CQ Guide - How to conduct Performance Evaluation for In Vitro Diagnostic (IVD) Devices

In vitro diagnostic (IVD) devices are an essential component of modern healthcare, used to diagnose and monitor a wide range of diseases and conditions. Establishing robust clinical evidence for IVD devices is critical to ensuring their safety, efficacy, and reliability.

EU Regulation 2017/746, known as the In Vitro Diagnostic Regulation (IVDR), is a regulation of the European Union that governs the manufacture, marketing, and use of in vitro diagnostic medical devices (IVDs). The regulation replaces the previous IVD Directive (98/79/EC) and introduces several changes and updates to the previous regulatory framework.

One of the key changes introduced by the IVDR is the requirement for IVD performance evaluation. Under the regulation, all IVDs must undergo a performance evaluation prior to being placed on the market. The performance evaluation is a systematic process that assesses the analytical and clinical performance of the IVD, including its sensitivity, specificity, accuracy, precision, and clinical validity.

The performance evaluation must be conducted in accordance with the requirements of the IVDR and using appropriate scientific methods and statistical analyses. The results of the performance evaluation must be documented in a performance evaluation report, which must be included in the technical documentation for the IVD.

The performance evaluation is an important aspect of the IVDR, as it ensures that IVDs are safe and effective for their intended use. It also helps to ensure that IVDs meet the requirements of the regulation and are fit for purpose.

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