Medical Devices Existing Nomenclatures: EMDN, GMDN, UMDNS, CND
A nomenclature for medical devices (MD) means a specific coding and naming system which aims to facilitate the classification and identification of all medical devices on the market. Unfortunately, the goal to establish a standardized system on a global level, to enhance MD management and communication without barriers is far from being reached. Many have tried to implement a harmonized system; however, this has only resulted in countless abbreviations and confusing codes for various purposes.
There are countries which don’t have any nomenclature system and base their MD regulatory procedures, procurement, customs operations, stock keeping and maintenance on their nationally established system (or none).
Do you know how many different nomenclature systems exist? I’ll give you some examples: GMDN, UMDNS, CND, GPC, SNOMED CT, EMDN, MCN, UNSPSC, ICD… and many more (not even counting the nationally developed systems).
Índice de contenidos
Index of contents
Index du contenu
- For god’s sake, let’s clarify this nomenclature mess!
- Universal Medical Device Nomenclature System (UMDNS)
- Global Medical Device Nomenclature (GMDN)
- Classificazione Nazionale dei Dispositivi Medici CND
- European Medical Device Nomenclature (EMDN)
Here is an overview of the most common nomenclature systems. The co-existence of different nomenclatures makes achieving universal health coverage more difficult.
The Universal Medical Device Nomenclature System, follows, as the name implies, a universal approach and was developed by the nongovernmental and not-for-profit organization Emergency Care Research Institute (ECRI).
- Poly-hierarchical system
- Five-digit codes for names
- Codes associated with definition and description of intended use
All users need to purchase a subscription to see hierarchy, structure and relationships between terms. Many users may need to purchase other ECRI products to have full access to different license types. In contrast to the GMDN system, the UMDNS is not officially required by any jurisdiction worldwide, but it is often used to base or adapt nationally developed nomenclatures (i. e. like Israel, Iran or Iraq).
For a long time, the Global Medical Device Nomenclature seemed to be a possible solution for the universal utility of nomenclature systems. The GMDN was developed by the European Committee for Standardization and medical device experts and is managed by the GMDN Agency.
- Poly-hierarchical system
- Product ID by unique five-digit numbers and associated term
- Definition with intended purpose(s)
- Device categories
This not-for-profit company, generates revenues by GMDN-code sales in order to maintain continuous data updates. This means that the GMDN nomenclature is not free for manufacturers and other consultants and, furthermore, requires subscription.
In Australia, the GMDN system is imposed by law, however, other countries use mixed or combined systems. For example, in France the GMDN system is used for procurement and commercialization, while the new EMDN will be implemented for purposes like regulation, registration or surveillance. Other countries like Poland incorporated the GMDN in their legislation, but also allow the use of other nomenclatures, which will be the additional implementation of the EMDN when available.
The CND was developed by the Italian authorities. The GMDN code was the mandatory registration key in Italy before, but due to user difficulty and unavailability, the GMDN has been removed by the request of MD manufacturers. In consequence the CND was created by mapping the two nomenclature systems since 2007, and therefore, facilitating access and use.
In the light of the MDR and IVDR regulation, the EU has decided to adopt the Italian CND system as base to develop the new European Medical Nomenclature (EMDN) to be used for MD registration and regulation in EUDAMED. In 2020 the European Commission and the Italian Technical Committee announced the updated input and full alignment of GMDN in CND. This is a milestone and a challenge for all 27 European countries.
The European Union has set new requirements for a common nomenclature system in accordance with the Article 26 of Regulation 2917/745 on medical devices (MDR) and Article 23 of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). The goal is to support the European database on medical devices (EUDAMED) and is used for regulatory purposes in the 27 EU Member States in order to meet all new established requirements.
- Seven-level hierarchy
- Alphanumeric structure
- Three main levels for MD: Category, Groups, Types
As mentioned before, the EMDN will be implemented by all 27 EU countries, which makes up 14% of the world’s countries.
- International recognition
The EMDN nomenclature will be free of charge, and terms, descriptions as well as codes will be fully accessible for every user.
Factsheet EMDN, European Commission 05/25/2021, states:
“No manufacturer or natural/legal person should be subject to a fee or suffer from any discrimination, compared to other operators, in relation to the use of the nomenclature.”
EMDN codes will be mandatory as well as including the EMDN-information in the MD’S technical file and declaration of conformity. As you can see, EMDN terminology is crucial for registering and selling your medical device in the European Union. That’s why you should always choose translation providers who are up to date and are able to provide quality translation procedures specialized in medical devices.
As presented in this blog, there are numerous nomenclatures used all over the world for a variety of purposes. However, the EU’s approach brings us one step closer to harmonizing the regulatory framework and achieving universal health coverage faster. Half of the world has not implemented any nomenclature system yet, but following the EMDN principles, I am sure that there will soon be many more countries adopting it into their legislature. Standardization is important and speaking the same language when it comes to medical devices is essential to globally strengthen our health systems.
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Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.