Comparing Regulation of IVD Medical Devices in Europe and Canada

Posted 01 May 2011 | By Ivor Barrett 

In vitro diagnostic (IVD) medical devices are reagents and related instruments used to test specimens derived from the human body to obtain information regarding physiological and pathological conditions, congenital abnormalities, compatibility of potential recipients of blood transfusions and tissue transplants and effectiveness of therapy. As the results of these tests are used to inform crucial clinical decisions, regulation of IVD devices is seen in many regions of the world as an important requirement to protect patient safety.

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