Med­Tech indus­try: Spe­cial path of Ger­ma­ny and Switzerland!

MRA bet­ween EU and Switz­er­land: Does it con­ti­nue to app­ly or not?

Our last news on the MRA bet­ween the EU and Switz­er­land was enti­t­led: “Mutu­al Reco­gni­ti­on Agree­ment bet­ween Switz­er­land and the EU falls through.”

In the mean­ti­me, the­re is dis­agree­ment among pro­mi­nent play­ers in the Swiss med­tech indus­try about the legal­ly valid ces­sa­ti­on of the old agree­ment. In addi­ti­on, indus­try repre­sen­ta­ti­ves on both the Ger­man and Swiss sides have spo­ken out in favour of coö­pe­ra­ti­on that the EU Com­mis­si­on does not envisage.

Who says what?

First, the­re seems to be agree­ment that the Mutu­al Reco­gni­ti­on Agree­ment (MRA) bet­ween EU mem­ber sta­tes and Switz­er­land has not been updated. As a result, the Swiss medi­cal tech­no­lo­gy indus­try lost access – also accord­ing to the view held by reu­sch­law – to a sta­te that was put on an equal foo­ting with the EU mem­ber sta­tes when the EU Medi­cal Tech­no­lo­gy Regu­la­ti­on (MDR) came into for­ce. Switz­er­land beca­me a “third coun­try” with all the atten­dant adver­se con­se­quen­ces for eco­no­mic actors in the EU and Switz­er­land.

The Swiss Federal Office of Public Health (FOPH) and the Swiss regu­la­to­ry aut­ho­ri­ty Swiss­me­dic still take the posi­ti­on that the old MRA is not lon­ger app­li­ca­ble becau­se no update has been made.

The Swiss Federal Coun­cil takes the oppo­si­te view. In its view, the old MRA con­ti­nues to app­ly even though it has not been updated. An ans­wer of the Federal Coun­cil of 13 Decem­ber 2021 to a ques­ti­on sub­mit­ted to the Natio­nal Coun­cil reads ver­ba­tim as fol­lows: “The Mutu­al Reco­gni­ti­on Agree­ment (MRA) con­ti­nues to app­ly”.

The view of the Swiss Federal Coun­cil is shared in par­ti­cu­lar by the Swiss indus­try asso­cia­ti­on Swiss Med­Tech, which on the one hand had con­sist­ent­ly vehe­ment­ly advo­ca­ted the updating of the MRA and on the other hand per­sist­ent­ly empha­sis­ed the mul­ti­tu­de of con­se­quen­ces asso­cia­ted with the “third coun­try sta­tus” for eco­no­mic actors. A legal opi­ni­on com­mis­sio­ned by Swiss Med­Tech comes to the con­clu­si­on – as does the Swiss Federal Coun­cil – that the old MRA is still valid and app­li­ca­ble. “It was neit­her ter­mi­na­ted nor sus­pen­ded by means of noti­fi­ca­ti­on”. The expert opi­ni­on can be acces­sed via the Swiss Med­Tech home­page.

Bila­te­ral coö­pe­ra­ti­on bet­ween Switz­er­land and Germany?

In a press release dated 26 May 2021 the EU Com­mis­si­on infor­med that fol­lowing the fail­u­re of nego­tia­ti­ons to update the old MRA bet­ween the EU and Switz­er­land, “mutu­al reco­gni­ti­on and rela­ted tra­de faci­li­ta­ti­on for medi­cal devices bet­ween the EU and Switz­er­land will no lon­ger app­ly as of 26 May. This is rela­ted to the new Medi­cal Devices Regu­la­ti­on, which comes into for­ce in the EU on the same day”.

The pro­po­sal to pro­vi­de for a limi­ted amend­ment to the Mutu­al Reco­gni­ti­on Agree­ment as a pre­cau­tio­na­ry mea­su­re to allow a tran­si­ti­on peri­od for exis­ting Swiss cer­ti­fi­ca­tes of con­for­mi­ty until (at most) 26 May 2024, during which time exis­ting cer­ti­fi­ca­tes issued in the EU would also remain valid, was not imple­men­ted until 26 May 2021. As a result, the EU Com­mis­si­on con­clu­ded, among other things, that exis­ting cer­ti­fi­ca­tes (so-called “SQS cer­ti­fi­ca­tes”) issued by a noti­fied body domic­i­led in Switz­er­land would no lon­ger be reco­gnis­ed by the EU.

As sta­ted abo­ve, the Swiss indus­try asso­cia­ti­on Swiss Med­Tech (as well as the Swiss Federal Coun­cil) is of the opi­ni­on that the old MRA is still valid and should be app­lied. But then the EU Com­mis­si­on vio­la­tes the app­li­ca­ble law with regard to exis­ting SQS cer­ti­fi­ca­tes: Assuming the vali­di­ty of the MRA, the exis­ting cer­ti­fi­ca­tes are to be reco­gnis­ed regard­less of the date of app­li­ca­ti­on of the MDR in the EU mem­ber states.

Swiss MedTech’s posi­ti­on is sup­por­ted among others by renow­ned Ger­man indus­try repre­sen­ta­ti­ves, first and fore­mo­st BVMed. Accord­ing to Swiss Med­Tech, BVMed has con­ta­c­ted the AG MP (Medi­cal Devices Working Group of the Supre­me Sta­te Health Aut­ho­ri­ties). The board of the ZLG is con­cer­ned with pro­blems of the enfor­ce­ment of medi­cal device law and here in par­ti­cu­lar with the coör­di­na­ti­on of the coö­pe­ra­ti­on of the coun­tries. Accord­ing to the assess­ment of the Working Group, the SQS cer­ti­fi­ca­ti­ons of the Swiss bodies still noti­fied in accordance with Direc­ti­ves 90/385/EEC and 93/42/EEC (PDF) con­ti­nue to be valid until the dead­lines set out in Arti­cle 120(2) MDR. This means that Swiss manu­fac­tu­rers may con­ti­nue to sell their MDD pro­ducts with SQS cer­ti­fi­ca­tes in Ger­ma­ny. Howe­ver, an EC REP must be appoin­ted for the­se pro­ducts as a prerequisite.

Thus, it seems clear (for the time being) that “spe­cial con­di­ti­ons” app­ly to the coö­pe­ra­ti­on bet­ween Switz­er­land and Ger­ma­ny. One con­se­quence of this is that this excep­ti­on can­not auto­ma­ti­cal­ly app­ly to the other EU mem­ber sta­tes, which con­tra­dicts the idea of har­mo­ni­sa­ti­on and the princi­ples of the free inter­nal mar­ket per se. It remains to be seen what result the Euro­pean Court of Jus­ti­ce, which has alrea­dy dealt with the ques­ti­on of the con­ti­nued vali­di­ty of SQS cer­ti­fi­ca­tes in all mem­ber sta­tes, will come to.

Recom­men­da­ti­on for action

Based on a fail­u­re of the MRA, reuschlaw’s recom­men­da­ti­on for action to dis­tri­bu­tors of medi­cal devices manu­fac­tu­red in Switz­er­land was to be awa­re that they could (unin­ten­tio­nal­ly) beco­me importers and would have to com­ply with the legal obli­ga­ti­ons of importers of medi­cal devices. Con­ver­se­ly, Euro­pean manu­fac­tu­rers of medi­cal devices and dis­tri­bu­tors with sales acti­vi­ties in Switz­er­land were advi­sed to seek and man­da­te a Swiss Rep wit­hin the app­li­ca­ble desi­gna­ti­on peri­od. This is still a pos­si­ble option.

On the other hand, eco­no­mic actors are in qui­te pro­mi­nent com­pa­ny with the Swiss Federal Coun­cil, Swiss Med­Tech and a sup­ple­men­ta­ry legal opi­ni­on when they take the posi­ti­on that the old MRA still app­lies and hence the known legal frame­work con­ti­nues to app­ly to the coö­pe­ra­ti­on of Swiss com­pa­nies and eco­no­mic actors of EU mem­ber states.

To end in the words of Swiss Med­Tech: “Each com­pa­ny must exami­ne [pen­ding the ECJ’s decisi­on] for its­elf the extent to which it takes into account the offi­cial posi­ti­on of the Federal Coun­cil as well as the avail­ab­le legal opi­ni­ons in its busi­ness decisions”.

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