UK PMS Requirements: Statutory Instrument (SI) 2024/1368 Published and Effective Mid-2025
26 December 2024
December “In All Other News”: Revised MDCG Docs, Team NB Guide on MDR Certification Stages & more
3 January 2025The update from Swissmedic is available: HERE
Background
Swissdamed is made up of two modules (Actors & Devices) and is being released in phases.
The swissdamed Actor registration module went live 6 August 2024, and its use is now mandatory. Only Swiss-based economic operators have access to register in the Actor module, i.e., if you are a non-Swiss based manufacturer, your Swiss Authorized Representative must enter your company details into swissdamed on your behalf.
Swissdamed was developed because of the lapsed Mutual Recognition Agreement between Europe and Switzerland. As a result, Swissmedic no longer has Competent Authority access to EUDAMED and developed its own equivalent to EUDAMED.
Overview
Registration in the Devices module will become mandatory as of 1 July 2026, followed by a 6-month transition period. By 31 December 2026, all devices and systems/procedure packs must be registered in swissdamed.
In the meantime, sections of the Devices module will be available for voluntary use in 2025.
