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The In-vitro Diagnostic Medical Device Regulation (EU) 2017/746 is the new regulatory basis for placing on the market, making available and putting into service, in-vitro diagnostic medical devices on the European market. It shall replace the EU’s current Directive on in-vitro diagnostic medical devices (IVD DEVICED 98/79/EC). The IVDR was first published on 5 May 2017 and entered into force on 26 May 2017. All manufacturers of currently approved in-vitro diagnostic medical devices will have a transition time of five years, up to 26 May 2022, to meet the requirements of the IVDR. The IVDR introduces a risk-based approach for classification, the monitoring, and supervision of notified bodies has been significantly improved. The regulation identifies the risk classes into 4 types: Class A (lowest risk), Class B, Class C, and Class D (highest risk). This regulation also emphasizes, at several instances, the importance of taking into consideration, the generally acknowledged “State of the Art” in order to demonstrate the general safety and performance requirements of the device, to develop and manufacture software incorporated in the device, and to adopt risk control measures. Download the whitepaper to continue reading