Update on the con­se­quen­ces of Brexit for the medi­cal devices industry

The United King­dom with­drew from the EU on 31 Janu­ary 2020, the fourth offi­ci­al with­dra­wal date. The drea­ded “Brexit” has now come to pass. The par­ties were able to avo­id a “hard” or “no-deal Brexit” for the time being: the With­dra­wal Agree­ment con­cluded bet­ween the EU and the United King­dom arran­ges the legal rela­ti­onships bet­ween the par­ties through the end of an 11-month tran­si­tio­nal peri­od expi­ring on 31 Decem­ber 2020. 

This peri­od may be exten­ded once by up to two years, i.e. through 31 Decem­ber 2022 at the latest. During this tran­si­tio­nal peri­od, the­re will be no radi­cal chan­ges for the medi­cal devices indus­try, as the United King­dom will con­ti­nue to be trea­ted as an EU mem­ber sta­te until the peri­od expi­res. This means that EU law will con­ti­nue to app­ly and the United King­dom will con­ti­nue to have all the rights and duties of a mem­ber state.

Howe­ver, it must be stres­sed that the With­dra­wal Agree­ment con­ta­ins pro­vi­si­ons about free move­ment of goods which are of signi­fi­can­ce for the medi­cal devices indus­try as well. For exam­p­le, the Agree­ment defi­nes pro­ce­du­res for the exch­an­ge of infor­ma­ti­on bet­ween noti­fied bodies in the EU and the United King­dom, which are refer­red to in the Agree­ment as “con­for­mi­ty assess­ment bodies.” This term is used not just for the limi­t­ed num­ber of estab­lished noti­fied bodies for medi­cal devices, but rather appli­es in a gene­ral man­ner to insti­tu­ti­ons which are aut­ho­ri­zed to con­duct con­for­mi­ty assess­ment pro­ce­du­res under EU law.

Ano­ther aspect of importance for manu­fac­tu­r­ers is that the With­dra­wal Agree­ment express­ly gua­ran­tees that devices which were lawful­ly pla­ced on the mar­ket pri­or to expi­ra­ti­on of the tran­si­tio­nal peri­od will be allo­wed to remain on the mar­ket even after the tran­si­tio­nal peri­od is over. This means that manu­fac­tu­r­ers and dis­tri­bu­tors of medi­cal devices can con­ti­nue to mar­ket and sell their medi­cal devices in both the EU and UK markets.

The impact which Brexit will have after the tran­si­tio­nal peri­od expi­res is still unclear. All we have so far is the “Poli­ti­cal Decla­ra­ti­on,” which con­ta­ins a rough sketch of the con­di­ti­ons for future coöpe­ra­ti­on bet­ween the EU and the United King­dom. This Decla­ra­ti­on allows for the cau­tious con­clu­si­on that the par­ties will keep regu­la­ted indus­tries like the medi­cal devices indus­try in mind and nego­tia­te the­se mat­ters exten­si­ve­ly in future agreements.

But if no via­ble agree­ment is rea­ched by the time the tran­si­tio­nal peri­od expi­res and the “no-deal Brexit” sce­na­rio ree­mer­ges ins­tead, the United King­dom would have to be trea­ted as a third coun­try, which could have a nega­ti­ve impact on the medi­cal devices indus­try, e.g. with respect to the vali­di­ty of exis­ting CE certificates.

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