Performance evaluation of medical devices is a must for all In Vitro Diagnostic Medical Devices (IVDs) entering the European market. The new European IVD Regulation (EU IVDR) 2017/746, specifically guides manufacturers to conduct a performance evaluation of IVDs and submit the Performance Evaluation Report (PER). The PER stands as a key aspect of the overall EU IVDR technical documentation. The purpose of the performance evaluation is to produce clinical evidence that supports the manufacturer’s intended use. As per Article 56 (paragraph 3) of the IVDR, a Performance Evaluation must demonstrate:
Within the Performance Evaluation Report (PER), the manufacturer must demonstrate sufficient clinical evidence that supports the intended use of the device in medical practice and this needs to be updated throughout the life cycle of the device for supporting clinical evaluation of IVDs.
For successful IVDR compliance, manufacturers of in vitro diagnostic medical devices are required to be vigilant all through the performance evaluation process, which spans planning, collecting, and assessing the clinical evidence data and preparing and submitting the Performance Evaluation Report (PER), as part of the IVDR technical documentation.
To ensure that manufacturers of IVDs align with IVDR technical documentation requirements, Freyr performs a systematic review of the scientific literature and develops a performance evaluation plan along with a compliant Performance Evaluation Report (PER).