This Regulation should cover clinical investigations intended to gather clinical evidence for the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and scientific assessments for other types of clinical investigations of medical devices.
Ba cheart na himscrúduithe cliniciúla sin a bheartaítear le fianaise chliniciúil a bhailiú chun comhréireacht na bhfeistí a thaispeáint a chumhdach leis an Rialachán seo, agus ba cheart, freisin, ceanglais bhunúsacha a leagan síos maidir le measúnuithe eiticiúla agus eolaíocha do chineáil eile imscrúduithe cliniciúla ar fheistí leighis.