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EU UDI Deadlines, Documents And Planning: What Does Industry Need To Know?

 
• By Amanda Maxwell

Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.

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The amount of work that still needs to be completed to implement a UDI system in Europe is "huge", according to Celine Bourguignon, head of quality, regulatory and clinical affairs, EMEA, at Cardinal Health Inc.

Implementation plan priorities for UDI were agreed in September 2018. Bourguignon spoke about the efforts and progress at the Association...

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