Performance Evaluation for In Vitro Diagnostic (IVD) Devices

Masuu Global Solutions offers comprehensive Performance Evaluation services for In Vitro Diagnostic (IVD) devices covering everything from structured Performance Evaluation Plans (PEPs) to consolidated Performance Evaluation Reports (PERs).

Our methodology ensures scientific validity, analytical performance and clinical performance are demonstrated continuously throughout the entire lifecycle of your IVD device, as required under EU IVDR 2017/746.

Our customized solutions include PER authoring, literature analysis, gap assessments, SME support, and lifecycle maintenance helping manufacturers generate strong, compliant evidence packages for EU market entry and global submissions.

Performance Evaluation of IVD Devices – Overview

Under EU IVDR, performance evaluation requires manufacturers to demonstrate three core pillars:
  1. Scientific Validity
    2. Evidence showing that the analyte is meaningfully associated with a physiological or clinical condition.
  1. Analytical Performance
    2. Evidence verifying the measurement accuracy, precision, sensitivity, specificity, trueness, detection limits, and reproducibility.
  1. Clinical Performance
    2. Evidence demonstrating clinical sensitivity, specificity, predictive values, and real‑world usability.

Masuu Global Solutions strengthens all three pillars with structured justification, scientifically sound evidence synthesis, and robust documentation aligned with Annex XIII.

Masuu’s Tailored Performance Evaluation Services

  1. Performance Evaluation Gap Analysis
    2. We assess all existing performance, analytical, and clinical documentation to pinpoint evidence gaps. Our analysis provides:
    • GSPR alignment insights
    • Missing evidence identification
    • Priority‑based remediation actions
    • NB‑ready recommendations
    • A clear roadmap toward full IVDR compliance
  1. Tailored Literature Strategy & SLR Support
    2. We develop device‑specific literature strategies to support:
    • State‑of‑the‑art (SOTA) establishment
    • Performance evaluation reports
    • PMPF activities
    • Scientific validity reports Our process includes multi‑database searches, structured screening, extraction, critical appraisal, and transparent synthesis.
  1. SME Support for Non‑Conformity (NC) Review
    2. When Notified Bodies raise NCs, Masuu’s senior evaluators:
    • Analyze NB feedback
    • Strengthen evidence arguments
    • Improve methodological detail
    • Refine clinical/analytical summaries
    • Craft targeted NB response letters
    This support helps minimize review cycles and accelerate approval.
  1. SOP Development
    2. We create IVDR‑aligned SOPs covering:
    • Performance evaluation
    • Literature methodology
    • Evidence appraisal
    • Traceability requirements
    • PMPF integration
    These SOPs establish robust internal processes that support audit‑ready compliance.
  1. Lifecycle Management of Clinical & Performance Reports
    2. Masuu maintains living performance documentation through:
    • Annual PER updates
    • CPR and APR revisions
    • SVR refresh cycles
    • Integration of new evidence, vigilance data, and PMPF findings
    This ensures your documentation remains current, traceable, and aligned with evolving IVDR expectations.
  1. Full‑Time Employee (FTE) Support
    2. We provide dedicated performance evaluation specialists who support:
    • PER authoring
    • Literature review
    • Analytical/clinical evidence synthesis
    • PMPF strategy
    Our FTE experts serve as seamless extensions of your internal team.
  1. Procedural Trainings
    2. Masuu offers training programs on:
    • IVDR performance evaluation methodology
    • Scientific validity principles
    • Analytical and clinical evidence expectations
    • Literature review techniques
    • Documentation best practices
These trainings equip your teams with NB‑ready skills and processes.

Masuu’s Performance Evaluation Service Portfolio

Scientific Validity Report (SVR)
We establish the association between the analyte and the clinical condition using validated scientific literature, clinical data, and recognized guidelines.
Analytical Performance Report (APR)
Covers analytical sensitivity, specificity, precision, trueness, LoD/LoQ, reproducibility, and accuracy. For IHC assays, we also prepare documentation based on NordiQC‑referenced evidence.
Clinical Performance Report (CPR)
Summarizes clinical sensitivity, specificity, predictive values, diagnostic accuracy, and usability—supported by structured literature appraisal and real‑world data review.
Trueness Report
We assess the accuracy of IVD measurements using validated comparative methods, ensuring strong evidence for performance claims.
Performance Evaluation Report (PER)
We consolidate all components—SVR, APR, CPR, PMPF—into a single, traceable, IVDR‑compliant PER linked to technical documentation.
Summary of Safety and Performance (SSP)
We prepare clear, compliant SSPs for Class C and D IVDs, ensuring transparency for clinicians, patients, and regulators.
Performance Evaluation Plan (PEP)
Defines methodology, acceptance criteria, evidence strategy, and lifecycle approach for IVD performance evaluation under Annex XIII.
Book a Demo