GMDN Codes Explained According to the GMDN Agency, GMDN codes are used to assign each medical dev

GMDN Codes Explained

According to the GMDN Agency, GMDN codes are used to assign each medical device or IVD with “… a single naming system that will support patient safety. Information in the form of a code is provided to indicate the generic descriptor within which the device can be identified, by reference to a globally accepted generic medical device nomenclature (the GMDN) so that other particular devices having substantially similar generic features but coming from another source can be identified, for reasons of data exchange between competent authorities and others, exchange of post-market vigilance information and inventory purposes.”

In addition, as defined by the GMDN Agency, preferred terms are those that “describe devices having the same or similar intended use or commonality of technology [and are] the only terms by which medical devices can be classified.”

Interestingly, as a result of the implications of Eudamed on IVD manufacturers, there is an increasing demand for new and translated preferred terms for IVDs. Currently, the GMDN terms cover mostly medical devices. It will be interesting to follow the growth of the GMDN Agency’s published terms, which is now expanding to include IVDs. Access to the GMDN terms is available to GMDN members. There are fees associated with membership, though reduced fees are available for smaller manufacturers (which are those who have less than 1 million euros in annual sales).

The Global Harmonization Task Force advocates the use of GMDN throughout the European Union; interestingly, the origin of GMDN was sponsored by the European Commission in response to the standard EN ISO 15224. GMDN codes and terms are used internationally, and industry officials hope that the GMDN will become the nomenclature scheme adopted by countries worldwide.