All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
Tá gach feiste neamhionrach arb éard atá iontu substaint nó meascán substaintí a beartaíodh lena n-úsáid in vitro i dteagmháil dhíreach le cealla daonna, fíocháin nó orgáin a bhaintear ó chorp an duine nó lena n-úsáid in vitro le suthanna daonna sula ndéantar iad a ionchlannú nó a thabhairt isteach sa cholainn aicmithe mar aicme III