IVDR Performance Evaluation — Prepare your PER for Technical Documentation

Under the EU In Vitro Diagnostic Regulation (IVDR) 2017/746, Performance Evaluation is a mandatory process that demonstrates that an IVD device consistently delivers accurate and clinically relevant results for its intended purpose. Think of it as proving to the Notified Body (or Competent Authority) that your IVD device actually works in the real world, not just on paper.

Performance evaluation is the continuous and methodical assessment and analysis of data to establish:

1. Scientific Validity:The relationship between the analyte your test measures and the clinical condition of interest (e.g., detecting a specific biomarker that is truly linked to the disease).

2. Analytical Performance:How accurately, precisely, and reliably your device detects or measures the analyte under various conditions.

3. Clinical Performance:How effectively your device achieves its intended purpose in a clinical setting (sensitivity, specificity, predictive values, likelihood ratios).

A robust Performance Evaluation is essential for successful CE certification under IVDR. Without it, your Technical Documentation will be incomplete, increasing the likelihood of non-conformities from the Notified Body. Inadequate evaluation also means you cannot demonstrate compliance with Annex XIII and Annex I (GSPRs) of the IVDR, which are critical regulatory requirements. Ultimately, the absence of a thorough Performance Evaluation can lead to the rejection of your CE marking application.