ComplyaHelp Center

Understand document status labels

Know what each of the six document status labels means.

Technical file basics

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.

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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