Global Medical Devices Nomenclature (GMDN) is an integral part of the MHRA MD and IVD Registration procedure; without valid GMDN codes the registration of an MD or IVD is not possible. While tracing specific medical devices without UDI codes becomes much more difficult both in the EU and UK.
But what are GMDN and UDI codes exactly? What is their exact function? How do they fit in the MD/IVD ecosystem, especially in the UK, and what value do they bring?
GMDN codes
Global Medical Devices Nomenclature (GMDN) is a set of terms that names and groups all medical devices, MDs and IVDs. The code and responsible agency stemmed from the requirement of the Global Harmonisation Task Force (GHTF), and now by the International Medical Device Regulators Forum, to speed up the regulatory harmonization of medical devices. The GMDN codes are in a five-digit numeric form accompanied by a GMDN Term Name, and a short GMDN Definition with additional information.
- In this manner, it becomes easy to classify medical devices in general terms and focus on their characteristics (e.g. sterile/non-sterile, single-use/reusable etc.). Finally, provide a “common language” in the MD/IVD environment that all relevant actors can understand and assist in Post Market Activities and Surveillance.
- To register an MD/IVD to the MHRA valid GMDN codes are mandatory to continue the procedure. The US authorities also require valid GMDN codes. The EU has developed its counterpart, the European Medical Device Nomenclature (EMDN), that is used on EUDAMED.
UDI codes
Unique Device Identification codes are defined in the UK as “a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market” (MHRA, 2022), and in the EU as “a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability” (European Commission, 2022).
In simple terms, UDI codes are unique codes that are traceable to a single MD/IVD and the manufacturer’s identity. They comprise two parts,
- the UDI Device Identifier (UDI-DI), which is specific to a manufacturer and a device model
- the UDI Production Identifier (UDI-PI), which identifies the MD unit of production and the packaged medical devices – if applicable.
There are four recognized UDI Issuing Entities currently in the EU: GSI, HIBCC, ICCBBA, and IFA and UK expressed the intention to designate those same entities. UDIs are not mandatory on MHRA portal at this stage, however it is very likely that UDI assignment will become needed in the future.
GMDN and UDI, what is the connection?
To summarize, GMDN and UDI codes are complementary to each other. GMDN codes provide a generic overview of MDs/IVDs, with their generally agreed upon characteristics and definitions. UDI codes are capable of detecting specific devices and their manufacturers. In conjunction, a valid GMDN and UDI code can very quickly provide a large amount of useful information to any relevant actors and ensure quick responses in Post Market Activities and in general health safety.
Obelis UK consultants use both GMDN and UDI codes as part of the Registration and Modification of Registration to the MHRA of Medical Devices services that Obelis UK provides. Additionally, Obelis UK provides a GMDN code research service to clients, in order to ensure their GMDN codes are valid but also representative of the device they wish to notify.
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Nikolaos Chatzistavrou
RA Department
11/10/2022
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References:
- GMDN Agency (2022). What is UDI?. Retrieved on 11/10/2022.
- GMDN Agency. The role of the GMDN Agency – GMDN Agency. Retrieved on 11/10/2022.
- GMDN Agency. What is GMDN? – GMDN Agency. Retrieved on 11/10/2022.
- European Commission. (2022). European Medical Device Nomenclature (EMDN) (europa.eu). Retrieved on 11/10/2022.
- European Commission. (2022). Unique Device Identifier – UDI (europa.eu). Retrieved on 11/10/2022.
- UK (2022). Chapter 4: Registration and UDI – GOV.UK (www.gov.uk). Retrieved on 11/10/2022.
- MHRA (2022). Government response to consultation on the future regulation of medical devices in the United Kingdom (publishing.service.gov.uk). Retrieved on 11/10/2022.
The information contained on Obelis UK is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.