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MDCG Guidance on UDI Integration -European Comission

Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how the UDI can be integrated within a medical device organisation’s quality management system in order to meet requirements of the Medical Device Regulation (MDR) and InVitro Diagnostics Regulation (IVDR).

What is a Unique Device Identification (UDI) System?

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.

The present guidance is intended to provide additional clarifications regarding the approach to be applied when implementing the UDI system and responsibilities associated thereto as part of a Quality Management System (QMS) employed by an organization.

The scope of the guidance covers all the parties involved in operations with medical devices, including medical device manufacturers and their authorized representatives, as well as distributors and importers.


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