How expert assignment works
Understand what the assigned expert reviews and why assignment matters.
An assigned expert reviews the case evidence, AI-generated drafts, classification, gaps, review findings, and delivery readiness. Assignment also controls which expert can access and act on the case.
The expert is not just proofreading. They check whether the regulatory logic is defensible, whether source evidence supports claims, and whether unresolved gaps need manufacturer action.
If a case is not yet assigned, you can still prepare evidence and answer structured prompts. Expert-dependent decisions happen after assignment.
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