What are the specific requirements for companion diagnostics under the IVDR Article 47?

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 ... Dec 6, 2024 ... IVDs must comply with the new IVD Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereafter abbreviated as IVDR). 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 Device Regulation (IVDR) becomes effective May 26, 2022 ... medical Devices (IVDs) has been successfully designated under EU IVDR. This ... Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical ... 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. This paper analyses the electromagnetic compatibility (EMC) of the In Vitro Diagnostic (IVD) medical device, according to the EMC test results. Medical devices and in vitro diagnostic medical devices · MDR · IVDR · New EU Regulation on IVD to take effect on 26 May 2022 · Notification · Free sales ... Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) ... ... in vitro diagnostic medical devices on the market · 34.Essential requirements for in vitro diagnostic medical devices · 34A.Approval requirement for coronavirus ...