It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.
Taispeánfar go soiléir go bhfuil leibhéil leordhóthanacha de rochtain ag monaróirí ar na sonraí a bhaineann leis na feistí sin a bhfuil siad ag maíomh go bhfuil coibhéis ag a bhfeistí leo chun údar a thabhairt don choibhéis atá maíte acu.