Streamlining European Medical Device Nomenclature: MDCG 2024-2

Written By MDRG

·         Annual Revision: MDCG 2024-2 details the process for yearly updates to the European Medical Device Nomenclature (EMDN), crucial for regulatory clarity and market oversight.

·         Multi-Phase Approach: From collecting user requests to MDCG endorsement, the update process involves comprehensive phases to ensure the EMDN's relevance and accuracy.

·         Ad-Hoc Procedure: For urgent needs, a pilot ad-hoc procedure allows expedited review of new code requests, primarily available to competent authorities and notified bodies.

·         Inclusive Collaboration: Involvement from a wide range of stakeholders, including manufacturers, healthcare professionals, and patients, ensures the EMDN remains effective and user-centric.

 

🔗 Original: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf 

MDRG
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