UDI
UDI (Unique Device Identification) is a global system for the unique identification of medical devices throughout the supply chain, designed to improve traceability, combat counterfeiting, and facilitate recalls.
The UDI system comprises two components:
- Device Identifier (DI): identifies the manufacturer and product model (broadly equivalent to the REF)
- Production Identifier (PI): contains variable information such as batch number (LOT), serial number, manufacturing date, and expiry date
Under MDR (EU) 2017/745 (Article 27 and Annex VI Part C), UDI is mandatory for all medical devices marketed in the EU in a phased rollout – from Class III (since 2021) to Class I (from 2025). The UDI code is placed on product packaging as a barcode and/or AIDC (Automatic Identification and Data Capture, e.g. DataMatrix).
UDI data must be registered in the European EUDAMED database. Designated UDI issuing entities include GS1, HIBCC, and ICCBBA.
Frequently asked questions
What is the difference between DI and PI in the UDI system?
The Device Identifier (DI) identifies the product model and manufacturer – it is the same for all units of a product type. The Production Identifier (PI) contains variable information such as batch number (LOT), serial number, and expiry date.
When does UDI become mandatory for each device class?
Which UDI issuing entities are approved for the EU?
Approved UDI issuing entities for the EU market are GS1 (EAN/DataMatrix), HIBCC, and ICCBBA. The choice of issuing entity is at the manufacturer's discretion.