Update: Mutu­al Reco­gni­ti­on Agree­ment bet­ween Switz­er­land and the EU falls through

The agree­ment bet­ween the EU and Switz­er­land on mutu­al reco­gni­ti­on in rela­ti­on to con­for­mi­ty assess­ment and on rem­oval of bar­riers to trade in the state-regulated sec­tor (the Mutu­al Reco­gni­ti­on Agree­ment, or MRA) has not been updated.

This will have serious con­se­quen­ces for the medi­cal device indus­try: in the absence of an updated MRA, the rules gover­ning the deve­lo­p­ment, manu­fac­tu­re and dis­tri­bu­ti­on of medi­cal devices are no lon­ger the same in EU mem­ber sta­tes and Switz­er­land ever sin­ce the EU Medi­cal Device Regu­la­ti­on (MDR) took effect on 26 May 2021. Swiss medi­cal device manu­fac­tu­r­ers fall under the rules for third count­ries from the view­point of EU mem­ber sta­tes, so that Swiss-made medi­cal devices will have to be “impor­ted” into the EU in the future, and the sta­tu­to­ry requi­re­ments for importers will app­ly in accordance with Artic­le 14 of the MDR. Swiss manu­fac­tu­r­ers will have to appoint an aut­ho­ri­zed repre­sen­ta­ti­ve in order to dis­tri­bu­te their pro­ducts in the EU. This EU aut­ho­ri­zed repre­sen­ta­ti­ve must have available  a com­pe­tent per­son with the neces­sa­ry exper­ti­se in EU medi­cal device law. Moreo­ver, the impor­ted pro­ducts must be label­led as requi­red in the MDR. Medi­cal devices which are appro­ved by the Swiss con­for­mi­ty assess­ment body will requi­re addi­tio­nal test­ing and appr­oval befo­re they can be impor­ted into the Euro­pean market.

The appli­ca­ble sta­tu­te in Switz­er­land as of 26 May 2021 is the Medi­cal Devices Ordi­nan­ce (Med­DO). EU manu­fac­tu­r­ers (still) plan­ning to dis­tri­bu­te their pro­ducts in Switz­er­land will requi­re an aut­ho­ri­zed repre­sen­ta­ti­ve in Switz­er­land (or CH-REP). In accordance with Artic­le 104a of the Med­DO, Swiss Reps must be appoin­ted by a cer­tain dead­line, depen­ding on the pro­duct: for manu­fac­tu­r­ers of Class III devices, implan­ta­ble Class IIb devices and acti­ve implan­ta­ble medi­cal devices, the appoint­ment has to be made by 31 Decem­ber 2021. For manu­fac­tu­r­ers of non-implantable Class IIb devices and Class IIa devices, the appoint­ment dead­line is 31 March 2022, and manu­fac­tu­r­ers of Class I devices have to appoint a Swiss Rep by 31 July 2022.

Swiss Reps and Swiss-based importers are requi­red to regis­ter with the Swiss Agen­cy for The­ra­peu­tic Pro­ducts, Swiss­me­dic. After their state­ments are che­cked, appli­cants recei­ve a uni­que Swiss ID num­ber (CHRN = Swiss Sin­gle Regis­tra­ti­on Num­ber). This regis­tra­ti­on must be com­ple­ted within three months after the pro­duct is first pla­ced on the mar­ket in Switz­er­land. Manu­fac­tu­r­ers or their Swiss Reps and importers which have pla­ced their pro­ducts on the mar­ket in Switz­er­land pri­or to 26 May 2021 are requi­red to regis­ter with Swiss­me­dic by 26 Novem­ber 2021 in accordance with Artic­le 104b of the MedDO.

Regis­tra­ti­on of the actu­al medi­cal devices impor­ted into Switz­er­land is not plan­ned until later.

Tur­key, on the other hand, is no lon­ger con­side­red to be a third coun­try with regard to the MDR as of 25 May 2021, sin­ce the EU has exten­ded its cus­toms uni­on with Tur­key to include medi­cal devices. At the same time, Tur­key has adopted the pro­vi­si­ons of the MDR into its natio­nal law, so that manu­fac­tu­r­ers of medi­cal devices and importers enga­ged in export­ing medi­cal devices to or from Tur­key will not be requi­red to meet any requi­re­ments other than tho­se of the MDR.


Under the­se new con­di­ti­ons, Euro­pean dis­tri­bu­tors of medi­cal devices which are manu­fac­tu­red in Switz­er­land may beco­me importers (against their will) and will the­r­e­fo­re have to adhe­re to the legal requi­re­ments for importers of medi­cal devices. Euro­pean manu­fac­tu­r­ers of medi­cal devices which dis­tri­bu­te their pro­ducts in Switz­er­land should make sure to find and man­da­te a Swiss Rep befo­re the appli­ca­ble appoint­ment dead­line. At the same time, Swiss medi­cal device manu­fac­tu­r­ers are requi­red to have an EU aut­ho­ri­zed repre­sen­ta­ti­ve as of 26 May 2021 inso­far as they dis­tri­bu­te their pro­ducts in the EU.


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