In order for manufacturers to be able to demonstrate the conformity of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety.
Chun go mbeidh monaróirí in ann comhréireacht táirgí den sórt sin a thaispeáint, ba cheart don Choimisiún sonraíochtaí comhchoiteanna a ghlacadh ar a laghad maidir le ceanglais i ndáil le bainistiú riosca a chur i bhfeidhm agus, nuair is gá, meastóireacht chliniciúil a dhéanamh ar na dálaí sábháilteachta.