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.