Before any change is made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes.
Sula ndéanfar aon athrú i ndáil le substaint choimhdeach atá ionchorpraithe i bhfeiste, go háirithe maidir lena phróiseas monaraíochta, cuirfidh an monaróir an comhlacht dá dtugtar fógra ar an eolas maidir leis na hathruithe.