Performance Evaluation Report for IVDR Compliance | i3cglobal
A Performance Evaluation Report isn’t just another regulatory document, it’s basically the backbone of your IVDR compliance story. This guide from i3cglobal breaks down what the report actually needs to include, why notified bodies care so much about it, and how manufacturers can avoid the common mistakes that delay approvals. If you’ve ever felt confused by clinical evidence, scientific validity, or performance data requirements, this page explains it in a way that feels practical instead of overly technical.
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