What are the ethical considerations for clinical trials involving medical devices in Canada?

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 2 Classification rules for medical devices other than IVD medical devices. This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with ... 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 ... On 26 May 2022, the In Vitro Diagnostic Medical Devices ( IVD ) Directive (98/79/ EC ) was replaced by Regulation ( EU ) 2017/746 on in vitro Diagnostic ... 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 new IVDR, like Regulation 2017/745 (MDR), adapts EU legislation to technological progress, medical developments and progress in lawmaking. May 16, 2012 ... Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device'. Study Group 1 Final Document GHTF/SG1/N071:2012. May ... (b) for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device--the relevant Level 2 collective term; and. (c) for a Class 3 ... Apr 11, 2025 ... Any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate or diagnose disease in man. "In vitro diagnostic medical device' (IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro ...