Switzer­land is mak­ing sig­nif­i­cant strides in its efforts to align its med­ical device indus­try with Euro­pean reg­u­la­tions. The country’s Mutu­al Recog­ni­tion Agree­ment (MRA) with the Euro­pean Union is back on track fol­low­ing a major trade deal reached on Decem­ber 20, last year. This agree­ment, which facil­i­tates the recog­ni­tion of med­ical device cer­ti­fi­ca­tions between Switzer­land and the EU, had been inac­tive since May 2021 due to stalled negotiations. 

Swiss and EU author­i­ties have held near­ly 200 meet­ings since March 2024, lead­ing to a nego­ti­at­ing man­date from both the Swiss pres­i­dent and the Euro­pean Com­mis­sion pres­i­dent. The for­mal sign­ing of the updat­ed MRA is expect­ed in spring 2025, fol­lowed by a nation­al con­sul­ta­tion and poten­tial par­lia­men­tary review in 2026. How­ev­er, the final approval process may face addi­tion­al hur­dles, as a ref­er­en­dum deci­sion is still under con­sid­er­a­tion by Switzerland’s fed­er­al council.

At the same time, Swiss med­ical tech­nol­o­gy sec­tor is also advo­cat­ing for reg­u­la­to­ry improve­ments with­in the EU. Along­side MedTech Europe and oth­er indus­try groups, Switzer­land is push­ing for reforms to MDR and IVDR that would make com­pli­ance more prac­ti­cal while main­tain­ing patient safe­ty. This push has gained momen­tum, and there is hope that a review of the EU’s med­ical devices reg­u­la­tions could take place in 2025 instead of the orig­i­nal­ly sched­uled 2027. 

In addi­tion to strength­en­ing ties with the EU, Switzer­land is mov­ing for­ward with a plan to allow US FDA-approved med­ical devices to enter its mar­ket. By ear­ly 2025, Swiss author­i­ties will sub­mit a for­mal pro­pos­al to the fed­er­al coun­cil, seek­ing approval for this reg­u­la­to­ry shift. If approved, the Fed­er­al Office of Pub­lic Health will draft new reg­u­la­tions, allow­ing Switzer­land to accept both EU- and US-approved med­ical devices. This ini­tia­tive is part­ly dri­ven by dis­sat­is­fac­tion with the com­plex­i­ty and inef­fi­cien­cies of MDR and IVDR and aims to ensure con­tin­ued access to high-qual­i­ty med­ical products.

The Swiss med­ical tech­nol­o­gy sec­tor hopes that this dual approach—renewing the MRA with the EU while inte­grat­ing FDA-approved devices—will encour­age EU reg­u­la­tors to reassess and refine MDR and IVDR reg­u­la­tions. By tak­ing these proac­tive steps, Switzer­land is posi­tion­ing itself as a key play­er in shap­ing the future of med­ical device reg­u­la­tion, ensur­ing that patients and health­care providers con­tin­ue to have access to inno­v­a­tive and safe med­ical technologies.

Source: Medtech Insight (an Infor­ma product)

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