Gaois

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2 results

  1. SOCIAL QUESTIONS|health|medical science

    #649307

    IATE #3545457
    Leistungsstudie
    de
    Definition "Studie zur Feststellung oder Bestätigung der Analyseleistung oder der klinischen Leistung IATE:3545136 eines Produkts" Reference "Verordnung (EU) 2017/746 über In-vitro-Diagnostika und zur Aufhebung der Richtlinie 98/79/EG und des Beschlusses 2010/227/EU der Kommission, Art.2 Nr.42; ABl. L_117/2017, S.176 CELEX:32017R0746/DE"
    clinical performance study | diagnostic clinical performance study
    en
    Definition "study undertaken to establish or confirm the clinical performance of an in vitro diagnostic medical device" Reference "COM-EN, based on: Regulation (EU) 2017/746 on in vitro diagnostic medical devices"
    Comment "Clinical performance studies are conducted only for in vitro medical devices. All other devices are subject to clinical investigations. See also the narrower concept of an interventional clinical performance study. The FDA gives the following definition: Study in which a test is characterized by performance measures that quantify how well the diagnostic device output agrees with true subject status as determined by a clinical reference standard. "
    étude des performances cliniques
    fr
    Definition "étude entreprise pour établir ou confirmer les performances cliniques d'un dispositif médical de diagnostic in vitro" Reference "Conseil-FR, d'après le règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro"
    Comment "Les études de performance clinique ne sont menées que pour les dispositifs médicaux in vitro. Tous les autres dispositifs sont soumis à des investigations cliniques.Voir également le concept plus étroit d'étude interventionnelle des performances cliniques"
  2. SOCIAL QUESTIONS|health|medical science

    #649309

    IATE #3545461
    staidéar feidhmíochta cliniciúil idirghabhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    interventionelle klinische Leistungsstudie
    de
    Definition "klinische Leistungsstudie IATE:3545457 , bei der die Testergebnisse Auswirkungen auf Entscheidungen über das Patientenmanagement haben und/oder zur Orientierung der Behandlung verwendet werden" Reference "Verordnung (EU) 2017/746 über In-vitro-Diagnostika und zur Aufhebung der Richtlinie 98/79/EG und des Beschlusses 2010/227/EU der Kommission, Art.2 Nr.46; ABl. L_117/2017, S.176 CELEX:32017R0746/DE"
    interventional clinical performance study
    en
    Definition "for in vitro diagnostic medical devices, clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment" Reference "COM-EN, based on: Article 2(46) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices"
    étude interventionnelle des performances cliniques
    fr
    Definition "pour les dispositifs médicaux de diagnostic in vitro, étude des performances cliniques dans laquelle les résultats des essais peuvent influencer les décisions relatives à la prise en charge du patient et/ou être utilisés pour orienter les soins" Reference "Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro, article 2, point 46)"