Yes, we provide full support for UDI implementation and registration in compliance with EU MDR 2017/745 and IVDR 2017/746 requirements. Our team assists manufacturers in assigning and structuring UDI-DI and UDI-PI codes based on the device classification and intended use. We also help in ensuring proper placement of UDI on labeling, packaging, and Instructions for Use (IFU), as well as preparing for UDI module submission once it becomes fully functional within EUDAMED.

Our services cover:

  • UDI-DI and UDI-PI structure guidance

  • Compliance with GS1, HIBCC, or ICCBBA issuing agencies

  • UDI label and packaging review

  • Preparation for EUDAMED UDI/Device registration module

  • UDI-related documentation for your Technical File and CE submission

By integrating UDI properly, we help ensure device traceability, reduce market delays, and support full regulatory compliance across the EU.