How can I stay updated on the latest developments in IVD?

Aug 1, 2020 ... What does this mean in practice? IVD definitions (Article 2). The IVDR definition of an IVD has been broadened and clarified to cover tests ... Stand-alone software now forms an IVD medical device on its own. Stand-alone software also brought about new types of device delivery. May 20, 2022 ... There are several points that every IVD manufacturer should be aware of: ... What does it mean for pathology professionals? Under the IVDD ... MALDI Biotyper sirius IVD System ... An IVD CE system for in vitro diagnostic identification of microorganisms originating from human specimens. For professional ... The timeline for compliance is more complex than suggested by the main compliance date of May 2022, but this does not affect classification decisions. 2 Global ... What constitutes an appropriate order for health care coverage in a particular case depends on whether or not health care coverage is available at a reasonable ... Apr 19, 2023 ... Therefore, it is imperative sponsors identify these investigational IVDs for the IRB. What IRB Regulations Apply to Research Involving ... May 3, 2019 ... Despite this, for those who can access it fertility treatment does work; in the UK the Human Fertility and Embryology Authority reported ~20,000 ... May 18, 2015 ... Devices for detection of agents of biological or chemical warfare in the environment are not IVD because they do not have a medical purpose. In vitro diagnostic medical devices (IVD) used to be subject to EU Directive 98/79/EC (IVDD). The requirements defined in the IVDD were implemented by the EU ...