‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
ciallaíonn “feiste shaincheaptha” aon fheiste leighis, nó gabhálas feiste leighis, a rinneadh go sonrach de réir oideas liachta aon duine atá údaraithe leis an dlí náisiúnta de bhua a cháilíochtaí gairmiúla, lena leagtar síos, faoi fhreagracht an duine sin, saintréithe a bhaineann leis an dearadh, agus ar feiste í a beartaíodh lena húsáid ar a shon féin ag othar áirithe chun a chuid dálaí agus riachtanas féin amháin a shásamh.