the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
tugann an institiúid sláinte bonn cirt ina cuid doiciméadachta gur féidir freastal, nó nach féidir, ar riachtanais shonracha an ghrúpa othar ar a bhfuil an fheiste dírithe, ar an leibhéal iomchuí feidhmíochta, le feiste chomhionann atá ar fáil ar an margadh,