Review IVDR intended use
Confirm the intended-use facts that govern an IVD's classification and description.
Classification and device facts
Where to find it
My Cases → Your case → Device classification
You need
- An IVDR case.
For an IVDR case, review the intended use as a set of the device facts the platform records. Correct a conflict in the fact workflow; do not resolve it by changing only a document sentence downstream.
What happens next
- The confirmed intended-use facts feed the IVD description and classification review.
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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