The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action, In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them.
Déanfaidh an monaróir aon taithí a fhaightear le linn na céime iartháirgthe a athbhreithniú agus a dhoiciméadú, lena n-áirítear ó MLCI dá dtagraítear i gCuid B d'Iarscríbhinn XIV, agus ar mhaithe le meáin iomchuí a chur chun feidhme chun aon ghníomh ceartaitheach is gá a chur i bhfeidhm, sa chomhthéacs sin, tuairisceoidh sé do na húdaráis inniúla, i gcomhréir le hAirteagal 87(1) aon teagmhais thromchúiseacha nó aon ghníomhartha ceartaitheacha um shábháilteacht allamuigh, nó an dá cheann acu, a luaithe a fhaigheann sé amach fúthu.