eIFU

On August 20, 2025 the Swiss reg­u­la­to­ry author­i­ty, Swissmedic, announced that it adopts the EU require­ments (EU) 2025/1234 for the elec­tron­ic pro­vi­sion of instruc­tions for use for med­ical devices with imme­di­ate effect. 

Switzer­land thus fol­lows its pre­vi­ous pol­i­cy to keep its reg­u­la­to­ry sys­tem adapt­ed to the EU.

Device reg­is­tra­tion

Swissmedic’s swiss­damed is the nation­al data­base for reg­is­ter­ing eco­nom­ic oper­a­tors and med­ical devices (includ­ing IVDs) mar­ket­ed in Switzer­land — a pub­lic search por­tal designed to increase trans­paren­cy for health­care pro­fes­sion­als and the public.

Key struc­ture and scope
• Two mod­ules: Actors (reg­is­tra­tion of eco­nom­ic oper­a­tors; live since Aug 2024) and UDI Devices (device reg­is­tra­tion rolled out in stages; vol­un­tary from Aug 2025).
• swiss­damed is aligned with EUDAMED mod­ules to min­imise dupli­cate effort, but there is no auto­mat­ic inter­face — man­u­fac­tur­ers and autho­rised rep­re­sen­ta­tives must active­ly upload data. 

Crit­i­cal dates & oblig­a­tions
• Manda­to­ry reg­is­tra­tion for devices/systems placed on the Swiss mar­ket begins 1 July 2026, with a tran­si­tion­al win­dow until 31 Dec 2026; devices sub­ject to seri­ous-inci­dent report­ing or field safe­ty cor­rec­tive actions require imme­di­ate reg­is­tra­tion from 1 July 2026. 

Prac­ti­cal impli­ca­tions for medtech teams
• Imme­di­ate­ly reg­is­ter your organ­i­sa­tion in the Actors mod­ule (if not done).
• Pre­pare UDI data and device mas­ter records in the for­mats accept­ed (an EUDAMED-com­pat­i­ble XML ‘GET/POST DEVICE’ upload is cur­rent­ly sup­port­ed).
• Review Swissmedic’s user guides, quick guides, and privacy/terms doc­u­ments to align process­es and work­flows before the manda­to­ry date.

Source: Swissmedic

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website