What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?

The In Vitro Diagnostic Medical Devices Regulation is the Regulation for placing on the market, making available and putting into service of in vitro diagnostic medical devices on the European market. The IVDR was published on May 5, 2017 and it entered into force on May 26, 2017. The Regulation (UE) 2017/746 applies from May 26, 2022 and it substitute the EU directive 98/79/EC on in vitro diagnostic medical devices.

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