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IVD Clinical Performance Studies for FDA & EU

June 02, 2020 IVDR

At present, the regulatory discussion pretty much focuses on MDR Regulation (EU) 2017/745 on medical devices. However, it seems the impact of Regulation (EU) 2017/746 on in vitro medical devices (IVDR).

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IVDR requirements for SOFTWARE

April 24, 2020 IVDR

Software fulfilling the definition of an in vitro diagnostic medical device falls under the In vitro diagnostic medical device regulation (EU) 2017/746 (IVDR). In the past, several of these are self-certified...

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