#743098
na TTNSanna dá dtagraítear in Airteagal 86;
the PSURs referred to in Article 86;
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#743905
faisnéis a bhaineann le teagmhais thromchúiseacha, lena n-áirítear faisnéis ó TTNS agus gníomhartha ceartaitheacha um shábháilteacht allamuigh;
information concerning serious incidents, including information from PSURs, and field safety corrective actions;
#746813
na PSURanna dá dtagraítear in Airteagal 81;
the PSURs referred to in Article 81;
#747499
faisnéis a bhaineann le teagmhais thromchúiseacha, lena n-áirítear faisnéis ó PSURanna agus gníomhaíochtaí ceartaitheacha um shábháilteacht allamuigh,
information concerning serious incidents, including information from PSURs, and field safety corrective actions,
#743014
Beidh TTNSanna den sórt sin agus an mheastóireacht ón gcomhlacht dá dtugtar fógra ar fáil d'údaráis inniúla tríd an gcóras leictreonach sin.
Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
#743015
I gcás feistí seachas na feistí sin dá dtagraítear i mír 2, cuirfidh monaróirí TTNSanna ar fáil don chomhlacht dá dtugtar fógra atá bainteach leis an measúnú comhréireachta agus, arna iarraidh sin, d'údaráis inniúla.
For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
#746733
I gcás feistí in aicme C, déanfaidh monaróirí PSURanna a chur ar fáil don chomhlacht dá dtugtar fógra atá bainteach leis an measúnú comhréireachta agus, arna iarraidh sin, d'údaráis inniúla.
For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
#743012
I gcás feistí in aicme III nó feistí so-ionchlannaithe, cuirfidh monaróirí TTNSanna faoi bhráid an chomhlachta dá dtugtar fógra trí bhíthin an chórais leictreonaigh dá dtagraítear in Airteagal 92, ar comhlacht é atá bainteach leis an measúnú comhréireachta i gcomhréir le hAirteagal 52.
For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52.
#743087
teagmhais thromchúiseacha agus gníomaíochtaí ceartaitheacha um shábháilteacht allamuigh agus fógraí sábháilteachta allamuigh a thuairisciú, agus tuarascálacha achoimre tréimhsiúla, tuarascálacha faireachais iarmhargaidh, TTNSanna agus tuarascálacha maidir le treochtaí ó na monaróirí amhail dá dtagraítear in Airteagail 85, 86, 87, 88 agus 89, faoi seach, a chur ar fáil;
the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;
#746802
teagmhais thromchúiseacha agus gníomhaíochtaí ceartaitheacha um shábháilteacht allamuigh agus fógraí um shábháilteacht allamuigh a thuairisciú, agus tuarascálacha achoimre tréimhsiúla, tuarascálacha faireachais iarmhargaidh, PSURanna agus tuarascálacha maidir le treochtaí ó na monaróirí dá dtagraítear in Airteagail 80, 81, 82, 83 agus 84 faoi seach a sholáthar;
the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 80, 81, 82, 83 and 84 respectively;