Medical device CE marking

MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system


The Unique Device Identification (UDI) System should allow the identification of medical devices, facilitate appropriate traceability of medical devices, enhance the effectiveness of the post-market safety-related activities for devices, improve incident reporting, enhance targeting field safety corrective actions, lead to better surveillance, reduce medical errors, and help fight against falsified devices. As such the UDI system is intended to be incorporated into the life-cycle of the device.

Integration of UDI in the Quality Management System

Amongst the applicable MDR/IVDR provisions to be included in the QMS of the manufacturer is Article 10(9)(h)/Article 10(8)(h) ‘verification of the UDI assignments made in accordance with Article 27(3)/24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29/26’. When implementing the requirements of the MDR/IVDR related to the QMS, manufacturers should therefore consider how the UDI System and obligations can also be integrated.

The following sections are considered in this MDCG guidance document:

  • Design and Development
  • Product documentation and retention
  • Production and process
  • Serious incidents and field safety corrective actions
  • Purchasing controls
  • Documentation and records
  • Enterprise Resource Planning
  • UDI data to be provided to EUDAMED database

The document can be downloaded in our library

Source: European Commission – MDCG