IVDRin-force
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
32017R0746
Applies from 2022-05-26
Summary
IVDR governs in vitro diagnostic medical devices: classification (A-D), conformity assessment, CE marking.
Scope
Applies to in vitro diagnostic medical devices (reagents, instruments for examining specimens from the human body) as defined in Art. 2. Relevant for food supplements/self-test kits only where they make IVD claims.
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Related regulations
Modified by (4)
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