swissmedic recent­ly announced that the Swiss med­ical device data­base, swiss­damed, is now expect­ed to be avail­able in the sec­ond half of 2024. The data­base will com­prise a mod­ule for actor reg­is­tra­tion (ACT) and a mod­ule for device reg­is­tra­tions (UDI). The UDI mod­ule is sched­uled to go live four months after the go live of the ACT module. 

The mutu­al recog­ni­tion agree­ment (MRA) between the EU and Switzer­land end­ed for med­ical devices May 26, 2021 or for in vit­ro diag­nos­tic med­ical devices May 26, 2022 respec­tive­ly. Since then, although Switzerland’s reg­u­la­to­ry sys­tem is aligned with the EU, Switzer­land is con­sid­ered a third coun­try from the per­spec­tive of the EU and vice ver­sa. One of the con­se­quences is that man­u­fac­tur­ers from Switzer­land need a Euro­pean Autho­rised Rep­re­sen­ta­tive. Man­u­fac­tur­ers out­side Switzer­land in turn need to engage a Swiss Autho­rised Rep­re­sen­ta­tive before plac­ing their devices on the mar­ket there.

swiss­damed will be a devel­oped as anoth­er con­se­quence – due to the expired MRA, Switzer­land may not access data pro­vid­ed to EUDAMED.

In the mean­time, promis­ing news have been pub­lished by the Euro­pean Com­mis­sion in anoth­er recent press release. The release states nego­ti­a­tions between the Com­mis­sion and Switzer­land start­ed on March 19 com­pris­ing sev­er­al aims. One of the goals is to “relaunch […] nego­ti­a­tions towards agree­ments on elec­tric­i­ty, food safe­ty and health”. Time­lines were not pro­vid­ed but it is hoped that the EU and Switzer­land find a time­ly way back to an inte­grat­ed market. 

Should you require addi­tion­al infor­ma­tion or details, please don’t hes­i­tate to get in touch. 

Source: swissmedic, Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website