Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
I gcás ina bhfaighidh údarás inniúil de chuid Ballstáit tuarascálacha den sórt sin faoi theagmhais thromchúiseacha amhrasta dá dtagraítear i bpointe (a) de mhír 1 ó ghairmithe cúraim sláinte, ó úsáideoirí nó ó othair, déanfaidh sé na bearta is gá chun a áirithiú go gcuirfear monaróir na feiste lena mbaineann ar an eolas i dtaobh an teagmhais thromchúisigh amhrasta gan mhoill.