For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
I gcás aon saintréith den fheiste a mhaíonn an monaróir a bheith nuálach nó i gcás aon táscairí nua, measfaidh an comhlacht dá dtugtar fógra an méid a thacaítear leis na héilimh shonracha le sonraí réamhchliniciúla agus cliniciúla ar leith agus leis an anailís riosca