Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer.
Gan dochar do mhír 4, má mheastar nach léirítear go hiomchuí go bhfuiltear ag comhlíonadh na gceanglas ginearálta sábháilteachta agus feidhmíochta bunaithe ar fhianaise chliniciúil, tabharfar údar cuí bunaithe d'aon eisceacht den sórt sin ar na torthaí ó bhainistiú riosca an mhonaróra agus ar shonraíochtaí an idirghníomhaithe idir an fheiste agus corp an duine a bhreithniú, an fheidhmíocht chliniciúil a beartaíodh agus an méid a mhaíonn an monaróir.