnostic.

Device class
Not a medical device
Status
In development
State
In progress
Owner
Cirocco Jones
Readiness
72
Blockers
2
How the identifiers work
The Basic UDI-DI is the access key to the device in the technical documentation and in EUDAMED, and never appears on a trade item. The UDI-DI identifies a specific version and is the thing that is registered. For software the UDI-PI is the version number; it is never registered on its own, and it is what a reporter quotes in a vigilance case.

Basic UDI-DI

Assigned once per device. It moves only when the device becomes a different device.

No Basic UDI-DI is assigned. Without it the device cannot be registered or referenced in a declaration of conformity.

UDI-DI and UDI-PI

One UDI-DI per released version. The UDI-PI is the version number and carries no registration of its own.

UDI-DIUDI-PICarrierRegistrationRegisteredChange

No UDI-DI assigned yet.

A UDI-DI hangs from a Basic UDI-DI. Assign the Basic UDI-DI first, then a version can be identified.

Evaluate a change

State what the change affects. The answer decides which identifier moves.

Change
Outcome
No UDI change

No effect is declared, so no identifier moves. Declare the effects to evaluate.

No identifier moves. The change is recorded in the audit trail only.

Recorded evaluations

Every change evaluation is kept.

DateChangeOutcomeDecided byReasoning

No change has been evaluated yet.