In choosing representative samples, the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 105 and in particular the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended purpose and the results of any previous relevant assessments such as with regard to physical, chemical, biological or clinical properties, 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 105 agus go háirithe úrnuacht na teicneolaíochta, cosúlachtaí idir dearadh, teicneolaíocht, monarú agus modhanna steirilithe, an chríoch a beartaíodh dóibh agus torthaí aon mheasúnuithe ábhartha eile amhail maidir le hairíonna fisiceacha, ceimiceacha, bitheolaíocha nó cliniciúla a rinneadh i gcomhréir leis an Rialachán seo.