MDCG 2025-1 introduces an ad hoc procedure form to facilitate the updating of the European Medical Device Nomenclature (EMDN). This document is crucial for manufacturers, national competent authorities (NCAs) and notified bodies (NBs) that need to register devices in the UDI-DI module of EUDAMED. The new approach allows proposals for new codes to be submitted when existing ones are insufficient, promoting the registration of innovative technologies and regulatory compliance. This initiative by the Medical Device Coordination Group (MDCG) contributes to standardisation and clarity in the medical device sector in the European Union.

MDCG 2021-12 Rev.1 FAQ provides a detailed explanation of the European Medical Device Nomenclature (EMDN), which is an essential resource for ensuring the compliance of medical devices and IVDs in the context of the European Union's MDR and IVDR regulations. With the January 2025 revision, this document guides manufacturers on how to correctly assign EMDN codes to their devices in EUDAMED. In addition, it clarifies aspects of the hierarchical structure of the nomenclature, the use of alphanumeric codes, and the annual nomenclature update process.

MDCG 2024-2 Rev.1 ushers in a new era for the European Medical Device Nomenclature (EMDN), establishing dynamic procedures that ensure innovation, safety, and efficiency in the medical device sector. This revision, aligned with the MDR and IVDR regulations, introduces annual updates and ad-hoc requests to meet rapid technological changes and growing market demands. With a focus on collaboration between stakeholders, the update reinforces trust between manufacturers, healthcare professionals and patients, ensuring that device classification is accurate, relevant and safe.