Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device.
I gcás ina bhféadfadh athruithe ar an bhfeiste fhormheasta difear a dhéanamh do shábháilteacht agus d'fheidhmíocht na feiste nó do na coinníollacha a fhorordaítear maidir le húsáid na feiste, an comhlacht dá dtugtar fógra a d'eisigh deimhniú AE do mheasúnú ar dhoiciméadacht theicniúil, ní mór dó na hathruithe sin ar an táirge formheasta a fhormheas.