“Hard Brexit” and its impact on the medi­cal device industry

BREXIT has effects across indus­tries, affec­ting medi­cal device manu­fac­tu­r­ers, their dis­tri­bu­ti­on pos­si­bi­li­ties in Gre­at Bri­tain and the impor­ta­ti­on of medi­cal devices into the EU 27. The ans­wer to the ques­ti­on of what effects it will have on the medi­cal devices indus­try and to what degree will depend to a lar­ge ext­ent on whe­ther BREXIT will be “hard” or “soft”.

For the case of a “hard BREXIT”, the Bri­tish Medi­ci­nes and Health­ca­re pro­ducts Regu­la­to­ry Agen­cy (MHRA) has published new gui­de­lines for medi­cal devices that are to be mar­ke­ted in Gre­at Bri­tain (and Nor­t­hern Ire­land and the EU) as of 1 Janu­ary 2021. After a “hard BREXIT” wit­hout agree­ment, the United King­dom will be con­side­red as a third coun­try. This means that manu­fac­tu­r­ers of medi­cal devices based in the Gre­at Bri­tain will need to retain a Euro­pean Aut­ho­ri­sed Repre­sen­ta­ti­ve domic­i­led in the EU 27. This com­mis­sio­ning pro­cess can be time-consuming. In addi­ti­on, as of 1 Janu­ary 2021, the Noti­fied Bodies (still) based in Gre­at Bri­tain will no be lon­ger allo­wed to issue CE mar­kings. As of the date the MDR enters into force on 26 May 2021, co-operation with an MDR-accredited Noti­fied Body based in the EU 27 will be requi­red. Impor­ta­ti­on of pro­ducts into the EU 27 will fol­low the rules of impor­ta­ti­on from a third coun­try. Importers will be sub­ject to the obli­ga­ti­ons of importers under the MDR, which go bey­ond the obli­ga­ti­ons of mere distributors.

Con­ver­se­ly, howe­ver, this will also app­ly to the access of Bri­tish devices to the Euro­pean market.

Manu­fac­tu­r­ers based out­side the United King­dom must desi­gna­te a UK Respon­si­ble Per­son in con­nec­tion with the new regis­tra­ti­on requi­re­ments. Coöpe­ra­ti­on with a Bri­tish part­ner will thus be essen­ti­al for the mar­ke­ta­bi­li­ty of Euro­pean medi­cal devices in Gre­at Bri­tain in the future. A UK Respon­si­ble Per­son will need to have been appoin­ted by 1 Janu­ary 2021. A tran­si­tio­nal peri­od exists for regis­tra­ti­on at the MHRA that is ali­gned with the plan­ned time frame for regis­tra­ti­on of devices in the indi­vi­du­al risk clas­ses. The pri­ma­ry respon­si­bi­li­ty of UK Respon­si­ble Per­sons will con­sist pre­cis­e­ly in this regis­tra­ti­on of non-UK manu­fac­tu­r­ers and their devices. Fur­ther respon­si­bi­li­ties descri­bed in the gui­de­lines essen­ti­al­ly cor­re­spond to tho­se of MDR and IVDR Aut­ho­ri­sed Repre­sen­ta­ti­ves. Examp­les of such respon­si­bi­li­ties include ensu­ring the avai­la­bi­li­ty of decla­ra­ti­ons of con­for­mi­ty and tech­ni­cal docu­men­ta­ti­on, and the kee­ping of copies of the rele­vant docu­ments and cer­ti­fi­ca­tes. After the tran­si­tio­nal peri­od for the vali­di­ty of the CE mar­king in Gre­at Bri­tain (end: 30 June 2023), a UK Con­for­mi­ty Asses­sed (UKCA) mar­king will also be requi­red for devices. Howe­ver, if a device is in com­pli­ance with both EU legis­la­ti­on and the new Bri­tish legis­la­ti­on, it will likely also be accep­ta­ble after 1 July 2023 for a device to be both CE and UKCA mark­ed. How such dou­ble mar­kings will take place in prac­ti­ce, in par­ti­cu­lar what infor­ma­ti­on will be affi­xed to the UKCA mar­king, remains to be work­ed out.

The spe­cial sta­tus for Nor­t­hern Ire­land nego­tia­ted thus far should be empha­sis­ed: due to the open bor­der with the Repu­blic of Ire­land, it has been plan­ned to date for EU regu­la­ti­ons to con­ti­nue to app­ly the­re in the future. A spe­cial arran­ge­ment has been made and a sepa­ra­te UK(NI) mar­king deve­lo­ped, who­se joint use along with the CE mar­king has been envi­sa­ged. Devices with the UK(NI) mar­king are only to be on the mar­ket in the UK and Nor­t­hern Ire­land, not in the rest of the EU. In con­trast, the CE mar­king will be reco­g­nis­ed both in Nor­t­hern Ire­land and the rest of the EU, but not in Gre­at Bri­tain after 30 June 2023. It is impos­si­ble to fore­see whe­ther this spe­cial arran­ge­ment will actual­ly come into force by way of the “Inter­nal Mar­ket Bill”, which was intro­du­ced into Par­lia­ment on 9 Sep­tem­ber 2020. The EU is curr­ent­ly pre­pa­ring legal pro­cee­dings against Gre­at Bri­tain becau­se it holds that the Inter­nal Mar­ket Bill vio­la­tes the joint­ly nego­tia­ted exit agreement.

Ulti­m­ate­ly, after the dead­lo­cked BREXIT nego­tia­ti­ons, the ques­ti­on of whe­ther BREXIT will be hard or soft and the con­se­quen­ces the­reof remains open. It remains to be seen whe­ther the recent ulti­ma­tum given by Boris John­son for an exe­cu­ta­ble trade agree­ment on 15 Octo­ber 2020 will be enough to avert a hard BREXIT.

The text reflects the sta­te of the deba­te as of 11 Octo­ber 2020. We keep you updated.

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