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:
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Scientific Validity – association between the analyte and the clinical condition.
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Analytical Performance – ability of the IVD to correctly detect/measure the analyte.
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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:
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Accuracy (trueness & precision)
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Analytical sensitivity (limit of detection)
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Analytical specificity (cross-reactivity, interference)
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Trueness of measurement
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Precision (repeatability, reproducibility, intermediate precision)
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Limits of detection, quantitation, measuring range
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Linearity
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Cut-off values (if applicable, e.g., qualitative tests)
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Carry-over
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Stability (specimen, reagent, calibrator, control materials)
Clinical Performance Tests:
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Diagnostic sensitivity (true positive rate)
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Diagnostic specificity (true negative rate)
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Positive predictive value (PPV) & Negative predictive value (NPV)
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Likelihood ratios
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Expected values in normal/affected populations
When a CRO is Mandatory / Highly Recommended
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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.
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Multicenter or international trials CROs manage coordination, logistics, and standardized data collection.
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High-risk IVDs (Class C & D) Notified Bodies expect independent, unbiased data. Manufacturer-led studies without third-party oversight often face credibility issues.
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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
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.
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
All MDD-certified devices must transition to MDR compliance by the applicable deadline. Significant changes to the product or intended use may require a full MDR re-certification.
The 510(k) file includes documents used to establish the safety and efficiency of the proposed medical device through substantial equivalence. The documents included in the 510(k) file are:
- Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet)
- FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This document includes basic administrative and device information.
- 510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any).
- FDA Form 3881: Indications for Use Statement
- 510(k) Summary or 510(k) Statement: This includes a summary of the device undergoing the 510(k) clearance.
- Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted.
- Class III Summary and Certification: If the proposed device is a Class III exempt from PMA, otherwise, this can be marked as not applicable.
- Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted
- Declarations of Conformity and Summary Reports: Lists the voluntary consensus standards used and includes DOC to such standards.
- Device Description: This document includes the description of the device design requirements and performance specifications.
- Executive Summary: a brief description of the device & comparison table with the predicate device identified.
- Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen.
- Proposed Labeling: Is discussed in detail to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s
- Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made.
- Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue.
- Software: This includes the documentation for any software used in the proposed device
- Electromagnetic Compatibility and Electrical Safety- If the proposed device is powered electrically, in which case the EMC must be evaluated.
- Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device.
- Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device.
- Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device.
The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.
All medical devices sold in England, Scotland, and Wales must be UKCA certified unless CE marked under special transition rules (valid until mid-2028 for some devices)
