Understand a class-raise warning
Read the warning before submitting an answer that may raise the device class.
Classification and device facts
Where to find it
My Cases → Your case → Device classification
You need
- A displayed fact answer whose effect may raise the proposed class.
When an answer can raise the proposed class, the page shows the warning before submission. Read the stated effect and check the answer rather than treating the warning as a later notification.
What happens next
- After submission, the page reflects the resulting fact state and any further work.
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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