The safety & performance of medical devices must be objectively demonstrated before bringing them to market.

This evidence, unless duly justified, needs to originate from thoroughly designed and executed clinical activities (both pre- and post-market), whose main objective is to provide evidence, that the device in question performs as intended and as officially claimed by its manufacturer.


In Europe, in particular, the regulatory landscape has been recently subject to considerable and dynamic changes associated with the ongoing implementation of the EU 2017/745 (MDR) and 2017/746 (IVDR) regulations for medical devices and in vitro diagnostics, respectively. Both of these regulations, as compared to their predecessors, increase considerably the importance of collecting robust and good-quality clinical data to the next level.

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