The European Commission may, by means of implementing acts, specify the data to be included in the UDI-PI of specific devices or device groups. Please remember that the manufacturer is responsible for assigning a risk class to its devices, not GS1.
The EU MDR and IVDR have defined a few principles concerning UDI-PIs:
- If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI
- Serial number is a mandatory UDI-PI for active implantable devices
- Serial number or lot number is a mandatory UDI-PI for other implantable devices
- The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI. Minor software revision shall require a new UDI-PI and not a new UDI-DI
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