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; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
Ceanglófar SF-SFU nua aon uair a tharlóidh athrú a bhféadfaí an fheiste a shainaithint go mícheart mar gheall air agus/nó a bhféadfadh débhríocht ina hinrianaitheacht a bheith mar thoradh air; go háirithe má dhéantar aon athrú ar cheann de na heilimintí sonraí seo a leanas i mbunachar sonraí SFU, ceanglófar SF-SFU nua: