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.
You may also be interested in...
While the EU has selected the CND system as the basis for its nomenclature, GMDN is becoming increasingly valued on the US and international scene. How does it see its latest role panning out globally?
Updated medtech notified body figures from the European Commission always make headline news. But industry needs to see real appointments now, not a list of tricky-to-understand numbers.
Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.