Medical Devices.
Medical-device UDI and custody programs are out of scope here, deliberately — the same decision that puts pharma/DSCSA out of scope puts med-device out with it, one cut, not two. The segment runs a validated/GxP buying environment served by entrenched DSCSA-era incumbents, and this project has no customers in that segment, no validated/GxP documentation history, and no attestation — none has ever been issued — so it does not court that evaluation, and says so rather than pretending otherwise.
whospine:capturedBy
Out of scope, on purpose.
segment: med-device / UDI (cut with pharma — one §3.1 ruling)
status: out of scope — a deliberate cut, revisited
only after references exist
reason: validated/GxP buying environment (CSV documentation, supplier
qualification, audit history) that a pre-launch
project cannot honestly serve
what stands anyway: EPCIS 2.0 validation, CBV §8.9 hashing, append-only
storage — written, tested, and industry-agnosticThe scope statement, plainly. The standard's mechanics on this page are true everywhere; the segment call is a targeting ruling, recorded, not a limitation of the written gateway.
If you are here from a UDI or device-custody program.
This gateway will not present itself as a validated-environment vendor, because it is not one. What the published package offers any EPCIS implementer — pinned official schemas, the standard's own event hash, RFC 7807 refusals, an append-only store with no edit verb — is checkable without believing anything on this page, and that is where this page stops.
Proof, not adjectives. The gateway's conformance tests pass against GS1's normative artifacts. See Who for the dimension, and What ships today for the dated ledger.