Understand document status labels
Know what each of the six document status labels means.
The tracker prints six labels: Not started, AI drafting, Expert review, Action required, Issued — awaiting full-file release, and Delivered (the ⌘K palette title-cases the middle three). Action required means the case shows work that must be resolved before issue; it is where a missing manufacturer answer surfaces. There is no separate stale label on the tracker — when an issued document later needs review, the deliverable page withdraws the download and says the file is being updated.
Do not treat a draft as final just because it exists. Expert-issued documents are the ones intended for inclusion in the delivered technical file.
If a document remains blocked, open the related gaps or messages. The blocker is often a missing source file, an unanswered manufacturer question, or a classification or clinical point requiring expert judgment.
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