Swissmedic Publishes Version 2.0 of the swissdamed UDI Data Dictionary
Swissmedic has published Version 2.0 of the swissdamed UDI Data Dictionary, introducing new data elements and clarifying requirements for the registration and management of UDI information for medical devices in Switzerland.
Swissmedic Publishes User Guide for the swissdamed UDI Devices Module
Swissmedic has published Version 3.0 of the swissdamed User Guide – UDI Devices Module, introducing new functionalities for device registration and management, including Machine-to-Machine (M2M) processes, manual UDI-DI management and Master UDI-DI requirements.
Swissmedic Publishes swissdamed Business Rules Version 4.0
Swissmedic has published swissdamed Business Rules Version 4.0, introducing new Master UDI-DI requirements, UDI registration rules, and data management obligations for medical device manufacturers in Switzerland.
European Commission Publishes Updated EUDAMED UDI Devices User Guide
The European Commission released version 2.27.0 of the EUDAMED UDI Devices User Guide, clarifying UDI registration, EMDN management, packaging levels, and lifecycle updates under MDR and IVDR.
Swissmedic Updates swissdamed Actors User Guide: What Manufacturers and Authorised Representatives Should Know
Swissmedic has updated the swissdamed Actors User Guide (v2.0), introducing AGOV login migration updates, mandate transfer functionality, and clarified actor management requirements for medical device manufacturers and authorised representatives in Switzerland.
ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026
ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.
EUDAMED version 2.15.0: New features and corrections to the European database of medical devices
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.
EUDAMED User Guide for Legacy Devices - Essential Tool for Compliance with European Regulations
The new EUDAMED guide for legacy devices is an essential tool for medical device manufacturers who continue to operate under the previous MDD and AIMDD directives, but want to remain compliant during the transition period to Regulation (EU) 2017/745 (MDR). The document covers the assignment of EUDAMED DI and EUDAMED ID codes, the structured registration of legacy devices, the management of certificates and linking to already registered regulated devices. With practical guidelines and examples of accepted formats, this guide contributes to strengthening the traceability, compliance and regulatory security of legacy devices still on the European market.