The timing of UDI implementation varies depending on the risk class of the device, as set out in the MDR (EU) Regulations 2017/745 for Medical Devices and IVDR (EU) 2017/746 for in vitro diagnostic Medical Devices.

The application dates are as follows:

For Medical Devices (MDR (EU) 2017/745):

  • Applying UDI on device labels:
    • For Class III and implantable devices, the deadline was May 26, 2021.
    • For Class IIa and Class IIb: the deadline was May 26, 2023.
    • For Class I: the deadline is May 26, 2025.
  • Direct Marking of Medical Devices
    • For Class III and implantable devices, the deadline was May 26, 2023.
    • For Class IIa and Class IIb: the deadline is May 26, 2025.
    • For Class I: the deadline is May 26, 2027.

For In Vitro Diagnostic Medical Devices (IVDR (EU) 2017/746):

  • Applying UDI on device labels:
    • For Class D IVD: the deadline was May 26, 2021.
    • For Class C and Class B: the deadline was May 26, 2023.
    • For Class A: the deadline is May 26, 2025.
  • Direct Marking of Medical Devices
    • For Class D IVD: the deadline was May 26, 2023.
    • For Class C and Class B: the deadline is May 26, 2025.
    • For Class A: the deadline is May 26, 2027.