December 2022 FDA Watch: More Approvals in US than EU
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
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.
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