GMDN and EMDN codes research
To safeguard patients’ safety and allow easier exchange of device information, medical devices are grouped in sets of terms, or nomenclature. In the European Union and worldwide, the two most used nomenclatures are the GMDN and the EMDN. GMDN stands for Global Medical Device Nomenclature, while EMDN stands for European Medical Device Nomenclature. Each term corresponds to a code. Therefore, these sets of terms are usually referred to as EMDN and GMDN codes.
Who needs GMDN and EMDN?
Medical devices manufacturers need to research and assign the correct codes to their devices. In the European Union, the manufacturer needs EMDN codes, whereas GMDN codes are recognized worldwide. Both codes support data exchange between manufacturers, regulators, and authorities, the exchange of post-market vigilance information, and supply chain management.
GMDN and EMDN issuing entities
The GMDN Agency is responsible for the GMDN codes. Against fees, users can access the database and purchase the codes which better describe their devices.
The Medical Devices and IVD Medical Devices Regulations (MDR and IVDR) have introduced EUDAMED, an EU database to increase devices’ traceability. To support EUDAMED functionality, the EU implemented the EMDN codes, which are freely available on the European Commission website.
If you want to sell in the EU, having EMDN codes is an essential step towards MDR and IVDR compliance. Both for your EUDAMED device registration as well as pre-market notification to the EU Competent Authorities until EUDAMED is not fully functional. Obelis can research GMDN and EMDN codes and help manufacturers select the most appropriate description and corresponding code for your device.
Are you looking for support to find the correct GMDN and EMDN codes? Contact us!