Facts, replies and expert review
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 Device information, read the prepared values, their sources and review states. Answer the focused requests released by your expert. The class, documents and questions depend on the facts that have been reviewed.
The rule
The platform uses the current governed fact — the value that stands right now — and never whichever suggestion happened to be shown last. Your ordinary reply provides information for your expert to review before adoption. An explicit manufacturer declaration records your own declaration, while the expert's verification and finalisation remain separate acts.
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