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.

Generate the HIBC Basic UDI-DI

The HIBC Basic UDI-DI enables manufacturers to connect and identify devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The Basic UDI-DI is required in the EU’s EUDAMED database and is referenced in relevant documentation (i.e. certificates and technical documentation).

Click Here to access the HIBC Basic UDI-DI Generator.

EU MDR and IVDR Useful Documents