New UKCA mark after Brexit

On Sep­tem­ber 1, 2020, the UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) has issued a new guid­ance how med­ical devices will be reg­u­lat­ed post-Brex­it as of Jan­u­ary 1, 2021. The doc­u­ment sug­gests reg­is­tra­tion time­lines, a tran­si­tion peri­od for CE marked prod­ucts and a new con­for­mi­ty assess­ment route (UKCA mark). 

The MHRA guid­ance says the EU CE mark­ing will still be in oper­a­tion for devices and in vit­ro diag­nos­tics in Great Britain until June 2023 and then a stand­alone reg­u­la­to­ry sys­tem will be brought in. The doc­u­ment fur­ther­more explains that after 30 June 2023, com­pa­nies access­ing the home device and diag­nos­tics mar­ket will have to attach a new UK Con­for­mi­ty Assessed (UKCA) mark on the devices. Man­u­fac­tur­ers may apply the new UK con­for­mi­ty assess­ment route already as of 1 Jan­u­ary 2021 if they wish to do so.

How­ev­er, the UKCA mark will not be accept­ed in the EU, EEA or in North­ern Ireland. 

Every device placed on the UK mar­ket has to be reg­is­tered with the MHRA under the fol­low­ing sched­ule in 2021:

• By 30 April 2021 for class III, class IIb implanta­bles and active implantable devices under the MDD; and IVDs under List A IVDs of the In Vit­ro Diag­nos­tics Direc­tive (IVDD);
• By 31 August 2021 for all oth­er class IIb, class IIa devices and List B IVDs and self-test IVDs; and
• By Decem­ber 2021 for all class I devices and gen­er­al IVDs.

All man­u­fac­tur­ers who com­ply with the new con­for­mi­ty assess­ment route, will have to attach a new UKCA num­ber to devices. The form of UKCA mark is not yet known.

The EU Med­ical Devices Reg­u­la­tion and IVD Med­ical Devices Reg­u­la­tion (MDR and IVDR) will apply in North­ern Ire­land, but not in the UK.

The post-Brex­it leg­is­la­ture that will apply in Great Britain are the Med­ical Devices Direc­tive (MDD), the IVD Direc­tive (IVDD) and the Active Implanta­bles Med­ical Devices Direc­tive (AIMDD). They will be valid in Great Britain after the tran­si­tion peri­od in the form in which they exist on 1 Jan­u­ary 2021. The UK is prepar­ing stand­alone pri­ma­ry devices leg­is­la­tion in the Med­i­cines and Med­ical Devices (MMD) law. The EU Med­ical Devices Reg­u­la­tion and IVD Med­ical Devices Reg­u­la­tion (MDR and IVDR) will apply in North­ern Ire­land, but not in the UK. 

UK noti­fied bod­ies with des­ig­na­tion under the MDD, IVDD or AIMDD will have their des­ig­na­tions rolled over auto­mat­i­cal­ly and will be known as ‘Approved Bod­ies’ from 1 January. 

The MHRA guid­ance advis­es man­u­fac­tur­ers that:

• Con­for­mi­ty assess­ments per­formed by UK noti­fied bodies/Approved bod­ies will not be recog­nised by the EU after 31 Decem­ber-even if the assess­ment was done before the end of the UK’s tran­si­tion peri­od;
• UK med­ical devices going on the EU mar­ket after 31 Decem­ber must go through a com­pul­so­ry third-par­ty con­for­mi­ty assess­ment, using an EEA-based noti­fied body.
• Great Britain-based ARs (Autho­rised Rep­re­sen­ta­tive) will not be recog­nised in the EU as of 1st Jan­u­ary, irre­spec­tive of when prod­ucts were placed on the market;
• Great Britain-based man­u­fac­tur­ers dis­trib­ut­ing CE-marked devices to the EU mar­ket must set up an AR based in the EU or North­ern Ire­land to reg­is­ter and act on their behalf; 
• UK man­u­fac­tur­ers must make sure that devices are in line with EU labelling require­ments so they can be placed on the market.

Man­u­fac­tur­ers that want to place a device on the North­ern Ire­land mar­ket have to reg­is­ter with the MHRA. Man­u­fac­tur­ers set up in Great Britain have to assign a North­ern Ire­land or EU AR to place a device on the North­ern Ire­land mar­ket. If the des­ig­nat­ed AR is based in North­ern Ire­land, it has to reg­is­ter devices of all class­es placed on the North­ern Ire­land mar­ket with the MHRA. If the AR is based in the EU, it does not have to reg­is­ter class I and cus­tom-made devices or gen­er­al IVDs. All oth­er devices place on the North­ern Ire­land mar­ket have to be reg­is­tered with MHRA. 

Approved Bod­ies will be able to car­ry out con­for­mi­ty assess­ments for the pur­pos­es of the North­ern Ire­land mar­ket. If a device has been assessed by a UK Approved Body, the UK(NI) mark will accom­pa­ny, but not replace, the CE mark. Prod­ucts dis­play­ing both the CE mark and UK(NI) can­not be placed on the EU mar­ket. UKCA marked devices will not be accept­ed on the North­ern Ire­land mar­ket unless it has the CE or CE UK(NI) mark. 

Man­u­fac­tur­ers out­side the UK and want­i­ng to access the UK mar­ket have to set up and reg­is­ter both a UK place of busi­ness and a UK Respon­si­ble Per­son (UKRP) before the end of the grace peri­od as above. The UKRP will take on the respon­si­bil­i­ties of the man­u­fac­tur­er when it comes to reg­is­ter­ing the device with the MHRA.

Man­u­fac­tur­ers based out­side the EEA who have an AR based in North­ern Ire­land do not have to des­ig­nate a UKRP to place a device on the North­ern Ire­land mar­ket. In this case, the North­ern Ire­land based AR will be able to reg­is­ter devices with the MHRA on the manufacturer’s behalf.

Source: Medtech Insight (an Infor­ma product)

Check out the new guidance

• Read the new guid­ance issued by the UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) now.

To receive fur­ther infor­ma­tion on this sub­ject, please notice our fol­low­ing articles

• News on Brexit
• New Guid­ance for the UK Respon­si­ble Per­son Published
• Unit­ed King­dom (UK) to Request ‘UK Respon­si­ble Person’
• Details about the Reg­u­la­tion of Med­ical Devices in Case of No-Deal Brexit
• Brex­it Key Chal­lenges – a Brief Case Study