Gaois

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  1. SOCIAL QUESTIONS|health|health policy|organisation of health care|medical device

    #663326

    IATE #3589454
    feiste intí Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Sula gcuirfear feiste i seirbhís nach feiste í a chuirtear ar an margadh, cé is moite d'fheistí intí arna monarú de bhun Airteagal 5(5), gabhfaidh na monaróirí de láimh comhréireacht na feiste sin a mheasúnú, i gcomhréir leis na nósanna imeachta um measúnú comhréireachta is infheidhme a leagtar síos in Iarscríbhinn IX go hIarscríbhinn XI.' Reference "Rialachán (AE) 2017/746 maidir le feistí leighis diagnóiseacha in vitro agus lena n-aisghairtear Treoir 98/79/CE agus Cinneadh 2010/227/AE ón gCoimisiún, CELEX:32017R0746/GA"
    hausinternes Produkt
    de
    in-house device
    en
    Definition "device for self-testing manufactured and used within the same health institution" Reference "COM-Terminology Coordination, based on: Art. 5(5) of Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU"