In the case of devices manufactured utilising tissues or cells of animal origin or their derivatives, such as from TSE susceptible species, as referred to in Regulation (EU) No 722/2012, the notified body shall have documented procedures in place that fulfil the requirements laid down in that Regulation, including for the preparation of a summary evaluation report for the relevant competent authority.
I gcás feistí a mhonaraítear agus fíochán nó cealla de bhunús ainmhíoch nó a ndíorthaigh, amhail speicis atá leochaileach ó thaobh TSE de, dá dtagraítear i Rialachán (AE) Uimh. 722/2012 á n-úsáid, beidh nósanna imeachta doiciméadaithe i bhfeidhm ag an gcomhlacht dá dtugtar fógra lena gcomhlíontar na ceanglais a leagtar síos sa Rialachán sin, lena n-áirítear achoimre ar thuarascáil na meastóireachta a ullmhú don údarás inniúil ábhartha.