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Italian CND nomenclature system selected for EUDAMED II
27 March 2019
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."
Commission releases MDR/IVDR corrigenda
22 March 2019
The eagerly-awaited corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been released by the European Commission.
To many in the industry, the revisions to the regulations will be disappointing, as they correct only typographic or other obvious errors in the original documents, without addressing any of the dozens of ambiguous requirements, which are already leading to different interpretations by manufacturers, notified bodies and competent authorities.
This result is despite the fact that the French competent authority ANSM published a report from a meeting with industry in which it went on the record saying that In addition to simple editorial corrections, it had been proposed to extend the transitional measures to Class I devices that newly require the use of a notified body or Class I devices that change class under the MDR, in order to avoid overloading NBs.
In the MDR corrigendum, there are 14 corrections, with some as simple as changing the word “trademark” to “trade mark” in Articles 2 and 7, or grammatical changes, while others, such as correction number 7, will mean that products of animal origins legally placed on the market prior to 26 May 2020 will not be allowed on the market after that transition date in such member states that previously allowed them.
The IVDR corrigendum, meanwhile, includes 17 corrections, with some minor tweaks that match the MDR changes, corrections of grammatical errors and others that may have more of an impact.