Guidance Note on Integrating UDI into an Organization’s Quality Management System

The Medical Device Coordination Group has just published guidance note MDCG 2021-19 on integrating UDI -within an organization’s quality management system.

One of the manufacturer’s obligations referenced in Article 10 of Regulations (EU) 2017/745 and (EU) 2017/746 is the implementation of a unique device identification (UDI) system.  The objective of this identification system is to allow for better traceability of medical devices and the collection of any data from post-market surveillance. Device identification is to be applied throughout the life cycle of the device.

The purpose of MDCG 2021-19 is to provide guidance on the integration of the UDI system into the quality management system of organizations, including manufacturers. The guide discusses an implementation plan for the UDI system and mentions the QMS activities that may be affected by the implementation of this system: design and development, technical documentation, manufacturing, document management, etc.

This guide also indicates the requirements for the UDI system to be verified by notified bodies during quality management system audits.

For more information, see MDCG 2021-19 guidance note

DOWNLOAD MDCG 2021-19  GUIDANCE NOTE