UDI Implementation for Medical Device and IVD Companies
Ensure compliance with the EU MDR and IVDR’s UDI system, which requires the tracking and traceability of medical devices and IVDs through a unique device identification (UDI).
What is a Medical Device UDI Under the EU MDR?
The UDI system is a new function under the EU MDR and IVDR designed to ensure the tracking and traceability of specific medical devices and IVDs. UDI uses a unique series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. The MDR/IVDR UDI system has two main components: UDI and Basic UDI-DI.
Prepare for UDI Data Input and EUDAMED Registration
Device manufacturers should prepare for mandatory UDI data input early in the roll out period, perhaps by the beginning of 2026 or even sooner. If your UDI system is not already in EUDAMED, we can help. Our experienced team can manage all aspects of UDI implementation and complete your EUDAMED registration.
How we can help:
UDI and labeling gap assessment
We will perform a thorough gap assessment of your current labeling, as well as your quality management system and production, to evaluate your UDI readiness and determine next steps.
Basic UDI-DI device family grouping
With insight to your device portfolio, our team of consultants will design a Basic UDI-DI grouping approach for your device, IVD, or procedure pack.
Coordinate with UDI issuing agencies
We will help you work with UDI issuing agencies as well as review your UDI data to ensure it meets EUDAMED and MDR/IVDR formatting requirements.
Maintain UDI data and process
Our team will design a plan to maintain your UDI data long term as well as provide guidance for embedding UDI processes into your QMS, supply chain management, and more.
