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  1. #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.

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  2. #297844

    Foroinn ICES IIb 1

    ICES subdivision IIb 1

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  3. #297845

    Foroinn ICES IIb 2

    ICES subdivision IIb 2

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  4. #297978

    - Roinn staidrimh ICES IIb

    - ICES statistical division IIb,

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  5. #297982

    - Foroinn staidrimh ICES IIb 1

    - ICES statistical subdivision IIb 1,

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  6. #297983

    An chuid sin de roinn IIb atá teorannaithe leis na comhordanáidí seo a leanas:

    That part of division IIb confined by the following coordinates:

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  7. #297984

    - Foroinn staidrimh ICES IIb 2

    - ICES statistical subdivision IIb 2,

    Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (recast)

  8. #508814

    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.

    Regulation (EU) No 1232/2011 of the European Parliament and of the Council of 16 November 2011 amending Council Regulation (EC) No 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items

  9. #508826

    IARSCRÍBHINN IIb

    ANNEX IIb

    Regulation (EU) No 1232/2011 of the European Parliament and of the Council of 16 November 2011 amending Council Regulation (EC) No 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items

  10. #687444

    Grúpa IIB

    Group IIB

    Regulation (EU) 2015/936 of the European Parliament and of the Council of 9 June 2015 on common rules for imports of textile products from certain third countries not covered by bilateral agreements, protocols or other arrangements, or by other specific Union import rules 

  11. #742557

    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

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  12. #742574

    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

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  13. #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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  14. #744603

    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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  15. #744605

    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:

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  16. #744618

    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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  17. #744653

    aicme IIb má bhaineann riosca íseal den nochtadh inmheánach leo; agus

    class IIb if they present a low potential for internal exposure; and

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  18. #744662

    is in aicme IIb atá siad i ngach cás eile,.

    class IIb in all other cases.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  19. #744723

    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

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  20. #744771

    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

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  21. #745321

    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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  22. #1680270

    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:

    Directive (EU) 2018/410 of the European Parliament and of the Council of 14 March 2018 amending Directive 2003/87/EC to enhance cost-effective emission reductions and low-carbon investments, and Decision (EU) 2015/1814 (Text with EEA relevance. )

  23. #1680271

    IARSCRÍBHINN IIb

    ANNEX IIb

    Directive (EU) 2018/410 of the European Parliament and of the Council of 14 March 2018 amending Directive 2003/87/EC to enhance cost-effective emission reductions and low-carbon investments, and Decision (EU) 2015/1814 (Text with EEA relevance. )

  24. #1750527

    IARSCRÍBHINN IIb

    ANNEX IIb

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting up a Union regime for the control of exports, transfer, brokering, technical assistance and transit of dual-use items (recast)

  25. #1751118

    Iarscríbhinn IIb

    Annex IIb

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting up a Union regime for the control of exports, transfer, brokering, technical assistance and transit of dual-use items (recast)

  26. #1886630

    feistí in aicme IIa agus in aicme IIb ón 26 Bealtaine 2025;

    class IIa and class IIb devices from 26 May 2025;

    Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance)

  27. #2059780

    Iarscríbhinn IIb

    Annex IIb

    Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items (recast)

  28. #2269234

    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:

    Guideline (EU) 2022/311 of the European Central Bank of 17 February 2022 amending Guideline ECB/2012/27 on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2022/4)

  29. #2269243

    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:

    Guideline (EU) 2022/311 of the European Central Bank of 17 February 2022 amending Guideline ECB/2012/27 on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2022/4)

  30. #2317273

    Nochtadh: IAS 36.130 f (ii), Nochtadh: IAS 36.134 e (iiB)

    Disclosure: IAS 36.130 f (ii), Disclosure: IAS 36.134 e (iiB)

    Commission Delegated Regulation (EU) 2022/352 of 29 November 2021 amending Delegated Regulation (EU) 2019/815 as regards the 2021 update of the taxonomy laid down in the regulatory technical standards on the single electronic reporting format (Text with EEA relevance)

  31. #2449579

    cuirtear Iarscríbhinn II a ghabhann leis an Treoirlíne seo in ionad Iarscríbhinn IIb.

    Annex IIb is replaced by Annex II to this Guideline.

    Guideline (EU) 2022/989 of the European Central Bank of 2 May 2022 amending Guideline ECB/2014/31 on additional temporary measures relating to Eurosystem refinancing operations and eligibility of collateral (ECB/2022/19)

  32. #2449604

    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:

    Guideline (EU) 2022/989 of the European Central Bank of 2 May 2022 amending Guideline ECB/2014/31 on additional temporary measures relating to Eurosystem refinancing operations and eligibility of collateral (ECB/2022/19)

  33. #2449605

    IARSCRÍBHINN IIb

    ANNEX IIb

    Guideline (EU) 2022/989 of the European Central Bank of 2 May 2022 amending Guideline ECB/2014/31 on additional temporary measures relating to Eurosystem refinancing operations and eligibility of collateral (ECB/2022/19)

  34. #2569851

    Dá bhrí sin, ba cheart na táirgí sin a aicmiú mar aicme IIb.

    Those products should therefore be classified as class IIb.

    Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (Text with EEA relevance)

  35. #2593190

    Nochtadh: IAS 36.130 f (ii), Nochtadh: IAS 36.134 e (iiB)

    Disclosure: IAS 36.130 f (ii), Disclosure: IAS 36.134 e (iiB)

    Commission Delegated Regulation (EU) 2022/2553 of 21 September 2022 amending the regulatory technical standards laid down in Delegated Regulation (EU) 2019/815 as regards the 2022 update of the taxonomy for the single electronic reporting format (Text with EEA relevance)

  36. #2693631

    cuirtear Iarscríbhinn II a ghabhann leis an Treoirlíne seo in ionad Iarscríbhinn IIb.

    Annex IIb is replaced by Annex II to this Guideline.

    Guideline (EU) 2023/833 of the European Central Bank of 16 December 2022 amending Guideline ECB/2014/31 on additional temporary measures relating to Eurosystem refinancing operations and eligibility of collateral (ECB/2022/50)

  37. #2693654

    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:

    Guideline (EU) 2023/833 of the European Central Bank of 16 December 2022 amending Guideline ECB/2014/31 on additional temporary measures relating to Eurosystem refinancing operations and eligibility of collateral (ECB/2022/50)

  38. #2693655

    IARSCRÍBHINN IIb

    ANNEX IIb

    Guideline (EU) 2023/833 of the European Central Bank of 16 December 2022 amending Guideline ECB/2014/31 on additional temporary measures relating to Eurosystem refinancing operations and eligibility of collateral (ECB/2022/50)

  39. #2803651

    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:

    Directive (EU) 2023/959 of the European Parliament and of the Council of 10 May 2023 amending Directive 2003/87/EC establishing a system for greenhouse gas emission allowance trading within the Union and Decision (EU) 2015/1814 concerning the establishment and operation of a market stability reserve for the Union greenhouse gas emission trading system (Text with EEA relevance)

  40. #2803652

    IARSCRÍBHINN IIb

    ANNEX IIb

    Directive (EU) 2023/959 of the European Parliament and of the Council of 10 May 2023 amending Directive 2003/87/EC establishing a system for greenhouse gas emission allowance trading within the Union and Decision (EU) 2015/1814 concerning the establishment and operation of a market stability reserve for the Union greenhouse gas emission trading system (Text with EEA relevance)

  41. #3036370

    cuirtear Caibidil IIb seo a leanas isteach:

    the following Chapter IIb is inserted:

    Commission Delegated Regulation (EU) 2023/2537 of 15 September 2023 amending Delegated Regulation (EU) 2019/856 supplementing Directive 2003/87/EC of the European Parliament and of the Council with regard to the operation of the Innovation Fund

  42. #3036371

    ‘CAIBIDIL IIb

    ‘CHAPTER IIb

    Commission Delegated Regulation (EU) 2023/2537 of 15 September 2023 amending Delegated Regulation (EU) 2019/856 supplementing Directive 2003/87/EC of the European Parliament and of the Council with regard to the operation of the Innovation Fund

  43. #3112298

    ‘Caibidil IIb

    ‘Chapter IIb

    Directive (EU) 2023/2864 of the European Parliament and of the Council of 13 December 2023 amending certain Directives as regards the establishment and functioning of the European single access point

  44. #742529

    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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  45. #741601

    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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  46. #742522

    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.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  47. #742560

    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).

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  48. #743957

    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,

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  49. #744358

    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,

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  50. #744405

    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,

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )