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Respond to gap requests and review findings

Understand how expert findings and manufacturer answers move the case forward.

Reviewer Process

Gap requests capture information that is missing, ambiguous, unsupported, or manufacturer-only. Answer them directly and provide evidence where available.

Review findings are expert-curated concerns, recommendations, questions, or gaps. They help the expert track what must be resolved before sign-off or what should be carried forward as an explicit decision.

If the expert rejects an answer, read the rejection note and revise the answer in place. This keeps the decision history clean and avoids uncertainty about which answer is current.

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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