What are the requirements for amendments to medical device licenses in Canada?

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) ... 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. 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, ... In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass'. ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice ... This publication ... Apr 11, 2025 ... Any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate or diagnose disease in man. The List of WHO-prequalified In Vitro Diagnostic products contains diagnostics used to diagnose a number of conditions and diseases, and that have been ... Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical ... May 5, 2017 ... The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) were published on May 5, 2017… Oct 7, 2016 ... An in vitro diagnostic device, or IVDD, means a medical device or a product subject to section 3 of the Medical Devices Regulations that is ...