26 May 2025: UDI labelling deadline for medical devices and IVDs in the EU

To comply with the EU Medical Devices Regulations (MDR and IVDR), an important deadline is approaching for labels of medical devices and IVDs. From 26 May 2025, manufacturers need to affix the UDI carriers on the following medical devices:

• All class I medical devices
• Class B and class C IVD medical devices

Earlier deadlines have already applied for other device classes, as follows:

• Implantable and Class III medical devices: 26 May 2021
• Class IIa and Class IIb medical devices: 26 May 2023
• Class D IVD medical devices: 26 May 2023

IVDR Class A devices have until 26 May 2027 to comply.

What is the Unique Device Identification (UDI)?

The UDI system provides a distinct numeric or alphanumeric code assigned to medical devices and IVDs. Its primary purpose is to enable clear, precise, and unambiguous identification and traceability of each device available on the EU market.

The implementation of UDI enhances traceability by enabling efficient tracking throughout the device’s lifecycle. It also improves recall management, allowing quick identification and removal of defective or unsafe devices. Additionally, UDI helps prevent counterfeits by verifying authenticity. Ultimately, this increases patient safety through accurate device identification, reducing risks associated with device usage.

Affixing the UDI on medical devices labels

The required labelling information should be displayed directly on the medical device, its packaging, or within the instructions for use. Additionally, if the manufacturer maintains a website, the relevant labelling details should be provided online and regularly updated. Nonetheless, when determining the appropriate placement of labelling information, manufacturers must first ensure compliance with the general requirements outlined in Section 23 of Annex I of MDR and Section 20 of Annex I of IVDR.

STAY COMPLIANT: Is Obelis s.a. your authorised representative? Inform us about your updated labels and we will inform the competent authority.

Do you have questions on how to affix UDI-carriers on your MDR and/or IVDR devices? Contact us here or at mdlaw@obelis.net.

References:

European Commission (2025). Unique Device Identifier – UDI – European Commission. Retrieved on 17/03/2025.

European Commission (2020). Unique Device Identification (UDI) System – FAQs. Retrieved on 17/03/2025.