A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability.
Ceanglófar SF-SFU nua aon uair a dhéantar athrú a bhféadfaí an fheiste a shainaithint go mícheart mar gheall air agus/nó a bhféadfadh débhríocht ina inrianaitheacht a bheith mar thoradh air.