GMDN Code & UDI
GMDN stands for “Global Medical Device Nomenclature.”
The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed descriptors used to identify medical device products. The GMDN Database lists all the terms, which are currently available to name and describe medical devices, although new terms are regularly issued to cope with new medical devices innovations. The GMDN is managed by the GMDN Agency. GMDN is composed of five digits, which is called GMDN code, term name, general name of the device, and its definition.
The GMDN Agency is not just an organization that regulates medical devices but provides information for the use of GMDN. By doing so, it provides better legal understanding of medical devices and to facilitate fast and accurate feedback.
GMDN Code and UDI
It is developed based on ISO 15225:2016 Medical devices – Quality Management – Medical device nomenclature data structure.
On December 2, 2003, the necessity of maintaining and implementing for European database on medical devices and the application of GMDN codes were consistently mentioned, so the European union countries have adopted GMDN code by the conclusion of committee on medical device.
Medical device regulators may specify the use of GMDN. The Conformity assessment for CE marking on medical devices may request the GMDN code applicable to the product in technical documentation.
In September 2013, the US FDA enacted the Unique Device Identification (UDI) Regulations to improve safety of patient and quality of the public health system. UDI is a system that uniquely identifies a medical device. It is introduced to accurately identify the distribution and use of medical devices in domestic, and to document the use of standardized medical devices on the Electronic Health Record (EHR).
US FDA UDI is required for every medical device by its Class. The Deadlines are as following :
- Class III – September 2, 2014
- Class II implants and life – supporting/life – sustaining devices – September 24, 2015
- Class II – September 24, 2016
- Class I – September 24, 2018
The UDI consists of three major components. Firstly, the unique identifier for each medical device, barcode allowing to read the identification code, and database where the information for each medical device is stored. The combination of three major components is called UDI system.
As the UDI regulation of US FDA is enacted, companies exporting medical devices to United states or commissioning medical devices distributed in United States should establish the UDI system.