What are the requirements for medical device distributors 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) ... 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 6, 2024 ... IVDs must comply with the new IVD Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereafter abbreviated as IVDR). 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, ... IVD devices are tests used on biological samples (such as tissues, blood, or urine) to determine the status of a person's health. Veristat offers a team of scientific-minded regulatory experts who understand how to develop the documentation and elaboration needed to support the CE mark ... Brazil IVD classification rules · Class I: Low risk to the individual and low risk to public health · Class II: Medium risk for the individual and: or low risk ... Oct 11, 2024 ... Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to ... Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices. 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 ...