In choosing representative samples the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 99 and in particular, the novelty of the technology, the potential impact on the patient and standard medical practice, similarities in design, technology, manufacturing and, where applicable, sterilisation methods, the intended purpose and the results of any previous relevant assessments that have been carried out in accordance with this Regulation.
Agus samplaí ionadaíocha á roghnú ag an gcomhlacht dá dtugtar fógra, cuirfidh sé san áireamh an treoir fhoilsithe a d'fhorbair an GCFL de bhun Airteagal 99 agus go háirithe úrnuacht na teicneolaíochta, an tionchar a d'fhéadfadh a bheith aige nó acu ar an othar agus ar chleachtadh caighdeánach leighis, cosúlachtaí idir dearadh, teicneolaíocht, monarú agus, i gcás inarb infheidhme, modhanna steirilithe, an chríoch a beartaíodh dó agus torthaí aon mheasúnuithe ábhartha eile a rinneadh i gcomhréir leis an Rialachán seo.