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 starting May 2020.
Compliance with EU MDR includes:
Learn how to use the GS1 barcode wizard in CODESOFT and LABELVIEW to create GS1 compliant barcodes.
Tell us a little about your company and we will be in touch to discuss your EU MDR labeling needs.
© Copyright 2023 TEKLYNX CORPORATION SAS. All Rights Reserved.