For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
I gcás feistí in aicme IIa, in aicme IIb agus in aicme III, ba cheart leibhéal iomchuí rannpháirtíochta ó chomhlacht dá dtugtar fógra a bheith éigeantach.