Reg­u­la­tion (EU) 2023/607 pro­vides for extend­ed tran­si­tion peri­ods for lega­cy devices until 2027 or 2028 under cer­tain con­di­tions, depend­ing on prod­uct clas­si­fi­ca­tion. The Swiss fed­er­al depart­ment of home affairs is deter­mined to incor­po­rate the EU Reg­u­la­tion, adopt­ed on 15 March, into Swiss law by amend­ing the Med­ical Devices Ordi­nance and the Ordi­nance in In Vit­ro Diag­nos­tic Med­ical Devices.

Switzer­land has kept equiv­a­len­cy of its med­ical devices in Switzer­land with that of the EU dur­ing the mutu­al recog­ni­tion agree­ment and also after the fail­ure to renew this agree­ment. The EU’s expand­ed tran­si­tion times for lega­cy med­ical devices and IVD med­ical devices, and the removal of the pre-imposed lega­cy prod­uct sell-off dead­lines (under both the MDR and IVDR) agreed to under the med­ical devices direc­tives, will be reflect­ed in Swiss leg­is­la­tion in autumn 2023 as per cur­rent sched­ule. In the mean­time, Switzer­land will per­mit devices that are cov­ered by a valid cer­tifi­cate accord­ing to the MDR and IVDR amend­ments to be placed on their mar­ket, so that there will be no imbal­ance in mar­ket sup­ply con­di­tions between the EU and Switzerland. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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