What are the requirements for translation of IVD labels and IFUs?

In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health. The industry employs about 75 000 people ... 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. Jan 10, 2024 ... After those dates, medical devices and IVDs that are compliant with MDR and IVDR can remain on the UK market until 30 June 2030. The legislation ... The new regulation focuses on a new classification of IVDs into four risk classes, a more precise description of their analytical and clinical performance. 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 ... The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, ... In Vitro Diagnostic medical devices (IVD). Reference, Title, Publication. MDCG ... medical devices for the information and instructions that accompany a device in ... Accordingly, IVDs are devices intended by the manufacturer for the “in vitro examination of specimens […] derived from the human body” and intended “solely or ... Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device ... Dec 19, 2021 ... Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation ... The In Vitro Diagnostic Medical Devices Regulation that will apply ...