Mathilde Merckx and Diane Courtier co-authored a study on in vitro diagnostic medical devices (IVDMD) for the Dictionnaire permanent Santé, bioéthique et biotechnologie published by Lefebvre Dalloz | Entreprise.
Particularly highlighted during the Covid-19 pandemic through the tests we all became familiar with, IVDMD are products or instruments intended for in vitro use (i.e., outside a living organism) to provide information, in particular regarding a person’s physiological or pathological condition, congenital deficiencies, or predisposition to a disease or medical condition.
These devices therefore play a central role in patient care. However, in practice, the implementation of the regulatory framework applicable to them proves to be particularly complex.
The study is available to subscribers on the ELnet website.