#743004
Le linn shaolré na feiste lena mbaineann, leagfar amach an méid seo a leanas in TTNS:
Throughout the lifetime of the device concerned, that PSUR shall set out:
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#743008
Déanfaidh monaróirí feistí in aicme IIb agus in aicme III TTNS a nuashonrú agus ar bhonn bliantúil ar a laghad.
Manufacturers of class IIb and class III devices shall update the PSUR at least annually.
#746728
Déanfaidh monaróirí feistí atá in aicme C agus in aicme D an PSUR a nuashonrú ar bhonn bliantúil ar a laghad.
Manufacturers of class C and D devices shall update the PSUR at least annually.
#746729
Beidh an PSUR sin mar chuid den doiciméadacht theicniúil mar a shonraítear in Iarscríbhinn II agus in Iarscríbhinn III.
That PSUR shall be part of the technical documentation as specified in Annexes II and III.
#748782
Monaróirí d'fheistí atá in aicme C agus in aicme D, ullmhóidh siad tuarascáil thréimhsiúil nuashonraithe maidir le sábháilteacht (“PSUR”) i ndáil le gach feiste agus i gcás inarb iomchuí i ndáil le gach catagóir nó grúpa feistí lena ndéanfar achoimre ar thorthaí agus ar chonclúidí na n-anailísí a rinneadh ar shonraí an fhaireachais iarmhargaidh a bailíodh mar thoradh ar an bplean faireachais iarmhargaidh dá dtagraítear in Airteagal 79 in éineacht le réasúnaíocht aon ghníomhaíochtaí coisctheacha agus ceartaitheacha a dhéantar agus le cur síos orthu. feadh shaolré na feiste lena mbaineann, leagfar amach an méid seo a leanas sa PSUR sin:
Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
#743009
Cé is moite d'fheistí saincheaptha, beidh TTNS, mar chuid den doiciméadacht theicniúil mar a shonraítear in Iarscríbhinn II agus III.
That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
#743010
Déanfaidh monaróirí feistí in aicme IIa TTNS a nuashonrú nuair is gá agus ar a laghad gach dhá bhliain.
Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
#743011
I gcás feistí saincheaptha, beidh TTNS mar chuid den doiciméadacht dá dtagraítear i Roinn 2 d'Iarscríbhinn XII.
For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.
#743923
TTNS dá dtagraítear in Airteagal 86 agus an tuarascáil maidir le faireachas iarmhargaidh dá dtagraítear in Airteagal 85.
The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
#746732
Cuirfear PSUR den sórt sin agus an mheastóireacht ón gcomhlacht dá dtugtar fógra ar fáil d'údaráis inniúla tríd an gcóras leictreonach sin.
Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
#747517
2 An PSUR dá dtagraítear in Airteagal 81 agus an tuarascáil maidir le faireachas iarmhargaidh dá dtagraítear in Airteagal 80.
The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.
#743003
Monaróirí feistí in aicme IIa, in aicme IIb agus in aicme III, ullmhóidh siad tuarascáil thréimhsiúil nuashonraithe sábháilteachta (“TTNS”) le haghaidh gach feiste agus i gcás inarb ábhartha le haghaidh gach catagóir nó gach grúpa feistí lena ndéanfar achoimre ar thorthaí agus ar chonclúidí na n-anailísí a rinneadh ar shonraí an fhaireachais iarmhargaidh a bailíodh mar thoradh ar an bplean faireachais iarmhargaidh dá dtagraítear in Airteagal 84 in éineacht le réasúnaíocht agus cur síos ar aon ghníomhaíocht choisctheach agus cheartaitheach a dhéantar.
Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken.
#746730
Monaróirí feistí in aicme D, cuirfidh siad PSUR faoi bhráid an chomhlachta dá dtugtar fógra tríd an gcóras leictreonach dá dtagraítear in Airteagal 87, ar comhlacht é a bhfuil baint aige le measúnú comhréireachta feistí den sórt sin i gcomhréir le hAirteagal 48.
Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48.