Facts and confirmation
Why a proposed fact is not yet a confirmed fact.
A fact is something specific about your device that the regulation cares about — its sterility, its duration of contact, whether it delivers energy. Complya reads your documents and proposes values for these. A proposal is a suggestion with a source attached, and nothing more.
Where you meet it
In your case, wherever a value is shown with the document it came from and an option to confirm or correct it. And indirectly everywhere else: the class, the document set and the questions you are asked all follow from the facts that stand.
The rule
The platform uses the current governed fact — the value that stands right now — and never whichever suggestion happened to be shown last. You confirm or correct facts about your device. Your expert resolves the regulated questions that need professional judgement. The two are kept apart because they are different kinds of statement.
Related guidance
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices