Performance studies which require a notification

Published: 15/10/2023

Changes

Information regarding performance studies which require a notification to NOMA. This includes PMPF-studies as described in IVDR article 70 (1), and studies involving companion diagnostics (CDx) where only left-over samples are used.

Post-market performance follow-up (PMPF) studies
Studies involving companion diagnostics (CDx)

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