SOCIAL QUESTIONS|health|medical science
- Leistungsstudie
- de
- Sainmhíniú "Studie zur Feststellung oder Bestätigung der Analyseleistung oder der klinischen Leistung IATE:3545136 eines Produkts" Tagairt "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
- Sainmhíniú "study undertaken to establish or confirm the clinical performance of an in vitro diagnostic medical device" Tagairt "COM-EN, based on: Regulation (EU) 2017/746 on in vitro diagnostic medical devices"
- Nóta "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
- Sainmhíniú "étude entreprise pour établir ou confirmer les performances cliniques d'un dispositif médical de diagnostic in vitro" Tagairt "Conseil-FR, d'après le règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro"
- Nóta "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"