Medical Innovation Exchange

notified bodies

The Real Impact of IVDR on Clinical Evidence Requirements

The Real Impact of IVDR on Clinical Evidence Requirements     For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …

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State-of-the-Art: Unpacking MDR’s Evolving Requirements

State-of-the-Art: Unpacking MDR’s Evolving Requirements     The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …

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