European Union Medical Device Regulation (EU MDR) Labeling

About EU MDR

Organizations distributing medical devices throughout the EU must comply with the EU MDR regulation established in May 2017.

The EU MDR is designed to ensure public health and patient safety across Europe and to increase quality and transparency of medical devices in the healthcare supply chain through label design, label approval, and label tracking standardization.

As a result, all medical device labels, with the exception of custom-made and performance study/investigational devices, will need to bear a Unique Device Identifier (UDI), which includes a Device Identifier (DI), Product Identifier (PI) and Human Readable Information (HRI). Medical device manufacturers and distributors across Europe must adhere to EU MDR labeling standards.

Compliance with EU MDR includes:

• The manufacturer needs to correctly submit the UDI information to the EUDAMED (European Database on Medical Devices) and maintain all UDIs for its devices
• The UDI needs to be on the label of the device or on its packaging, or in the case of reusable devices, on the device itself (direct marking)
• Various universal symbols can be implemented on medical device labels depending on where the device is made available to alleviate language translation to the 24 official European languages

EU MDR LABEL SAMPLE