Switzerland’s reg­u­la­to­ry sys­tem remains aligned with EU stan­dards. How­ev­er, since the mutu­al recog­ni­tion agree­ment between Switzer­land and the EU expired in 2021, non-Swiss man­u­fac­tur­ers must now appoint a Switzer­land-based Autho­rized Rep­re­sen­ta­tive to mar­ket prod­ucts in Switzerland.

Sim­i­lar­ly, Swiss man­u­fac­tur­ers need an EU-based Autho­rized Rep­re­sen­ta­tive to sell their prod­ucts with­in the EU or EEA.

mdi Europa is here to sup­port your reg­u­la­to­ry needs in this evolv­ing land­scape. As a proud mem­ber of the reg­u­lan­et® net­work – a glob­al alliance of qual­i­fied inde­pen­dent con­sul­tan­cies spe­cial­iz­ing in devel­op­ment, reg­u­la­to­ry affairs, mar­ket access, and life­cy­cle man­age­ment – mdi Europa offers com­pre­hen­sive exper­tise. Our reg­u­lan­et® affil­i­a­tion enables us to con­nect you with trust­ed part­ners who can serve as your Swiss Autho­rized Rep­re­sen­ta­tive, pro­vid­ing you with tar­get­ed reg­u­la­to­ry support.

For more infor­ma­tion or assis­tance, please feel free to con­tact us.