A regulation changed. Which of your documents does it touch?
Pick a category of recent EU regulatory change, answer six questions about a device portfolio, and get a deterministic impacted-surface checklist with severity bands plus an ordered evidence-review queue. Everything runs in this browser page — nothing you enter leaves it.
Method boundary. This is a sanitized demonstration of a working method using generic change categories and fictional sample data. It is not regulatory monitoring, not legal or regulatory advice, and not a compliance determination — severity bands are an operator triage mechanism, not a regulatory-risk score. Always confirm the specific change against the primary source (EUR-Lex, the European Commission's medical-devices pages) and route decisions through your own QA/RA function.
1 · Choose the change category
Categories are generic classes of change, not references to a specific legal act. Verify the actual document at the primary source before acting.
2 · Describe the portfolio
Fictional example — an invented Class III implantable portfolio with an SS(C)P obligation and twelve maintained languages. No real company, device or record is referenced.
Impact map
Choose a change category and portfolio profile, then map the impact.
NOT RUN
0deadline / data-bearing
0review & disposition
0verify no change
Impacted surface
Band
Action
What to check
No impact map built yet.
Evidence-review queue
No queue generated yet.
A "verify no change" outcome still produces an evidence row: record what was checked, in which version, on which date.
Export & handoff
The exported JSON repeats the method boundary and carries the full checklist, queue and portfolio profile for your own change-control record.
DeterministicIdentical inputs always produce the identical checklist and queue. No scoring model, no inference.
Fail-closedSurfaces the profile does not support are excluded, not guessed. A missing obligation maps to a consistency check, not an assumed duty.
Human-ownedBands route review effort. Regulatory interpretation and every disposition stay with your qualified owner.
From triage structure to reviewed evidence
This mapper structures the first hour after a regulatory change lands: which surfaces to look at, in what order, and what evidence each look should leave behind. When the queue exposes cross-document reconciliation work, unclear ownership or a register that no longer matches the documents, that is the bounded problem a scoped review resolves.