MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature (EMDN)

The MDCG 2021-12 Rev.1 document, updated in January 2025, offers a set of guidelines and clarifications on the European Medical Device Nomenclature (EMDN). This set of rules is essential to support compliance with the European Union Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR), establishing how medical devices should be identified and registered in the EUDAMED database.

The EMDN is a structured nomenclature that groups medical devices into seven levels. Each alphanumeric code assigned to devices follows a well-defined logic, allowing for precise categorization that facilitates post-market surveillance, data analysis and technical documentation. The latest revision of the document reinforces the crucial role of the EMDN, ensuring that everyone involved in the process - from manufacturers to regulatory authorities and even patients - can consult clear and concise information about the medical devices available on the market.

In addition, the FAQ clarifies fundamental points about assigning EMDN codes to devices, the use of multiple codes on devices with different purposes and the annual nomenclature review process. The aim is to ensure transparency, accessibility and availability of data, promoting better management and use of the nomenclature by all the players involved.

For manufacturers, it is important to note that the implementation of changes to the EMDN, such as the obsolescence of codes or the creation of new ones, must be reflected in the registration of devices in EUDAMED and in the corresponding regulatory documentation. The annual update of the EMDN can affect companies' device portfolios, and it is crucial to keep track of these changes to ensure ongoing compliance.

To consult the full document and gain an in-depth understanding of the updates and guidelines provided, access the available PDF.