Read a provisional classification
Distinguish the working classification from a current expert-reviewed result.
Device information and classification
Where to find it
My Cases → Your case → Device information
You need
- A case with a displayed classification result.
The classification shown in the case summary follows the recorded facts and expert review. A provisional result is not a released conclusion and can change when the factual basis changes.
Your expert finalises the Device profile and performs the required classification review. You contribute source material and replies to released questions; there is no manufacturer fact-set lock to complete.
What happens next
- Answer any released requests and follow the case's current classification and review state.
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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