UDI-DI mandatory from May 26, 2025: A guide for manufacturers
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
An important deadline is coming up under the EU Medical Devices Regulations (MDR and IVDR), and it’s all about your product labels.
From this date, manufacturers will be required to place the UDI (Unique Device Identification) carrier on:
🔹 All Class I medical devices (under MDR)
🔹 Class B and Class C in vitro diagnostic devices (under IVDR)
The obligation applies to all manufacturers, regardless of whether a Notified Body is involved. It also applies to Software medical Devices. For many manufacturers, especially those working with Class I or self-certified devices, this may represent a significant regulatory shift.
What is the UDI?
The UDI is a sequence of numbers and/or letters following globally accepted standards. Its purpose is to allow clear identification of a specific medical device on the market.
The UDI is composed by two elements the UDI-DI and the UDI-PI.
How it works
The UDI-DI (Device identifier) is specific to a manufacturer and a device model.
The UDI-PI (Production Identifier) includes information like lot number, manufacturing or expiration date, and serial number—used for batch-level traceability.
Together they form the UDI, which must be readable for both humans and “machines”. To achieve this, Manufacturers must include the UDI Carrier on the label or on the device itself and on all higher levels of device packaging. The UDI Carrier typically looks like a barcode or QR accompanied by text.
Basic UDI-DI vs. UDI-DI
Main differences
• Basic UDI-DI: A code that groups together devices with the same intended purpose, risk class, and essential design and manufacturing characteristics. It appears in the Declaration of Conformity (DoC), certificates, and EUDAMED. It is independent of product labelling and does not appear on the commercial item.
• UDI-DI: A code that unambiguously identifies a device version. A different UDI-DI will be necessary for products with different trade names, sterilisation requirements, contra-indications or quantity of devices included in a package. It appears in the labelling of the devices and EUDAMED.
Each UDI-DI shall be associated with one, and only one, Basic UDI-DI.
Why is this important
The Unique Device Identifier System is designed to enhance the traceability, transparency, and safety of medical devices across the European market.
Even if your device does not require certification from a Notified Body, the obligation to implement the UDI system remains. This includes both the generation of the codes and the proper use of identifiers across documentation, labelling, and registration platforms like EUDAMED.
What are the risks of non-compliance?
• Loss of CE marking
• Inability to market devices in the EU
• Risk of product recalls or enforcement actions
• Reputational damage and loss of distributor or customer trust
What should you do now?
Steps to take
1. Verify if your devices are affected by the UDI requirements
2. Obtain UDI and Basic UDI-DI codes from a recognized issuing entity (e.g., GS1, HIBCC, ICCBBA)
3. Include the UDI information in your labelling, packaging, and technical documentation
4. Register the UDI-DI and Basic UDI-DI in EUDAMED, once fully functional
5. Ensure full alignment with the requirements of MDR or IVDR
Need support?
Implementing UDI isn’t just about assigning codes. It means rethinking labelling workflows, ensuring consistent data entry across documents, and managing regulatory deadlines with precision.
We assist manufacturers with:
• Choosing the right issuing entity
• Assigning and structuring UDI and Basic UDI-DI
• Registering data in EUDAMED
• Ensuring complete documentation and labelling compliance
Want to talk to an expert or receive a personalized plan? Get in touch with our team, we’re here to make compliance simple and strategic.
