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Italian medical device nomenclature to be adapted for Eudamed database

Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature.
  • CND codes will be mapped to Global Medical Device Nomenclature (GMDN) for ease of use.
  • Using CND nomenclature provides public access to medical device codes within Eudamed.

Authorities overseeing implementation of the European Database for Medical Devices (Eudamed) have decided to adapt medical device codes used by the Italian Ministry of Health for use as nomenclature for the database.

The Medical Device Coordination Group’s (MDCG) decision stems from requirements in the European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) that free nomenclature for devices be made available in Eudamed. Global Medical Device Nomenclature (GMDN), currently used worldwide as a nomenclature tool, requires membership fees for access.

To meet MDR and IVDR requirements, MDCG will map Italian CND (Classificazione Nazionale dei Dispositivi medici) codes to GMDN codes for ease of use by manufacturers and other entities utilizing Eudamed. The Italian coding system has been in use since 2007 to support that country’s device database; the CND system is up-to-date and used on a daily basis.

Learn more about European medical device regulations and Eudamed requirements:

  • European MDR gap assessment and transition strategy for medical device companies
  • On-site European MDR training for manufacturers
  • Webinar: Eudamed requirements under the European MDR and IVDR
  • Whitepaper: The role of Eudamed under the MDR and IVDR

 

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