reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
tuarascálacha a fhoilsítear i litríocht eolaíochta a ndéantar athbhreithniú piaraí uirthi ar thaithí chliniciúil eile a bhaineann leis an bhfeiste atá i gceist nó le feiste eile den chineál céanna ar féidir a coibhéis leis an bhfeiste atá i gceist a thaispeáint,