Medtech Insight has just recent­ly pub­lished an arti­cle on the updat­ed guid­ance from for the post-Brex­it era. The Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) issued a guid­ance update on 21 Octo­ber for the post-Brex­it era. It offers infor­ma­tion to com­pa­nies con­cern­ing the North­ern Ire­land (NI) and EU27 markets. 

The guid­ance states explic­it­ly for NI that:

Class I devices and gen­er­al IVDs placed on the NI mar­ket by local man­u­fac­tur­ers or by NI-based autho­rised rep­re­sen­ta­tives (AR) must be reg­is­tered with the MHRA from 1 Jan­u­ary 2021.

Fur­ther­more, Great Britain(GB)-based man­u­fac­tur­ers will have to assign an EU27 or NI-based AR to place devices on the NI mar­ket – CE mark­ing and com­pli­ance with EU device reg­u­la­tions will still apply in NI after 1 Jan­u­ary. This includes use of EU27 based noti­fied bod­ies. UK (GB and NI) approved bod­ies will be able to do con­for­mi­ty assess­ment of devices for the NI mar­ket. How­ev­er, the guid­ance says that, for NI mar­ket access, device man­u­fac­tur­ers will nev­er apply the UKNI mark­ing on its own-it will be adjunct to a CE mark­ing each time. Also, to place devices on the EU mar­ket, man­u­fac­tur­ers have to use the CE mark­ing by itself, with­out the UKNI mark­ing. Devices hav­ing both CE and UKNI mark­ings will not be allowed on the EU market.

Man­u­fac­tur­ers out­side the UK must arrange a UK Respon­si­ble Per­son (UKRP) who will estab­lish com­pli­ance with UK reg­is­tra­tion oblig­a­tions. The rules apply to EU/EEA-based and third coun­try man­u­fac­tur­ers. Where a company’s AR is based in NI, the AR can assume the tasks of a UKRP as well. GB com­pa­nies will have to take on an AR based in the EU or NI so they can place a device on the NI mar­ket. NI-based ARs must reg­is­ter all device class­es with the MHRA. 

NI device man­u­fac­tur­ers will still prof­it from unre­strict­ed access to the rest of the UK after 1 Jan­u­ary. NI com­pa­nies will still be able to place CE and both CE- and UKNI-marked devices on the rest of the GB mar­ket after 30 June 2023. EU27-based man­u­fac­tur­ers will not be able to prof­it from this stipulation.

The new UKCA mark­ing will not be accept­ed on the EU mar­ket and CE mark­ings will be required

The new UKCA mark­ing will not be accept­ed on the EU mar­ket and CE mark­ings will be required. Manda­to­ry con­for­mi­ty assess­ments done by UK noti­fied bod­ies will not be recog­nised by the EU, even if the assess­ment has been done before the end of the tran­si­tion peri­od, unless the prod­uct has been placed on the EU mar­ket before 1 Jan­u­ary 2021.

From 1 Jan­u­ary 2021 man­u­fac­tur­ers have to make sure that their devices con­form to EU labelling require­ments so that they can place them on the EU mar­ket. Both the CE and UKCA mark­ings can be put on a prod­uct, only if nei­ther obstruct the vis­i­bil­i­ty of the oth­er and both labelling require­ments are met. How­ev­er, the UKCA mark­ing holds no reg­u­la­to­ry force in the EU. Devices placed on the NI mar­ket from 1 Jan­u­ary will also need to con­form with EU labelling require­ments. They must show a ‘CE UKNI’ mark if manda­to­ry con­for­mi­ty assess­ment has been car­ried out by a UK approved body. 

Source: Medtech Insight (an Infor­ma product)

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