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, a new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilisation before use, quantity of devices provided in a package, critical warnings or contra-indications and CMR/Endocrine disruptors.
A UDI-DI shall be associated with one and only one Basic UDI-DI.
Additional information on this aspect is available at MDCG 2018-1 v3 guidance document.