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Italian CND nomenclature system selected for EUDAMED II

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Medical Devices Coordination Group (MDCG) has apparently agreed, at its 14-15 February 2019 meeting, to endorse the Italian ‘Classificazione Nazionale Dispositivi Medici’ (CND) nomenclature system for use with the EUDAMED II medical device centralised database, to support operation of the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746).

That this decision might be taken was reported in this News column on 8 March, following rumours emanating from the MDCG meeting, but it is still a surprise that the Global Medical Device Nomenclature (GMDN) system was not selected, as this system has been the nomenclature of choice for Europe and beyond for a number of years.

The main problem with selection of GMDN was the difficulty in meeting the requirement of MDR Article 26 (and the equivalent in the IVDR) that stated: “The Commission shall also endeavor to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable”. Users of the GMDN system have to pay fees to access their codes, whereas the Italian Ministry of Health is making the CND codes freely available.

The CND codes, which were established many years before GMDN, are already available in dual (Italian and English) language, and the “correspondence between the nomenclatures will be visible to operators and incorporated in the future [EUDAMED] database. This will allow all operators registering their device to find CND nomenclature equivalent to a GMDN code”, states MDCG.

MDCG adds that: “Any additional informational on the details related to the governance and operational functioning of the system will be provided in the course of the next few months.”

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