The Medical Devices Coordination Group (MDCG) has just published an explanatory note regarding code assignment under Regulation (EU) 2017/746.

The purpose of this note is to harmonize practices for Notified Bodies and to ensure that conformity assessments are performed by the appropriate expertise.

This document presents the different type of codes, their usage and examples of assignment.

 

DOWNLOAD MDCG 2021-14: EXPLANATORY NOTE ON IVDR CODES

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