The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the documentation of the notified body concerning the device.
Áiritheofar i ndoiciméadacht an chomhlachta dá dtugtar fógra maidir leis an bhfeiste tuairim eolaíoch shaotharlann tagartha AE agus, i gcás ina bhfuil an nós imeachta a leagtar síos in Airteagal 48(6) infheidhme, dearcthaí na saineolaithe a ndeachthas i gcomhairle leo, agus aon nuashonruithe a d'fhéadfadh a bheith ann.