Since 1991 Medical Device experts from around the world (regulators, healthcare providers and manufacturers) have worked together to create the Global Medical Device Nomenclature (GMDN). This work was requested by the inter-governmental body, the Global Harmonisation Task Force (GHTF) to help accelerate international medical device regulatory harmonization and convergence. The GHTF has now been superseded by the IMDRF (see www.imdrf.org).
GMDN terms & codes are a system of internationally agreed descriptors used to identify medical device products which will meet a global need for identification purposes.
The GMDN Agency, who are based in the UK, were the preferred choice for the MDR/IVDR. However, once Brexit had been decided, the EU changed course and adopted the Italian CND system with revisions and named it the European Medical Device Nomenclature (EMDN).
Crucially, EMDN codes are available free of charge [Click Here]
An EMDN code is now required for every medical device in the EU.
As a manufacturer you will need to include this important information with the device description section of your technical file, and it must be displayed on your declaration of conformity.
