European Union UDI Requirements
Utilize the HIBC Standard for European Labeling
The HIBC Supplier Labeling Standard has been used globally for over 30 years. The HIBC standard allows labelers to use the same barcode world-wide. HIBCC is working closely with regulatory bodies and labelers to ensure all HIBC UDIs meet the EU MDR requirements.
If you need to create a UDI, first apply for an LIC assignment by submitting an application online or offline. If your organization already has an LIC, you can create, calculate, and confirm UDIs with our new UDI-Builder. To contact HIBCC for more information on EU labeling requirements, email firstname.lastname@example.org .
European Union Medical Device Regulation (MDR) Labeling Requirements
The European Parliament adopted two new regulations, Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), on April 5th, 2017. The new regulations aim to improve tracking and trace-ability of medical devices, increase patient safety, and create a more transparent environment. The MDR requires all medical devices to bear a UDI.
European Union Useful Documents
- EU UDI FAQs
- European Union Legislation – Issuing Entity Designation
- European Union Medical Device Regulation
- Guiding Principles for Issuing Entities Rules on Basic UDI-DI
- Guidance on Application of UDI Rules to Device-Part of Products
- Draft Guidance on Basic UDI-DI and Changes to UDI-DI
- Future EU Medical Device Nomenclature
- Guidance on UDI Systems for Procedure Packs
- Definitions/Descriptions and Formats of the UDI Core Elements for Systems or Procedure Packs
- UDI Assignment to Medical Device Software
- Clarifications of UDI Related Responsibilities
- Provisional Considerations Regarding Language Issues Associates with the UDI Database
- Timelines for Registration of Deice Data Elements in EUDAMED