Tag a document as clinical evidence
Point a linked source at a clinical evaluation requirement without claiming the expert has accepted it.
Where to find it
My Cases → Your case → Clinical evidence
You need
- A document uploaded to the case and declared with a source kind (Documents › ⋯ › Edit metadata) that carries a clinical archetype — "Clinical evidence / clinical report" for reports, studies, literature, state-of-the-art guidelines, PMS/PMCF summaries, comparator/equivalence and usability material; "Quality-system procedure or record" only for an evaluator CV. A file whose kind is not set, or is any other kind (Risk Management File, a technical specification), never appears in the picker.
- A clinical evaluation requirement the document speaks to.
The Clinical evidence tab lists each clinical evaluation requirement with the evidence currently offered for it. Its standing instruction is the whole job in one line: "Tag your source documents as evidence for each clinical evaluation requirement."
What you see
| Row label | What it means |
|---|---|
| No evidence yet | Nothing has been tagged for this requirement. |
| Awaiting review | Something is tagged and your expert has not yet judged it. |
| Accepted | Your expert accepted the tagged basis as covering the requirement. |
| 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. |
| Waiting on your expert | As a ROW status: this requirement is held on an expert decision — nothing more is needed from you. (The block above the list with the same heading is different: it holds your own tags awaiting review.) |
| Expert re-confirmation needed | Your expert must re-confirm the equivalent-device decision before evidence here can be reviewed. |
| Not applicable | This requirement does not apply to your device. |
Tag a document
- Open the case and choose the Clinical evidence tab.
- On the requirement row, choose from "Tag a linked document…", then press "Tag".
- Read the confirmation — "Document tagged as clinical evidence." — and leave the judgement alone. A tag proposes a relationship; whether it covers the requirement is your expert's decision.
- Look for it in the "Waiting on your expert" block ABOVE the requirement list: that block is the tag working and waiting, not an error. (The same words also appear as a status on a requirement row, where they mean something different — see the table.)
Remove a tagged source
Every linked document carries a "Remove" button. It opens a dialog headed "Remove this source from your clinical evidence?" — and on a delivered case the dialog warns that your delivered documents may be taken out of service, withheld from download, until your expert has re-reviewed the evidence and re-issued them. A tag still waiting in the block above can be removed at any time.
What happens next
- The row moves from Awaiting review to Accepted, Returned — action needed, or Needs re-review as your expert acts.
- A returned row carries your expert's note; a re-tag is the response, not a message.
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