Understand document statuses
Distinguish drafting, review, issued and delivered states.
Technical file and documents
Where to find it
My Cases → Your case → Technical file
You need
- A document row in a case.
The status belongs to that document row. It is not the same as the case status and it does not by itself prove that the full file has been released.
What the states mean
| State | Meaning |
|---|---|
| Not started | No current drafting work is recorded for the row. |
| AI drafting (AI Drafting in the ⌘K palette) | The drafting workflow is running. |
| Expert review (Expert Review in the ⌘K palette) | The document is with the expert before issue. |
| Action required (Action Required in the ⌘K palette) | The case shows work that must be resolved before issue. |
| Issued — awaiting full-file release | The document was sealed but the whole technical file has not yet been released. |
| Delivered | The released file includes this document state. |
What happens next
- Open the row or its action card to see what currently blocks progress.
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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