DNV recognized as a Notified Body for Certification under In Vitro Diagnostic Regulation (IVDR)
Norway, May 8 -- DNV has been recognized by the European Commission as a notified body for the certification of devices under the European Union's In Vitro Diagnostic Regulation (IVDR). The designation increases capacity for certifying in vitro diagnostic devices and providing access to the EU market.DNV offers device manufacturers a fully digital process for faster, more transparent device certification.In vitro diagnostics (IVDs) are tests used to determine a person's health status. They range from pregnancy and cholesterol tests through to HIV screening, COVID-19 tests and cancer marker detection. The safety and effectiveness of such devices is therefore crucial to public and personal health.The EU introduced the IVDR in 2017, replacing ...
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