What are the requirements for medical device accessories in Canada?

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 on the market · 34.Essential requirements for in vitro diagnostic medical devices · 34A.Approval requirement for coronavirus ... “Modified Device” is a medical device(or an IVD) that is equivalent in 'Intended Use', 'Mechanism of Action(MoA)', 'Raw Materials(Limited to implanted/contacted ... This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with ... 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 ... Apr 11, 2025 ... Any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate or diagnose disease in man. 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, ... Mar 17, 2025 ... The MDR and IVDR require all medical devices and in vitro diagnostics (IVDs), including those that have been on the EU market for many years, to ... This consultation aims to confirm views on aligning classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro ... D2a. Investigational In Vitro Medical Device Dossier (IMDD-IVD. The Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) specifies the content ...