Currently, there is concern and uncertainty in the European and North American markets for in vitro diagnostics regarding the regulation of in vitro diagnostic tests. In the European Union, starting from May 2022, the regulation on vitro diagnostic medical devices (IVDR) has replaced the directive on in vitro diagnostic medical devices (IVDD). The IVDR, while written with the good intentions to ensure patient safety and health while supporting innovation and transparency, has resulted in uncertainty, instances of disruption of diagnostic development, and concerns related to pandemic preparedness and response. We here outline the history, current situation and concerns regarding pandemic preparedness in Europe. Finally, we make recommendations that could improve the IVDR while supporting pandemic preparedness.
Molenkamp et al. (Thu,) studied this question.
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