The GMDN (Global Medical Device Nomenclature) Agency, is an international non-profit organisation which has been appointed by its stakeholders, Medical Device Regulators and Industry, to manage the GMDN database and maintain the nomenclature.
The Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other Healthcare related products, mostly under the scope and definition of the MDD 93/42/EEC.
More and more, the GMDN is considered as the leading nomenclature and is being requested by the various industry players and authorities, such as at the time of MDD Class I Pre-Market Notifications or National Device Registration (such as in Italy or Portugal).
A GMDN code can only be a 5 digit code - The database contains over 20,000 defined terms for medical devices.
There are 3 types of term that the database contains:
- Preferred Terms (P terms) – used for identifying devices for regulatory purposes.
- Template Terms (T terms) – collections of terms, used for finding P terms.
- Synonym Terms (S terms) – historic or common names of devices, used for finding P terms.
Obelis is a licensed consultant for the GMDN agency.
If you are not familiar with your GMDN codes, Obelis can assist you finding the correct GMDN code for your device.