Notify path themes
Who gets notified, in what order, and which deadlines the draft tracks.
The notification path is where incident playbooks fail, because it is the part everybody assumes is obvious. It is not: the order, the recipients, and the clock all have specific shapes, and a slow internal investigation does not pause any of them.
The order
Tell the provider without undue delay, then report to the market surveillance authority. The first does not replace the second — telling the vendor is not reporting.
The clock
Awareness starts the timeline. Which means the reportability call has to be made early, with the facts you have, and updated as they firm up.
The evidence gaps
What an authority asks for after the fact: when you knew, what you assessed, who decided, and when the notifications went out. A playbook that does not capture those four facts is a document, not a control.
How the tool frames it
It asks for the outcome facts and shows the notify path the rules encode. The decision stays with your team; the timing gets written down.
Decision-support drafting only — not legal advice. Confirm the duty set against the current consolidated text of Regulation (EU) 2024/1689.