Write to us. Reduces risk of regulatory rejection due to poorly designed studies.

Under Regulation (EU) 2017/746 (IVDR), manufacturers must establish sufficient analytical and clinical performance evidence in the intended-use population. A study must be designed to verify diagnostic accuracy of the test through direct comparison to validated reference methods and to demonstrate analytical robustness across relevant specimen matrices and operational variables.

IVD Performance Evaluation

IVD Performance evaluation is a mandatory requirement for all IVD devices. The regulation is clear that manufacturers must demonstrate three pillars of performance:

Scientific Validity – association between the analyte and the clinical condition.
Analytical Performance – ability of the IVD to correctly detect/measure the analyte.
Clinical Performance – ability of the IVD to yield results correlated with a particular clinical condition or physiological state.

The exact tests depend on the type of IVD (e.g., molecular, immunoassay, self-test, companion diagnostic), but IVDR Annex I (GSPR 9–13) outlines minimum mandatory parameters:

Analytical Performance Tests:

Accuracy (trueness & precision)
Analytical sensitivity (limit of detection)
Analytical specificity (cross-reactivity, interference)
Trueness of measurement
Precision (repeatability, reproducibility, intermediate precision)
Limits of detection, quantitation, measuring range
Linearity
Cut-off values (if applicable, e.g., qualitative tests)
Carry-over
Stability (specimen, reagent, calibrator, control materials)

Clinical Performance Tests:

Diagnostic sensitivity (true positive rate)
Diagnostic specificity (true negative rate)
Positive predictive value (PPV) & Negative predictive value (NPV)
Likelihood ratios
Expected values in normal/affected populations

When a CRO is Mandatory / Highly Recommended

Prospective clinical performance studies with patient samples, CRO involvement is almost unavoidable because you need ethics committee submission, informed consent, study site management, and monitoring and CROs ensure compliance with ISO 20916 and GCP.
Multicenter or international trials CROs manage coordination, logistics, and standardized data collection.
High-risk IVDs (Class C & D) Notified Bodies expect independent, unbiased data. Manufacturer-led studies without third-party oversight often face credibility issues.
Lack of in-house clinical research infrastructure If the manufacturer cannot demonstrate expertise in study management, monitoring, and data handling, outsourcing to a CRO becomes necessary.

Reghelps SRC CRO Service Scope covering IVD devices

A Contract Research Organization can be a major asset for completing IVD performance evaluations under both EU IVDR and US FDA regulations. Here’s a detailed breakdown:

Planning Stage
- Assist in drafting the IVD Performance Evaluation Plan (IVDR Annex XIII) or Analytical/Clinical Validation Plan (FDA guidance).
- Identify which tests are mandatory vs optional for your device class.
- Define sample size, inclusion/exclusion criteria, study endpoints, and statistical analysis methods.
- Ensure the plan aligns with ISO 20916 (IVDR) or FDA 21 CFR Part 11 & 812 where applicable.
Customer Benefit: You get a regulatory-aligned blueprint before spending resources on lab or clinical studies.
Study Management / Operational Support
- Site selection & management: Identify clinical sites, labs, or biobanks for sample collection.
- Ethics and regulatory approvals: Submit study protocols to Ethics Committees / IRBs and manage approvals.
- Sample handling & logistics: Ensure chain of custody, storage conditions, and traceability for patient specimens.
- Patient recruitment & consent: Manage enrollment, informed consent, and data privacy compliance.
Customer Benefit: Ensures that studies are conducted ethically, efficiently, and in compliance with IVDR/FDA requirements.
Analytical Performance
- Conduct analytical tests such as:
  - Accuracy, precision, repeatability
  - Sensitivity, specificity
  - Limit of detection / quantitation
  - Interference and cross-reactivity studies
  - Stability and robustness testing
- Maintain GLP or ISO 13485-compliant lab practices.
Customer Benefit: High-quality, traceable data for regulatory submission.
Clinical Performance / Human Studies
- Design prospective or retrospective clinical studies per IVDR Annex XIII or FDA guidance.
- Implement study protocols, patient stratification, endpoint measurement, and data collection.
- Perform statistical analysis to calculate diagnostic sensitivity, specificity, PPV, NPV, and likelihood ratios.
- Provide audit-ready clinical study reports for Notified Body or FDA review.
Customer Benefit: Reduces risk of regulatory rejection due to poorly designed studies or flawed data.
Data Management & Regulatory Documentation
- Ensure data integrity and compliance with 21 CFR Part 11 (FDA) or IVDR GSPR documentation requirements.
- Draft or support Performance Evaluation Report (PER) under IVDR or Analytical/Clinical Validation Reportfor FDA.
- Assist in literature review & scientific justification where applicable.
- Prepare regulatory submission packages (technical documentation for CE marking or 510(k) for FDA).
Customer Benefit: Streamlines compilation of submission-ready documents, saving time and reducing errors.