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).
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...