Discussion and overall conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation.
Plé agus conclúidí foriomlána lena gcumhdaítear sábháilteacht agus torthaí feidhmíochta, an measúnú ar rioscaí agus ar shochair chliniciúla, plé ar ábharthacht chliniciúil i gcomhréir leis an úrscothacht cliniciúil, aon réamhchúraimí sonracha le haghaidh pobail shonracha othar, impleachtaí maidir leis an bhfeiste atá faoi imscrúdú, teorainneacha an imscrúdaithe.