Performance Evaluation Plan (PEP)

What is a Performance Evaluation Plan?

The Performance Evaluation Plan (PEP) is a regulatory document that describes how you (the manufacturer) plan to identify, screen, assess and analyse relevant clinical evidence that supports the performance of your in vitro diagnostic medical device. The outcome of this plan will be documented in the Scientific Validity Report, Analytical Performance Report, Clinical Performance Report and will be summarized in the Performance Evaluation Report.

The PEP will follow the requirements as defined in the European In-Vitro Diagnostic Regulation 2017/746 (IVDR), Annex XIII, Part A, Section 1.1. The PEP will include an IVDR-compliant State of the Art (SotA) description.

AML Christensen’s service

At AML Christensen, we know how to develop PEPs that comply with the requirements of the IVDR and relevant guidelines. As such, we are happy to help you create the first PEP for your device and ensure that the PEP is regularly updated throughout the device’s lifetime.

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

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Performance Evaluation Plan (PEP)

What is a Performance Evaluation Plan?

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