#744570
i gcás inar féidir iad a nascadh le feiste ghníomhach in aicme IIa, in aicme IIb nó in aicme III; nó
if they may be connected to a class IIa, class IIb or class III active device; or
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#744579
aicme IIb má beartaíodh iad lena n-úsáid go príomha le haghaidh gortuithe don chraiceann a bhfuil díobháil déanta acu don deirm nó don seicin mhúcasach agus nach féidir iad a chneasú ach le haontú le gránúchán;
class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;
#744589
Na feistí ionracha ar fad i ndáil le hoscailtí colainne, seachas feistí máinliachta ionraí, a beartaíodh lena nascadh le feiste ghníomhach in aicme IIa, in aicme IIb nó in aicme III, is in aicme IIa atá siad.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.
#744595
má beartaíodh iad chun fuinneamh a sholáthar i bhfoirm radaíochta ianúcháin, agus sa chás sin tá siad aicmithe mar aicme IIb;
are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
#744596
má tá éifeacht bhitheolaíoch acu nó má ionsúitear iad ina n-iomláine nó den chuid is mó, agus sa chás sin tá siad aicmithe aicme IIb; nó
have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or
#744600
má beartaíodh iad chun fuinneamh a sholáthar i bhfoirm radaíochta ianúcháin, agus sa chás sin tá siad aicmithe mar aicme IIb;
are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;
#744602
má beartaíodh iad le dul faoi athrú ceimiceach sa cholainn, agus sa chás sin tá siad aicmithe mar aicme IIb, seachas má chuirtear na feistí sna fiacla; nó
are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or
#744619
Tá na feistí gníomhacha ar fad a beartaíodh le radaíocht ianúcháin a astú i gcomhair cuspóirí teiripí, lena n-áirítear feistí lena rialaítear feistí den sórt sin nó lena ndéantar faireachán orthu, nó a bhfuil tionchar díreach acu ar a bhfeidhmíocht aicmithe mar aicme IIb.
All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
#744630
meath tromchúiseach ar an staid sláinte duine nó idirghabháil mháinliach, agus sa chás sin tá siad aicmithe mar aicme IIb.
a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
#744643
Tá na feistí ar fad a beartaíodh go sonrach chun lionsaí tadhaill a dhífhabhtú, a ghlanadh, a shruthlú nó, nuair is iomchuí, a hiodráitiú aicmithe mar aicme IIb.
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.
#744747
Measúnú ar an doiciméadacht theicniúil is infheidhme maidir le feistí aicme III agus aidir le feistí aicme IIb dá dtagraítear sa dara fomhír d'Airteagal 45(4)
Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4)
#744948
Áireofar ar dheimhnithe córais bainistithe cháilíochta AE agus ar dheimhnithe dearbhaithe cáilíochta AE sainaithint na bhfeistí nó na ngrúpaí feistí, an t-aicmiú riosca agus, i gcás na bhfeistí sin in aicme IIb, an chríoch a beartaíodh dóibh.
EU quality management system certificates and EU quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose.
#1680099
Dáilfear an t-ioncam ar na Ballstáit agus de réir na sciartha a leagtar amach in Iarscríbhinn IIb, i gcomhréir le mír 6 go mír 12 den Airteagal seo.
The revenues shall be distributed amongst the Member States and according to the shares set out in Annex IIb, in accordance with paragraphs 6 to 12 of this Article.
#1680219
Cuirtear an téacs atá in Iarscríbhinn I a ghabhann leis an Treoir seo in ionad Iarscríbhinn IIb a ghabhann le Treoir 2003/87/CE.
Annex IIb to Directive 2003/87/EC is replaced by the text appearing in Annex I to this Directive.
#1748177
(iib) athonnmhairiú de réir bhrí Airteagal 182 270(1) den Chód sin Ö de Chód Custaim an Aontais Õ ach gan ítimí ar idirthuras san áireamh;
(iib) a re-export within the meaning of Article 182 270(1) of that Ö the Union Customs Õ Code but not including items in transit;
#2269221
Leasaítear Iarscríbhinn II agus Iarscríbhinn IIb a ghabhann le Treoirlíne 2013/47/AE (BCE/2012/27) i gcomhréir leis an Iarscríbhinn a ghabhann leis an Treoirlíne seo.
Annexes II and IIb to Guideline 2013/47/EU (ECB/2012/27) are amended in accordance with the Annex to this Guideline.
#2425982
Tá Éire faoi cheangal ag Rialachán IIb na Bruiséile agus, dá bhrí sin, tá sí rannpháirteach i nglacadh agus i gcur i bhfeidhm an Chinnidh seo.
Ireland is bound by the Brussels IIb Regulation and is therefore taking part in the adoption and application of this Decision.
#2426363
Tá Éire faoi cheangal ag Rialachán IIb na Bruiséile agus, dá bhrí sin, tá sí rannpháirteach i nglacadh agus i gcur i bhfeidhm an Chinnidh seo.
Ireland is bound by the Brussels IIb Regulation and is therefore taking part in the adoption and application of this Decision.
#2470669
Fiontair gan aon ghníomhaíochtaí T&F (Próifíl IB + Próifíl IIB + Próifíl IIIB + Próifíl IVB + Próifíl VB + Próifíl VI + Próifíl VII),
Enterprises without R & D activities (Profile IB + Profile IIB + Profile IIIB + Profile IVB + Profile VB + Profile VI + Profile VII),
#2569864
trealamh atá beartaithe lena úsáid chun fíochán saille dá dtagraítear i Roinn 4 d’Iarscríbhinn XVI a ghabhann le Rialachán (AE) 2017/745 a laghdú, a bhaint nó a scriosadh, déantar é a athaicmiú mar aicme IIb;
equipment intended to be used to reduce, remove or destroy adipose tissue as referred to in Section 4 of Annex XVI to Regulation (EU) 2017/745, is reclassified as class IIb;
#2732897
an 31 Nollaig 2027, le haghaidh na bhfeistí uile in aicme III, agus le haghaidh feistí so-ionchlannaithe in aicme IIb seachas uamanna, stáplaí, líonadh déidliachta, teanntáin déidliachta, corónacha fiacla, scriúnna, dingeacha, plátaí, sreanga, bioranna, fáiscíní agus nascóirí;
31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
#2803818
Leithdháilfear na cistí a chomhfhreagraíonn don mhéid sin lamháltas i gcomhréir le Cuid B d’Iarscríbhinn IIb.’;
The funds corresponding to that amount of allowances shall be distributed in accordance with Part B of Annex IIb.’;
#3036280
‘Forálacha sonracha is infheidhme maidir le deontais nach ndámhtar ar bhonn Chaibidlí IIa, IIb nó IIc’;
‘Specific provisions applicable to grants that are not awarded on the basis of Chapters IIa, IIb or IIc’;
#456739
(iib) cion a bheidh faoi réim Choinbhinsiún na Ginéive le haghaidh Feabhsú Staid na gComhaltaí Créachtaithe, Breoite agus Longbhriste d’Fhórsaí Armtha ar Muir, a rinneadh sa Ghinéiv an 12ú lá de Lúnasa, 1949,
(iib) an offence within the scope of the Geneva Convention for the Amelioration of the Condition of Wounded, Sick and Shipwrecked Members of Armed Forces at Sea, done at Geneva on the 12th day of August, 1949,
#508794
Tráth nach déanaí ná an 31 Nollaig 2013, déanfaidh an Coimisiún tuarascáil a thíolacadh do Pharlaimint na hEorpa agus don Chomhairle ar tuarascáil í lena ndéanfar meastóireacht ar chur chun feidhme an Rialacháin seo agus díreofar léi go speisialta ar chur chun feidhme Iarscríbhinn IIb, Údarú Ginearálta Onnmhairiúcháin Uimh. EU002 ón Aontas, lena ngabhfaidh, más iomchuí, togra reachtach chun an Rialachán seo a leasú, go háirithe maidir leis an tsaincheist i dtaobh lastais ar luach íseal.";
No later than 31 December 2013, the Commission shall submit to the European Parliament and to the Council a report evaluating the implementation of this Regulation with a specific focus on the implementation of Annex IIb, Union General Export Authorisation No EU002, accompanied by, if appropriate, a legislative proposal to amend this Regulation, in particular as regards the issue of low-value shipments.";
#741590
I gcás feistí so-ionchlannaithe in aicme III agus feistí gníomhacha in aicme IIb arb í an chríoch a beartaíodh dóibh tairge íocshláinte a riar agus/nó a bhaint, ba cheart do chomhlachtaí dá dtugtar fógra a bheith faoi oibleagáid, seachas i gcásanna áirithe, a iarraidh ar phainéil saineolaithe grinnscrúdú a dhéanamh ar a dtuarascáil measúnaithe ar a meastóireacht chliniciúil.
For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report.
#741593
I gcás feistí in aicme III agus i gcás feistí áirithe in aicme IIb, ba cheart do mhonaróir a bheith in ann dul i gcomhairle, ar bhonn deonach, le painéal saineolaithe, sula ndéanfadh an monaróir sin meastóireacht chliniciúil agus/nó imscrúdú, maidir le tograí le haghaidh imscrúduithe cliniciúla.
For class III devices and for certain class IIb devices, a manufacturer should be able to consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation, on its clinical development strategy and on proposals for clinical investigations.
#742545
minicíocht agus bonn samplála an mheasúnaithe ar an doiciméadacht theicniúil ar bhonn ionadaíoch mar a leagtar amach sa tríú mír de Roinn 2.3 agus i Roinn 3.5 d'Iarscríbhinn IX i gcás feistí in aicme IIa agus in aicme IIb, agus i Roinn 10.2 d'Iarscríbhinn XI i gcás feistí in aicme IIa;
the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa devices;
#742633
I gcás na bhfeistí uile in aicme III agus i gcás feistí in aicme IIb dá dtagraítear i bpointe (b) d'Airteagal 54(1), féadfaidh an monaróir, roimh mheastóireacht chliniciúil agus/nó imscrúdú ar an bhfeiste, dul i gcomhairle le painéal saineolaithe amhail dá dtagraítear in Airteagal 106, agus é mar aidhm straitéis bheartaithe forbartha an mhonaróra agus a thograí le haghaidh imscrúdú cliniciúil a athbhreithniú agus a mheas.
For all class III devices and for the class IIb devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy and proposals for clinical investigation.
#742795
i gcás feistí imscrúdaitheacha in aicme I nó i gcás feistí neamh-ionracha in aicme IIa agus in aicme IIb, mura sonraítear a mhalairt leis an dlí náisiúnta, díreach tar éis dháta bailíochtaithe an iarratais de bhun mhír 5, agus ar choinníoll nach ndearna an coiste eitice inniúil sa Bhallstát lena mbaineann tuairim dhiúltach maidir leis an imscrúdú cliniciúil, atá bailí don Bhallstát sin ina iomláine a thabhairt faoin dlí náisiúnta;
in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;
#742913
I gcás feistí in aicme IIb agus in aicme III, féadfaidh an Ballstát comhordúcháin freisin síneadh 50 lá breise a chur leis na tréimhsí dá dtagraítear i mír 4, chun dul i gcomhairle le saineolaithe.
For class IIb and class III devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
#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.
#744368
le haghaidh feistí in aicme IIa agus in aicme IIb, plean samplála a tharraingt suas agus a chothabháil le haghaidh measúnú ar an doiciméadacht theicniúil dá dtagraítear in Iarscríbhinn II agus in Iarscríbhinn III, lena gcumhdaítear réimse feistí den sórt sin a chumhdaítear in iarratas an mhonaróra.
draw up and keep up to date, for class IIa and class IIb devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application.
#744571
i gcás inar beartaíodh iad lena n-úsáid chun fuil nó leachtanna coirp eile a stóráil nó a shruthú nó chun orgáin, codanna d'orgáin nó cealla agus fíochán coirp a stóráil, seachas málaí fola, atá aicmithe mar aicme IIb.
if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
#744574
Tá na feistí neamhionracha ar fad a beartaíodh chun an comhdhéanamh bitheolaíoch nó ceimiceach a mhodhnú i ndáil le fíocháin dhaonna nó cealla daonna, fuil dhaonna, leachtanna coirp eile nó leachtanna eile a beartaíodh le hionchlannú nó le tabhairt isteach sa cholainn aicmithe mar aicme IIb, ach amháin má tá scagachán, lártheifneoiriú nó malartuithe gáis, teasa i gceist sa chóireáil, agus sa chás sin, aicmítear iad mar aicme IIa
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.
#744588
in aicme IIb má beartaíodh iad lena n-úsáid go fadtéarmach, seachas má úsáidtear iad i gcuas an bhéil chomh fada leis an bhfaraing, i gcanáil chluaise suas go tiompán na cluaise nó i gcuas na sróine agus nach dóigh go n-ionsúfaidh an tseicin mhúcasach iad, agus sa chás sin tá siad aicmithe mar aicme IIa.
class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.
#744597
má beartaíodh iad chun táirgí íocshláinte a thabhairt trí bhíthin córais seachadta, má dhéantar an táirge íocshláinte a thabhairt ar bhealach a d'fhéadfadh a bheith guaiseach nuair a chuirtear san áireamh modh an chur i bhfeidhm, agus sa chás sin tá siad aicmithe mar aicme IIb.
are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.
#744617
Tá na feistí teiripeacha gníomhacha ar fad a beartaíodh chun fuinneamh a thabhairt nó a mhalartú aicmithe mar aicme IIa seachas má tá saintréithe acu lenar féidir fuinneamh a thabhairt nó a mhalartú chuig corp an duine nó uaidh ar bhealach a d'fhéadfadh a bheith guaiseach, agus cineál, dlús agus láthair fhorchur an fhuinnimh á gcur san áireamh, agus sa chás sin tá siad aicmithe mar aicme IIb.
All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.
#744625
má beartaíodh iad chun diagnóis dhíreach nó faireachán ar phróisis fhiseolaíocha bheatha a cheadú, ach amháin má beartaíodh iad go sonrach chun faireachán a dhéanamh ar pharaiméadair fhiseolaíocha bheatha agus más rud é go bhféadfadh contúirt láithreach a bheith ann don othar mar thoradh ar chineál na n-athruithe ar na paraiméadair sin, mar shampla athruithe i bhfeidhmíocht chairdiach, i riospráid, in oibriú lárchóras na néaróg, nó má beartaíodh iad i gcomhair diagnóisiú i gcásanna cliniciúla ina bhfuil an t-othar i mbaol láithreach, agus sna cásanna sin tá siad aicmithe mar aicme IIb.
if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.
#744626
Tá feistí gníomhacha a beartaíodh le radaíocht ianúcháin a astú agus a beartaíodh don raideolaíocht dhiagnóiseach nó theiripeach, lena n-áirítear feistí don raideolaíocht idirghabhálach agus feistí lena rialaítear feistí den sórt sin nó lena ndéantar faireachán orthu, nó a bhfuil tionchar díreach acu ar a bhfeidhmíocht aicmithe mar aicme IIb.
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
#744631
Is in aicme IIa atá bogearraí a beartaíodh chun faireachán a dhéanamh ar phróisis fhiseolaíocha, ach amháin má beartaíodh iad chun faireachán a dhéanamh ar pharaiméadair fhiseolaíocha bheatha, i gcás ina bhféadfadh contúirt láithreach a bheith ann don othar mar thoradh ar chineál na n-athruithe ar na paraiméadair sin, agus sa chás sin tá siad aicmithe mar aicme IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
#744634
Is faoi aicme IIa a aicmítear na feistí gníomhacha ar fad a beartaíodh le haghaidh táirgí íocshláinte, leachtanna coirp nó substaintí eile a thabhairt don chorp agus/nó a aistriú chuig an gcorp nó uaidh, ach amháin má dhéantar é sin ar bhealach a d'fhéadfadh a bheith guaiseach, lena gcuirfear san áireamh na substaintí lena mbaineann, an ball coirp atá i gceist agus modh an fhorchuir, agus sa chás sin tá siad aicmithe mar aicme IIb.
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.
#744641
Tá na feistí ar fad a úsáidtear i gcomhair frithghiniúna nó chun tarchur galar gnéas-tarchurtha a chosc aicmithe mar aicme IIb, ach amháin más feistí so-ionchlannaithe nó feistí ionracha fadtéarmacha iad, agus sa chás sin tá siad aicmithe mar aicme III.
All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.
#744644
Tá na feistí ar fad a beartaíodh go sonrach chun feistí a dhífhabhtú nó a steiriliú aicmithe mar aicme IIa, ach amháin más tuaslagáin dhífhabhtaithe nó dífhabhtóirí glantóra iad a beartaíodh go sonrach le haghaidh feistí ionracha a dhífhabhtú, mar chríochphointe na próiseála, agus sa chás sin tá siad aicmithe mar aicme IIb.
All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.
#744656
Na feistí ionracha ar fad i ndáil le hoscailtí colainne, seachas feistí máinliachta ionraí, a beartaíodh le haghaidh táirgí íocshláinte a thabhairt trí ionanálú, aicmítear mar aicme IIa iad, ach amháin má bhíonn tionchar bunriachtanach ag a modh gníomhaíochta ar éifeachtúlacht agus ar shábháilteacht na dtáirgí íocshláinte a thugtar agus iad sin a beartaíodh chun riochtaí lena ngabhann baol don bheatha a chóireáil, agus sa chás sin aicmítear mar aicme IIb iad.
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.
#744713
Ina theannta sin, i gcás feistí in aicme IIa agus in aicme IIb, beidh an measúnú ar an gcóras bainistithe cáilíochta ag gabháil leis an measúnú ar an doiciméadacht theicniúil d'fheistí a roghnaítear ar bhonn ionadaíoch, i gcomhréir le Roinn 4.4 go Roinn 4.8.
Moreover, in the case of class IIa and class IIb devices, the quality management system assessment shall be accompanied by the assessment of technical documentation for devices selected on a representative basis in accordance with Sections 4.4 to 4.8.
#744741
I gcás na bhfeistí in aicme IIa nó in aicme IIb, áireofar sa mheasúnú faireachais freisin measúnú ar an doiciméadacht theicniúil dá dtagraítear i Roinn 4.4 go Roinn 4.8 le haghaidh na feiste nó na bhfeistí lena mbaineann ar bhonn samplaí ionadaíocha breise arna roghnú i gcomhréir leis an réasúnaíocht arna doiciméadú ag an gcomhlacht dá dtugtar fógra i gcomhréir leis an dara fhomhír i Roinn 2.3.
In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the second paragraph of Section 2.3.
#744772
I gcás feistí so-ionchlannaithe in aicme III agus feistí gníomhacha in aicme IIb a beartaíodh le táirge íocshláinte a riaradh agus/nó a bhaint, amhail dá dtagraítear i Roinn 6.4 d'Iarscríbhinn VIII (Riail 12), an comhlacht dá dtugtar fógra, tar éis dó cáilíocht na sonraí cliniciúla lena dtacaítear leis an tuarascáil ar an meastóireacht chliniciúil ón monaróir dá dtagraítear in Airteagal 61(12) a fhíorú, déanfaidh sé tuarascáil mheasúnaithe ar an meastóireacht chliniciúil a ullmhú ina leagfar amach a chonclúidí maidir leis an bhfianaise chliniciúil atá curtha ar fáil ag an monaróir, go háirithe maidir le tairbhe-riosca a chinneadh, agus comhsheasmhacht na fianaise sin leis an gcríoch a beartaíodh don fheiste, lena n-áirítear an tásc nó na tásca leighis, agus leis an bplean MLCI dá dtagraítear in Airteagal 10(3) agus i gCuid B d'Iarscríbhinn XIV.
For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
#745309
Beidh monaróirí feistí in aicme IIb, nach feistí saincheaptha nó feistí imscrúdaitheacha iad, faoi réir measúnú comhréireachta mar a shonraítear i gCaibidil I agus i gCaibidil III d'Iarscríbhinn IX, agus lena n-áirítear measúnú ar an doiciméadacht theicniúil, mar a shonraítear i Roinn 4 den Iarscríbhinn sin, a bhaineann le feiste ionadaíoch amháin ar a laghad le haghaidh gach grúpa feistí cineálacha.
Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.
#745310
Mar sin féin, maidir le feistí so-ionchlannaithe in aicme IIb seachas uamanna, stáplaí, líonadh déidliachta, teanntáin déidliachta, corónacha fiacla, scriúnna, dingeacha, plátaí, sreanga, hioranna, fáiscíní agus nascóirí, beidh feidhm ag an measúnú ar an doiciméadacht theicniúil faoi mar a shonraítear i Roinn 4 d'Iarscríbhinn IX maidir le gach feiste.
However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.