What are the requirements for clinical performance data?

Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) ... Dec 20, 2022 ... Types of In Vitro Diagnostic Devices. There are 2 main types of IVD devices – laboratory-based tests and point-of-care tests. Laboratory-based ... In vitro diagnostic (IVDs) are typically tests that are used to examine human samples to assist with diagnosing and managing a patient's health. IVDs are ... In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the ... "In vitro diagnostic medical device' (IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro ... The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro ... Dec 6, 2024 ... IVDs must comply with the new IVD Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereafter abbreviated as IVDR). Jul 19, 2022 ... In vitro diagnostic medical device ... A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control ... Oct 11, 2024 ... Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to ... ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice ... This publication ...