solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
na réitigh chun na ceanglais shonracha is infheidhme maidir le dearadh agus tógáil a chomhlíonadh, lena n-áirítear meastóireacht réamhchliniciúil iomchuí, go háirithe ceanglais Chaibidil II d'Iarscríbhinn I,