The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici’(CND) as the basis for the EMDN.
Since its initial release in 2021, the EMDN has undergone annual updates through a public consultation process via the EMDN submission platform, in accordance with the procedures described in MDCG 2024-2 rev.1.
Every EMDN release is identified by its year of publication (e.g., v.2024, v.2025). The latest version currently integrated into EUDAMED and in force can be consulted via the MDCG Guidance documentation or downloaded from the EMDN submissions page.
Access to the EMDN
The entirety of the EMDN is accessible to all stakeholders, free of charge. It can hence be utilised by a non-exhaustive list of stakeholders such as manufacturers, patients, research organisations, practitioners, hospitals, pharmacies etc.
The EMDN can be accessed and downloaded in excel format. Download EMDN (download full list)
SMEMDN project
The SMEMDN project (Supporting the maintenance of the European Medical Device Nomenclature), under the leadership of the Italian Ministry of the Health (beneficiary), with the collaboration of the Friuli Venezia Giulia Region (affiliated entity), builds on the experience gained from the past five years of EMDN implementation at European level and further enhance the activities carried out for the EMDN. In particular the aim is to support the:
- in the periodic update of the EMDN
- in the communication with Member States’ authorities and stakeholders regarding needs for information and clarification on the nomenclature
- in making available tools to support the use of the EMDN, including trainings
- in the support the Commission in its collaboration with the World Health Organisation
EMDN Helpdesk
The EMDN Helpdesk service is ready to respond to your request on the European Medical Device Nomenclature.
The service, which is part of the SMEMDN project co-funded by the European Commission, aims to provide users with information on the nomenclature structure (category/groups/types) as well as any useful information to enable manufacturers to choose the appropriate EMDN code(s) for their medical devices and in vitro diagnostic medical devices.
- To access the EMDN helpdesk platform, please consult the user manual.
- Technical malfunctions of the platform can be reported to the email address: SMEMDN
regione [dot] fvg [dot] it (SMEMDN[at]regione[dot]fvg[dot]it)
Trainings
The SMEMDN project foresees the development of three trainings on EMDN for regulators and stakeholders.
First training (2024)
The first training took place on 12 November 2024 and provided an overview on the EMDN, its update procedure, the relevant available support tools and good practices on EMDN submissions. The training materials are available, alongside the training recordings:
- Part I.1- SMEMDN Project Supporting the maintenance of the European Medical Device Nomenclature
- Part I.2 - Overview of EMDN Project
- Part I.3 - From the Italian CND classification to the European Medical Device Nomenclature (EMDN) principles and features
- Part I.4 - Informative support to the EMDN - web access, FAQ and Helpdesk platform
- Part II - How to choose the EMDN code examples of real usage of the nomenclature
- Part III.1 - Description of the procedure
- Part III.2 - Good & bad EMDN update requests how to submit a valid request
Videos
- Part I - Intro, Overview of EMDN Project, Basic principles (from CND2EMDN) and Important tools (guidance, helpdesk)
- Part II - How to choose the EMDN code and first Q&A Session
Second training (2025)
The second training provided an overview of the EMDN, its structure, the consultation process, and Annex XVI. It also covered the practical application of code selection and update requests, as well as perspectives from Competent Authorities, Notified Bodies, and industry. The session concluded with a Q&A and closing remarks.
- Part I.1 – The road to EMDN v2 development and publication
- Part I.2 – Key features of the EMDN structure and specific codes extension
- Part I.3 – Understanding, Consulting and Using EMDN
- Part I.4 – EMDN v2 focus on Annex XVI codes and terms
- Part II.1 – The choice of EMDN code examples of real usage of the nomenclature
- Part II.2 – Participating in EMDN updates how to submit a successful request
- Part III.1 – CA’s point of view on the use of MDs nomenclatures
- Part III.2 – Notified Body’s point of view on EMDN use for MD & IVD
- Part III.3 – Industry’s point of view on EMDN use
Videos
- Part I – Intro, road to EMDN v2, Structure, Consultation and Annex XVI, Q&A
- Part II – Practical Application Code Selection and Update Requests
- Part III – Perspectives from Competent Authorities, Notified Bodies, and Industry, Q&A and Closing Remarks
Third training (2026)
The third training provided an overview of the evolving role of the EMDN, with particular focus on its practical use throughout the device lifecycle. It covered the application of the nomenclature in regulatory activities, practical case studies on EMDN code assignment and annual updates, as well as perspectives from industry, Notified Bodies and regional authorities.
- Part I.1 - The role of nomenclature system in the national governance of medical devices
- Part I.2 - Navigating EMDN solving nomenclature assignments through HelpDesk case studies
- Part I.3 - Two years of field experience, best practices and lesson from the EMDN update cycle
- Part II.1 - EMDN update toolkit key resources and support documents
- Part II.2 - Escaping the 99 bucket
- Part II.3 - Usage of EMDN by PRRC
- Part III.1 - Consistent and aligned use of EMDN by manufacturers, from identification to management of changes
- Part III.2 - The Power of EMDN, Efficiency, Consistency and Certification
- Part III.3 - Medical device classification and data-driven governance, The Emilia-Romagna Regional Model
