the device or the submitted documents, especially the investigation plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the clinical investigation, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients,
nach bhfreagraítear, leis an bhfeiste leighis nó leis na doiciméid a tíolacadh, go háirithe an plean don imscrúdú agus bróisiúr an imscrúdaitheora, don eolas eolaíoch is déanaí, agus nach bhfuil an t-imscrúdú cliniciúil, go háirithe, oiriúnach chun fianaise a chur ar fáil maidir le sábháilteacht, saintréithe feidhmíochta nó tairbhe na feiste i leith ábhair nó othair,