Performance Evaluation Plan (PEP)

A well defined Performance Evaluation Plan (PEP) helps ensure that the evaluation process complies with relevant regulations, such as those set forth by the European Union’s In Vitro Diagnostic Regulation (IVDR). It outlines the efficacy of the entire procedure while also providing a documented scientific rationale for the methodologies employed. It is imperative for the plan to incorporate acceptance criteria for the methodologies utilized, along with delineating the method by which the acceptability of the benefit-risk ratio will be assessed.

A well-defined PEP helps ensure that the evaluation process complies with relevant regulations, such as those set forth by the European Union’s In Vitro Diagnostic Regulation (IVDR). It outlines the efficacy of the entire procedure while also providing a documented scientific rationale for the methodologies employed. It is imperative for the plan to incorporate acceptance criteria for the methodologies utilized, along with delineating the method by which the acceptability of the benefit-risk ratio will be assessed.

The plan of performance evaluation should be established and updated based on the aspects listed below:

• A specification of the intended purpose of the device.
• A Specification of the characteristics of the device is described in section 9 of chapter II of Annex I and in point (c) of section 20.4.1. of chapter III of Annex I.
• A specification of the analyte or marker is to be determined by the device.
• A specification of the intended use of the device
• Identification of certified reference materials or reference measurement procedures to allow for metrological traceability.
• Clear identification of specified target patient groups with clear indications, limitations, and contra-indications
• Identification of the general safety and performance requirements as laid down in sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data.
• A Specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and the limitations of the device and information provided by it.
• Description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents
• Indication and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the intended purpose or purposes and the analytical and clinical performance of the device.
• For software qualified as a device, identification and specification of reference databases and other sources of data are used as the basis for its decision-making.
• An outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria.
• The PMPF planning
• A List of responsible personnel along with the required skills and qualifications for the performance evaluation process with a planned schedule must be created.

• Consultants assist in analyzing and interpreting performance data, adhering to regulatory standards and preparing required documentation, such as study protocols and clinical evidence summaries.
• Also, facilitate communication with notified bodies, addressing any concerns during assessment.