What are the labeling requirements for IVDs in the US according to 21 CFR Part 809?

Nov 13, 2024 ... In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. IVD devices are tests used on biological samples (such as tissues, blood, or urine) to determine the status of a person's health. In-Vitro Diagnostic Device Regulation (IVDR) becomes effective May 26, 2022 ... medical Devices (IVDs) has been successfully designated under EU IVDR. This ... Registration of medical devices and in vitro diagnostic devices. This concerns the registration (notification) of Dutch manufacturers or authorised ... Any Medical Device or In Vitro Diagnostic reagents manufacturer seeking to market their product in China must apply for and acquire the Medical Device ... Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device ... 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 ... Mar 25, 2024 ... Below are 7 key steps in the CE certification process, from application submission to certificate issuance. May 27, 2022 ... The EU's new In Vitro Diagnostic Medical Device Regulation (IVDR) "will have a tremendous impact on the MedTech industry". Read more here. 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, ...