Are you ready for the upcoming UDI deadline?
Key requirements for class I medical devices, class IIa / IIb reusable medical devices and class B & C IVD medical devices.
The UDI requirements under the EU MDR and IVDR will officially take effect for new above mentioned device risk classes on 26 May 2025.
If you’re a manufacturer of class I medical devices, class IIa / IIb reusable medical devices or class B and C IVDs, this is your last call to meet the requirements for documentation, labeling and data submission processes to ensure full compliance.
UDI plays a key role in improving traceability, post-market surveillance, and overall patient safety — but only if implemented correctly and on time.
What you need to know
- Deadline
UDI requirements will apply to class I medical devices, class IIa / IIb reusable medical devices under MDR and class B and C devices under IVDR starting 26 May 2025. - Labeling obligations
Devices must carry the UDI in both human-readable and machine-readable formats on the label and packaging. - Direct marking
For reusable devices that require reprocessing, the UDI must also be directly marked on the device itself. - EUDAMED submission
UDI data must be submitted to EUDAMED once it becomes fully operational. - IVD legacy devices reminder
For legacy IVD devices, manufacturers must have implemented a quality management system in line with Article 10(8) of the IVDR no later than 26 May 2025.
Act now to avoid disruption
Non-compliance with UDI obligations could lead to market access issues, recalls, or reputational damage. Ensuring your labeling, documentation, and quality systems are up to date is not just about meeting a deadline — it’s about ensuring safety, traceability, and regulatory trust.
Steps to take before the deadline
- Review your current labeling and packaging
- Ensure all applicable devices are properly marked with UDI
- Prepare for UDI data upload in EUDAMED
- Confirm your QMS meets the requirements for IVD legacy devices
Need support navigating UDI compliance or MDR/IVDR requirements?
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