What is ivdr regulation?


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Question: What is ivdr regulation?

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The IVDR 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. The IVDR, the EU regulation for in-vitro diagnostic devices, succeeds the IVDD, the EU in-vitro device directive. The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. What is the IVDR? There has been an EU Directive (98/79/EC) regulating in vitro diagnostic medical devices (IVDs). In this white paper, Emergo takes an in-depth look at the IVDR and answers your biggest questions about Europe's changing regulatory landscape. REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical.


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Vijayawada, India

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