The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system within the Quality Management System (QMS) of a manufacturer, an economic operator or a person assuming the obligations of the manufacturer according to Article 16(1) MDR/IVDR and Article 22(4) MDR.
Firstly, the MDCG highlights that the UDI and Basic UDI-DI assignment, and management of the UDI-related information, can impact many other lifecycle QMS processes (MDCG, 2021) and advises the manufacturer to generate a UDI implementation plan (elements listed below)
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