Before any change is made with respect to non-viable tissues or cells of human origin or their derivatives incorporated in a device, in particular relating to their donation, testing or procurement, the manufacturer shall inform the notified body of the intended changes.
Sula ndéanfar aon athrú i ndáil le fíocháin nó cealla neamh-inmharthana de bhunús daonna nó a ndíorthaígh atá ionchorpraithe i bhfeiste, go háirithe maidir lena ndeonú, lena dtástáil nó lena soláthar, cuirfidh an monaróir an comhlacht dá dtugtar fógra ar an eolas maidir leis na hathruithe a beartaíodh.