Read a provisional classification
Know why a displayed class is not released until facts and expert sign-off are complete.
Classification and device facts
Where to find it
My Cases → Your case → Device classification
You need
- A case with a displayed classification result.
Provisional means the current facts produce a result, but the two release conditions are not both met: you have not yet locked the fact set, or your expert has not yet signed off. The rail says it in one line — "Withheld until you lock these facts and your expert signs off."
What happens next
- Lock the fact set, then wait for the expert's classification review and release.
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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