Release 3.22 of the EUDAMED UDI/Devices User Guide provides updated guidance on MDR and IVDR device registration, UDI requirements, EMDN codes and lifecycle management for manufacturers.

The new EUDAMED Guide to the Registration of Legacy Medical Devices provides detailed and practical instructions for manufacturers operating under the MDD or AIMDD directives. The transition to MDR requires legacy devices to be identified with EUDAMED DI and EUDAMED ID, even in the absence of a UDI-DI. This registration in the EUDAMED database is essential to ensure regulatory compliance and maintain the placement of devices on the European market.

A atualização da EUDAMED versão 2.15.0 introduz melhorias relevantes para o registo de dispositivos médicos e IVD, incluindo a gestão de UDI-DI, funcionalidades para Master UDI-DI em lentes de contacto, e novas opções de pesquisa no portal público. Esta versão corrige mais de 50 erros reportados pelos utilizadores, reforçando a fiabilidade da base de dados europeia de dispositivos médicos. Para os fabricantes, mandatários e importadores, é essencial rever os dados submetidos e preparar os processos internos para assegurar a conformidade com o MDR e IVDR.

The new EUDAMED user guide for Unique Identifier (UDI) devices is an indispensable reference for all medical device manufacturers who want to ensure compliance with the MDR and IVDR regulations. The document covers aspects such as registering Basic UDI-DI and UDI-DI, managing data in EUDAMED, connecting to legacy devices, and updating versions. It also includes crucial information on requirements for accessing the EUDAMED platform, user profiles, and the procedures for structured data submission. This guide is essential for ensuring an effective compliance strategy in the European regulatory context.

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.