UDI Labelling Requirement for Class I Medical Devices

UDI marking requirement for Class I medical devices starting May 26, 2025

As part of the EU Medical Device Regulation (MDR – EU 2017/745), another important deadline is approaching: As of May 26, 2025, all Class I medical devices newly placed on the European market must carry a UDI marking (Unique Device Identification).

This regulation is part of the European Union's ongoing efforts to enhance safety, transparency, and traceability in the field of medical products.

What is the UDI?

The UDI is an internationally standardized product identification system that enables clear identification and traceability of medical devices throughout their entire lifecycle. The goal is to ensure seamless documentation, identify potential risks early, and implement recalls and market surveillance efficiently.

Components of the UDI

The UDI consists of two components:

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

Placement and display

The UDI must be affixed to the product or its packaging in both machine-readable format (e.g., 1D barcode or 2D DataMatrix) and human-readable interpretation. These requirements apply to every level of packaging, from individual units to transport packaging.

Application date for Class I products

For manufacturers of Class I products:

As of May 26, 2025, only products with a complete UDI marking may be newly placed on the market.

This specifically applies to:

• New products placed on the market for the first time from this date
• Products with technical modifications requiring a new UDI-DI
• Products previously not UDI-marked

Registration in the EUDAMED database

In addition to labeling on the product, the UDI-DI must be registered in the European medical device database EUDAMED. UDI data serves there as a reference for linking additional regulatory information such as declarations of conformity, clinical evaluations, and vigilance reports.

AMPri is prepared

As a responsible manufacturer and wholesaler, AMPri already fulfills all relevant requirements for MDR-compliant product labeling. Our Class I medical devices first placed on the market after May 26, 2025, will nat