Provide quality-system evidence
Answer your expert's requests, keep your quality documents read and tagged, and follow how each case's processes are being reviewed — without deciding acceptance yourself.
Where to find it
Quality system → Quality evidenceYou need
- A controlled quality-system document relevant to the process or request.
The Quality evidence tab reads top to bottom: What needs your response, Your quality documents, How your evidence is being reviewed (one row per case, the thirteen MDR Article 10(9) processes behind it), and Request history. Choose a row on the left and its detail opens on the right; the Showing chips narrow everything to one case.
Add documents is where a new quality document enters; Read documents asks Complya to read what you added and suggest the evidence tags it supports. Reading and tagging are proposals — your expert decides what covers a process.
Answer a request
- Open the request. The detail says what is asked, what Complya examined and why it matters.
- Choose how you respond: point to a document already in your Quality system, provide a document (add it first, then choose it), explain in writing, or replace a revision of a document the request names.
- Where no such event has occurred in the period concerned, say so instead of attaching a document.
- Submit the response. The request then reads "Submitted · with your expert" until they review it; a returned one reads "Returned · your action" with the expert's note.
What the states mean
| State | Meaning |
|---|---|
| Not yet assessed | No reviewed evidence stands against this process yet. |
| With your expert | Something is tagged and your expert has not yet judged it. |
| Reviewed by your expert | Your expert accepted the tagged basis as covering the process. |
| Returned by your expert | Your expert returned it; the note says what to change. |
| Being reviewed again | 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 behind each process; your responses show as with your expert until then.
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