Unique Identification Number

One of the most important changes for Medical Device manufacturers along with the MDR is to ensure traceability in all markets where medical devices are available. This traceability process is intended by the European Commission through the UDI Codes.

UDI is a series of numeric or alphanumeric characters created through a globally recognized device identification and encoding standard. It provides a clear identification of a specific Medical Device on the market.

The main purpose of the UDI system is to ensure product traceability. In addition, it is intended to be executed through UDI Codes in the following topics.

  • Effective execution of recall and corrective activities under the vigilance system,
  • Provide faster data exchange between authorized authorities on post-market activities,
  • Anti-counterfeiting and trafficking,
  • Distribution channel control,
  • Stock control,
  • Determination of refund policy

Last Date of Transition to UDI System:

The UDI requirement depends on the risk of your product. So if there are more risks, you should apply the UDI earlier. Below are the application dates that follow the class:

  • Class I: May 26, 2025
  • Class IIa and IIb: 26 may 2023
  • Implantable and Class III: 26 may 2021

 

Note: For reusable devices such as surgical instruments, the UDI carrier must be on the product and the European Commission is postponing the UDI transitions to 2 years from now for products already in the market. If the reusable product is class III, implementation of the UDI is postponed to May 26, 2023.