Placing an in vitro diagnostic (IVD) medical device on the EU market requires manufacturers to demonstrate compliance with Regulation (EU) 2017/746 (IVDR) through a structured, evidence-based Performance Evaluation. This is a lifecycle-based regulatory process that involves multiple interlinked activities and comprehensive documentation to demonstrate scientific validity, confirm analytical performance, and support clinical relevance for the intended use.
Three essential pillars support performance evaluation under Regulation (EU) 2017/746 (IVDR):
- Scientific Validity
- Analytical Performance
- Clinical Performance
Together, these pillars demonstrate that the device measures what it claims to measure, performs reliably, and is clinically relevant for its intended purpose.
Maven supports medical device manufacturers by providing end-to-end support for the preparation and submission of performance evaluation documents.
Regulatory Framework for Performance Evaluation under EU IVDR
Performance evaluation activities for IVD medical devices are governed by Annex XIII, Part A of Regulation (EU) 2017/746 (IVDR). This annex outlines the methodological framework for planning, generating, and assessing performance evidence and clearly defines the documentation required for pre-market conformity assessment.
The Performance Evaluation framework is supported by a set of key regulatory documents, including:
- Performance Evaluation Plan (PEP)
- Analytical and Clinical Performance Protocol
- Analytical and Clinical Performance Report
- Scientific Validity Protocol
- Scientific Validity Report
- Performance Evaluation Report (PER)
Performance Evaluation Plan (PEP)
The performance evaluation process begins with the establishment of the Performance Evaluation Plan (PEP). To generate the necessary clinical evidence, the PEP should define the key characteristics and performance of the device, as well as the methods, processes, and criteria to be applied.
In accordance with Regulation (EU) 2017/746 (IVDR), we support manufacturers in planning, organizing, and preparing the Performance Evaluation Plan. Our approach is risk-based, practical, and tailored to each device’s specific features and intended purpose, ensuring that the performance evaluation is both regulator-ready and supported by appropriate evidence.
In line with Part A of Annex XIII, of Regulation (EU) 2017/746 (IVDR), Performance Evaluation Plan at least includes:
- The intended purpose and key characteristics of the device
- Specification of the analyte or marker to be determined by the device
- Intended use, and intended user
- Identification of certified reference materials or reference measurement procedures to allow for metrological traceability
- Target patient population, including any indications, limitations, and contraindications
- General Safety and Performance Requirements (GSPR) supported by scientific validity and analytical and clinical performance data
- The approach and methods used to demonstrate scientific validity, analytical performance, and clinical performance
- A description of the current state of the art including applicable standards, common specifications, guidance, and best practices
- Acceptability of Benefit–risk ratio based on available performance evidence
- Development phases, milestones, and acceptance criteria for demonstrating performance
- The Post-Market Performance Follow-up (PMPF) planning
- Justifications, providing rationale where any element is not applicable due to device-specific characteristics
Maven supports medical device manufacturer in preparation of EU IVDR compliant Performance Evaluation Plan tailored to specific device, intended purpose and risk class. Our experts develop robust and well-established Performance Evaluation Plan aligned with Annex XIII, Part A of Regulation (EU) 2017/746 and MDCG 2022-2 expectations, ensuring clear traceability between scientific validity, analytical performance, clinical performance, and the associated performance claims. By proactively addressing common Notified Body expectations at the planning stage, Maven helps minimize evidence gaps, reduce rework, and support an efficient and timely conformity assessment process.
Performance Evaluation Report (PER)
As per Regulation (EU) 2017/746, the Performance Evaluation Report (PER) must compile the relevant evidence, determine the benefit–risk profile, and document the performance evaluation along with its outcomes. All the relevant scientific validity, analytical performance, and clinical performance data shall be assessed to verify that the device conforms to the applicable General Safety and Performance Requirements (GSPRs) outlined in Annex I.
Annex XIII, Section 3 also refers to studies other than clinical performance studies. These may include analytical performance studies or post-market performance follow-up (PMPF) studies, which should be documented by analogy to clinical performance studies and appropriately reflected in the PER.
At Maven, we support medical device manufacturers in developing and maintaining clear, well-structured Performance Evaluation Reports (PERs) that meet IVDR requirements. We review and organize scientific validity, analytical performance, and clinical performance evidence to demonstrate that the IVD device performs as intended and complies with regulatory standards.
Our support goes beyond document preparation. We critically evaluate whether the available evidence is adequate, sufficient, and appropriately justified based on the device’s risk class and intended purpose. We also assist in identifying and addressing any data gaps. By presenting performance data in a transparent and regulator-ready format, Maven ensures that the PER is suitable for notified body assessment and facilitates effective compliance with IVDR.
In line with Regulation (EU) 2017/746 (IVDR), Performance Evaluation Report at least includes:
- the justification for the approach taken to gather the clinical evidence;
- the literature search methodology and the literature search protocol and literature search report of a literature review;
- the technology on which the device is based, the intended purpose of the device and any claims made about the device’s performance or safety;
- the nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated;
- the clinical evidence as the acceptable performances against the state of the art in medicine;
- any new conclusions derived from PMPF reports in accordance with Part B of this Annex.
Through this structured approach, Maven ensures that the Performance Evaluation Report remains compliant, consistent, and aligned with IVDR expectations, supporting a smoother notified body review and sustained EU market access.
Lifecycle Management of Performance Evaluation
As described previously, performance evaluation is a continuous process conducted throughout the lifecycle of an IVD. The safety, effectiveness, and performance of the device are supported by data that is actively and continuously monitored and collected by the manufacturer. Such data may include developments in the state of the art, post-market information (e.g., complaints), PMPF data, direct end-user feedback, as well as newly published research, guidelines, and harmonized standards.
In addition, any changes to an IVD such as modifications to its intended purpose, product design, characteristics, or technology should be carefully evaluated. The clinical evidence must be updated or re-established, as appropriate, before such changes are implemented.
Furthermore, developments or changes in the state of the art, harmonized standards, or Common Specifications (CS), by reference to which the conformity of an IVD is declared, should be taken into account, as they may trigger additional activities to update the clinical evidence.
Maven supports manufacturers through an Annual Maintenance Contract (AMC) by ensuring that Performance Evaluation documentation is continuously maintained, updated, and aligned with information collected through Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) activities. This ongoing support ensures that the Performance Evaluation remains current and compliant with EU IVDR requirements by systematically incorporating new scientific evidence, post-market performance data, and evolving regulatory expectations throughout the device lifecycle.
Why to Choose Maven for Performance Evaluation
The performance evaluation process often involves multiple steps, data sources, and testing requirements, making it complex and time-consuming if not planned correctly. With the right preparation from the manufacturer and structured regulatory guidance from Maven, this process becomes more efficient, well-controlled, and easier to manage, improving the likelihood of a smooth conformity assessment.
- Over 10 years of experience in regulatory affairs, helping manufacturers achieve CE certification and comply with EU regulatory requirements.
- Deep expertise in Performance Evaluation for all classes (Class A, B, C and D) of IVDs.
- Complete support with preparing and evaluating the Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER).
- Scientifically robust, well-structured, and audit-ready documentation aligned with Notified Body expectation
- Lifecycle-oriented compliance support, integrating Performance Evaluation with PMS, PMPF, and ongoing regulatory updates
For further information on Performance Evaluation, refer to the following documents:
FAQ:
In vitro diagnostic (IVD) device performance evaluation is a systematic process used for proving that an IVD device meets its intended function and operates safely and effectively over the course of its lifetime.
Performance evaluation, as defined by EU IVDR, combines analytical performance, clinical performance evidence, and scientific validity to support the device’s claimed performance.
Yes. All IVD devices sold in the EU under EU IVDR must undergo a performance evaluation.
Manufacturers have the duty to create and maintain performance evaluation documentation in compliance with Annex XIII of EU IVDR, regardless of the risk class (A, B, C, or D). In order to ensure continuous compliance, performance evaluation is necessary ahead of CE marking, during conformity assessment, and via post-market performance follow-up operations.
Yes, if the manufacturer plans to keep selling legacy IVD devices on the EU market during the IVDR transition period or after, they must comply with the performance evaluation requirements of EU IVDR. These devices were previously sold under the IVDD (Directive 98/79/EC). The IVDR makes it clear that performance evaluation is a continuous lifecycle obligation, and manufacturers are required to demonstrate scientific validity, analytical performance, and, where applicable, clinical performance in accordance with IVDR expectations, even though such devices may temporarily remain on the market under valid IVDD certificates or self-declarations. In practice, this implies that performance data from the IVDD era must be examined, updated, or augmented as needed to conform to the depth and structure demanded by IVDR, particularly with respect to documented performance evaluation planning, reporting, and post-market performance follow-up.
Maven can support manufacturers in developing Performance Evaluation documentation compliant with EU IVDR by providing structured regulatory and scientific assistance throughout the process.
Our support includes identifying sources of clinical evidence, selecting an appropriate performance evaluation strategy based on the device’s intended purpose, and guiding the creation of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER) in compliance with Annex XIII requirements of EU IVDR. Additionally, Maven helps organize and assess clinical performance data, analytical performance, and scientific validity while ensuring compliance with GSPR, risk management, IFU claims, and Post-Market Surveillance activities.
