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News & Views_April, 2019 - CND code


CND code

The MDR requires the Commission to select a medical device code for the grouping of medical devices. 

Article 26 - Medical devices nomenclature

"To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable."

And the winner is… The Italian CND code Classificazione Nazionale Dispositivi Medici! Here you can find the official announcement document by the MDCG and here the link to an English translation.
Even though it was a surprise, MDSS being familiar with national registration understood that the Italian code system was selected, since it is well maintained and quite sophisticated.  Does this mean the GMDN is not useful any longer?  It is stated that the CND will be aligned with the GMDN code. As of today, Australia mandates the GMDN code, but may follow the CND when they align their law with the EU regulation in order to maintain the very successful Mutual Recognition Agreement (MRA) with the EU.  Other regions in the world also do not follow the GMDN code system (Asian countries follow the UMDNS code system) and therefore, it will be interesting to see what may happen with the GMDN.

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