The GMDN Agency welcomes the recent announcement from the European Commission regarding its intention that the nomenclature used in the EU for naming and categorising medical devices will, in future, need to strongly align to the GMDN (https://ec.europa.eu/docsroom/documents/34264?locale=en).
The European Commission is the latest body recognising the GMDN as the standard nomenclature for regulation, with such countries as the USA, UK, Australia, Canada and Russia also making recent announcements of regulatory procedures requiring its use.
It is our understanding that in the future manufacturers will continue to be able to use the GMDN Code in the EUDAMED system.
Our ethos, shared by regulators, is that better patient outcomes come from the consistent and clear categorisation of medical devices, so that information can be collected, analysed and shared on a reliably consistent basis. This use of the GMDN by regulators also means that manufacturers can reach many more markets and healthcare providers by ensuring their products have GMDN codes.
Over 7,000 medical device manufacturers around the world subscribe to the GMDN, which is administered by the GMDN Agency: a not-for-profit charity that oversees the GMDN’s database and development. The GMDN is constantly evolving to reflect the latest innovations in medical devices and in 2018 created over 700 new and retired over 200 obsolete categories.