Unique Identification Number (UID)
One of the most important changes introduced for Medical Device Manufacturers along with the MDR is ensuring the traceability of medical devices in all markets where they are sold. The European Commission aims to achieve this traceability through UDI Codes.
UDI is a series of numeric or alphanumeric characters created through a globally recognized device identification and coding standard. It ensures the clear identification of a specific medical device in the market.
The main purpose of the UDI system is to ensure product traceability. In addition, the following goals are also targeted to be carried out through UDI Codes:
- Effective execution of recall and corrective actions within the scope of the alert system,
- Enabling faster data exchange between competent authorities about post-market activities,
- Combating counterfeiting and smuggling,
- Control of the distribution channel,
- Stock control,
- Policy determination related to reimbursement.
Final Transition Date for the UDI System
The UDI requirement depends on the risk of your product. That is, the higher the risk, the earlier you must implement the UDI.
The implementation dates according to the class are as follows:
- Class I: May 26, 2025
- Class IIa and IIb: May 26, 2023
- Implantable and Class III: May 26, 2021
Note: For reusable devices such as surgical instruments, the UDI carrier must be on the product, and for products already on the market, the European Commission has postponed UDI transitions for 2 years.
For reusable Class III products, UDI implementation is postponed to May 26, 2023.
UDI consists of UDI-DI and UDI-PI.