The application shall enable the characteristics and performance of the device to be understood, and shall enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to the suitability of the device in relation to the medicinal product concerned.
Leis an iarratas, beifear in ann saintréithe agus feidhmíocht na feiste a thuiscint, agus áiritheofar comhréireacht le ceanglais an Rialacháin seo a bhaineann leis an dearadh a mheas, go háirithe, ag féachaint d'oiriúnacht na feiste maidir leis an táirge íocshláinte lena mbaineann.