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  CEN-TR 17223 Open for Ballot

A draft CEN Technical Report, CEN/TR 17223, provides guidance on the relationship between EN ISO 13485:2016 and European MDR and IVDR. The draft guidance is open for voting.


The format is similar to the familiar Z Annexes used in harmonized standards. It lists requirements from applicable articles and annexes, identifies the corresponding reference from EN ISO 13485:2016, and provides information on whether or not the standard covers the regulation’s requirement.



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