Performance evaluation of an in vitro diagnostic medical device (IVD) is a mandatory process required under Regulation (EU) 2017/746 (IVDR), which replaced Directive 98/79/EC. Articles 56–58 and Annex XIII of the IVDR specify that each IVD must undergo a comprehensive performance assessment, documented in a Performance Evaluation Plan (PEP) and a Performance Evaluation Report (PER). These documents are fundamental to demonstrating conformity and are prerequisites for CE marking.

Scope and objectives of performance evaluation

The goal of performance evaluation is to demonstrate that the IVD achieves its intended purpose as defined by the manufacturer and meets the essential requirements of the IVDR. The evaluation comprises:

  • scientific validity assessment (literature review, secondary data, expert inputs),
  • analytical performance evaluation (technical validation parameters),
  • clinical performance evaluation (clinical relevance and utility of results).

Performance Evaluation Plan (PEP)

The PEP is a strategic document that outlines the methodology, scope, and success criteria of the performance evaluation. It includes:

  • the objectives and design of the evaluation process,
  • data sources and literature review strategies,
  • a clinical performance study plan, if applicable,
  • a justification for selected standards and reference materials.

The PEP is an integral part of the technical documentation and must be submitted during conformity assessment procedures.

Performance Evaluation Report (PER)

The PER is the final document that consolidates all findings from the performance evaluation. It includes:

  • scientific, analytical, and clinical data analysis,
  • a benefit-risk assessment for the intended population,
  • evidence of compliance with IVDR essential requirements,
  • a conclusion confirming the IVD’s performance and safety.

The PER must be continuously updated based on post-market surveillance (PMS) and post-market performance follow-up (PMPF) activities.

Analytical performance evaluation

Analytical performance assessment validates whether the declared performance characteristics of an IVD are met. It involves:

  • limit of detection (LOD) and limit of quantification (LOQ),
  • accuracy, precision, and reproducibility (intra- and inter-laboratory),
  • analytical sensitivity and specificity, interference, and stability studies.

Studies must be conducted in accordance with relevant standards such as ISO 17025 and ISO 13485, depending on the scope of testing.

Clinical performance evaluation

Clinical performance evaluates whether the test results are clinically relevant for decision-making. This can be demonstrated through:

  • peer-reviewed literature and scientific data,
  • real-world data from reference markets,
  • clinical performance studies when secondary data is insufficient.

IVD performance studies

Performance studies are typically required for Class C and all Class D IVDs, or when data from literature is insufficient. These may include:

  • prospective clinical studies,
  • retrospective data analyses,
  • comparative studies with reference methods or technologies.

All studies must be designed in line with clinical trial design principles and reported in the PER.

Documentation and IVDR compliance

Comprehensive performance evaluation documentation should include:

  • a Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER),
  • analytical and clinical study reports,
  • a benefit-risk assessment for the IVD’s intended use,
  • usability testing documentation where applicable, as per usability testing requirements.

This evaluation is reviewed by a Notified Body as part of the conformity assessment process.

How Pure Clinical can support your IVD performance evaluation

Pure Clinical offers expert regulatory support throughout the entire IVD performance evaluation process, including:

  • development of PEP and PER according to IVDR,
  • design and execution of performance studies,
  • literature reviews and analysis of analytical/clinical data,
  • preparation of full documentation for Notified Body assessment.

We support manufacturers of Class B, C, and D IVDs, including molecular, genetic, microbiological, and virological diagnostics.

FAQ

What is a Performance Evaluation Plan (PEP) in IVD assessment?

The PEP is a planning document outlining the objectives, methods, criteria, and strategy for conducting the IVD performance evaluation.

Which standards apply to IVD analytical performance validation?

ISO 15189 and ISO 23640 are most commonly used, alongside other harmonised standards as applicable.

What are the components of a full IVD performance evaluation?

It includes scientific validity, analytical performance, and clinical performance evaluation.

When are clinical performance studies required for IVDs?

When literature or market data is insufficient—typically for Class C and all Class D devices.

Does the Performance Evaluation Report (PER) need to be updated?

Yes. The PER is a dynamic document that must be regularly updated with PMS and PMPF data.

Who reviews the IVD performance evaluation?

The performance evaluation is assessed by a Notified Body during the conformity assessment process.

Can literature-based IVDs skip clinical studies?

Yes, if the literature data is robust and directly supports the IVD’s intended use.