Safety reporting, including definitions of adverse events and serious adverse events, device deficiencies, procedures and timelines for reporting.
Tuairisciú maidir le sábháilteacht, lena n-áirítear sainmhínithe ar tharluithe díobhálacha agus ar tharluithe díobhálacha tromchúiseacha, laigí feistis agus freisin nósanna imeachta agus amlínte maidir le tuairisciú.