Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble
Executive Summary
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.
You may also be interested in...
GMed Designated Under EU IVD Regulation
In the EU, there are now six EU notified bodies designated under the IVD Regulation.
Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.
Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.