There is con­tin­u­ing doubt about the out­come of the Insti­tu­tion­al Agree­ment (Ins­tA) Switzer­land nego­ti­at­ed with the EU. Hence, the advice from Switzerland’s Medtech indus­try asso­ci­a­tion is to begin con­sid­er­ing prepar­ing to meet third-coun­try require­ments with regards to mar­ket­ing prod­ucts in the EU. 

It is unclear if Switzerland’s Fed­er­al Coun­cil will rat­i­fy last year’s Ins­tA with the EU so there is no guar­an­tee that Swiss com­pa­nies will be able to mar­ket their prod­ucts under the EU Reg­u­la­tion 2017/745 on med­ical devices (MDR) when it takes effect next year. 

The absence of an MRA means that man­u­fac­tur­ers will have to employ an Autho­rised Rep­re­sen­ta­tive resid­ing in the EU.

The mutu­al recog­ni­tion agree­ment (MRA) that is present between Switzer­land and the EU has to be updat­ed to con­tin­ue bar­ri­er-free access to the EU sin­gle mar­ket. But it appears that the MRA can only be updat­ed if the Fed­er­al Coun­cil gives its back­ing to the Ins­tA dur­ing 2019. If this does not occur, man­u­fac­tur­ers will have to employ an Autho­rised Rep­re­sen­ta­tive resid­ing in the EU who will assume the manufacturer’s respon­si­bil­i­ties, includ­ing lia­bil­i­ty, as a rep­re­sen­ta­tive. They would also have to mod­i­fy their prod­uct labels accord­ing­ly. This could take a con­sid­er­able amount of time depend­ing on the scope and intri­ca­cy of the prod­uct range. 

Fur­ther­more, Swiss Medtech warns that com­pa­nies should be informed about aspects that could affect the tran­si­tion­al pro­vi­sions of the MDR. Excep­tions to the MDR could apply if Brex­it occurs and there is a Europe-wide sup­ply holdup or if there are not suf­fi­cient Noti­fied Bod­ies to cer­ti­fy prod­ucts before the end of the tran­si­tion­al peri­od ends in May 2020. 

Source: Medtech Insight (an Infor­ma product)