Understand expert sign-off and delivery
Distinguish expert approval, document issue and release of the full file.
Working with your expert and assistant
Where to find it
My Cases → Your case → Ready to download
You need
- A case progressing through expert review.
Expert sign-off records the relevant recorded decision. A document can then be issued, while the complete file still waits for its release gate. The deliverable page is the authority for the external package currently available.
Three steps, not one
| Step | What it means | What you see |
|---|---|---|
| Expert sign-off | Your expert takes responsibility for a recorded decision. | Often nothing yet — sign-off is not release. |
| Document issued | One document is sealed into the technical file. | Issued — awaiting full-file release. |
| File released | A package is published to you. | Delivered, with the deliverable available. |
What happens next
- Download the released revision when it is available, or address the outstanding state shown by the case.
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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