Gaps and their owners
Why different gaps ask for different kinds of action.
A gap is the platform saying: this document needs something it does not have. Every gap names what is missing, who has to supply it, and where it has to go.
Where you meet it
In your gap list, sorted into what needs you, what needs changes, what is with your expert, and what is done. A gap assigned to your expert is not waiting on you and will not appear in your queue.
The rule
Some gaps accept a written answer or an upload. Others must be resolved in a specific place — a particular fact, a structured table, an attestation, an expert decision — because that is the record the document actually reads. When a gap asks for one of those, a written explanation cannot close it, however good the explanation is.
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