What are the requirements for IVDs used for monitoring disease progression?

Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements. On 26 May 2022, the In Vitro Diagnostic Medical Devices ( IVD ) Directive (98/79/ EC ) was replaced by Regulation ( EU ) 2017/746 on in vitro Diagnostic ... ... In Vitro Diagnostic Medical Devices (Directive 98/79/EC)]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and ... "In vitro diagnostic medical device' (IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro ... In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine the status of a person's health. Dec 3, 2010 ... A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, ... Sep 26, 2012 ... The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European ... 2 days ago ... Is your IVD medical device ready for the EU IVDR deadline? The IVDR enhances in vitro diagnostic medical device safety and performance, ... ... in-vitro diagnostic (IVD) medical devices. Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10. Dec 20, 2024 ... What is an in vitro diagnostic product (IVD)? ... Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are ...