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Answer missing-information requests

Resolve manufacturer-only gaps in a way your expert can review and approve.

Technical file basics

Some information cannot be reliably inferred from uploaded files. Examples include design intent, commercial launch plans, exact material grades, unpublished clinical rationale, or the manufacturer’s chosen PMS activities.

When a gap request appears, answer with the specific fact requested and reference the supporting document by name — the card takes a written answer and a Send action; files are uploaded to the case, not attached to the answer. Avoid broad narrative answers when a precise value, date, material, or rationale is needed.

After you submit an answer, the expert may approve it, ask for changes, or use it as input to regenerate affected documents. Rejected answers should be revised in the same workflow so the decision history remains visible.

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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