Supply chain software EU MDR

safetydesignmanagement

Easily create and print EU MDR-compliant labels CODESOFT for EU MDR label creation Health Industry Barcode (HIBC) and GS1 Databar barcode creation Easy-to-use wizards Create user rights and enable label security controls TEKLYNX CENTRAL CFR for Label Management Pull label elements from a centralized database for EU MDR-compliant labels Automate labeling process with central management to ensure process enforcement and additional control 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)