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.
Maidir le hathruithe ar an bhfeiste fhormheasta, beidh formheas ón gcomhlacht dá dtugtar fógra a d'eisigh an deimhniú AE maidir le measúnú ar dhoiciméadacht theicniúil, i gcás ina bhféadfadh athruithe den sórt sin difear a dhéanamh do shábháilteacht agus d'fheidhmíocht na feiste nó do na coinníollacha a fhorordaítear maidir le húsáid na feiste.