The European Medical Device Nomenclature (EMDN) is the official and internationally recognised nomenclature for medical devices, as established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro medical devices (IVDR). It is a classification tool assigning codes to medical devices based on their typology and characteristics.
The EMDN builds on the Italian Classificazione Nazionale dei Dispositivi Medici (CND), a system previously used in Italy, Greece and Portugal for domestic devices’ registration and notification procedures. The EU nomenclature was developed in line with given guidelines, and a set of core principles, including that it must be regulator‑led, structured, freely available and accessible, and suitable for international use.
Regulatory role of EMDN codes: essential for EUDAMED registration
The EMDN nomenclature plays a central role for the functioning of the European database on medical devices (EUDAMED). Manufacturers must use the nomenclature for the registration of their medical devices in the database.
During the registration phase, each device Unique Device Identifier – Device Identifier (UDI-DI) is associated with an EMDN code: manufacturers are expected to assign the most specific code that accurately reflects the device’s functional and structural characteristics. An exception can apply only to devices intended for multiple purposes. In such cases, particularly for complex medical device systems that support a wide range of diagnostic or therapeutic functions, manufacturers can choose more than one code.
Beyond devices’ registration, this nomenclature supports notified body activities, as well as technical documentation drafting, and post-market surveillance and vigilance activities.
Structure of the EU nomenclature for medical devices
The nomenclature follows a hierarchical structure, allowing devices to be classified with increasing levels of specificity. The EMDN code structure is based on:
- Categories – identified by a letter. Each letter refers to a medical device category, while letter W and X respectively represent in vitro diagnostic devices and products subject to Annex XVI of the MDR.
- Groups – represented by a pair of numbers, defining the second hierarchical level.
- Types – represented by further series of pairs of numbers
Medical devices are distributed across 22 categories in total. These categories can be grouped into:
- 8 anatomical categories, covering devices used for specific apparatuses, anatomical regions or organs.
- 9 functional categories, covering devices characterised by similar use, intended use or clinical method.
- 5 special categories, including active implantable devices, implantable prostheses, software, and products without an indented medical purpose.
How to identify the correct EMDN code
The full nomenclature is freely accessible and can be consulted or downloaded via the EMDN proposals submission platform or the and EUDAMED registration platform.
Manufacturers can identify the appropriate EMDN code for their devices by applying either:
- a top‑down approach, navigating from the main category through groups and types based on the device’s characteristics; or
- a keyword‑based approach, searching keywords to identify the relevant code description.
Where no specific terminal code exists for a device, manufacturers may use the generic code identified by final number “99”. This code is available throughout the nomenclature and allows the device registration in EUDAMED.
Annual revision of the EMDN
The EMDN is subject to annual revision and update.
The revision process involves multiple actors, including the Medical Device Coordination Group Nomenclature Working Group (MDCG NOM WG), the EMDN Technical Team (TT), and a broad range of users such as authorised representatives, competent authorities, notified bodies, and manufacturers. The revision process is structured in four phases. The first phase concerns the collection of requests directly by users via the platform for EMDN requests, giving them the opportunity to submit proposals and inputs on EMDN terms and codes. The final three phases cover technical evaluations and final endorsement of proposals by the EMDN TT, the NOM WG, and the MDCG. EMDN codes are a cornerstone of the MDR and IVDR framework, enabling consistent device identification and supporting EUDAMED functioning. For manufacturers, correct EMDN assignment is a key element of compliance, transparency, and devices’ traceability across the EU.
Contact MDlaw Team for any questions on EMDN and how to correctly identify them.
References:
European Commission. (2024) EMDN codes. Retrieved on 20/03/2026.
European Commission. (2026). EUDAMED – Devices/Systems/Procedure packs. Retrieved on 20/03/2026.
European Commission. (2026). European Medical Device Nomenclature (EMDN). Retrieved on 20/03/2026.
MDCG. (2018). MDCG 2018-2 Future EU medical device nomenclature. Description of requirements. Retrieved on 20/03/2026.
MDCG. (2025). MDCG 2024‑2 – Procedures for the updates of the European Medical Device Nomenclature. Retrieved on 20/03/2026.
MedTech Europe. (2025). Practical guide to the use of the European Medical Device Nomenclature (EMDN). Retrieved on 20/03/2026.
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