IVD industry loses battle for 5-yr EU IVD Reg transition: where does Council position lie?
This article was originally published in Clinica
The IVD industry was dealt a disappointing blow by the European Parliament yesterday (22 October) when the top item on its wish list – to be given five years, instead of three, to transition to the new proposed IVD Regulation – was rejected during the plenary vote. This means that the IVD industry must ensure that each and every one of its products complies with the new regulations within three years following adoption of the IVD Regulation. In many cases this will also involve an audit – often for the first time for companies’ products – by a notified body to demonstrate compliance with EU regulatory requirements.