31 Jan­u­ary 2020 was a some­what sig­nif­i­cant day as the UK for­mal­ly left the EU at a strate­gic point in the imple­men­ta­tion of the Med­ical Devices and IVD Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR). At the moment, the sit­u­a­tion for the medtech indus­try will stay seem­ing­ly unchanged from the reg­u­la­to­ry posi­tion. But for how long?

From 1 Feb­ru­ary 2020, the UK moves into the with­draw­al agree­ment peri­od with the EU dur­ing which depar­ture nego­ti­a­tions will take place and the MDR and IVDR will con­tin­ue to apply. The with­draw­al agree­ment con­tin­ues until 31 Decem­ber and because noth­ing is clear about its future trad­ing agree­ments, it is hard to know what exact­ly will happen. 

Cur­rent com­mon prac­tice shows that dai­ly busi­ness is not yet sig­nif­i­cant­ly affected

Cur­rent com­mon prac­tice shows that dai­ly busi­ness is not yet sig­nif­i­cant­ly affect­ed. For exam­ple, cer­tifi­cates issues by UK Noti­fied Bod­ies will con­tin­ue to be rec­og­nized and the require­ments for extra-UK man­u­fac­tur­ers to appoint a UK Respon­si­ble Per­son seems to be delayed as well. Nonethe­less, EU medtech reg­u­la­to­ry experts feel that the lack of offi­cial state­ments denotes uncer­tain­ty for med­ical devices com­pa­nies world­wide and guid­ance from author­i­ties about the cir­cum­stances, par­tic­u­lar­ly about the roll-ever dates would be help­ful for industry. 

On the whole, medtech experts are dis­ap­point­ed that the UK have left the EU and feel that it is a bad step for every­one in the mid­dle of the largest reg­u­la­to­ry changes for the medtech sec­tor and that there will be a more oner­ous reg­u­la­to­ry frame­work by hav­ing a split-up between the EU and the UK. 

Source: Medtech Insight (an Infor­ma product)

For fur­ther in depth infor­ma­tion on Brex­it, we warm­ly rec­om­mend our fol­low­ing tags, arti­cles and pages