The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe.
Leis an bhfianaise chliniciúil, léireofar go heolaíoch, de réir an úrscothacht i gcúrsaí leighis, go mbainfear amach an sochar cliniciúil nó na sochair chliniciúla atá beartaithe agus go bhfuil an fheiste slán.