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.

With the publication of the preliminary SIUD manual, Anvisa has begun the official implementation of the Unique Identification of Medical Devices (UDI) system in Brazil. This system, provided for in RDC 591/2021, obliges manufacturers and legal representatives to register the UDI-DI code in the system, ensuring greater traceability and transparency in the Brazilian market. Separate submissions are required per model, with mandatory fields such as GMDN codes and technical data for the device.

The Swiss Federal Council recently approved a series of amendments to national legislation on medical devices, with a focus on strengthening patient safety, traceability through UDI and partial alignment with the European MDR Regulation. This legislative update aims to guarantee the continued safety and quality of medical devices marketed in Switzerland, even in the absence of an up-to-date Mutual Recognition Agreement with the European Union.

Anvisa has opened Public Consultation No. 1,313/2025 to receive suggestions on the Normative Instruction that regulates the transmission and management of the UDI Brasil database, as provided for in RDC No. 591/2021. The regulation will detail the technical and operational criteria for data transmission, making it essential for companies in the sector to be prepared for the future obligation.