Published: 10th August 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Understanding IVDR Performance Evaluation
Performance Evaluation sits at the heart of compliance with the European Union In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Regardless of whether an in vitro diagnostic medical device (IVD) is classified as Class A, B, C or D, manufacturers must demonstrate through objective evidence that the device consistently achieves its intended purpose and delivers clinically meaningful results throughout its lifecycle.
Unlike the previous In Vitro Diagnostic Directive (IVDD 98/79/EC), where the expectations surrounding performance evidence were often less clearly defined, the IVDR introduces a comprehensive and structured Performance Evaluation framework. Manufacturers are now expected to systematically collect, assess and maintain evidence demonstrating the scientific validity, analytical performance and clinical performance of their devices before they can be CE marked and placed on the European market.
Performance Evaluation is far more than a one-off regulatory exercise. It begins during product development with the creation of a Performance Evaluation Plan (PEP), continues through verification and validation activities, and culminates in a comprehensive Performance Evaluation Report (PER) that forms part of the device’s technical documentation. Following market approval, manufacturers must continue to review new evidence through Post-Market Performance Follow-up (PMPF) and update their Performance Evaluation whenever new information becomes available.
The extent of Performance Evaluation required depends on factors such as the device’s intended purpose, its classification under Annex VIII, the potential risks associated with incorrect results and the current state of scientific knowledge. Higher-risk devices, particularly Class C and Class D IVDs, are generally expected to provide more comprehensive evidence and undergo greater regulatory scrutiny during conformity assessment.
Ultimately, Performance Evaluation provides the objective evidence that regulators, Notified Bodies, healthcare professionals and patients rely upon to demonstrate that an IVD is safe, performs as intended and provides clinically useful information. A well-planned Performance Evaluation not only supports successful CE marking but also strengthens confidence in the device throughout its entire lifecycle.
What Is IVDR Performance Evaluation?
Performance Evaluation is the systematic process used to demonstrate that an in vitro diagnostic medical device (IVD) achieves its intended purpose and produces results that are scientifically valid, analytically reliable and clinically meaningful. Under the EU In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, every manufacturer must perform a Performance Evaluation before placing an IVD on the European market.
The legal requirements for Performance Evaluation are set out primarily within Article 56 and Annex XIII of the IVDR. Together, these establish a structured framework requiring manufacturers to generate, assess and maintain objective evidence demonstrating that their device performs safely and effectively throughout its entire lifecycle.
Unlike product testing alone, Performance Evaluation is a comprehensive scientific assessment that considers all available evidence supporting the intended purpose of the device. It draws upon published scientific literature, laboratory studies, clinical performance investigations, post-market experience and other relevant data to build an overall body of evidence demonstrating conformity with the IVDR’s General Safety and Performance Requirements (GSPRs).
Every Performance Evaluation must be planned, documented and maintained throughout the lifecycle of the device. Manufacturers are expected to prepare a Performance Evaluation Plan (PEP) before generating evidence, produce a Performance Evaluation Report (PER) summarising the findings, and continually update this documentation as new scientific knowledge and real-world performance data become available.
Although the depth of evidence required varies according to the intended purpose and classification of the device, Performance Evaluation is mandatory for all IVDs. Whether developing a low-risk Class A specimen receptacle or a high-risk Class D blood donor screening assay, manufacturers must be able to demonstrate that their device performs as intended and that the benefits outweigh any residual risks.
Rather than relying on a single clinical study or laboratory test, the IVDR adopts a holistic approach to Performance Evaluation. Manufacturers are expected to critically assess all relevant evidence and determine whether it collectively supports the safety, performance and intended clinical use of the device.
Ultimately, Performance Evaluation provides the scientific foundation for CE marking under the IVDR. It enables manufacturers to demonstrate regulatory compliance, supports conformity assessment by Notified Bodies and provides confidence that healthcare professionals and patients can rely on the results generated by the device.
New to the EU IVDR?
Performance Evaluation is just one part of complying with Regulation (EU) 2017/746. If you're looking for a complete introduction to the EU IVDR, including IVD classification, General Safety and Performance Requirements (GSPRs), Technical Documentation, conformity assessment, Notified Bodies, UDI, EUDAMED, Performance Evaluation and post-market surveillance, explore our Complete Guide to the EU IVDR.
Why IVDR Performance Evaluation Matters
Performance Evaluation is far more than a regulatory requirement—it is the process that demonstrates an in vitro diagnostic medical device (IVD) is capable of delivering accurate, reliable and clinically meaningful results throughout its intended lifecycle. Without robust Performance Evaluation, manufacturers cannot objectively demonstrate that their device meets the General Safety and Performance Requirements (GSPRs) of the IVDR or provides sufficient benefit to outweigh any residual risks.
Under Regulation (EU) 2017/746, manufacturers are expected to build an evidence-based justification for the safety and performance of their devices. This evidence supports conformity assessment, provides confidence to healthcare professionals and patients, and ensures that clinical decisions are based on reliable diagnostic information.
Performance Evaluation influences almost every stage of the regulatory process, from product development and technical documentation through to CE marking and ongoing post-market surveillance.
Protecting Patient Safety
One of the primary objectives of Performance Evaluation is to protect patients from the consequences of inaccurate or misleading diagnostic results. An incorrect test result may lead to delayed diagnosis, unnecessary treatment, missed opportunities for early intervention or inappropriate clinical management.
By demonstrating that an IVD consistently performs as intended, manufacturers help ensure that healthcare professionals can rely on the information generated by the device when making important clinical decisions.
For higher-risk devices, such as companion diagnostics, blood donor screening assays and genetic tests, the potential consequences of an inaccurate result can be significant, making robust Performance Evaluation essential for patient safety.
Supporting Clinical Decision-Making
Healthcare professionals depend on IVDs to provide accurate and reliable information that supports diagnosis, disease monitoring, treatment selection and patient management.
Performance Evaluation demonstrates that the results produced by the device are clinically meaningful and appropriate for the intended purpose defined by the manufacturer. This helps ensure that clinicians can make informed decisions based on evidence they can trust.
Whether an IVD is used to detect an infectious disease, identify a genetic mutation or monitor treatment effectiveness, the quality of clinical decision-making depends upon the quality of the evidence supporting the device.
Demonstrating Compliance with the IVDR
Performance Evaluation forms a central component of the manufacturer’s technical documentation and provides objective evidence that the device complies with the IVDR.
Rather than relying on assumptions or theoretical performance claims, manufacturers must generate and evaluate appropriate scientific evidence demonstrating that the device achieves its intended purpose.
This evidence supports compliance with Article 56, Annex XIII and the applicable General Safety and Performance Requirements (GSPRs), allowing manufacturers to demonstrate conformity before applying the CE mark.
Supporting Notified Body Assessment
For most Class B, Class C and Class D IVDs, the Performance Evaluation will be reviewed as part of the Notified Body conformity assessment process.
Notified Bodies expect to see a well-structured Performance Evaluation that clearly demonstrates:
- The scientific basis for the device.
- Appropriate analytical performance studies.
- Sufficient clinical performance evidence.
- A justified benefit-risk determination.
- Traceability between the evidence and the intended purpose.
A poorly prepared Performance Evaluation can result in requests for additional information, major non-conformities or significant delays to certification.
Strengthening Technical Documentation
Performance Evaluation is not a standalone document. It supports and interacts with many other sections of the technical documentation.
For example, the evidence generated during Performance Evaluation helps support:
- Risk management activities.
- General Safety and Performance Requirements (GSPR) compliance.
- Labelling and Instructions for Use.
- Benefit-risk analysis.
- Performance claims made by the manufacturer.
- Post-market surveillance planning.
Maintaining clear traceability between these documents helps demonstrate a robust and well-controlled development process during regulatory review.
Enabling Successful CE Marking
Before an IVD can be placed on the European market, manufacturers must demonstrate that it satisfies the applicable conformity assessment requirements.
Performance Evaluation provides much of the objective evidence needed to support this assessment. Without sufficient evidence demonstrating scientific validity, analytical performance and clinical performance, manufacturers are unlikely to achieve successful CE marking under the IVDR.
Planning Performance Evaluation activities early in the product development process can help avoid unnecessary delays and ensure that appropriate evidence is available before conformity assessment begins.
Supporting Continuous Compliance
Performance Evaluation does not end when a device receives CE marking. Manufacturers are expected to continually review new scientific information, monitor real-world device performance and assess whether the existing evidence remains sufficient throughout the product lifecycle.
This ongoing process is supported by Post-Market Performance Follow-up (PMPF), post-market surveillance activities and periodic updates to the Performance Evaluation Report (PER).
By continually reviewing new evidence, manufacturers can identify emerging risks, confirm that performance claims remain valid and demonstrate continued compliance with the IVDR as scientific knowledge evolves.
The Three Scientific Pillars of IVDR Performance Evaluation
The IVDR requires manufacturers to demonstrate that their in vitro diagnostic medical device achieves its intended purpose through a structured assessment of three complementary elements: scientific validity, analytical performance and clinical performance. Together, these form the foundation of every Performance Evaluation and provide the evidence needed to demonstrate conformity with Regulation (EU) 2017/746.
Rather than considering these elements independently, manufacturers should view them as interconnected components of a single body of evidence. Each pillar answers a different question about the device, and together they demonstrate that the test is scientifically justified, technically reliable and clinically useful.
The extent of evidence required for each pillar will depend on the intended purpose, classification and risk profile of the device. While a lower-risk Class A IVD may require relatively limited evidence, manufacturers of Class C and Class D devices should expect to provide extensive supporting documentation across all three areas.
Understanding the role of each pillar is essential when planning a Performance Evaluation and preparing the Performance Evaluation Report (PER).
Scientific Validity
Scientific validity establishes the relationship between the analyte or biomarker being measured and the clinical condition or physiological state that the device is intended to assess.
In simple terms, it answers the question:
“Is there sound scientific evidence that this marker is associated with the disease or condition the device claims to detect?”
Manufacturers must demonstrate that the scientific principles underpinning the device are well established and supported by objective evidence. This may include published scientific literature, clinical guidelines, consensus documents, recognised reference materials and other authoritative sources.
For example, a device intended to detect cardiac troponin must be supported by robust scientific evidence demonstrating the established relationship between elevated troponin levels and myocardial injury. Likewise, a companion diagnostic should demonstrate that the biomarker being measured is scientifically linked to the effectiveness or safety of the associated medicinal product.
Scientific validity provides the biological and clinical rationale for the device before analytical and clinical performance are considered.
Analytical Performance
Analytical performance demonstrates how accurately and reliably the device measures the analyte under controlled conditions.
Where scientific validity establishes what should be measured, analytical performance demonstrates how well the device measures it.
Manufacturers are expected to generate objective evidence showing that the device performs consistently and accurately within its specified operating conditions. Depending on the intended purpose of the device, analytical performance studies may evaluate characteristics such as:
- Accuracy
- Precision (repeatability and reproducibility)
- Analytical sensitivity
- Analytical specificity
- Measuring range
- Limit of detection
- Limit of quantification
- Interfering substances
- Cross-reactivity
- Stability of specimens and reagents
The specific studies required will vary depending on the technology, intended purpose and classification of the IVD. Collectively, these investigations provide confidence that the device can reliably generate accurate analytical results before it is used in clinical practice.
Clinical Performance
Clinical performance demonstrates that the results generated by the device are clinically meaningful for the intended patient population and intended use.
It answers the question:
“Do the results produced by the device support appropriate clinical decisions in real-world use?”
Clinical performance evidence is typically generated through clinical performance studies, published clinical literature or other appropriate clinical data. The objective is to demonstrate that the device correctly identifies or predicts the clinical condition, disease or physiological state described in its intended purpose.
Depending on the type of IVD, clinical performance may be demonstrated using measures such as:
- Diagnostic sensitivity
- Diagnostic specificity
- Positive predictive value
- Negative predictive value
- Clinical agreement
- Comparison with established reference methods
For higher-risk devices, particularly Class C and Class D IVDs, clinical performance often represents one of the most extensively reviewed components of the Performance Evaluation during Notified Body assessment.
Developing a Home Testing Kit Under the IVDR?
Self-testing IVDs are subject to additional regulatory requirements because they are intended for use by lay persons. Learn how home testing kits are classified under the IVDR, the performance evaluation and usability evidence required, Notified Body expectations and the key compliance requirements in our Guide to Home Testing Kit Regulations and IVDR Compliance.
Bringing the Three Pillars Together
Although each pillar evaluates a different aspect of device performance, they should never be considered in isolation. A successful Performance Evaluation integrates scientific validity, analytical performance and clinical performance into a single, coherent body of evidence demonstrating that the device achieves its intended purpose safely and effectively.
For example, a manufacturer may demonstrate that a biomarker is scientifically associated with a disease, develop a test that accurately detects that biomarker under laboratory conditions and then confirm through clinical studies that the test supports reliable diagnosis in the intended patient population. Only when all three elements are considered together can manufacturers demonstrate that their device provides meaningful clinical benefit while maintaining an acceptable benefit-risk profile.
This integrated approach forms the basis of the Performance Evaluation Report (PER) and provides the objective evidence reviewed by Notified Bodies during conformity assessment.
The IVDR Performance Evaluation Lifecycle
Performance Evaluation should not be viewed as a single document produced shortly before CE marking. Instead, it is a continuous lifecycle process that begins during device development and continues throughout the entire commercial life of the IVD.
Under the IVDR, manufacturers are expected to plan Performance Evaluation activities from the earliest stages of development, generate appropriate evidence before placing the device on the market and continually review new information after CE marking has been achieved. This ensures that the evidence supporting the device remains current, scientifically robust and appropriate for its intended purpose.
The Performance Evaluation lifecycle follows a structured and iterative approach, with each stage building upon the previous one to create a comprehensive body of evidence supporting the safety and performance of the device.
Step 1 – Develop the Performance Evaluation Plan (PEP)
The first stage of the lifecycle is the preparation of a Performance Evaluation Plan (PEP). This document defines how the manufacturer intends to demonstrate that the device achieves its intended purpose and meets the applicable IVDR requirements.
The PEP should be developed early in the product development process and establish a clear strategy for generating and evaluating evidence. It typically defines:
- The intended purpose of the device.
- The intended users and target patient population.
- The applicable Performance Evaluation requirements.
- The approach to assessing scientific validity.
- Planned analytical performance studies.
- Planned clinical performance investigations or supporting evidence.
- The methods used to evaluate and analyse performance data.
- The criteria for determining whether sufficient evidence has been obtained.
A well-developed PEP provides the foundation for all subsequent Performance Evaluation activities and helps ensure that evidence generation is both systematic and proportionate to the risks associated with the device.
Step 2 – Generate Performance Evidence
Once the Performance Evaluation Plan has been established, manufacturers begin collecting the evidence required to support the safety and performance of the device.
Evidence may be generated from a variety of sources depending on the intended purpose and classification of the IVD, including:
- Published scientific literature.
- Analytical laboratory studies.
- Clinical performance investigations.
- Existing clinical data.
- Comparator device studies.
- Reference methods.
- Real-world performance data where appropriate.
Rather than relying on a single study, manufacturers should critically evaluate all available evidence to determine whether it collectively demonstrates that the device performs as intended.
The depth of evidence required will generally increase with the potential risks associated with the device. For example, a Class D blood donor screening assay would normally require considerably more supporting evidence than a lower-risk Class A laboratory reagent.
Step 3 – Evaluate the Evidence
Collecting evidence alone is not sufficient. Manufacturers must critically assess the quality, relevance and reliability of the available data before determining whether it adequately supports the intended purpose of the device.
During this stage, manufacturers should consider questions such as:
- Is the evidence scientifically robust?
- Are the study methodologies appropriate?
- Does the evidence represent the intended patient population?
- Are any conflicting results adequately explained?
- Are there limitations that could affect the conclusions?
- Is additional evidence required?
This critical appraisal ensures that conclusions are based upon objective scientific evidence rather than simply the quantity of available data.
Step 4 – Prepare the Performance Evaluation Report (PER)
Following completion of the evidence assessment, manufacturers should document their conclusions within a Performance Evaluation Report (PER).
The PER brings together all aspects of the Performance Evaluation into a single document and explains how the available evidence demonstrates that the device achieves its intended purpose.
A typical Performance Evaluation Report will include:
- The Performance Evaluation strategy.
- Scientific validity assessment.
- Analytical performance assessment.
- Clinical performance assessment.
- Critical evaluation of the evidence.
- Conclusions regarding safety and performance.
- Benefit-risk considerations.
- Recommendations for ongoing evidence generation where appropriate.
For most Class B, Class C and Class D devices, the PER forms a key component of the technical documentation reviewed during conformity assessment.
Step 5 – Maintain Performance Evaluation Through PMPF
Performance Evaluation does not end when the device receives CE marking.
Manufacturers are expected to continually monitor the safety and performance of their devices throughout their lifecycle by reviewing new scientific knowledge, analysing post-market data and updating the Performance Evaluation whenever appropriate.
This ongoing activity is supported by Post-Market Performance Follow-up (PMPF), which helps manufacturers:
- Confirm that the device continues to perform as intended.
- Identify emerging risks or performance trends.
- Validate benefit-risk conclusions.
- Support continual improvement.
- Maintain compliance with the IVDR.
Where new evidence becomes available, manufacturers should update the Performance Evaluation Report and associated technical documentation to ensure they continue to reflect the current state of scientific knowledge.
Performance Evaluation Is a Continuous Process
One of the most significant changes introduced by the IVDR is the expectation that Performance Evaluation remains a living process rather than a one-time regulatory submission.
As scientific understanding evolves, new technologies emerge and additional post-market experience is gained, manufacturers should continually assess whether their existing evidence remains sufficient to support the intended purpose of the device.
By adopting a lifecycle approach to Performance Evaluation, manufacturers can demonstrate continued compliance, maintain confidence in the safety and performance of their devices and ensure that patients and healthcare professionals continue to benefit from accurate and reliable diagnostic information throughout the product’s lifetime.
Performance Evaluation Plan (PEP)
The Performance Evaluation Plan (PEP) is the foundation of every IVDR Performance Evaluation. It establishes the manufacturer’s strategy for demonstrating that an in vitro diagnostic medical device (IVD) achieves its intended purpose and provides a structured framework for generating, collecting and assessing performance evidence.
Rather than beginning studies without a defined objective, manufacturers should prepare a Performance Evaluation Plan early in the product development process. This ensures that scientific validity, analytical performance and clinical performance activities are appropriately planned, proportionate to the intended purpose of the device and aligned with the requirements of Regulation (EU) 2017/746.
A well-developed PEP helps manufacturers identify the evidence that will be required for conformity assessment, allocate appropriate resources and reduce the likelihood of gaps being identified during Notified Body review.
Why Is a Performance Evaluation Plan Important?
The IVDR places significant emphasis on planning Performance Evaluation before evidence is generated. Without a clear strategy, manufacturers risk undertaking unnecessary studies, overlooking important evidence or failing to demonstrate that the device meets the applicable General Safety and Performance Requirements (GSPRs).
A Performance Evaluation Plan provides a documented roadmap for the entire evaluation process. It defines what evidence is required, how that evidence will be generated and the methods that will be used to assess whether the device achieves its intended purpose.
Developing the PEP at an early stage also allows manufacturers to identify potential evidence gaps before significant time and resources have been invested in development.
What Should a Performance Evaluation Plan Include?
Although the exact content will vary depending on the complexity and intended purpose of the device, a comprehensive Performance Evaluation Plan will typically include:
- A description of the device and its intended purpose.
- The intended users and target patient population.
- The applicable IVDR classification.
- The intended clinical claims and performance claims.
- The strategy for demonstrating scientific validity.
- Planned analytical performance studies.
- Planned clinical performance investigations or supporting clinical evidence.
- The methods for identifying and evaluating published scientific literature.
- Acceptance criteria for determining whether sufficient evidence has been generated.
- A strategy for identifying and addressing evidence gaps.
- The planned approach to updating the Performance Evaluation following CE marking through Post-Market Performance Follow-up (PMPF).
The level of detail should be proportionate to the classification and complexity of the device, with higher-risk IVDs generally requiring more comprehensive planning.
Aligning the PEP with Other IVDR Documentation
The Performance Evaluation Plan should not be developed in isolation. It forms part of the wider technical documentation and should align with several other key regulatory documents prepared during device development.
For example, the PEP should be consistent with:
- The intended purpose described within the technical documentation.
- The manufacturer’s Risk Management File developed in accordance with ISO 14971.
- The General Safety and Performance Requirements (GSPR) checklist.
- The clinical and performance claims described within the Instructions for Use.
- The Post-Market Surveillance (PMS) Plan.
- The Post-Market Performance Follow-up (PMPF) Plan, where applicable.
- The manufacturer’s Quality Management System established under Article 10 and typically aligned with ISO 13485.
Maintaining clear traceability between these documents demonstrates that Performance Evaluation has been fully integrated into the manufacturer’s quality and regulatory processes.
The Performance Evaluation Plan Is a Living Document
Although the PEP is created during product development, it should not remain static throughout the device lifecycle.
As new scientific evidence becomes available, study results are generated or the intended purpose of the device changes, manufacturers should review and update the Performance Evaluation Plan to ensure it continues to reflect the current evaluation strategy.
For example, changes may be required when:
- Additional analytical performance studies are undertaken.
- New clinical evidence becomes available.
- Published scientific literature changes the understanding of the analyte or disease.
- New risks are identified through post-market surveillance.
- The intended purpose or target patient population is expanded.
- Significant design changes are made to the device.
Regularly reviewing the PEP helps ensure that the Performance Evaluation remains scientifically robust and aligned with the current state of knowledge throughout the product lifecycle.
Benefits of a Well-Prepared Performance Evaluation Plan
Investing time in preparing a comprehensive Performance Evaluation Plan offers significant advantages throughout the regulatory process.
A robust PEP helps manufacturers to:
- Plan Performance Evaluation activities systematically.
- Identify evidence requirements at an early stage.
- Avoid unnecessary testing and duplication of studies.
- Demonstrate traceability between planned activities and regulatory requirements.
- Support efficient preparation of the Performance Evaluation Report (PER).
- Facilitate smoother Notified Body reviews.
- Reduce the likelihood of regulatory delays during conformity assessment.
Ultimately, a well-structured Performance Evaluation Plan provides the foundation for an effective Performance Evaluation and helps manufacturers generate the high-quality evidence needed to support successful CE marking under the IVDR.
Generating Performance Evidence
Once the Performance Evaluation Plan (PEP) has been established, manufacturers must generate and collect the evidence needed to demonstrate that their in vitro diagnostic medical device (IVD) achieves its intended purpose. Under the IVDR, Performance Evaluation is based on the critical assessment of all relevant scientific and clinical evidence rather than reliance on a single study or data source.
The type and quantity of evidence required will depend on the intended purpose, technology, classification and risk profile of the device. While lower-risk devices may rely on a relatively limited body of evidence, manufacturers of Class C and Class D IVDs should generally expect to undertake more extensive investigations and provide a broader range of supporting documentation.
Rather than considering each source of evidence independently, manufacturers should evaluate how the available data collectively demonstrates scientific validity, analytical performance and clinical performance.
Published Scientific Literature
Published scientific literature often provides an important source of evidence, particularly when demonstrating scientific validity.
Manufacturers should conduct systematic literature searches to identify relevant peer-reviewed publications, clinical guidelines, consensus statements and other authoritative sources that support the relationship between the analyte being measured and the clinical condition or physiological state described within the intended purpose.
The literature review should follow a documented and reproducible methodology, including clearly defined search strategies, inclusion and exclusion criteria, critical appraisal of the available evidence and justification for the conclusions reached.
Where published literature is used to support analytical or clinical performance claims, manufacturers should ensure that the studies are relevant to the specific device or are scientifically justified as being applicable.
Analytical Performance Studies
Analytical performance studies provide objective evidence that the device accurately and reliably measures the intended analyte under controlled laboratory conditions.
The specific investigations required will vary depending on the technology and intended purpose of the device but may include assessments of:
- Accuracy.
- Precision.
- Repeatability.
- Reproducibility.
- Analytical sensitivity.
- Analytical specificity.
- Limit of detection.
- Limit of quantification.
- Measuring range.
- Interference.
- Cross-reactivity.
- Stability.
Manufacturers should ensure that study designs are scientifically justified, appropriately documented and conducted using validated methods wherever possible.
Clinical Performance Studies
Clinical performance studies demonstrate that the results produced by the device are clinically meaningful within the intended patient population and support appropriate clinical decision-making.
Depending on the nature of the IVD, manufacturers may generate clinical performance evidence through prospective or retrospective studies, comparison with established reference methods or analysis of existing clinical datasets.
Typical endpoints assessed during clinical performance investigations may include:
- Diagnostic sensitivity.
- Diagnostic specificity.
- Positive predictive value.
- Negative predictive value.
- Clinical agreement.
- Concordance with comparator methods.
Manufacturers should ensure that the study population, sample size and statistical analyses are appropriate for the intended purpose and expected clinical claims.
Existing Clinical and Performance Data
In some cases, manufacturers may be able to utilise existing data rather than generating entirely new studies.
Relevant sources may include:
- Previous clinical investigations.
- Legacy performance data.
- Published validation studies.
- Registry data.
- Real-world evidence.
- Data generated for earlier versions of the device.
- Information from equivalent devices, where appropriate and scientifically justified.
However, manufacturers remain responsible for demonstrating that the available evidence is directly applicable to the device under evaluation and adequately supports its intended purpose under the IVDR.
Comparator Methods and Reference Materials
Many Performance Evaluations involve comparing the performance of the device against recognised reference methods or comparator devices.
Using established reference materials or internationally recognised testing methods helps demonstrate that the device produces results consistent with accepted clinical practice.
Where comparator devices are used, manufacturers should justify why the comparator is appropriate and explain any differences that may influence the interpretation of the results.
Careful selection of comparator methods can significantly strengthen the overall body of evidence presented during conformity assessment.
Real-World Performance Data
Performance evidence does not stop once a device has been placed on the market.
As part of the ongoing Performance Evaluation process, manufacturers should continue to collect and assess real-world data generated during routine clinical use. This information may provide valuable evidence supporting the continued safety, performance and clinical utility of the device.
Examples of real-world evidence include:
- Complaint investigations.
- Customer feedback.
- Vigilance reports.
- External quality assessment (EQA) data.
- Laboratory performance monitoring.
- Scientific publications.
- Post-Market Performance Follow-up (PMPF) activities.
This information should be critically reviewed and incorporated into the Performance Evaluation whenever appropriate.
Building a Robust Body of Evidence
One of the key principles of IVDR Performance Evaluation is that no single study is likely to provide all the evidence needed to demonstrate conformity.
Instead, manufacturers should assemble a comprehensive body of evidence by combining multiple complementary sources of information. Published literature may establish scientific validity, analytical studies may demonstrate technical performance and clinical investigations may confirm that the device delivers meaningful results in the intended clinical setting.
The Performance Evaluation should critically assess the strengths and limitations of each evidence source, identify any remaining uncertainties and explain how the combined evidence demonstrates that the device consistently achieves its intended purpose.
By adopting this evidence-based approach, manufacturers can provide regulators and Notified Bodies with confidence that the device is supported by robust scientific data and remains safe and effective throughout its lifecycle.
Performance Evaluation Report (PER)
The Performance Evaluation Report (PER) is the document that brings together all of the evidence generated during the Performance Evaluation process and demonstrates that the in vitro diagnostic medical device (IVD) achieves its intended purpose. It provides a structured, evidence-based assessment of the device’s scientific validity, analytical performance and clinical performance, allowing manufacturers to demonstrate conformity with the requirements of the IVDR.
Rather than simply presenting the results of individual studies, the PER critically evaluates all available evidence and explains how that evidence collectively supports the safety, performance and intended clinical use of the device. It should provide a balanced assessment of both the strengths and limitations of the available data, identify any remaining uncertainties and justify the manufacturer’s conclusions.
For many Class B, Class C and Class D IVDs, the Performance Evaluation Report is one of the principal documents reviewed during Notified Body conformity assessment and forms a core component of the technical documentation required under Regulation (EU) 2017/746.
What Is the Purpose of the Performance Evaluation Report?
The primary purpose of the Performance Evaluation Report is to demonstrate, through objective scientific evidence, that the device consistently performs as intended and that the benefits of its use outweigh any residual risks.
Rather than focusing solely on individual performance studies, the PER presents an integrated assessment of all available evidence. It should explain how scientific validity, analytical performance and clinical performance support one another and collectively demonstrate that the device is suitable for its intended purpose.
A well-prepared PER provides confidence to regulators, Notified Bodies, healthcare professionals and manufacturers that the device has been evaluated using a systematic, evidence-based approach consistent with the expectations of the IVDR.
What Should a Performance Evaluation Report Include?
Although the exact structure will vary depending on the intended purpose and complexity of the device, a comprehensive Performance Evaluation Report will typically include:
- A summary of the device and its intended purpose.
- Reference to the Performance Evaluation Plan (PEP).
- An assessment of scientific validity.
- A review of analytical performance evidence.
- A review of clinical performance evidence.
- Critical appraisal of all available scientific and clinical data.
- Discussion of any limitations or evidence gaps.
- Benefit-risk considerations.
- Conclusions regarding the overall safety and performance of the device.
- Recommendations for ongoing evidence generation through Post-Market Performance Follow-up (PMPF), where applicable.
Each section should be fully traceable to the supporting evidence contained within the technical documentation.
Critical Evaluation of the Evidence
One of the defining characteristics of a strong Performance Evaluation Report is the quality of its critical appraisal.
Manufacturers should not simply summarise published studies or laboratory results. Instead, they should objectively evaluate the reliability, relevance and scientific quality of each source of evidence.
For example, manufacturers should consider:
- Whether study methodologies were appropriate.
- The size and representativeness of study populations.
- Potential sources of bias.
- The consistency of findings across multiple studies.
- Any conflicting evidence.
- The applicability of published literature to the device under evaluation.
Where limitations exist, these should be acknowledged and discussed openly. Demonstrating an objective and balanced assessment of the available evidence is often viewed more favourably by regulators than attempting to present only positive findings.
Demonstrating Traceability
An effective Performance Evaluation Report should clearly demonstrate traceability between the evidence reviewed and the conclusions reached.
For example, the PER should show how:
- Published literature supports scientific validity.
- Analytical studies demonstrate measurement performance.
- Clinical investigations confirm clinical utility.
- Performance claims made within the Instructions for Use are supported by objective evidence.
- Risks identified within the Risk Management File have been considered during the evaluation.
- The conclusions align with the intended purpose defined within the technical documentation.
Maintaining this traceability makes it easier for Notified Bodies to understand the manufacturer’s rationale and assess whether the available evidence adequately supports conformity with the IVDR.
Integration with the Technical Documentation
The Performance Evaluation Report does not exist as a standalone document. It forms an integral part of the technical documentation and should align closely with other regulatory records prepared throughout the product lifecycle.
The PER should be consistent with:
- The intended purpose of the device.
- The General Safety and Performance Requirements (GSPR) checklist.
- The Risk Management File prepared in accordance with ISO 14971.
- The Instructions for Use and labelling.
- The Post-Market Surveillance (PMS) Plan.
- The Post-Market Performance Follow-up (PMPF) Plan, where applicable.
- The manufacturer’s Quality Management System.
Consistency across these documents demonstrates that Performance Evaluation has been fully integrated into the manufacturer’s quality and regulatory processes.
Maintaining the Performance Evaluation Report
The Performance Evaluation Report should be regarded as a living document that evolves throughout the lifecycle of the device.
Following CE marking, manufacturers are expected to review new scientific publications, monitor post-market experience, analyse complaint trends and evaluate any new clinical evidence that may affect the safety or performance of the device.
Where new information influences the benefit-risk profile or supports updated performance claims, the Performance Evaluation Report should be revised accordingly. Regular updates help ensure that the PER continues to reflect the current state of scientific knowledge and remains aligned with the ongoing requirements of the IVDR.
Preparing for Notified Body Review
For manufacturers of Class B, Class C and Class D IVDs, the Performance Evaluation Report will receive detailed scrutiny during conformity assessment.
Notified Bodies typically expect the PER to demonstrate:
- A clearly defined evaluation strategy.
- Robust scientific validity evidence.
- Appropriate analytical performance studies.
- Sufficient clinical performance evidence.
- Objective critical appraisal of the available data.
- Clear traceability between the evidence and the manufacturer’s conclusions.
- Appropriate plans for ongoing Post-Market Performance Follow-up.
A well-structured Performance Evaluation Report not only supports successful certification but can also reduce requests for additional information and help streamline the conformity assessment process.
Common IVDR Performance Evaluation Mistakes
Performance Evaluation is one of the most heavily scrutinised aspects of IVDR conformity assessment, yet it is also one of the areas where manufacturers most frequently encounter regulatory challenges. Many of the issues identified by Notified Bodies arise not because Performance Evaluation has been omitted, but because the evidence has not been planned, documented or critically assessed in a systematic manner.
Fortunately, many of these problems can be avoided by adopting a structured, lifecycle-based approach to Performance Evaluation from the earliest stages of device development.
Treating Performance Evaluation as a One-Off Activity
One of the most common misconceptions is that Performance Evaluation is simply another document that needs to be completed before submitting technical documentation for CE marking.
In reality, Performance Evaluation is a continuous process that begins during product development and continues throughout the entire lifecycle of the device. Manufacturers should plan evidence generation early, critically evaluate new information as it becomes available and periodically review whether the existing evidence continues to support the intended purpose of the device.
Viewing Performance Evaluation as an ongoing process rather than a one-time regulatory exercise helps maintain compliance and supports continual improvement.
Developing the Performance Evaluation Plan Too Late
Some manufacturers only begin planning their Performance Evaluation after analytical testing or clinical studies have already been completed.
Without a clearly defined Performance Evaluation Plan (PEP), there is a greater risk of collecting insufficient evidence, overlooking important study endpoints or generating data that does not adequately support the intended purpose of the device.
Preparing the PEP early allows manufacturers to define an appropriate evidence generation strategy before significant development resources have been committed.
Relying on Limited Sources of Evidence
Performance Evaluation should be based upon the critical assessment of all relevant evidence rather than relying on a single publication or individual performance study.
Manufacturers should consider multiple complementary sources of information, including:
- Published scientific literature.
- Analytical performance studies.
- Clinical performance investigations.
- Existing clinical data.
- Reference methods.
- Real-world performance information, where appropriate.
Combining multiple evidence sources provides a more robust demonstration that the device consistently achieves its intended purpose.
Failing to Critically Appraise the Evidence
Simply collecting evidence is not enough.
Manufacturers should critically evaluate the quality, relevance and limitations of each study before drawing conclusions. Notified Bodies expect to see an objective scientific assessment rather than a summary of favourable results.
Acknowledging limitations, discussing conflicting evidence and explaining why the overall body of evidence remains sufficient demonstrates a mature and scientifically rigorous approach to Performance Evaluation.
Poor Traceability Within the Technical Documentation
Performance Evaluation should not exist in isolation from the rest of the technical documentation.
Manufacturers should maintain clear traceability between the Performance Evaluation and documents such as:
- The intended purpose.
- The Risk Management File.
- The General Safety and Performance Requirements (GSPR) checklist.
- The Instructions for Use.
- Device performance claims.
- The Post-Market Surveillance Plan.
Clear traceability makes it easier for regulators and Notified Bodies to understand how the available evidence supports conformity with the IVDR.
Overlooking Changes in Scientific Knowledge
Scientific understanding and clinical practice continue to evolve throughout the lifecycle of a device.
Manufacturers should regularly review new publications, guidance documents and relevant clinical evidence to determine whether updates to the Performance Evaluation are required. Failing to consider new information may result in outdated conclusions that no longer reflect the current state of scientific knowledge.
Regular reviews help ensure that Performance Evaluation remains accurate, relevant and aligned with evolving regulatory expectations.
Underestimating Notified Body Expectations
Manufacturers sometimes assume that presenting a large volume of data is sufficient to demonstrate compliance.
In practice, Notified Bodies focus on the quality of the evidence, the strength of the scientific justification and the consistency of the manufacturer’s conclusions. A concise, well-structured Performance Evaluation supported by robust critical appraisal is generally more effective than an extensive report containing poorly organised or weakly justified evidence.
Planning the Performance Evaluation with regulatory review in mind can significantly improve the efficiency of the conformity assessment process.
Submitted Your IVDR Application – What Happens Next?
Preparing a robust Performance Evaluation is only one step in the IVDR conformity assessment process. Learn what happens after your application is submitted, including administrative review, technical documentation assessment, Notified Body questions, certification timelines and how to maintain your path to CE marking in our Guide to the IVDR Post-Submission Process.
Key Takeaways
Many Performance Evaluation challenges can be avoided through careful planning, robust scientific assessment and effective document management.
Before finalising your Performance Evaluation, consider the following questions:
✔ Has a comprehensive Performance Evaluation Plan been developed?
✔ Does the evidence adequately demonstrate scientific validity, analytical performance and clinical performance?
✔ Have all relevant sources of evidence been critically appraised?
✔ Are the conclusions supported by objective scientific evidence?
✔ Is there clear traceability between the Performance Evaluation and the technical documentation?
✔ Have any limitations or evidence gaps been appropriately addressed?
✔ Will the Performance Evaluation continue to be reviewed and updated throughout the device lifecycle?
Taking a structured and evidence-based approach from the outset can help reduce regulatory delays, support smoother Notified Body assessments and establish a strong foundation for long-term IVDR compliance.
How Performance Evaluation Supports Your IVDR Regulatory Strategy
Performance Evaluation is not an isolated regulatory activity. It underpins many of the documents, processes and decisions required to demonstrate conformity with Regulation (EU) 2017/746. The evidence generated throughout the Performance Evaluation process supports technical documentation, risk management, conformity assessment and the ongoing monitoring of device performance throughout its lifecycle.
Manufacturers that integrate Performance Evaluation into their wider regulatory strategy from the outset are better positioned to produce consistent documentation, avoid evidence gaps and achieve a smoother conformity assessment process.
Rather than preparing Performance Evaluation as a standalone exercise, manufacturers should ensure that it remains closely aligned with every stage of the product lifecycle.
Technical Documentation
The Performance Evaluation Report (PER) forms one of the core components of the IVDR technical documentation and provides objective evidence that the device achieves its intended purpose.
The conclusions presented within the PER should be fully supported by the information contained throughout the technical file, including the device description, intended purpose, design documentation, verification and validation activities, labelling and Instructions for Use.
Maintaining consistency across the technical documentation demonstrates that the manufacturer has taken a systematic approach to regulatory compliance and helps facilitate efficient review by Notified Bodies.
Risk Management
Performance Evaluation and risk management are closely linked throughout the product lifecycle.
The evidence generated during scientific validity, analytical performance and clinical performance activities helps confirm whether identified risks have been adequately controlled and whether the expected clinical benefits continue to outweigh any residual risks.
Likewise, risks identified during the risk management process may influence the design of analytical studies or clinical investigations, ensuring that areas of greatest potential impact receive appropriate evaluation.
Maintaining clear traceability between the Performance Evaluation and the Risk Management File, prepared in accordance with ISO 14971, helps demonstrate a coherent and evidence-based approach to device safety.
General Safety and Performance Requirements (GSPRs)
Manufacturers are required to demonstrate conformity with the applicable General Safety and Performance Requirements (GSPRs) contained within Annex I of the IVDR.
Performance Evaluation provides much of the objective evidence needed to support this demonstration by confirming that the device performs as intended and that the manufacturer’s performance claims are supported by appropriate scientific and clinical data.
The conclusions reached within the Performance Evaluation should therefore be reflected within the GSPR checklist and supported by clear references to the relevant evidence contained within the technical documentation.
Quality Management System
An effective Quality Management System (QMS) provides the framework for planning, conducting, reviewing and maintaining Performance Evaluation activities.
Processes for document control, design and development, supplier management, internal audits, corrective and preventive actions (CAPA) and management review all contribute to ensuring that Performance Evaluation remains current and appropriately controlled throughout the device lifecycle.
Although the IVDR does not mandate certification to ISO 13485, compliance with the standard is widely recognised as the most effective way of demonstrating that appropriate quality management processes are in place.
Conformity Assessment
For most Class B, Class C and Class D IVDs, the Performance Evaluation forms an important part of the documentation reviewed during conformity assessment by a Notified Body.
The quality of the evidence presented, the strength of the scientific justification and the consistency of the manufacturer’s conclusions all influence the efficiency of the review process.
Manufacturers that prepare comprehensive, well-structured Performance Evaluation documentation are generally better positioned to respond to regulatory questions and minimise delays during certification.
Planning for the Entire Device Lifecycle
Performance Evaluation should support every stage of the product lifecycle, from initial concept through to eventual product retirement.
By integrating Performance Evaluation into the wider regulatory strategy, manufacturers can more effectively manage design changes, respond to new scientific evidence and maintain compliance as regulatory expectations continue to evolve.
This proactive approach not only supports successful CE marking but also provides a strong foundation for continual improvement and long-term regulatory compliance.
Preparing for the IVDR 2026 Milestones?
Performance Evaluation is only one part of maintaining market access during the IVDR transition. Learn about the 2026 milestone deadlines, Notified Body application requirements, written agreement obligations and the conditions manufacturers must meet to remain eligible for the extended IVDR transitional provisions in our Guide to the IVDR 2026 Transitional Milestones.
Real-World IVDR Performance Evaluation Examples
Although the principles of Performance Evaluation are consistent across all in vitro diagnostic medical devices (IVDs), the evidence required can vary significantly depending on the intended purpose, technology and classification of the device. Manufacturers should develop a Performance Evaluation strategy that is proportionate to the potential risks associated with incorrect results and reflects the current state of scientific knowledge.
The examples below illustrate how Performance Evaluation may differ for common categories of IVDs. They are intended as general guidance only, and manufacturers should always determine the appropriate evidence requirements for their specific device.
Blood Glucose Monitoring Systems
Blood glucose monitoring systems are commonly classified as Class C under the IVDR because they directly influence patient management and treatment decisions.
A typical Performance Evaluation for a blood glucose monitoring system may include:
- Scientific evidence demonstrating the relationship between blood glucose concentration and diabetes management.
- Analytical performance studies assessing accuracy, precision, measuring range, interference and stability.
- Clinical performance studies comparing results against recognised laboratory reference methods.
- Evidence supporting use by the intended user population, including healthcare professionals or lay users where applicable.
Given the importance of accurate glucose measurements in insulin dosing and ongoing diabetes management, manufacturers should ensure that sufficient analytical and clinical evidence supports all performance claims.
Companion Diagnostics
Companion diagnostics are specifically identified within the IVDR and are generally classified as Class C due to their role in guiding treatment decisions.
Performance Evaluation for these devices typically requires evidence demonstrating:
- Scientific validity linking the biomarker to the associated medicinal product.
- Analytical performance confirming accurate detection of the biomarker.
- Clinical performance demonstrating that test results reliably identify patients who are likely to benefit from, or be harmed by, a specific therapy.
Manufacturers should also consider relevant clinical guidelines and published evidence supporting the clinical use of the biomarker.
Genetic Testing Devices
Genetic tests are increasingly used to identify inherited disorders, predict disease susceptibility and support personalised medicine.
Performance Evaluation should demonstrate that the device accurately detects the intended genetic variants and that these variants have a well-established relationship with the clinical condition described within the intended purpose.
Evidence may include published scientific literature, analytical validation studies, clinical investigations and comparison with recognised reference methods.
Given the potential consequences of incorrect genetic results, manufacturers should ensure that both analytical and clinical performance are supported by robust evidence.
Infectious Disease Assays
Devices used to detect infectious diseases, such as SARS-CoV-2, influenza or hepatitis viruses, often require comprehensive Performance Evaluation due to the potential impact of false positive or false negative results.
Manufacturers should typically provide evidence demonstrating:
- Scientific validity linking the infectious agent with the disease.
- Analytical sensitivity and specificity.
- Performance across relevant specimen types.
- Cross-reactivity and interference studies.
- Clinical performance within the intended patient population.
Where tests are intended for public health screening or blood donor screening, additional evidence may be required because of the increased risks associated with incorrect results.
Blood Donor Screening Tests
Blood donor screening assays are among the highest-risk IVDs regulated under the IVDR and are generally classified as Class D.
Performance Evaluation for these devices is expected to be particularly robust, with manufacturers providing comprehensive evidence demonstrating:
- Established scientific validity.
- High analytical sensitivity for detecting target infectious agents.
- Reliable performance across different populations and specimen types.
- Strong clinical performance supported by appropriately designed studies.
Because these devices play a critical role in protecting both individual patients and public health, they are subject to a high level of regulatory scrutiny during conformity assessment.
Pregnancy Tests
Pregnancy tests intended for self-testing are generally classified as Class B under the IVDR, despite being used by lay persons.
Manufacturers should demonstrate:
- Scientific validity linking human chorionic gonadotropin (hCG) to pregnancy.
- Analytical performance confirming accurate detection of hCG across the claimed measuring range.
- Clinical performance demonstrating agreement with established reference methods.
- Evidence supporting safe and effective use by lay users, including clear labelling and instructions for use.
Usability considerations are particularly important for self-testing devices, as the performance of the device depends not only on analytical accuracy but also on the user’s ability to correctly perform the test and interpret the results.
General Laboratory Reagents
General laboratory reagents, buffer solutions and wash solutions are typically lower-risk devices that may fall within Class A under the IVDR.
Although the Performance Evaluation requirements for these devices are generally less extensive than for higher-risk IVDs, manufacturers must still demonstrate that the products perform consistently and support their intended laboratory function.
The scope of evidence should remain proportionate to the intended purpose while still demonstrating compliance with the applicable IVDR requirements.
Key Message
These examples illustrate that there is no single approach to IVDR Performance Evaluation. The evidence required should always be proportionate to the intended purpose, classification and potential risks associated with the device.
Regardless of whether an IVD is a simple laboratory reagent or a high-risk blood donor screening assay, manufacturers should adopt a structured, evidence-based approach that demonstrates scientific validity, analytical performance and clinical performance. By tailoring the Performance Evaluation strategy to the characteristics of the device, manufacturers can support a smoother conformity assessment process and provide confidence that their products are safe, effective and fit for their intended clinical use.
Conclusion
Performance Evaluation is one of the fundamental requirements of the EU In Vitro Diagnostic Regulation and provides the scientific evidence demonstrating that an IVD achieves its intended purpose safely and effectively. By systematically evaluating scientific validity, analytical performance and clinical performance, manufacturers can build a robust body of evidence that supports technical documentation, conformity assessment and long-term regulatory compliance.
A successful Performance Evaluation begins with careful planning, continues through the generation and critical appraisal of evidence, and remains an ongoing process throughout the lifecycle of the device. Integrating Performance Evaluation into the wider regulatory strategy helps manufacturers produce consistent documentation, support risk management activities and demonstrate conformity with the General Safety and Performance Requirements of the IVDR.
As the regulatory expectations for in vitro diagnostic medical devices continue to evolve, adopting a structured, evidence-based approach to Performance Evaluation has never been more important. Whether you are developing a new IVD, transitioning a legacy device from the IVDD or preparing for Notified Body assessment, investing in a comprehensive Performance Evaluation will help reduce regulatory uncertainty and support a smoother route to CE marking.
If you need support with IVDR Performance Evaluation, Patient Guard’s regulatory specialists can help you develop Performance Evaluation Plans, prepare Performance Evaluation Reports, assess scientific evidence and build compliant technical documentation tailored to your device and intended market.
Frequently Asked Questions About IVDR Performance Evaluation
Performance Evaluation is the systematic process required under Regulation (EU) 2017/746 (IVDR) to demonstrate that an in vitro diagnostic medical device (IVD) achieves its intended purpose. Manufacturers must generate and critically assess evidence relating to scientific validity, analytical performance and clinical performance before placing a device on the European market.
Yes. Performance Evaluation is a mandatory requirement for all IVDs placed on the European market under the IVDR. The extent of evidence required depends on the intended purpose, classification and risk profile of the device, but every manufacturer must demonstrate that their device performs safely and effectively.
The primary requirements are set out in:
- Article 56 of Regulation (EU) 2017/746.
- Annex XIII – Performance Evaluation, Performance Studies and Post-Market Performance Follow-up.
- Annex I – General Safety and Performance Requirements (GSPRs).
These sections establish the legal framework for planning, conducting and maintaining Performance Evaluation throughout the lifecycle of an IVD.
The IVDR requires manufacturers to evaluate three key areas:
- Scientific validity – demonstrating the relationship between the analyte and the clinical condition.
- Analytical performance – demonstrating that the device accurately and reliably measures the analyte.
- Clinical performance – demonstrating that the results generated by the device are clinically meaningful for the intended use.
Together, these provide the evidence supporting the Performance Evaluation.
A Performance Evaluation Plan (PEP) is the document that defines how the manufacturer intends to demonstrate the safety and performance of the device. It outlines the strategy for generating and assessing scientific validity, analytical performance and clinical performance evidence before studies begin.
The Performance Evaluation Report (PER) is the document that summarises and critically evaluates all evidence generated during the Performance Evaluation process. It demonstrates that the device achieves its intended purpose and forms an important part of the IVDR technical documentation reviewed during conformity assessment.
Yes. Every IVD requires a Performance Evaluation and the associated documentation. The complexity and level of detail within the Performance Evaluation Report will vary depending on the intended purpose, classification and risk associated with the device.
The IVDR introduces a much more structured and evidence-based approach than the previous In Vitro Diagnostic Directive (IVDD). Manufacturers are now expected to prepare documented Performance Evaluation Plans, critically assess scientific evidence, maintain Performance Evaluation Reports and continually review new evidence throughout the product lifecycle.
Not necessarily. The evidence required depends on the device and its intended purpose. Some manufacturers may be able to demonstrate clinical performance using existing clinical data or published literature, while others may need to undertake dedicated clinical performance studies to generate sufficient evidence.
Scientific validity demonstrates that there is an established relationship between the analyte being measured and the clinical condition or physiological state described in the intended purpose. It provides the scientific rationale supporting the use of the device.
Analytical performance demonstrates that the device accurately and reliably measures the intended analyte under defined laboratory conditions. Typical characteristics assessed include accuracy, precision, analytical sensitivity, analytical specificity and stability.
Clinical performance demonstrates that the results produced by the device are clinically meaningful and support appropriate clinical decisions for the intended patient population.
Yes. Performance Evaluation is a lifecycle process. Manufacturers are expected to review new scientific evidence, monitor device performance and update their Performance Evaluation documentation where appropriate to ensure continued compliance with the IVDR.
Yes. For Class B, Class C and Class D IVDs, the Notified Body will review the Performance Evaluation as part of the conformity assessment process. They will expect to see robust scientific evidence, critical appraisal of the available data and clear justification supporting the manufacturer's conclusions.
Yes. Patient Guard supports manufacturers throughout the entire Performance Evaluation process, including Performance Evaluation planning, literature reviews, scientific validity assessments, analytical and clinical performance strategies, Performance Evaluation Reports (PERs) and IVDR technical documentation. We also provide regulatory consultancy to support successful conformity assessment and CE marking under Regulation (EU) 2017/746.
References
This guide is based on the following European legislation, international standards and official regulatory guidance relating to IVDR Performance Evaluation, scientific validity, analytical performance, clinical performance, Performance Evaluation Plans, Performance Evaluation Reports and Post-Market Performance Follow-up.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Provides the legal framework for placing in vitro diagnostic medical devices on the European Union market. Article 56 and Annex XIII establish the principal requirements for Performance Evaluation, including scientific validity, analytical performance, clinical performance, Performance Evaluation Plans, Performance Evaluation Reports and Post-Market Performance Follow-up. |
| Medical Device Coordination Group (MDCG) | MDCG 2022-2 – Guidance on General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices | Provides detailed guidance on the generation, collection and documentation of clinical evidence for IVDs. It explains the Performance Evaluation process, the three scientific pillars, the role of the Performance Evaluation Plan and Report, integration with risk management and the continuous updating of evidence through PMPF. |
| Medical Device Coordination Group (MDCG) | MDCG 2025-5 – Questions and Answers Regarding Performance Studies of In Vitro Diagnostic Medical Devices Under Regulation (EU) 2017/746 | Clarifies the regulatory requirements applying to analytical and clinical performance studies, including study categorisation, sponsor and manufacturer responsibilities, application and notification requirements and the circumstances in which IVDR performance-study provisions apply. |
| Medical Device Coordination Group (MDCG) | MDCG 2024-4 – Safety Reporting in Performance Studies of In Vitro Diagnostic Medical Devices | Provides guidance on reporting serious adverse events, device deficiencies and new findings arising during IVDR performance studies. It is particularly relevant where clinical performance evidence is generated through prospective or interventional studies. |
| International Organization for Standardization (ISO) | ISO 20916:2019 – In Vitro Diagnostic Medical Devices – Clinical Performance Studies Using Specimens from Human Subjects – Good Study Practice | Defines good study practice for planning, designing, conducting, recording and reporting clinical performance studies involving specimens from human subjects. It supports the generation of reliable clinical performance evidence for regulatory purposes. |
| International Organization for Standardization (ISO) | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | Provides the internationally recognised risk management framework for medical devices and IVDs. Performance Evaluation evidence should be aligned with identified risks, benefit-risk conclusions, performance claims and the ongoing assessment of residual risk throughout the device lifecycle. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the Quality Management System requirements supporting the planning, conduct, review, approval and lifecycle maintenance of Performance Evaluation activities, including design controls, document control, competence, change management and post-market processes. |
| Medical Device Coordination Group (MDCG) | MDCG-Endorsed Documents and Other Medical Device Guidance | Provides the European Commission’s central index of current MDCG guidance supporting implementation of the IVDR, including documents covering clinical evidence, performance studies, IVD classification, post-market surveillance, software and conformity assessment. |
IVDR Performance Evaluation is a continuous lifecycle process rather than a one-time regulatory submission. Manufacturers should consult the latest consolidated legislation, applicable international standards and current MDCG guidance when planning Performance Evaluation activities, generating scientific and performance evidence, preparing the Performance Evaluation Report and maintaining the evaluation through Post-Market Performance Follow-up.
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