How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

Abstract

Abstract The Corona Virus Disease 2019 (COVID-19) pandemic has demonstrated that the ability for laboratories to quickly set up and implement labdeveloped tests (LDTs) is essential to respond to an emerging health crisis. The Regulation on in vitro diagnostic medical devices (IVDR) could, however, profoundly impact our ability to respond to a future pandemic since the IVDR could significant restrict the use of LDTs. We address using the example of the current pandemic a number of LDT implementing issues problems which should be addressed. We conclude that the COVID-19 pandemic illustrates that commercial tests cannot cover all patient needs under any given circumstance and that sufficient degrees of freedom for laboratories to ensure their expertise to develop and implement LDTs ultimately benefit European citizens.