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172 results in 8 documents

  1. #639392

    Deimhniú ar scrúdú cineáil an AE

    EU type-examination certificate

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  2. #639407

    D’fhéadfaí iarscríbhinn nó níos mó bheith ag gabháil le deimhniú ar scrúdú cineáil an AE.

    The EU type-examination certificate may have one or more annexes attached.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  3. #639412

    Athbhreithniú ar dheimhniú ar scrúdú cineáil an AE

    Review of the EU type-examination certificate

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  4. #639418

    Iarrfaidh an monaróir ar an gcomhlacht dá dtugtar fógra athbhreithniú a dhéanamh ar dheimhniú ar scrúdú cineáil an AE:

    The manufacturer shall ask the notified body to review the EU type-examination certificate:

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  5. #639423

    Sa chás sin, déanfaidh sé athnuachan ar dheimhniú ar scrúdú cineáil an AE.

    In that case, it shall renew the EU type-examination certificate.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  6. #639452

    cóip de dheimhniú ar scrúdú cineáil an AE.

    a copy of the EU type-examination certificate.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  7. #700493

    Deimhniú ar chineálscrúdú AE

    EU type-examination certificate

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  8. #700496

    Is é a bheidh sa deimhniú ar chineálscrúdú AE an fhaisnéis seo a leanas ar a laghad:

    The EU type-examination certificate shall contain at least the following information:

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  9. #700508

    Féadfaidh Iarscríbhinn amháin nó níos mó a bheith ag gabháil le deimhniú ar chineálscrúdú AE.

    The EU type-examination certificate may have one or more annexes attached.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  10. #700510

    Athbhreithniú ar dheimhniú ar chineálscrúdú AE

    Review of the EU type-examination certificate

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  11. #700516

    Iarrfaidh an monaróir ar an gcomhlacht dá dtugtar fógra athbhreithniú a dhéanamh ar an deimhniú ar chineálscrúdú AE:

    The manufacturer shall ask the notified body to review the EU type-examination certificate either:

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  12. #700526

    a ainm agus a sheoladh agus na sonraí lena sainaithnítear an deimhniú lena mbaineann ar chineálscrúdú AE;

    his name and address and data identifying the EU type-examination certificate concerned;

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  13. #700532

    I gcásanna den sórt sin, déanfaidh an comhlacht dá dtugtar fógra an deimhniú ar chineálscrúdú AE a athnuachan.

    In such cases, the notified body shall renew the EU type-examination certificate.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  14. #700562

    cóip den deimhniú ar chineálscrúdú AE.

    a copy of the EU type-examination certificate.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  15. #701452

    an doiciméadacht theicniúil den chineál ceadaithe agus cóip den deimhniú ar scrúdú de chineál AE.

    the technical documentation of the approved type and a copy of the EU type-examination certificate.

    Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (Text with EEA relevance)

  16. #744934

    an deimhniú ar scrúdú cineáil AE dá dtagraítear in Iarscríbhinn IX.

    the EU type-examination certificate referred to in Annex X.

    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. #1807012

    Deimhniú ar chineálscrúdú AE

    EU-type examination certificate

    Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

  18. #1807015

    Féadfar iarscríbhinn amháin nó níos mó a cheangal leis an deimhniú ar chineálscrúdú AE.

    The EU-type examination certificate may have one or more annexes attached.

    Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

  19. #1807028

    Infhaighteacht an deimhnithe ar chineálscrúdú AE

    Availability of the EU-type examination certificate

    Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

  20. #1807021

    Maidir leis na modhnuithe uile a rinneadh ar an gcineál formheasta agus a d’fhéadfadh difear a dhéanamh do chomhréireacht an táirge leasacháin AE le ceanglais an Rialacháin seo nó le coinníollacha bailíochta an deimhnithe, cuirfidh an monaróir sin in iúl don chomhlacht dá dtugtar fógra ar aige atá na doiciméid theicniúla a bhaineann leis an deimhniú ar chineálscrúdú AE.

    The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the EU fertilising product with the requirements of this Regulation or the conditions for validity of the EU-type examination certificate.

    Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

  21. #1807029

    An comhlacht dá dtugtar fógra, coinneoidh sé cóip den deimhniú ar chineálscrúdú AE, dá Iarscríbhinní agus ábhair bhreise, agus den chomhad teicniúil lena n-áirítear na doiciméid a chuir an monaróir isteach, nó go dté bailíocht an deimhnithe ar chineálscrúdú AE sin as feidhm.

    The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the EU-type examination certificate.

    Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

  22. #632668

    I gcás ina gcomhlíonann an cineál ceanglais an Rialacháin seo, eiseoidh an comhlacht dá dtugtar fógra deimhniú ar scrúdú cineáil an AE chuig an monaróir.

    Where the type meets the requirements of this Regulation, the notified body shall issue an EU-type examination certificate to the manufacturer.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations /* COM/2014/0187 final - 2014/0107 (COD) */

  23. #632677

    Déanfaidh an comhlacht dá dtugtar fógra imscrúdú ar an modhnú agus cuirfidh sé in iúl don mhonaróir cibé an bhfuil an deimhniú ar scrúdú cineáil an AE fós bailí nó cibé an bhfuil gá le tuilleadh scrúduithe, fíoruithe nó tástálacha.

    The notified body shall examine the modification and inform the manufacturer whether the EU type-examination certificate remains valid or whether further examinations, verifications or tests are needed.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations /* COM/2014/0187 final - 2014/0107 (COD) */

  24. #632678

    Mar is iomchuí, eiseoidh an comhlacht dá dtugtar fógra ábhar breise leis an deimhniú ar scrúdú cineáil an AE nó iarrfaidh sé go gcuirfear iarratas nua ar scrúdú cineáil an AE isteach.

    As appropriate, the notified body shall issue an addition to the original EU type-examination certificate or ask for a new application for an EU type-examination to be submitted.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations /* COM/2014/0187 final - 2014/0107 (COD) */

  25. #632699

    an doiciméadacht theicniúil maidir leis an gcineál formheasta agus cóip den deimhniú (deimhnithe) ar scrúdú cineáil AE;

    the technical documentation of the approved type and a copy of the EU-type examination certificate(s);

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations /* COM/2014/0187 final - 2014/0107 (COD) */

  26. #632859

    tagairt don deimhniú ar scrúdú cineáil an AE mar aon le sonraí, lena n‑áirítear a dháta, agus nuair is iomchuí, faisnéis maidir le fad agus coinníollacha a bhailíochta;

    reference to the EU-type examination certificate with details, including its date, and where appropriate, information on the duration and conditions of its validity;

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations /* COM/2014/0187 final - 2014/0107 (COD) */

  27. #639393

    Nuair a chomhlíonann an cineál na ceanglais sláinte agus sábháilteachta riachtanacha is infheidhme, tabharfaidh an comhlacht dá dtugtar fógra deimhniú ar scrúdú cineáil an AE don mhonaróir.

    Where the type meets the applicable essential health and safety requirements, the notified body shall issue an EU type-examination certificate to the manufacturer.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  28. #639408

    Do TCP atá déanta de réir toisí, mura bhfuil an duine ar eisíodh deimhniú ar scrúdú cineáil an AE dó ina mhonaróir ar an TCP atá déanta de réir toisí:

    For made-to-measure PPE, if the person to whom the EU type-examination certificate was issued is not the manufacturer of the made-to-measure PPE:

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  29. #639416

    Beidh formheas sa bhreis ag teastáil ó leasuithe mar sin a chuirfear isteach i mbundeimhniú ar scrúdú cineáil an AE.

    Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  30. #639456

    Déanfar na chéad scrúduithe agus tástálacha laistigh d’aon bhliain tar éis dáta eisiúna den deimhniú ar scrúdú cineáil an AE.

    The first examinations and tests shall be carried out no more than one year after the date of issue of the EU type-examination certificate.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  31. #639480

    Áiritheoidh an córas cáilíochta go gcomhlíonann an TCP an cineál, a bhfuil tuairisc i ndeimhniú ar scrúdú cineáil an AE air, agus na ceanglais sláinte agus sábháilteachta riachtanacha is infheidhme.

    The quality system shall ensure that the PPE is in conformity with the type described in the EU type-examination certificate and fulfils the applicable essential health and safety requirements.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */

  32. #699416

    I gcás ina gcomhlíonann an cineál ceanglais an Rialacháin seo, eiseoidh an comhlacht dá dtugtar fógra deimhniú ar chineálscrúdú AE don mhonaróir.

    Where the type meets the requirements of this Regulation, the notified body shall issue an EU-type examination certificate to the manufacturer.

    Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance)

  33. #699426

    Scrúdóidh an comhlacht dá dtugtar fógra an modhnú agus cuirfidh sé in iúl don mhonaróir cibé an bhfuil an deimhniú ar chineálscrúdú AE fós bailí nó cibé an bhfuil gá le tuilleadh scrúduithe, fíoruithe nó tástálacha.

    The notified body shall examine the modification and inform the manufacturer whether the EU-type examination certificate remains valid or whether further examinations, verifications or tests are needed.

    Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance)

  34. #699427

    Mar is iomchuí, eiseoidh an comhlacht dá dtugtar fógra ábhar breise leis an deimhniú ar chineálscrúdú AE nó iarrfaidh sé go gcuirfear iarratas nua ar chineálscrúdú AE isteach.

    As appropriate, the notified body shall issue an addition to the original EU-type examination certificate or ask for a new application for an EU-type examination to be submitted.

    Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance)

  35. #699444

    an doiciméadacht theicniúil maidir leis an gcineál formheasta agus cóip den deimhniú (deimhnithe) ar chineálscrúdú AE;

    the technical documentation of the approved type and a copy of the EU-type examination certificate(s);

    Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance)

  36. #700494

    Nuair a chomhlíonann an cineál na ceanglais riachtanacha sláinte agus sábháilteachta is infheidhme, eiseoidh an comhlacht dá dtugtar fógra deimhniú ar chineálscrúdú AE don mhonaróir.

    Where the type meets the applicable essential health and safety requirements, the notified body shall issue an EU type-examination certificate to the manufacturer.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  37. #700514

    Beidh formheas sa bhreis ag teastáil maidir le leasuithe den sórt sin, is é sin le rá formheas breise a chuirfear isteach sa bhundeimhniú ar chineálscrúdú AE.

    Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  38. #700522

    Más rud é go bhfuil an comhlacht dá dtugtar fógra sásta go leanfar, leis an gcineál formheasta, de na ceanglais sláinte agus sábháilteachta is infheidhme a chomhlíonadh, déanfaidh sé an deimhniú ar chineálscrúdú AE a athnuachan.

    If the notified body is satisfied that the approved type continues to fulfil the applicable health and safety requirements, it shall renew the EU type-examination certificate.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  39. #700523

    Áiritheoidh an comhlacht dá dtugtar fógra go dtabharfar an nós imeachta athbhreithnithe chun críche roimh dháta éaga an deimhnithe ar chineálscrúdú AE.

    The notified body shall ensure that the review procedure is finalised before the expiry date of the EU type-examination certificate.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  40. #700566

    Déanfar na chéad seiceálacha ar tháirgí tráth nach déanaí ná aon bhliain tar éis dáta eisiúna an deimhniú ar chineálscrúdú AE.

    The first product checks shall be carried out no more than one year after the date of issue of the EU type-examination certificate.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  41. #700592

    Áiritheofar sa chóras cáilíochta go bhfuil an TCP i gcomhréir leis an gcineál a bhfuil tuairisc air sa deimhniú ar chineálscrúdú AE, agus go gcomhlíonann sé ceanglais infheidhme an Rialacháin seo.

    The quality system shall ensure that the PPE is in conformity with the type described in the EU type-examination certificate and complies with the applicable requirements of this Regulation.

    Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

  42. #701395

    an deimhniú ar scrúdú de chineál AE agus an dearbhú comhréireachta de chuid AE a bhaineann leis na feistis arna gcorprú san fhearas;

    the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance;

    Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (Text with EEA relevance)

  43. #701408

    I gcás ina gcomhlíonfaidh an fearas nó an feisteas ceanglais an Rialacháin seo, eiseoidh an comhlacht dá dtugtar fógra deimhniú ar scrúdú de chineál AE chuig an monaróir.

    Where the appliance or the fitting type meets the requirements of this Regulation, the notified body shall issue an EU type-examination certificate to the manufacturer.

    Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (Text with EEA relevance)

  44. #701418

    Éileoidh na modhnuithe sin ceadú breise i bhfoirm cur leis an mbundeimhniú ar scrúdú de chineál AE.

    Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.

    Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (Text with EEA relevance)

  45. #701497

    Áiritheoidh an córas cáilíochta go gcomhlíonann na fearais nó na feistis an cineál a thuairiscítear sa deimhniú ar scrúdú de chineál AE agus ceanglais infheidhme an Rialacháin seo.

    The quality system shall ensure compliance of the appliances or the fittings with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation.

    Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (Text with EEA relevance)

  46. #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. )

  47. #744866

    Má chomhlíonann an cineál an Rialachán seo, eiseoidh an comhlacht dá dtugtar fógra deimhniú ar scrúdú cineáil AE.

    If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate.

    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. #744871

    Cuirfidh an t-iarratasóir an comhlacht dá dtugtar fógra agus a d'eisigh an deimhniú ar scrúdú cineáil AE ar an eolas faoi aon athrú atá beartaithe a dhéanamh ar an gcineál formheasta nó ar an gcríoch nó coinníollacha na húsáide a beartaíodh dó.

    The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type or of its intended purpose and conditions of use.

    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. #744874

    Is i bhfoirm forlíonadh leis an deimhniú ar scrúdú cineáil AE a bheidh an formheas ar aon athrú ar an gcineál formheasta.

    The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate.

    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. #744876

    Beidh feidhm ag Roinn 5 d'Iarscríbhinn IX, ach ar an gcoinníoll go dtuigfear aon tagairt do dheimhniú AE do mheasúnú ar dhoiciméadacht theicniúil mar thagairt do dheimhniú ar scrúdú cineáil AE.

    Section 5 of Annex IX shall apply with the proviso that any reference to an EU technical documentation assessment certificate shall be understood as a reference to an EU type-examination certificate.

    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. )