Sign-off and delivery
Know what happens before the expert releases a case to the client.
Before delivery, applicable documents should be issued, stale outputs resolved, critical gaps addressed, and classification or release-sensitive facts signed off as required by the workflow.
The expert release is a deliberate action. It moves the case into a delivered state and makes the client-facing delivery bundle available.
After delivery, treat significant device, evidence, claim, label, or intended-purpose changes as controlled changes. The previous delivery bundle reflects the case at the time it was released.
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