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.
The Representative of choice for
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.
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.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
