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
Yes. According to MDR and IVDR requirements, the EC REP’s name and address must be clearly visible on the product labeling, outer packaging, or accompanying documents, allowing EU authorities to easily identify the representative.
Yes, manufacturers / exporter any time they can transfer the US Agent. We are happy to act as US Agent for any non-US manufacturers. Please bring us the FDA FURLS account login details to update the Agent Information.
Yes we provide Food, Cosmetic, Drug and cosmetic label review service.
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
https://www.fda.gov/drugs/development-resources/labeling-information-drug-products
Not always. If sufficient historical data or literature exists to demonstrate the safety of materials used in the device, some tests may be waived. A gap analysis helps determine whether existing data is adequate or if additional testing (e.g., cytotoxicity, irritation, sensitization) is required to meet regulatory expectations.
Its highly recommended to conduct testing of finished salable device before you apply for regulatory clearance.
The drug Master Files are divided into 4 Types
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information
We provide US Agent service and E copy submission service. We also help with DMF preparation.
