The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
Déanfar torthaí na meastóireachta cliniciúla agus na fianaise cliniciúla ar a bhfuil sí bunaithe a dhoiciméadú i dtuarascáil ar an meastóireacht chliniciúil a thacóidh leis an measúnú ar chomhréireacht na feiste.