CONFORMITY · MARKET ACCESS
A CE marking is not a promise of AI quality
CE communicates declared conformity of a specific system – not general quality, authority endorsement or absence of risk.

01 · ROLEAre the system, intended purpose and accountable provider role classified?
02 · EVIDENCEDoes every requirement lead to a control, test, result and decision?
03 · CONTINUITYDo change control and monitoring keep the claim current after market access?
CORE METHOD
CLASSIFY → EVIDENCE → ASSESS → DECLARE → REGISTER → MONITOR
A mark is defensible only when system boundary, assessment route and evidence remain aligned through change.
Review every claim using ‘certified’, ‘authority-approved’, ‘safe’ or ‘trusted’. What exact evidence supports it, and which limit must be disclosed?