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 Suite.

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