Read IVDR intended use and answer clarification requests
Read the prepared intended-use information while your expert checks the complete IVD profile.
Device information and classification
Where to find it
My Cases → Your case → Device information
You need
- An IVDR case with source information about its intended use.
Complya prepares the intended-use profile from your information and sources. Your expert reviews the related intended-use fields together, including any missing or conflicting information.
If clarification or a manufacturer declaration is needed, answer the released request in Needs your answer. Changing a generated document sentence does not replace review of the underlying intended-use record.
What happens next
- Your expert reviews the response and the related intended-use information before finalising the factual basis.
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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