Roadblocks Still Exist in Transition to IVD Regulation

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It is indisputable that the amending Regulation (EU) 2022/112, which extended the IVD Regulation’s transitional provisions, brought significant relief and protected patients, laboratories and healthcare systems from immediate shortages of needed IVD medical tests. Around 21% of today’s total IVD market is already certified under the IVDR. This represents a three-fold increase compared to July 2021.

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