SOCIAL QUESTIONS|health|health policy|organisation of health care|medical device
- feiste intí Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs '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.' Tagairt "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"
- in-house device
- en
- Sainmhíniú "device for self-testing manufactured and used within the same health institution" Tagairt "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"