Identification and description of the device, including its intended purpose, its manufacturer, its traceability, the target population, materials coming into contact with the human body, the medical or surgical procedures involved in its use and the necessary training and experience for its use, background literature review, the current state of the art in clinical care in the relevant field of application and the proposed benefits of the new device.
Sainaithint na feiste agus tuairisc uirthi, lena n-áirítear an chríoch a beartaíodh di, a monaróir, a hinrianaitheacht, an spriocdhaonra, na hábhair a dhéanann teagmháil le corp an duine, na gnáthaimh leighis nó máinliachta a bhaineann le húsáid na feiste agus an oiliúint agus an taithí is gá lena húsáid, cuardach litríochta cúlra, an úrscothacht sa chúram cliniciúil i réimse ábhartha an chur i bhfeidhm agus na sochair a beartaíodh a bheith ag baint leis an bhfeiste nua.