UDI Labelling Requirement for Class I Medical Devices

In accordance with the EU Medical Device Regulation (MDR – EU 2017/745), another important deadline is approaching: As of 26 May 2025, all Class I medical devices placed on the European market for the first time must be marked with a UDI (Unique Device Identification).

This regulation is part of the European Union’s broader efforts to enhance safety, transparency, and traceability in the field of medical devices.

What is the UDI?

The UDI is an internationally standardized product identification system designed to enable the unique identification and traceability of medical devices throughout their entire lifecycle. The objective is to ensure seamless documentation, identify potential risks at an early stage, and implement recalls and market surveillance measures efficiently.

Components of the UDI

The UDI consists of two components:

• UDI-DI (Device Identifier)
  The static part of the identification. It uniquely identifies the product model and remains unchanged throughout the product’s lifecycle.
• UDI-PI (Production Identifier)
  The dynamic part, which contains production-specific information, such as:
  • Batch or serial number
  • Manufacturing or expiry date

Placement and Presentation

The UDI must be affixed to the product or packaging in both machine-readable format (e.g., as a 1D barcode or 2D DataMatrix) and human-readable text (Human Readable Interpretation). These requirements apply to each level of packaging, from individual units to transport packaging. Shipping containers are not considered a higher packaging level.

AMPri is prepared

As a responsible manufacturer and wholesaler, AMPri meets all relevant requirements for compliant product labeling of medical devices.