Insights
Latest posts from our newsroom covering UDI compliance, regulatory updates, and global medical device submission requirements.
December 8, 2025
As of November 27th, 2025, The Official Journal of the EU has published a notice that 4 modules of EUDAMED have been audited with successful results. These modules are: Actor Registration UDI/Device Registration Notified Bodies and Certificates Market Surveillance What does this
Read full articleNovember 25, 2025
The Medical Device Coordination Group (MDCG) recently released a new guidance, MDCG 2025-8 , “Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles,” which aims to provide guidance in the implement
Read full articleJuly 31, 2025
The European Commission has delayed the mandatory use of the EUDAMED UDI/Device Registration module. While it was expected to become required starting in January 2026, no publication confirming module functionality has yet appeared in the Official Journal of the EU (OJEU). With t
Read full articleJuly 29, 2025
Master UDI-DI, the European Union’s answer to creating UDI-DIs for Highly Individualized Devices, is a type of UDI-DI unique to the European Union. The Master UDI-DI technical solution aims to group highly individualised devices with specific similarities in terms of relevant des
Read full articleJuly 28, 2025
In June 2025, the FDA issued a draft guidance clarifying Unique Device Identifier (UDI) labeling requirements for combination products — including single-entity, co-packaged, and cross-labeled products. This document outlines the agency’s current thinking, expectations, and examp
Read full articleJuly 10, 2025
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