One of the many changes between MDD and MDR is the investigational device, but it seems that the whole focus on investigational devices is completely addressed from the perspective of running clinical investigations for gathering data for conformance assessment or similar. What about investigator-initiated clinical investigations where the object of the study is to research on the medical device it-self and the "manufacturer" is the own research team behind the study? To me that scenario is missing from the current MDR. Shall we assume that MDR does not apply at all to medical device research or shall we expect that the states will fell the gap?