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SOP Performance Evaluation

Use this SOP Performance Evaluation template to systematically document and manage the evaluation of your in vitro diagnostic (IVD) device’s scientific validity, analytical performance, and clinical performance in compliance with IVDR Article 56 and Annex XIII. This template is essential for demonstrating conformity with relevant safety and performance requirements and should be completed during product development and updated continuously with post-market data. Completing this SOP ensures robust clinical evidence and supports your device’s technical documentation for regulatory submissions and ongoing compliance.
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SOP Performance Evaluation

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1. Purpose

This SOP describes the process of performance evaluation for in vitro diagnostic medical devices (IVDs) in accordance with the regulatory requirements of IVDR 2017/746 Article 56 and Annex XIII.

2. Scope

Performance evaluation according to IVDR is defined as a systematic and planned process to continuously generate, collect, analyze and assess data pertaining to an IVD device in order to verify its scientific validity, analytical performance, and clinical performance relative to its intended purpose as stated by the manufacturer.

This process ensures the demonstration of conformity with the relevant general safety and performance requirements (GSPRs) under Annex I of the IVDR, particularly concerning performance characteristics.

3. Definitions

4. Performance Evaluation Process

The performance evaluation shall be thorough and objective, considering both favorable and unfavorable data. Its depth and extent shall be proportionate and appropriate to the characteristics of the device, including the risks, risk class, intended purpose, and the manufacturer's claims. The performance evaluation process is interdependent with the risk management process outlined in SOP Risk Management, feeding into the identification and assessment of risks and the evaluation of the overall benefit-risk determination.

The performance evaluation process involves the following key stages as outlined in IVDR Annex XIII, Part A:

4.1 Performance Evaluation Team

The performance evaluation shall be conducted by suitably qualified individual(s). Evaluators should possess relevant qualifications, expertise, and experience to examine, appraise, and analyze performance evaluation data and assess the scientific validity, analytical performance, and clinical performance of the device.

As a general principle, evaluators are recommended to possess knowledge of:

  • The device technology and its application (intended purpose, analyte/marker, methodology).
  • Research methodology (study design, biostatistics, data analysis).
  • Information management and literature review techniques.
  • IVDR regulatory requirements.
  • Diagnosis and management of the conditions related to the device's intended purpose.

Evaluators are not required to possess knowledge of all of these topics, but they should be able to understand the performance evaluation process and the results. The level of expertise required may vary depending on the device's risk class and complexity. The evaluators and their qualifications shall be documented.

4.2 Performance Evaluation Plan (PEP)

A Performance Evaluation Plan (PEP) shall be established and maintained for each device. The PEP specifies the characteristics and performance of the device and the process and criteria applied to generate the necessary clinical evidence.

The PEP shall include at least:

  • The intended purpose, target population, intended users, and indications/contra-indications.
  • A specification of the analyte(s) or marker(s) to be determined by the device.
  • Identification of the relevant GSPRs that require support from performance data.
  • Specification of methods and criteria for demonstrating scientific validity, analytical performance, and clinical performance.
  • An outline of the different development phases, including the sequence and means of demonstrating performance.
  • A plan for performance studies, if applicable.
  • A description of the state-of-the-art in the relevant field.
  • An outline of the Post-Market Performance Follow-up (PMPF) plan.

4.3 Data Identification, Appraisal, and Analysis

Data relevant to demonstrating the scientific validity, analytical performance, and clinical performance of the device must be identified, collected, and appraised. This includes:

  • Literature searching and screening.
  • Data from performance studies (analytical and clinical).
  • Data from relevant peer-reviewed scientific literature.
  • Experience gained from routine diagnostic testing (if applicable).
  • Information from Post-Market Surveillance (PMS) and PMPF activities.

All relevant data shall be critically appraised for its suitability and contribution to the performance evaluation. The analysis should demonstrate conformity with the GSPRs related to performance characteristics (Annex I, Chapter II).

4.4 Performance Evaluation Report (PER)

The results of the performance evaluation, including the supporting data and literature, shall be documented in a Performance Evaluation Report (PER). The PER demonstrates:

  • The scientific validity of the analyte's link to the clinical condition.
  • The analytical performance of the device.
  • The clinical performance of the device.
  • The justification for the claimed intended purpose.
  • The acceptability of the benefit-risk determination based on the performance data.

The PER is part of the technical documentation and supports the conformity assessment. It must include both favorable and unfavorable data.

5. Post-Market Performance Follow-up (PMPF)

Performance evaluation is a continuous process. The manufacturer shall establish and update a Post-Market Performance Follow-up (PMPF) plan as part of their Post-Market Surveillance (PMS) system. PMPF proactively collects and evaluates performance and relevant scientific data from the use of the device after it has been placed on the market or put into service.

The findings from PMPF activities serve as input for updating the Performance Evaluation Report (PER) and the overall technical documentation.

6. Update of the Performance Evaluation

The performance evaluation and its documentation (PEP, PER) shall be actively updated throughout the life cycle of the device with data obtained from the implementation of the PMPF plan and the general PMS plan. Updates are required when new information relevant to the device's scientific validity, analytical performance, or clinical performance becomes available.

7. Mapping of Requirements

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