The various laboratory diagnostic methods, reagents and devices developed in research groups are considered as medical devices or in vitro diagnostic devices for regulatory purposes.

The development of device methods may work up to a certain level of sophistication using in silico or animal experimental methods, but after exhausting these tools, developers need to move on and complete their development on human cells and tissues. Once back home, international regulation, following the ICH GCP guidelines, places this development step in the context of a clinical sample collection framework. To obtain a sufficient number of human samples, a researcher must start a collection project that deposits these samples in a biobank that is strictly regulated in all respects. In the next step, once development is complete, a validation clinical trial following MDR or IVDR guidelines is required to bring the developed methods and devices to market. The HCEMM has identified the need to set up a supporting research group to assist the teams of researchers involved in basic research in the above processes. The present call is for the establishment of such a translational medicine group. A key task for the research team will be to establish appropriate ethical and regulatory pathways and enforce regulatory requirements for human sample collection and variant validation studies.