IVDR Performance Evaluation — Evidence Architecture
Under Annex XIII, the Performance Evaluation Report (PER) integrates Scientific Validity, Analytical Performance and Clinical Performance into one definitive conclusion on whether clinical evidence supports safety, diagnostic accuracy and GSPR conformity.
The IVDR Performance Evaluation Model
Intended Purpose
Performance Claims
Scientific Validity
Analytical Performance
Clinical Performance
PER Integration
PMPF Lifecycle
Performance Evaluation Plan (PEP) Scope
Evidence Matrix Before Writing
We do not start by blindly writing the PER. We first construct an evidence matrix linking each intended-purpose element and performance claim to the specific data needed to substantiate it, identifying and closing gaps before Notified Body review.
PER Deliverables
• Performance Evaluation Plan (PEP)
• Scientific Validity Report (SVR)
• Analytical Performance Report (APR)
• Clinical Performance Report (CPR)
• Integrated Performance Evaluation Report (PER)
• Post-Market Performance Follow-up (PMPF) Plan
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