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 CRO (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:
IVD Performance Evaluation Related FAQ’s
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
Yes. If your company is based outside the EEA and wishes to market medical devices or IVDs in Europe, it is legally required to appoint an EC REP. This representative’s name and address must appear on the product labeling, outer packaging, or Instructions for Use (IFU).
A Biological Evaluation Report (BER) summarizes the device’s biological risk assessment, including device description, material characterization, exposure categorization, literature review, testing results (if applicable), and a toxicological risk assessment. It concludes whether the device is biologically safe and compliant with ISO 10993.
We offer fast onboarding, typically within 1–2 working days upon receipt of the necessary documentation and agreement. We also guide you through label updates and document handovers to ensure a smooth transition.
