Although Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) are in oper­a­tion in the EU, med­ical devices leg­is­la­tion in Great Britain is still aligned with the for­mer Direc­tives for active implantable med­ical devices, med­ical devices and in vit­ro diag­nos­tic med­ical devices. 

The Med­i­cines and Med­ical Devices Act 2021 allows changes in the reg­u­la­tions for med­ical devices in order to pro­tect pub­lic safe­ty and so should take the safe­ty of med­ical devices into account. The avail­abil­i­ty of med­ical devices should also be weighed up, as should the odds of the UK being deemed as a promis­ing place to do research on med­ical devices, in addi­tion to devel­op­ment, man­u­fac­ture and sup­ply of med­ical devices. 

The Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) has ini­ti­at­ed a con­sul­ta­tion exer­cise to get feed­back on pos­si­ble changes, with the view of updat­ing the UK reg­u­la­tions on plac­ing med­ical devices on the UK mar­ket, from all stake­hold­ers. It closed on 25 Novem­ber 2021 and cov­ered top­ics like the scope of the reg­u­la­tions, con­for­mi­ty assess­ment process­es, post-mar­ket sur­veil­lance, vig­i­lance and mar­ket sur­veil­lance, re-man­u­fac­ture of sin­gle use devices and reg­is­tra­tion und UDI among many oth­er impor­tant subjects. 

It is thought that the new reg­u­la­to­ry sys­tem will be brought in at the begin­ning of July 2023

It is thought that the new reg­u­la­to­ry sys­tem will be brought in at the begin­ning of July 2023 when the UK is sched­uled to stop accept­ing CE mark­ing for med­ical devices in Great Britain and will use the UKCA mark. Although North­ern Ire­land is part of the Unit­ed King­dom, the EU MDR was imple­ment­ed there in May this year and the EU IVDR will take effect there from 26 May 2022. This con­sul­ta­tion exer­cise out­lines pro­pos­als for a future UK-wide regime to reg­u­late med­ical devices which should pro­ceed par­al­lel with any exist­ing or future EU rules in keep­ing with the North­ern Ire­land Protocol.

Source: bsi 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website