IVD Regulation Amendment: It’s Now All Down To The European Parliament
The Council of the EU has paved the way for swift adoption of the proposal to amend the IVD Regulation, given the pressures the IVD sector is under. All eyes are now on the European Parliament.
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With the European Parliament, Council of the EU and European Commission aligned over the urgent need for some staggering of deadlines for products under the forthcoming IVD Regulation, adoption of the amending regulation is expected on 21 December.
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.