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.

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.