European Medical Device Nomenclature (EMDN): A Key to EU Compliance
European Medical Device Nomenclature (EMDN): A Key to EU Compliance
The European Medical Device Nomenclature (EMDN) plays a pivotal role in the regulatory landscape of medical devices within the European Union. This comprehensive system is crucial for manufacturers who are navigating the complexities of EU regulations and aiming to register their products in the EUDAMED database. Let's dive into what the EMDN is, its regulatory roots, and why it matters to medical device stakeholders.
What is the EMDN?
The EMDN is the official nomenclature used by medical device manufacturers to register their devices with the European database on medical devices (EUDAMED). As outlined in Article 26 of the Medical Device Regulation (MDR) 2017/745 and Article 23 of the In Vitro Diagnostic Regulation (IVDR) 2017/746, it supports the functionality of EUDAMED, which is integral to compliance with these regulations. The nomenclature ensures that devices are properly classified, aiding in their regulation and oversight throughout the EU.
Origins and Development
Developed based on the ‘Classificazione Nazionale Dispositivi medici’ (CND), used by Italy, Greece, and Portugal, the EMDN was chosen by the European Commission following guidance from the Medical Device Coordination Group (MDCG). This adoption provided a robust foundation for the EMDN, facilitating the inclusion of a wide range of medical devices in the regulatory framework.
Structure and Accessibility
The EMDN is structured in a hierarchical system, simplifying medical device categorisation into various groups and types. This structure is alphanumeric and spans seven levels, allowing for precise and granular device classification. Best of all, the EMDN is freely accessible to all stakeholders, including manufacturers, healthcare providers, and the general public, ensuring transparency and widespread usability. The entire nomenclature can be accessed and downloaded in PDF and Excel formats from the EUDAMED public site.
Recent Updates to the EMDN
To keep the industry stakeholders well-informed and compliant, recent documents have been published detailing procedures and frequently asked questions regarding the EMDN:
- MDCG 2021-12 Rev.1 – FAQ on the European Medical Device Nomenclature (EMDN), providing insights and clarifications for users of the nomenclature. Read more.
- MDCG 2025-1 details the EMDN Ad hoc procedure form, which is essential for urgent updates to the nomenclature outside of the regular update cycle. Read more.
- MDCG 2024-2 Rev.1 – Outlines the procedures for regular updates of the EMDN, ensuring its continuous alignment with the evolving medical device sector. Read more.
These resources are invaluable for keeping abreast of the latest methodologies and procedural changes in managing medical device registrations within the EU.
How Med-Di-Dia Can Help
At Med-Di-Dia, our experts and specialists are dedicated to supporting manufacturers with the complexities of EMDN compliance and broader regulatory requirements. Our team is here to assist if you're navigating the registration process or need detailed guidance on complying with the latest EU regulations.
Reach out to us via email at mdd@mddltd.com or fill out our contact form to get the support you need.
