Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the Annexes to Directives 90/385/EEC and 93/42/EEC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.
Roinnt de na hoibleagáidí ar mhonaróirí, amhail meastóireacht chliniciúil nó tuairisciú aireachais, nach raibh leagtha amach ach sna hIarscríbhinní a ghabhann le Treoir 90/385/CEE agus le Treoir 93/42/CEE, ba cheart iad a ionchorprú i bhforálacha achtúcháin an Rialacháin seo lena fheidhmiú a éascú.