Clarify information that may affect classification
Answer the released question accurately so your expert can review its effect on the device's classification.
Device information and classification
Where to find it
My Cases → Your case → Device information
You need
- A released request about missing or conflicting device information.
Read What was found and Why this is needed before answering. These explain the uncertainty your expert needs to resolve. Supply the device information the request asks for, including any explicit declaration.
Saving an ordinary reply records your answer for expert review; it does not itself confirm the extracted fact or release a classification. Your expert reviews the reply before adopting the supported information.
What happens next
- The request shows that your response is waiting for expert review. Any classification decision remains the expert's recorded act.
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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