IVDR: A risk of shortages of tests?

The new In Vitro Diagnostic Medical Devices Regulation (IVD Regulation) will enter into full application on 26 May 2022. This Regulation will bring many benefits to the healthcare sector by strengthening safety and performance and enforcing stricter oversight of medical tests. However, at the current rate of work, the new regulatory system will not be ready in time, as the needed infrastructure will not be there to ensure timely transition of tens of thousands of medical tests to the new regime.

There may therefore be severe shortages of medical tests  which are key to prevent and diagnose many illnesses such as cancer, strokes and even COVID-19. Check below for more information.