Gaois

Search direction

Search mode

Filter results

Collections

191 results in 94 documents

  1. #504083

    Déanfar sonraí faoi chruinneas, stóinseacht agus in-athdhéantacht na modhanna a sholáthar in éineacht leis an gcomhad.

    Data on the accuracy, robustness and repeatability of the methods shall be provided with the file.

    Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (Text with EEA relevance)

  2. #590540

    stóinseacht institiúidí;

    the robustness of institutions;

    Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 Text with EEA relevance

  3. #640990

    breithnithe maidir le sábháilteacht na ndaoine is ábhar agus iontaofacht agus stóinseacht sonraí arna dtíolacadh faoi mhír 5 nó faoi mhír 6.

    considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 6.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  4. #649740

    stóinseacht agus bailíochtú staidrimh, soiléireacht an léirmhínithe normataigh, sofhreagracht don bheartas, bailiú tráthúil sonraí;

    robustness and statistical validation, clarity of normative interpretation, responsiveness to policy, timely collection of data;

    Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006

  5. #745108

    Dearadh an imscrúdaithe chliniciúil mar aon le fianaise dá stóinseacht agus dá bhailíocht eolaíoch.

    Design of the clinical investigation with evidence of its scientific robustness and validity.

    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. )

  6. #1475708

    (b) chun oibreacha a sheoladh chun cur le daingne an fhoirgnimh;

    ( b ) carrying out works to enhance the robustness of the building;

    Number 29 of 1988: LOCAL GOVERNMENT (MULTI-STOREY BUILDINGS) ACT, 1988

  7. #1713384

    Leis an iniúchóireacht sin, déanfar minicíocht agus modheolaíocht na samplála, mar aon le stóinseacht na sonraí, a mheasúnú.

    It shall evaluate the frequency and methodology of sampling and the robustness of the data.

    Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (Text with EEA relevance.)

  8. #1720977

    comhlíonfaidh sé na ceanglais seo a leanas maidir le hinrochtaineacht gréasáin: inbhraiteacht, inoibritheacht, intuigtheacht agus stóinseacht.

    it meets the following web accessibility requirements: perceivability, operability, understandability and robustness.

    Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012Text with EEA relevance.

  9. #1914148

    gurb ann do chomhaontuithe ar leibhéal na seirbhíse agus gur comhaontuithe láidre iad;

    the existence and robustness of service level agreements;

    Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (Text with EEA relevance)

  10. #2016902

    Ioncaim an-láidir ar fad

    Excellent robustness of the revenues

    Commission Delegated Regulation (EU) 2021/598 of 14 December 2020 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for assigning risk weights to specialised lending exposures (Text with EEA relevance)

  11. #2016903

    Ioncaim láidre

    Good robustness of the revenues

    Commission Delegated Regulation (EU) 2021/598 of 14 December 2020 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for assigning risk weights to specialised lending exposures (Text with EEA relevance)

  12. #2016904

    Ioncaim inghlactha ó thaobh láidreachta de

    Acceptable robustness of the revenues

    Commission Delegated Regulation (EU) 2021/598 of 14 December 2020 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for assigning risk weights to specialised lending exposures (Text with EEA relevance)

  13. #2037332

    Le cumais iomarcacha, ba cheart leanúnachas, cáilíocht agus stóinseacht sheirbhísí SST a áirithiú.

    Redundant capabilities should ensure SST services’ continuity, quality and robustness.

    Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU

  14. #2202475

    Is ceanglas bunriachtanach é an stóinseacht theicniúil le haghaidh córais intleachta saorga ardriosca.

    The technical robustness is a key requirement for high-risk AI systems.

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS

  15. #2203855

    An cruinneas, an stóinseacht agus an chibearshlándáil

    Accuracy, robustness and cybersecurity

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS

  16. #2293238

    cleachtais lena gcuirtear le stóinseacht agus fad saoil ainmhithe, lena n-áirítear pórtha a fhásann níos moille;

    practices that increase animal robustness and longevity, including slower growing breeds;

    Commission Delegated Regulation (EU) 2022/126 of 7 December 2021 supplementing Regulation (EU) 2021/2115 of the European Parliament and of the Council with additional requirements for certain types of intervention specified by Member States in their CAP Strategic Plans for the period 2023 to 2027 under that Regulation as well as rules on the ratio for the good agricultural and environmental condition (GAEC) standard 1

  17. #2337846

    Stóinseacht agus éifeachtacht an phróisis chun mainneachtain oibleagáideora a shainaithint

    Robustness and effectiveness of the process of identifying the default of an obligor

    Commission Delegated Regulation (EU) 2022/439 of 20 October 2021 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the specification of the assessment methodology competent authorities are to follow when assessing the compliance of credit institutions and investment firms with the requirements to use the Internal Ratings Based Approach (Text with EEA relevance)

  18. #2338286

    stóinseacht eagrúchán phróiseas na tástála struis, i gcomhréir le hAirteagal 65;

    the robustness of the organisation of the stress testing process, in accordance with Article 65;

    Commission Delegated Regulation (EU) 2022/439 of 20 October 2021 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the specification of the assessment methodology competent authorities are to follow when assessing the compliance of credit institutions and investment firms with the requirements to use the Internal Ratings Based Approach (Text with EEA relevance)

  19. #2580010

    cleachtais lena gcuirtear le stóinseacht agus fad saoil ainmhithe, lena n-áirítear pórtha a fhásann níos moille;

    practices that increase animal robustness and longevity, including slower growing breeds;

    Commission Regulation (EU) 2022/2472 of 14 December 2022 declaring certain categories of aid in the agricultural and forestry sectors and in rural areas compatible with the internal market in application of Articles 107 and 108 of the Treaty on the Functioning of the European Union (Text with EEA relevance)

  20. #2642514

    Freagraíonn príomhtháscairí le prionsabail na barainne, na hinfhaighteachta, na hinchomparáideachta, agus na stóinseachta staidrimh.

    Headline indicators respond to principles of parsimony, availability, comparability, and statistical robustness.

    PROPOSAL FOR A JOINT EMPLOYMENT REPORT FROM THE COMMISSION AND THE COUNCIL

  21. #2748622

    Tá tábhacht mhór ag baint le stóinseacht na dtuarascálacha fardail a chuirtear isteach.

    The robustness of the submitted inventory reports is of high importance.

    Regulation (EU) 2023/839 of the European Parliament and of the Council of 19 April 2023 amending Regulation (EU) 2018/841 as regards the scope, simplifying the reporting and compliance rules, and setting out the targets of the Member States for 2030, and Regulation (EU) 2018/1999 as regards improvement in monitoring, reporting, tracking of progress and review (Text with EEA relevance)

  22. #2748776

    Stóinseacht chreat bainistíochta riosca an CPL

    The robustness of the CCP’s risk management framework

    Commission Delegated Regulation (EU) 2023/840 of 25 November 2022 supplementing Regulation (EU) 2021/23 of the European Parliament and of the Council with regard to regulatory technical standards specifying the methodology for calculation and maintenance of the additional amount of pre-funded dedicated own resources to be used in accordance with Article 9(14) of that Regulation (Text with EEA relevance)

  23. #2748777

    Tagraíonn an paraiméadar A4 do stóinseacht chreat bainistíochta riosca an CPL.

    The parameter A4 refers to the robustness of the CCP’s risk management framework.

    Commission Delegated Regulation (EU) 2023/840 of 25 November 2022 supplementing Regulation (EU) 2021/23 of the European Parliament and of the Council with regard to regulatory technical standards specifying the methodology for calculation and maintenance of the additional amount of pre-funded dedicated own resources to be used in accordance with Article 9(14) of that Regulation (Text with EEA relevance)

  24. #2748784

    Iincident lena léirítear stóinseacht oibríochtúil an CPL, bunaithe ar líon na dteagmhas trádála.

    Iincident reflects the operational robustness of the CCP, based on the number of trade incidents.

    Commission Delegated Regulation (EU) 2023/840 of 25 November 2022 supplementing Regulation (EU) 2021/23 of the European Parliament and of the Council with regard to regulatory technical standards specifying the methodology for calculation and maintenance of the additional amount of pre-funded dedicated own resources to be used in accordance with Article 9(14) of that Regulation (Text with EEA relevance)

  25. #2748788

    Ipayments lena léirítear stóinseacht oibríochtúil an CPL, bunaithe ar líon na dteagmhas íocaíochta.

    Ipayments reflects the operational robustness of the CCP, based on the number of payment incidents.

    Commission Delegated Regulation (EU) 2023/840 of 25 November 2022 supplementing Regulation (EU) 2021/23 of the European Parliament and of the Council with regard to regulatory technical standards specifying the methodology for calculation and maintenance of the additional amount of pre-funded dedicated own resources to be used in accordance with Article 9(14) of that Regulation (Text with EEA relevance)

  26. #2787219

    Stóinseacht agus gnéithe slándála

    Robustness and security features

    Commission Implementing Decision (EU) 2023/1053 of 30 May 2023 laying down rules for the application of Regulation (EU) 2023/588 of the European Parliament and of the Council as regards operational requirements for governmental services provided under Union Secure Connectivity Programme and its service portfolio

  27. #3063874

    Stóinseacht eolaíochta agus trédhearcacht i bpróisis údaraithe shonraithe

    Scientific robustness and transparency in specified authorisation processes

    22024A0022

  28. #3063876

    Rachaidh na Páirtithe i gcomhar maidir le stóinseacht agus trédhearcacht na bpróiseas údaraithe sin a mhéadú.

    The Parties shall cooperate on increasing the robustness and transparency of those authorisation processes.

    22024A0022

  29. #3131893

    faisnéis a sholáthar faoi stóinseacht an mhodha ar dhálaí sa tsaotharlann a chuireann an modh i bhfeidhm;

    providing information on robustness of the method at conditions in the laboratory that applies the method;

    Commission Implementing Regulation (EU) 2023/2782 of 14 December 2023 laying down the methods of sampling and analysis for the control of the levels of mycotoxins in food and repealing Regulation (EC) No 401/2006

  30. #3132224

    faisnéis a sholáthar faoi stóinseacht an mhodha ar dhálaí sa tsaotharlann a chuireann an modh i bhfeidhm

    providing information on robustness of the method at conditions in the laboratory that applies the method

    Commission Implementing Regulation (EU) 2023/2783 of 14 December 2023 laying down the methods of sampling and analysis for the control of the levels of plant toxins in food and repealing Regulation (EU) 2015/705

  31. #3180196

    Tugtar tosaíocht do mhodh den sórt sin de bharr a infheidhmitheachta, a stóinseachta agus a thrédhearcachta.

    The preference for such a method is due to its practicability, robustness and transparency.

    Commission Recommendation (EU) 2024/539 of 6 February 2024 on the regulatory promotion of gigabit connectivity (notified under document C(2024) 523)

  32. #3213836

    Ba cheart stóinseacht na rialuithe inmheánacha sin a bheith mar bhunús leis an rogha tástálacha.

    The choice of tests should be informed by the robustness of those internal controls.

    Commission Delegated Regulation (EU) 2024/436 of 20 October 2023 supplementing Regulation (EU) 2022/2065 of the European Parliament and of the Council, by laying down rules on the performance of audits for very large online platforms and very large online search engines

  33. #2202753

    an leibhéal cruinnis, stóinseachta agus cibearshlándála dá dtagraítear in Airteagal 15, a ndearnadh an córas intleachta saorga ardriosca a thástáil agus a bhailíochtú ina leith agus ar féidir a bheith ag súil leis, agus aon imthosca atá ar eolas agus intuartha a d’fhéadfadh tionchar a bheith acu ar an leibhéal cruinnis, stóinseachta agus cibearshlándála a mheastar a bheith ann;

    the level of accuracy, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS

  34. #3140733

    stóinseacht agus rialú rochtana, chun a áirithiú go bhfuil an conradh cliste deartha chun sásraí rialaithe rochtana agus leibhéal an-ard stóinseachta a thairiscint chun earráidí feidhmiúla a sheachaint agus chun ionramháil ag tríú páirtithe a sheasamh;

    robustness and access control, to ensure that the smart contract has been designed to offer access control mechanisms and a very high degree of robustness to avoid functional errors and to withstand manipulation by third parties;

    Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act)

  35. #292594

    Nuair a chruthaíonn faisnéis den sórt sin amhras faoi ábharthacht i ndaoine, fad agus a bhíonn muinín as stóinseacht agus cáilíocht na sonraí, d'fhéadfadh sé go mbeadh údar maith le haicmiú níos ísle.

    When such information, as far as there is reassurance about the robustness and quality of the data, raises doubt about relevance in humans, a lower classification may be warranted.

    Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

  36. #570862

    Taifeadfar an t-athrú sin i gcuntas satailíte, agus áireofar é sna bunchuntais nuair a bheidh stóinseacht agus comhchuibheas leordhóthanach inbhreathnaithe sna haonaid tomhais i measc Bhallstáit an AE;

    This change shall be recorded in a satellite account, and included in the core accounts when sufficient robustness and harmonisation of measures is observable amongst Member States;

    Regulation (EU) No 549/2013 of the European Parliament and of the Council of 21 May 2013 on the European system of national and regional accounts in the European Union Text with EEA relevance

  37. #585874

    Beidh líon na risíochtaí sa sampla agus an tréimhse shonraí a úsáideadh le haghaidh an chainníochtú leordhóthanach le go mbeidh muinín ag an institiúid as beachtas agus as stóinseacht a meastachán;

    The number of exposures in the sample and the data period used for quantification shall be sufficient to provide the institution with confidence in the accuracy and robustness of its estimates;

    Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 Text with EEA relevance

  38. #640607

    Ba cheart go ndíreodh údarú chun triail chliniciúil a stiúradh ar na gnéithe uile a bhaineann le cosaint na ndaoine is ábhar agus le hiontaofacht agus stóinseacht sonraí.

    The authorisation to conduct a clinical trial should address all aspects of subject protection and data reliability and robustness.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  39. #640676

    Ba cheart don urraitheoir faireachán leormhaith a dhéanamh ar stiúradh trialach chliniciúla chun iontaofacht agus stóinseacht na dtorthaí a áirithiú.

    The conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  40. #640703

    Dá bhrí sin, ba cheart go bhféadfadh roinnt solúbthachta a bheith sna rialacha is infheidhme, ar choinníoll nach ndéantar díobháil do shábháilteacht na ndaoine is ábhar, ná iontaofacht agus stóinseacht na sonraí a ghintear sa triail chliniciúil ach oiread.

    Therefore, the applicable rules should allow for some flexibility, provided that subject safety, as well as reliability and robustness of the data generated in the clinical trial are not compromised.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  41. #640706

    Ba cheart na rialacha maidir le lipéadú a oiriúnú do na rioscaí do shábháilteacht na ndaoine is ábhar agus d'iontaofacht agus stóinseacht na sonraí a ghintear i dtrialacha cliniciúla.

    The rules for labelling should be adapted to the risks to subject safety and the reliability and robustness of data generated in clinical trials.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  42. #640941

    breithnithe maidir le sábháilteacht na ndaoine is ábhar agus maidir le iontaofacht agus stóinseacht na sonraí arna dtíolacadh faoi mhír 5 nó faoi mhír 8 d'Airteagal 6.

    considerations as regards subject safety and data reliability and robustness submitted under paragraph 5 or 8 of Article 6.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  43. #641058

    breithnithe maidir le sábháilteacht na ndaoine is ábhar agus iontaofacht agus stóinseacht sonraí arna dtíolacadh faoi mhír 4 nó faoi mhír 6 d'Airteagal 18.

    considerations as regards subject safety and data reliability and robustness submitted under paragraph 4 or 6 of Article 18.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  44. #641098

    breithnithe maidir le sábháilteacht daoine is ábhar agus iontaofacht agus stóinseacht sonraí arna dtíolacadh faoi mhír 4 nó faoi mhír 6 d'Airteagal 18.

    considerations as regards suject safety and data reliability and robustness submitted under paragraph 4 or 6 of Article 18.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  45. #641123

    tuairisc shoiléir ar na hiarmhairtí a bheidh ag baint leis an modhnú substaintiúil maidir le cearta agus sábháilteacht na ndaoine is ábhar agus iontaofacht agus stóinseacht na sonraí a ghinfear sa triail chliniciúil.

    a clear description of the consequences of the substantial modification as regards the rights and safety of the subject and the reliability and robustness of the data generated in the clinical trial.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  46. #641493

    Beidh an tarmligean sin gan dochar d'fhreagracht an urraitheora, go háirithe maidir le sábháilteacht na ndaoine is ábhar agus le hiontaofacht agus stóinseacht na sonraí arna nginiúint sa triail chiniciúil.

    Such delegation shall be without prejudice to the responsibility of the sponsor, in particular regarding the safety of subjects and the reliability and robustness of the data generated in the clinical trial.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  47. #711695

    Is gá, dá bhrí sin, cruinneas, láidreacht agus sláine tagarmharcanna agus an phróisis faoina gcinntear tagarmharcanna a áirithiú.

    It is therefore necessary to ensure the accuracy, robustness and integrity of benchmarks and of the benchmark determination process.

    Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (Text with EEA relevance)

  48. #742811

    iontaofacht agus stóinseacht na sonraí a ghintear san imscrúdú cliniciúil, agus cur chuige staidrimh, dearadh an imscrúdaithe agus gnéithe modheolaíocha, lena n-áirítear samplamhéid, comparadóir agus críochphointí, á gcur san áireamh;

    the reliability and robustness of the data generated in the clinical investigation, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;

    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. #742920

    breithnithe maidir le sábháilteacht na n-ábhar agus iontaofacht agus stóinseacht na sonraí arna dtíolacadh faoi phointe (b) de mhír 4.

    considerations as regards subject safety and data reliability and robustness submitted under point (b) of paragraph 4.

    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. #746542

    iontaofacht agus stóinseacht na sonraí a ghintear sa staidéar feidhmíochta, agus cur chuige staidrimh, dearadh an staidéir feidhmíochta agus gnéithe modheolaíocha, lena n-áirítear samplamhéid, comparadóir agus críochphointí, á gcur san áireamh;

    the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints;

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )