**Questions? [[Contact us!]]** 'Performance evaluation' refers to the process of assessing and analyzing data to either establish or confirm the scientific validity, analytical performance, and, when relevant, the clinical performance of a medical device. This evaluation aims to ensure that the device functions as intended and produces reliable and accurate results. Manufacturers shall conduct a performance evaluation in accordance with the requirements set out in Article 56 and Annex XIII IVDR. Performance evaluation is an essential component of the verification and validation process for assessing and confirming the product's performance. The results of this evaluation are documented in the technical documentation necessary for the placement of [[In vitro diagnostic medical devices]] (IVD) on the European Union (EU) market. While the core concept and requirements of performance evaluation have remained relatively consistent over the past two decades, there have been significant changes in the technical documentation demanded by the IVDR compared to its predecessor, the In Vitro Diagnostic Devices Directive (IVDD). Under the IVDR, there are two new documents explicitly defined in Annex XIII: the Performance Evaluation Plan (PEP) and the Performance Evaluation Report (PER). The PEP allows manufacturers to integrate design inputs related to performance and safety with outputs from risk management, aligning them with the requirements outlined in Annex I, Sections 1–9 of the IVDR. These sections cover a wide range of aspects, including safety, risk assessment, performance (covering scientific validity, analytical performance, and clinical performance), and stability (addressing device lifetime, transport, storage, and in-use conditions). These changes reflect the evolving regulatory landscape and the need for more comprehensive and detailed documentation to ensure the safety and effectiveness of in vitro diagnostic medical devices.