Sev­er­al guid­ance doc­u­ments have been pub­lished by the Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) in Decem­ber 2020 and sub­se­quent­ly, includ­ing guide­lines on the UK Respon­si­ble Per­son (UKRP) and UK prod­uct reg­is­tra­tions, intend­ed to help med­ical device com­pa­nies to fol­low the new sys­tem and con­tin­ue to reach the market. 

Med­ical device and IVD man­u­fac­tur­ers not res­i­dent in the UK have to engage a UKRP as soon as pos­si­ble. Prod­uct reg­is­tra­tions for prod­ucts placed on the mar­ket in Great Britain must be done in the course of 2021 with grace peri­ods depend­ing on the risk class. The guid­ance doc­u­ment can be found here.

For North­ern Ire­land, spe­cif­ic pro­vi­sions apply: For exam­ple, man­u­fac­tur­ers based out­side the UK who want to put a device on the North­ern Ire­land mar­ket must employ a UKRP that has premis­es in the UK if they do not have a des­ig­nat­ed autho­rised rep­re­sen­ta­tive that has a reg­is­tered place of busi­ness in North­ern Ire­land. Devices reg­is­tered with the MHRA for the pur­pos­es of Great Britain can be placed on the North­ern Ire­land mar­ket with­out hav­ing to reg­is­ter again in North­ern Ire­land. Man­u­fac­tur­ers and UKRPs can reg­is­ter for the new reg­is­tra­tion regime with the MHRA data­base since 1 Jan­u­ary, 2021. 

The MHRA issued anoth­er doc­u­ment on the last day of 2020 giv­ing guid­ance on reg­u­lat­ing med­ical devices in the UK. It also includ­ed infor­ma­tion on the new domes­tic UK data­base to replace the EU’s NANDO infor­ma­tion system.

The guid­ance advis­es that UK approved bod­ies can car­ry out UKCA mark con­for­mi­ty assess­ments for med­ical devices, active implantable med­ical devices and in vit­ro diag­nos­tic med­ical devices for the Great Britain mar­ket. How­ev­er, they can­not per­form con­for­mi­ty assess­ments with respect to the CE mark­ing, except for pur­pos­es of the CE UKNI mark­ing which is valid in North­ern Ireland.

Sev­er­al oth­er guid­ance and updates were also pub­lished regarding 

  1. inform­ing the MHRA about a clin­i­cal inves­ti­ga­tion for a med­ical device, 
  2. EU reg­u­la­tions for the MDR and IVDR (North­ern Ire­land), and 
  3. an update on the Bor­der Oper­at­ing Mod­el (how the UK/EU bor­der will oper­ate in the post-tran­si­tion period.

The com­plete set of pub­lished guid­ance doc­u­ments may be retrieved here.

Source: Medtech Insight (an Infor­ma product)

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website