2026 Is a Global UDI Turning Point — Are You Ready?
Major UDI requirements are taking effect across the EU, Australia, and Switzerland. Ensure your compliance strategy is aligned before deadlines arrive.
What’s Changing in 2026
Global UDI Requirements Are Accelerating
Regulatory authorities around the world are advancing Unique Device Identification (UDI) requirements — and 2026 marks a critical milestone year.
- European Union (EUDAMED): Expanded module implementation and increased enforcement activity.
- Australia (TGA / AusUDID): Phased UDI compliance obligations begin.
- Switzerland (Swissdamed): Mandatory use of the Product Module begins July 1, 2026.
For manufacturers operating across multiple markets, these changes introduce new data submission, maintenance, and lifecycle management obligations.
Managing UDI in one region is complex. Managing it across three requires a coordinated global strategy.
The Complexity of Global UDI Compliance
Each regulatory system has unique data structures, submission requirements, and timelines. Yet your product data must remain:
- Accurate
- Synchronized
- Audit-ready
- Continuously maintained
Disconnected processes increase risk — from submission errors to inspection findings to market access delays.
One Partner for Global UDI Compliance
LexisNexis Life Sciences simplifies global UDI management.
We support manufacturers across the entire product lifecycle — from initial UDI data preparation and submission to ongoing updates, change management, and post-market compliance.
Our technology-driven solutions and global regulatory expertise help ensure your device data remains compliant across EUDAMED, AusUDID, and Swissdamed — reducing operational burden and regulatory risk.
You focus on innovation. We help safeguard compliance.
Explore 2026 UDI Resources
The State of Global Regulatory Compliance 2026
The European Commission formally confirmed in the OJEU that the Actors, UDI/Devices, Notified Bodies/Certificates, and Market Surveillance modules meet the required specifications.
Breaking Down the EU’s Latest EUDAMED Functional Confirmation
The European Commission formally confirmed in the OJEU that the Actors, UDI/Devices, Notified Bodies/Certificates, and Market Surveillance modules meet the required specifications
Swissmedic Launches UDI Module in swissdamed
Voluntary submissions begin in August 2025, with mandatory registration starting July 2026. The system aligns with EUDAMED standards, compliance, and post-market surveillance.
EUDAMED Rollout Delay: What It Means for Medical Device
The European Commission did not declare EUDAMED “fully functional” by the previously anticipated July 1, 2025 deadline, and no notice was published in the Official Journal of the EU.
Leverage Our Expertise in Life Sciences
34%
of FDA GUDID Electronic Records Submitted Annually
450+
Medical Device unique customers since inception
750,000+
Records Submitted to FDA Global UDI Database
15+
Years of Structured Product Labeling Experience
1,000+
Pharmaceutical customers including manufacturers
99.95%
Pharma FDA SPL submissions delivered within contracted time
Prepare for 2026 UDI Compliance
Complete the form to connect with the LexisNexis Life Sciences team about your global UDI compliance needs. We’ll follow up to discuss how to support your strategy across EUDAMED, AusUDID, and Swissdamed ahead of 2026 requirements.
