Provide quality-system evidence
Use the coverage table and document library without deciding acceptance yourself.
Quality system
Where to find it
Quality system → Quality evidenceYou need
- A controlled quality-system document relevant to an obligation row.
The coverage table shows the current evidence basis for each obligation. Add or tag a controlled source from the document library where the surface allows it.
The client request surface is deliberately narrow: expert return and untagged document are the request shapes exposed here. A generic QMS free-text information-needed card is not built.
Work a row that needs evidence
- Read which obligation the row is about before choosing a document for it.
- Tag a controlled source from the document library where the surface allows it.
- If a row still shows as needing evidence after you tagged something, check which obligation the source was offered against — the file arriving is not the same as it covering.
- Wait for the expert decision. Only they can move a row to accepted.
What the states mean
| State | Meaning |
|---|---|
| No evidence yet | Nothing is tagged for this obligation. |
| Awaiting review | Something is tagged and your expert has not yet judged it. |
| Accepted | Your expert accepted the tagged basis as covering the obligation. |
| Returned — action needed | Your expert returned it; the note says what to change. |
| Needs re-review | Something moved under an earlier decision and it has to be looked at again. |
What happens next
- The assigned expert accepts, returns or re-reviews the evidence basis.
Related guidance
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Official references
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