a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure of the device;
athrú suntasach chun donais ar an bpróifíl tairbhe-riosca de chuid catagóire ar leith nó grúpa feistí ar leith mar thoradh ar údar imní sláinte atá bailí ó thaobh na heolaíochta de maidir le comhpháirteanna nó maidir leis an ábhar foinseach nó maidir leis an tionchar ar shláinte i gcás ina dteipeann ar an bhfeiste;