New EU IV Diagnostic Regulation Set to Roll Out
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.
While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.
Even when accounting for the impact of COVID-19, recent report suggests the future of direct-to-consumer genetic testing remains bright.
According to a recent report, this market will see almost seven percent annual growth over the next five years, reaching US $1.29 billion in 2026.