What are the regulatory considerations for IVDs used in public health emergencies?

Dec 21, 2021 ... What is an IVD medical device? An IVD medical device is an in vitro diagnostic medical device intended to be used for the testing of human ... Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements. May 26, 2021 ... ... IVDs. In 2017, the EU put into force its new regulations on medical devices and IVD. This development obligated the Swiss government to ... In vitro diagnostic medical devices (IVDs) according to IVDR2 that are placed on the market in Switzerland and/or in Liechtenstein for the first time by ... 'In Vitro Diagnostic (IVD) medical device' means a medical device, whether used alone or in combination, intended by the manufacturer for the in‐vitro ... Mar 25, 2024 ... Below are 7 key steps in the CE certification process, from application submission to certificate issuance. The new regulation focuses on a new classification of IVDs into four risk classes, a more precise description of their analytical and clinical performance. 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 ... Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device ... D2a. Investigational In Vitro Medical Device Dossier (IMDD-IVD. The Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) specifies the content ...