In vitro diagnostic medical device regulation (IVD-R) is quite an obscure topic; one that many of us are not aware of, unless working in relation to the diagnostics field has already brought us across the matter. Here we try and put in layman’ s terms what IVD-R is all about and understand the impact it may have on the rapidity by which diagnostics are developed, especially in case of a pathogen outbreak.
Semeli Platsaki (Tue,) studied this question.