EU IVDR Performance Evaluation in 8 Steps

The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 outlines specific guidelines for the performance evaluation of In Vitro Diagnostic Medical Devices (IVDs). These regulations, updated in Article 56 of the IVDR, require manufacturers to prepare a Performance Evaluation Report (PER) demonstrating the safety and performance of the device according to its intended use. The preparation of the PER must be underpinned by three essential pillars: scientific validity, analytical performance, and clinical performance. 

If you are a manufacturer unsure about how to prepare a compliant PER for your IVD device, understanding the performance evaluation requirements under the IVDR is crucial. The following steps will guide you through the process of successfully introducing your IVD to the European market. 

 

Step 1: Understand Article 56 and the General Safety and Performance Requirements (GSPR) 

Article 56 of the IVDR sets out the General Safety and Performance Requirements (GSPR) that are essential for the performance characteristics of your IVD. Manufacturers must demonstrate that their device complies with these requirements through scientific validity, analytical, and clinical performance. Annexes XIII and ISO 20916:2019 details the steps IVD manufacturers must follow to plan, carry out, and document the Performance Evaluation. It is vital to recognize that this evaluation is a continuous process, aligned closely with risk management practices throughout the lifecycle of the device. 

 

Step 2: Developing the Performance Evaluation Plan (PEP) 

The Performance Evaluation Plan (PEP) is a device-specific document that outlines the methods and procedures for evaluating your IVD. As stipulated in Annex XIII, paragraph 1.1 of the IVDR, your PEP should cover: 

• The current state of the art in medical diagnostics and related technology. 

• Reference to relevant standards, guidelines, and best practices. 

• A comprehensive plan detailing the device’s intended purpose, characteristics, and intended users. 

• Methods for evaluating analytical and clinical performance. 

• A Post-market Performance Follow-up (PMPF) plan for continuous monitoring. 

 

Step 3: Demonstrating Scientific Validity 

The scientific validity of your IVD is foundational, ensuring that the analytes or biomarkers the device measures are scientifically sound. This step involves conducting a systematic literature search and documenting the strategy, sources, and criteria used. If gaps in scientific validity are found, manufacturers must conduct additional studies, such as proof of concept or preclinical studies. All findings should be summarized in a scientific validity report, which will be a part of the Performance Evaluation Report (PER). 

 

Step 4: Conducting Analytical Performance Evaluation 

The analytical performance of your IVD focuses on its accuracy, specificity, sensitivity, reproducibility, and stability. Analytical performance evaluation typically involves: 

• Bench studies for cross-reactivity, interference, and stability. 

• Verification of subsystems, integration, and sampling methods, especially for complex devices. The results of these tests will be documented in an analytical performance report that will form part of the PER. 

 

Step 5: Conducting Clinical Performance Evaluation 

Clinical performance is the ability of your IVD to produce results that correlate with a defined clinical, physiological, or pathological condition in the target population. To demonstrate clinical performance: 

• Use literature references for well-established technologies or standardized tests. 

• Prepare a clinical performance study protocol in line with Annex XIII and ISO 20916:2019. Once clinical performance data is gathered, it will be summarized in a clinical performance report. 

 

Step 6: Demonstrating Stability of the IVD 

For IVDs, stability is a critical factor that must be demonstrated throughout the device’s lifecycle. Stability studies will address aspects such as shelf life, in-use stability, and transport stability. The EP25 guidance from the Clinical and Laboratory Standards Institute (CLSI) and Annex II of the IVDR provide standards for conducting these studies. 

 

Step 7: Preparing the Performance Evaluation Report (PER) 

Once you have completed the performance evaluation (PE) steps, it is time to compile your findings into the Performance Evaluation Report (PER). The PER must demonstrate sufficient clinical evidence, including: 

• A summary of scientific validity, analytical performance, and clinical performance. 

• An evaluation of the data considering the current state of the art in medicine. 

• The benefit-risk ratio of the device, confirming its safety and performance. 

All PER requirements are outlined in Annex XIII, part A, section 1.3.2 of the IVDR. 

 

Step 8: Post-Market Performance Follow-Up (PMPF) Plan & Report 

The Post-market Performance Follow-Up (PMPF) is an ongoing process to monitor the safety and performance of your IVD after it has entered the market. The PMPF plan should outline the procedures for collecting and evaluating data to identify emerging risks and assess the device’s benefit-risk profile. Class C and D devices require annual updates to the PMPF report and should include a Periodic Safety Update Report (PSUR) as part of the technical documentation. 

 

Need Help Navigating IVDR Compliance? 

If you are struggling with the performance evaluation process or need assistance ensuring that your In Vitro Diagnostic Devices (IVDs) comply with the EU IVDR 2017/746, BioBoston Consulting is here to help. Our team of regulatory specialists can guide you through the entire process—from creating the Performance Evaluation Plan (PEP) to managing the post-market surveillance requirements. 

Book a consultation with us today to ensure your IVDs meet all regulatory requirements and smoothly enter the European market.