Performance Evaluation Report (PER)

What is a Performance Evaluation Report?

The Performance Evaluation Report (PER) is a regulatory document that summarizes the clinical evidence from the Scientific Validity Report (SVR), Analytical Performance Report (APR) and Clinical Performance Report (CPR) and justifies the approach taken to gather this evidence.

The PER will follow the requirements as defined in the European In-Vitro Diagnostic Regulation 2017/746 (IVDR), Annex XIII, Part A, Section 1.3.2.

AML Christensen’s service

AML Christensen will help ensure that the clinical evidence pertinent to your device is critically appraised and presented in a clear, consistent and concise manner proving that it achieves its intended performance. As such, we are happy to help you create the first PER for your device and ensure that the PER is regularly updated throughout the device’s lifetime.

At AML Christensen, we have developed a well-structured PER template, which ensures that the requirements of the IVDR are met. This template is continuously improved by incorporating new MDCG guidelines. Your PER may be built using the AML template or we can use your own template, depending on your preference.

Reach out