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Message your expert from the case page

Use the case thread for questions that should stay tied to the device review.

Reviewer Process

Use case messages for device-specific questions, clarification, and follow-up. Keeping discussion in the case helps preserve context for later review and avoids losing decisions in separate email threads.

Be specific in messages. Mention the document, section, file, claim, or deadline you are asking about. If your question relates to a source document, include the file name.

The message thread is for coordination and clarification. Formal manufacturer answers to structured gaps should still be submitted through the gap workflow so they can be reviewed and reused.

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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