While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER).
To help manufacturers prepare and comply with the IVDR, we have compiled some tips for developing and implementing a successful PEP as you prepare for your IVDR submissions.
Learning Objectives:
Describe the scope and objectives of the PEP, including considerations to identify the clinical claims, the target population, the clinical conditions, the comparators, and the endpoints.
Review how to conduct a comprehensive systematic literature review, a critical component of the PEP which provides the basis for the clinical evidence, both favorable and unfavorable.
Discuss strategies to prepare a detailed scientific validity report (SVR), a new requirement under the IVDR to provide a clear rationale and scientific justification for the choice of the analyte or marker, as well as the evidence of its association with the clinical condition or physiological state.
Define the requirements of the analytical performance report (APR), another new requirement under the IVDR which seeks to demonstrate the analytical performance of the IVD in terms of its ability to correctly measure the analyte or marker.
Clarify the expectations for sufficient clinical data contained within the clinical performance report (CPR), a key requirement under the IVDR that demonstrates the clinical performance of the IVD in terms of its ability to correctly identify or predict the clinical condition or physiological state of the target population