This template delineates a systematic process for assigning and managing unique identifiers to devices. This document ensures compliance with regulatory requirements by accurately labeling products with standardized UDI codes, thereby enhancing traceability and facilitating post-market surveillance. Aligned with regulatory standards, this procedure outlines the steps for assigning and managing UDIs, ensuring consistency and accuracy in labeling practices. By following this documented process, manufacturers can streamline the identification and tracking of devices across the supply chain. The implementation of this procedure promotes patient safety and regulatory adherence within the EU market.
This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.
