#297985
An chuid sin de roinn IIb nach bhfuil suite laistigh d'fhoroinn IIb 1.
That part of division IIb not falling within subdivision IIb 1.
An chuid sin de roinn IIb nach bhfuil suite laistigh d'fhoroinn IIb 1.
That part of division IIb not falling within subdivision IIb 1.
Foroinn ICES IIb 1
ICES subdivision IIb 1
Foroinn ICES IIb 2
ICES subdivision IIb 2
- Roinn staidrimh ICES IIb
- ICES statistical division IIb,
- Foroinn staidrimh ICES IIb 1
- ICES statistical subdivision IIb 1,
An chuid sin de roinn IIb atá teorannaithe leis na comhordanáidí seo a leanas:
That part of division IIb confined by the following coordinates:
- Foroinn staidrimh ICES IIb 2
- ICES statistical subdivision IIb 2,
cuirtear isteach Iarscríbhinní IIb go IIg mar a leagtar amach iad san Iarscríbhinn a ghabhann leis an Rialachán seo.
Annexes IIb to IIg, as set out in the Annex to this Regulation, are inserted.
IARSCRÍBHINN IIb
ANNEX IIb
Grúpa IIB
Group IIB
Nós imeachta maidir le comhairliúchán i ndáil le meastóireacht chliniciúil le haghaidh feistí áirithe in aicme III agus in aicme IIb
Clinical evaluation consultation procedure for certain class III and class IIb devices
Sásra maidir le grinnscrúdú a dhéanamh ar mheasúnuithe comhréireachta i gcás feistí áirithe in aicme III agus in aicme IIb
Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
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.
má beartaíodh iad le cógais a thabhairt, agus sa chás sin tá siad aicmithe mar aicme IIb.
are intended to administer medicines, in which case they are classified as class IIb.
Tá na feistí so-ionchlannaithe agus na feistí máinliachta ionraí fadtéarmacha ar fad aicmithe mar aicme IIb ach amháin:
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
Na feistí gníomhacha ar fad a beartaíodh chun feidhmíocht feistí teiripeacha gníomhacha in aicme IIb a rialú nó faireachán a dhéanamh orthu, nó a beartaíodh chun tionchar a imirt go díreach ar fheidhmíocht feistí den sórt sin, tá siad aicmithe mar aicme IIb.
All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.
aicme IIb má bhaineann riosca íseal den nochtadh inmheánach leo; agus
class IIb if they present a low potential for internal exposure; and
is in aicme IIb atá siad i ngach cás eile,.
class IIb in all other cases.
Measúnú faireachais is infheidhme maidir le feistí in aicme IIa, aicme IIb agus aicme III
Surveillance assessment applicable to class IIa, class IIb and class III devices
Nós imeachta um measúnú le haghaidh feistí áirithe in aicme III agus in aicme IIb
Assessment procedure for certain class III and class IIb devices
I gcás feistí in aicme IIa agus in aicme IIb, beidh feidhm ag Airteagal 27(4) ón 26 Bealtaine 2023.
For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023.
Cuirtear an méid seo a leanas in ionad Iarscríbhinn IIb a ghabhann le Treoir 2003/87/CE:
Annex IIb to Directive 2003/87/EC is replaced by the following:
IARSCRÍBHINN IIb
ANNEX IIb
IARSCRÍBHINN IIb
ANNEX IIb
Iarscríbhinn IIb
Annex IIb
feistí in aicme IIa agus in aicme IIb ón 26 Bealtaine 2025;
class IIa and class IIb devices from 26 May 2025;
Iarscríbhinn IIb
Annex IIb
Leasaítear Iarscríbhinn II agus Iarscríbhinn IIb a ghabhann le Treoirlíne 2013/47/AE (BCE/2012/27) mar a leanas:
Annexes II and IIb to Guideline 2013/47/EU (ECB/2012/27) are amended as follows:
in Iarscríbhinn IIb, Teideal IV, Airteagal 15, cuirtear an méid seo a leanas in ionad mhír 5:
in Annex IIb, Title IV, Article 15, paragraph 5 is replaced by the following:
Nochtadh: IAS 36.130 f (ii), Nochtadh: IAS 36.134 e (iiB)
Disclosure: IAS 36.130 f (ii), Disclosure: IAS 36.134 e (iiB)
cuirtear Iarscríbhinn II a ghabhann leis an Treoirlíne seo in ionad Iarscríbhinn IIb.
Annex IIb is replaced by Annex II to this Guideline.
Cuirtear an méid seo a leanas in ionad Iarscríbhinn IIb a ghabhann le Treoirlíne BCE/2014/31:
Annex IIb to Guideline ECB/2014/31 is replaced by the following:
IARSCRÍBHINN IIb
ANNEX IIb
Dá bhrí sin, ba cheart na táirgí sin a aicmiú mar aicme IIb.
Those products should therefore be classified as class IIb.
Nochtadh: IAS 36.130 f (ii), Nochtadh: IAS 36.134 e (iiB)
Disclosure: IAS 36.130 f (ii), Disclosure: IAS 36.134 e (iiB)
cuirtear Iarscríbhinn II a ghabhann leis an Treoirlíne seo in ionad Iarscríbhinn IIb.
Annex IIb is replaced by Annex II to this Guideline.
Cuirtear an méid seo a leanas in ionad Iarscríbhinn IIb a ghabhann le Treoirlíne BCE/2014/31:
Annex IIb to Guideline ECB/2014/31 is replaced by the following:
IARSCRÍBHINN IIb
ANNEX IIb
Cuirtear an méid seo a leanas in ionad Iarscríbhinn IIb a ghabhann le Treoir 2003/87/CE:
Annex IIb to Directive 2003/87/EC is replaced by the following:
IARSCRÍBHINN IIb
ANNEX IIb
cuirtear Caibidil IIb seo a leanas isteach:
the following Chapter IIb is inserted:
‘CAIBIDIL IIb
‘CHAPTER IIb
‘Caibidil IIb
‘Chapter IIb
I gcás ina bhfuil bonn cirt leis toisc go bhfuil teicneolaíochtaí seanbhunaithe á n-úsáid i bhfeistí eile so-ionchlannaithe in aicme IIb, atá comhchosúil leis na teicneolaíochtaí siúd a úsáidtear sna feistí díolmhaithe atá sa liosta sa dara fomhír de mhír 4 den Airteagal seo, nó i gcás ina bhfuil bonn cirt leis d'fhonn sláinte agus sábháilteacht othar, úsáideoirí agus daoine eile a chosaint nó d'fhonn gnéithe eile den tsláinte phoiblí a chosaint, tugtar de chumhacht don Choimisiún gníomhartha tarmligthe a ghlacadh i gcomhréir le hAirteagal 115 chun an liosta sin a leasú trí chineálacha eile feistí so-ionchlannaithe in aicme IIb a chur leis nó trí fheistí a bhaint as.
Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.
I gcás feistí in aicme IIa, in aicme IIb agus in aicme III, ba cheart leibhéal iomchuí rannpháirtíochta ó chomhlacht dá dtugtar fógra a bheith éigeantach.
For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
Roinnfear feistí ina n-aicmí I, IIa, IIb agus III, agus an chríoch a beartaíodh do na feistí agus na rioscaí dosheachanta a bhaineann leo á gcur san áireamh.
Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks.
feistí gníomhacha in aicme IIb arb í an chríoch a beartaíodh dóibh táirge íocshláinte a riaradh agus/nó a bhaint, amhail dá dtagraítear i Roinn 6.4 d'Iarscríbhinn VIII (Riail 12).
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).
i gcás feistí in aicme IIa, in aicme IIb nó in aicme III: Na Ballstáit ina bhfuil an fheiste ar fáil nó ina bhfuil an fheiste le cur ar fáil,
in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
i gcás feistí in aicme IIa nó in aicme IIb, measúnú a dhéanamh ar dhoiciméadacht theicniúil na bhfeistí a roghnaítear ar bhonn ionadaíoch,
in the case of class IIa or class IIb devices, assess the technical documentation of devices selected on a representative basis,
i gcás feistí in aicme IIb, fíoróidh siad comhréireacht na feiste leis an gcineál a ndéantar cur síos air sa deimhniú cineálscrúdaithe AE agus le ceanglais an Rialacháin seo a bhfuil feidhm acu maidir leis na feistí sin,
verify, for class IIb devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices,