# Medical Device Codes: EMDN, UMDNS, GMDN and MDR Author: Sven Piechottka Published: 2025-04-25 Updated: 2025-04-25 Source: https://openregulatory.com/articles/medical-device-codes-emdn-umdns-gmdn-and-mdr --- Once you embark on your regulatory journey towards CE certification, you will inevitably come across the strange land of medical device codes. It's not software code, but literally coded categories of medical devices, ostensibly created by regulatory people to further confuse anyone who is not part of their tribe. In this article, I will try to explain which codes are relevant for you and why.  Short summary: what you need to do • Nomenclature codes are used to define groups of medical devices. • As a manufacturer, you typically need to specify your device's code when filing a Notified Body application, when registering the device in a medical device database or when reporting a device incident to authorities. • For EU manufacturers strictly confined to the EU market, it might be sufficient to use the EMDN system only. Internationally, the GMDN system is most widely adopted. Don't use UMDNS codes, they're outdated. MDR codes are only relevant for your EU Notified Body. Long story: UMDNS, EMDN, GMDN ... wth? Once upon a time, people grew increasingly overwhelmed with the variety of medical devices out there. Several attempts where made to categorize medical devices into similar groups, leading to multiple coexisting systems of naming and categorizing. As of now, we're still using multiple systems at the same time for different purposes, as no single system as been established as the de facto standard for every country worldwide. Great job, people! (At some point, the WHO even published a comparative analysis of the available systems. You can find the file here. They also hosted a webinar on the topic in 2024.) So, in a nutshell, all of these abbreviations stand for medical device nomenclature systems. Let's look into the most commonly used systems and why they might be relevant for you. Universal Medical Device Nomenclature System (UMDNS) The UMDNS system is the oldest attempt to come up with a harmonized nomenclature system for medical devices, developed by the U.S. Emergency Care Research Institute (ECRI) in the 1970s. If you look at their taxonomy of devices, then the list doesn't seem to follow any systematic approach and it doesn't provide any hierarchy of groups, which makes it harder to browse the list. And as if that wasn't enough, the latest available versions can be used free of charge only for non-commercial purposes. In other words: the UMDNS system sucks, and this system is only relevant if you're a German manufacturer ... because we're nostalgic people who like to keep old systems around as long as possible. The German medical device database (DMIDS) requires users to enter an UMDNS or EMDN code if they want to register your device for market entry. German manufacturers can access a free version 1.1 of the UMDNS list from 1996 and 1998 (!) on the website of the German BfArM agency. [Example-of-UMDNS-v.1.0-in-German-948x1024.png] Global Medical Device Nomenclature (GMDN) In 1992, regulators from the U.S., Europe, Canada, Japan and Australia founded the Global Harmonization Task Force (GHTF) with the aim of achieving better harmonization between the medical device regulatory systems. These guys also came up with their own nomenclature system, which was later formally defined as part of the ISO 15225:2000 standard. Today, the GMDN system is maintained and continuously updated by its own non-profit GMDN agency. While most people use GMDN codes for free as part of the basic membership, you still have to create an account and membership plan to use it, and manufacturers have to purchase a several-hundred-dollars annual subscription to use all of its functionalities. It's fair to say that GMDN codes present one of the most modern and most well-adopted nomenclature systems worldwide. You could even say, it's more universal than the UMDNS ... chuckle. The GMDN taxonomy is structured in hierarchical groups, and the European Commission decided to align their EMDN system closely with the GMDNS. So, in case you decide to market your device also outside of Europe in international markets, I would strongly recommend to come up with a GMDNS code for your device. And by the way, they also provide user manuals for different user groups on their website. [GMDN-database-search-for-software-1024x501.png] European Medical Device Nomenclature (EMDN) Some national health authorities also came up with their own systems, because ... why not? In the early 2000s, Italy replaced the previously mandatory GMDNS with its own classification, the CND codes ('Classificazione Nazionale Dispositivi Medici'). At least, their work wasn't for nothing: CND codes were later selected as the basis for the European Union's harmonized EMDN system. For those who are weirdly fascinated by EMDN history: the MDCG 2018-2 stated general requirements for the future EMDN system, and MDCG 2019-3 decided to use CND as its starting base. MDCG 2021-12 published an FAQ on the topic and finally, MDCG 2024-2 is the latest relevant publication, describing procedures for future updates to the EMDN system. The EMDN system will be, according to the MDCG, updated annually and follows a thorough alphanumerical structure. It established seven hierarchical levels and clusters devices into categories, groups and types. [EMDN-seven-hierarchical-levels-of-medical-devices-1024x635.png] [EMDN-alphanumerical-code-structure-1024x361.png] If you are a manufacturer that intends to sell products only in the EU, then EMDN codes might be the only nomenclature system that is relevant for you. There are two main use cases: your product's EMDN code will be required when you register the device in the European medical device database Eudamed before market entry. And the code will be also relevant when handling the reporting of serious incidents. EMDN codes can be accessed and used free of charge on the respective European Commission's website. MDR Codes But the European Union wouldn't be the European Union as we know her, if they had defined only one (relatively) straightforward system that can be accessed and browsed online, free of charge. Too easy! That's why the EU also came up with MDR codes. These codes also refer to groups of medical devices, but different! In a simplified way, these are the code categories: • MDA codes for active devices • MDA codes for non-active devices • MDS codes for devices with specific characteristics • MDT codes for devices for which specific technologies or processes are used Explaining the details of each of the medical device codes would be a whole article of its own, so if you want to learn more about that, read MDCG 2019-14 or the original text of the EU's implementing decision 2017/2185. What you need to know in the context of this article is that, different from the EMDN system, MDR codes serve primarily for Notified Body activities. MDCG 2019-14 says: "These codes are primarily used by designating authorities to define the notified body scope of designation (...)". In other words, Notified Bodies must demonstrate appropriate qualification of each of their staff members to handle certain categories of devices. That's why you will be likely asked for your medical device codes as part of filing an initial application with a Notified Body. Example: Software devices Let's look at some examples for software devices in those nomenclature systems. And let's start with the MDR codes, just because they're the weird exception from the rest. For software, I would generally assume that you can use the following MDR codes: • MDA: 0315 (software) • MDN: not applicable since active device • MDS: 1009 (software) • MDT: not applicable UMDNS codes - as mentioned before - are quirky. There's no "software" in their database, instead, they use the term "information system". Relevant examples might be: • 17-222: information system • 18-118: information system, cardiology • 17-175: information system, radiology  Finally, the GMDN defines various software terms, for example "multidisciplinary medical image management software" (60724). The EMDN database also offers various options such as  Z11030292 for mammography medical device software, Z11030692 for CT medical device software or Z11050192 for MRI medical device software. [Example-of-EMDN-codes-for-software-1024x628.png]