IVDR Consulting Services

The performance evaluation forms part of the technical documentation required under IVDR and includes:

• Performance Evaluation Plan (PEP): Outlines the strategy for evaluating your device’s performance across scientific, analytical, and clinical aspects.
• Scientific Validity Report (SVR): The SVR establishes a direct link between the analyte and the clinical condition or physiological state it is intended to diagnose.
• Analytical Performance Report (APR): The APR demonstrates how well your IVD device performs in detecting or measuring the analyte under controlled conditions.
• Clinical Performance Report (CPR): The CPR assesses how well your device performs in a real-world clinical setting.
• Performance Evaluation Report (PER): Compiles the findings from the SVR, APR, and CPR to demonstrate your IVD meets the general safety and performance requirements (GSPRs) outlined in Annex I.

This should establish the device as state-of-the-art and demonstrate its clinical benefit, and include:

• A systematic literature review
• A review of expert opinions
• A competitor analysis
• Proof-of-concept studies
• Clinical performance study results for similar devices

How We Help: Our experts conduct a comprehensive literature review, analyse competitor products, and compile scientific, analytical, and clinical evidence to produce an SVR that meets IVDR expectations.

This demonstrates how well the IVD works under controlled conditions and includes:

• Accuracy, precision, and sensitivity testing
• Limit of detection (LoD) and limit of quantification (LoQ) studies
• Stability and robustness assessments

How We Help: We assist in data interpretation and documentation, ensuring your APR provides the necessary evidence for regulatory approval.

This should demonstrate the device's ability to provide the intended clinical benefit in a real-world setting and includes:

• Summary of all clinical performance data
• Address special device characteristics
• Demonstrate state-of-the-art status

How We Help: We support manufacturers in collecting relevant real-world evidence, and preparing a comprehensive CPR that meets IVDR standards.

The Performance Evaluation Report (PER) consolidates the findings from the SVR, APR, and CPR. This essential document must include:

• A clear justification of the device’s intended use and purpose
• A cohesive summary of scientific, analytical, and clinical performance
• A clear demonstration of the device’s benefits versus risks

How We Help: Our team compiles the PER with precision, ensuring a structured, compliant submission that meets Notified Body expectations.