The Euro­pean Com­mis­sion issued an arti­cle that announces the expi­ra­tion of the EU-Switzer­land Mutu­al Recog­ni­tion Agree­ment (MRA). The arti­cle says:

“The Mutu­al Recog­ni­tion Agree­ment (MRA) is one of the key agree­ments between the EU and Switzer­land facil­i­tat­ing bilat­er­al trade in a num­ber of key sec­tors. It is essen­tial­ly a “sin­gle mar­ket access” and “dynam­ic align­ment” with EU rules agree­ment, two prin­ci­ples which are at the core of the Insti­tu­tion­al Frame­work Agree­ment in nego­ti­a­tion with Switzer­land since 2014.”

The Euro­pean Commission

Switzer­land has already aligned its reg­u­la­to­ry sys­tem to the new med­ical devices reg­u­la­tions (MDR and IVDR).  Nonethe­less, due to the cur­rent sit­u­a­tion, Switzer­land is treat­ed as a third coun­try. Swiss man­u­fac­tur­ers thus need an EU Autho­rised Rep­re­sen­ta­tive since May 26, 2021. Vice ver­sa, man­u­fac­tur­ers out­side Switzer­land who want to place their prod­ucts on the Swiss mar­ket, need a Switzer­land-based Autho­rised Rep­re­sen­ta­tive. 

Source: Euro­pean Commission

For fur­ther in depth infor­ma­tion on this sub­ject we rec­om­mend the fol­low­ing con­tent on our website