New Trends in In-Vitro Diagnostic Trials: Case Example COVID-19 Tests
9:55 AM - 10:20 AM
Current European legislation on In Vitro Diagnostic Medical Devices (IVDD), the Directive 98/79/EC, requires manufacturers to ensure that their devices achieve the claimed performances when used as intended by the manufacturer, in terms of sensitivity and specificity. Many IVD tests are made available on the market after self-declaration and subsequent CE marking by manufacturers. The new European Regulation on In Vitro Diagnostic Medical Devices, (EU) 2017/746 “IVDR”, which will apply from May 2022, will reinforce requirements on performance evaluation. Manufacturers will have to establish a performance evaluation procedure, and to report on scientific validity, analytical performance, and clinical performance. Manufacturers are further obliged to establish a post-market surveillance procedure, including post-market performance follow-up (PMPF): The usage and performance of devices shall actively be monitored throughout the lifecycle of the devices, and actions taken when necessary. By a case example of COVID-19 tests, the upcoming In-Vitro Diagnostic trial requirements will be presented.