Under Article 26 of the MDR, the European Commission was tasked to make available an internationally recognised medical devices nomenclature that will be free of charge – among others – for manufacturers; and which will facilitate the functioning of EUDAMED.
Today, the European Commission informed of the progress and concluded that ”having due regard to the views provided by the MDCG, the CND nomenclature, to be mapped to the GMDN nomenclature, will be made available in the future Eudamed.”
”The correspondence between the nomenclatures will be visible to operators and incorporated in the future database. This will allow all operators registering their device to find CND nomenclature equivalent to a GMDN code. To the purpose of providing better regulatory oversight over the EU nomenclature system, a sub-group of the Medical Device Coordination Group (MDCG) will be soon established.”
The Commission also informed that the governance and operational functioning of the system will be provided in the next months.
Subscribe to MDlaw.eu and stay updated with the most recent and relevant MDR/IVDR news.