Renew­al of the Swiss–EU Mutu­al Recog­ni­tion Agree­ment (MRA) for med­ical devices is back in focus after polit­i­cal lead­ers in March signed the remain­ing com­po­nents of a relat­ed agree­ment pack­age. For med­ical device man­u­fac­tur­ers, the mes­sage is cau­tious­ly pos­i­tive: align­ment is mov­ing again, but a full update of the devices chap­ter is unlike­ly to take effect for sev­er­al years.

What happened—and why it matters

Talks over the past months have aimed to make Switzer­land less of an EU “third coun­try” and more of a seam­less trad­ing part­ner in select­ed areas. That mat­ters to Swiss med­ical device com­pa­nies: the EU remains the industry’s largest export mar­ket, and the cur­rent sit­u­a­tion adds fric­tion for com­pa­nies on both sides of the bor­der. The chal­lenge dates back to May 2021, when Switzer­land declined to sign the insti­tu­tion­al frame­work agree­ment. In the same month, the EU’s Med­ical Devices Reg­u­la­tion (MDR) took effect and the Swiss–EU MRA chap­ter on med­ical devices was not updated. 

The long road to an updat­ed devices MRA

Despite the improved tone, renew­ing the devices MRA remains a mul­ti-step process. The agree­ment must pass par­lia­men­tary cham­bers before going to a pub­lic ref­er­en­dum. Cur­rent expec­ta­tions point to no pub­lic vote before sum­mer 2028, with par­lia­men­tary debate on the pack­age antic­i­pat­ed in 2027.

Process risk

The ref­er­en­dum may bun­dle mul­ti­ple pol­i­cy areas (e.g., ener­gy, research, uni­ver­si­ties and mar­ket access) into one vote, or split them into sev­er­al votes by polit­i­cal sen­si­tiv­i­ty. For med­ical device indus­try, the key con­cern is risk attri­bu­tion: if a bun­dled pack­age were reject­ed, Switzer­land typ­i­cal­ly does not vote twice on the same sub­ject, mak­ing a “no” out­come hard to reverse.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website