‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;
ciallaíonn “sochar cliniciúil” an tionchar dearfach atá ag feiste a bhaineann lena feidhm, amhail scagthástáil, faireachán, diagnóisiú othar nó cabhrú le diagnóisiú othar, nó tionchar dearfach ar bhainistiú othar nó ar an tsláinte phoiblí;