Authorization of medical devices in Europe in the context of COVID-19

The standard registration procedure* for medical devices, in vitro diagnostic devices (IVD) and personal protective equipment includes a Conformity Assessment. Depending on the risk class of MD, IVD and the category of personal protective equipment, the manufacturer either registers its product independently through the EUDAMED system (for non-sterile MDs that are not measuring instruments, I risk class), or applies to
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