The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients.
Mar riail ghinearálta, ba cheart an nós imeachta um measúnú comhréireachta d'fheistí in aicme A a bheith faoi fhreagracht monaróirí amháin, ós rud é nach bhfuil ach riosca íseal ag baint leis na feistí sin d'othair.