The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation.
Déanfaidh an comhlacht dá dtugtar fógra, na himthosca ina mbunaítear an fhianaise chliniciúil, ina n-iomláine nó i bpáirt, ar shonraí ó fheistí a mhaítear a bheith comhionann leis an bhfeiste atá á measúnú, oiriúnacht úsáid sonraí den sórt sin a mheas, agus fachtóirí amhail táscairí nua agus nuáil á gcur san áireamh.