Update: impact of Bre­x­it on the medi­cal device industry

Now that Bre­x­it took place on 31 Decem­ber 2020, a new Bri­tish sys­tem is in effect e.g. for pro­duct cer­ti­fi­ca­ti­on, con­for­mi­ty mar­king and for the regis­tra­ti­on of devices with the Medi­ci­nes and Health­ca­re pro­ducts Regu­la­to­ry Agen­cy (MHRA), the agen­cy respon­si­ble for regu­la­ting the Bri­tish medi­cal device mar­ket. The rules in effect for Gre­at Bri­tain, which con­sists of Eng­land, Wales and Scot­land, dif­fer from tho­se in effect for Nort­hern Ireland.

Regu­la­ti­ons in Gre­at Britain

For medi­cal device manu­fac­tu­rers, e.g. the fol­lowing rules app­ly with respect to the pla­ce­ment of their devices on the market:

  • CE mar­kings will con­ti­nue to be reco­gni­zed in Gre­at Bri­tain through 30 June 2023.
  • Cer­ti­fi­ca­tes issued by EU-recognized Noti­fied Bodies will be valid in the Gre­at Bri­tain mar­ket through 30 June 2023.
  • The EU no lon­ger reco­gni­zes UK Noti­fied Bodies.
  • UK Noti­fied Bodies may not issue CE cer­ti­fi­ca­tes (other than for pur­po­ses of “CE UKNI” mar­king, which is valid in Nort­hern Ire­land) and have beco­me “UK Appro­ved Bodies.”
  • New rules app­ly for mar­ket and pro­duct marking.

As of 1 Janu­a­ry 2021, all medi­cal devices which are pla­ced on the mar­ket in Gre­at Bri­tain, inclu­ding in-vitro dia­gnostics (IVDs), must be regis­tered with the MHRA. The fol­lowing peri­ods app­ly for registration:

  • Class III and Class IIb implan­ta­ble pro­ducts and all acti­ve implan­ta­ble medi­cal devices and IVD List A pro­ducts must be regis­tered as of 1 May 2021.
  • Other Class IIb devices and all Class IIa devices, as well as IVD List B pro­ducts and Self-Test IVDs, must be regis­tered as of 1 Sep­tem­ber 2021.
  • Class I devices, custom-made devices and gene­ral IVDs (which cur­r­ent­ly do not have to be regis­tered) must be regis­tered as of 1 Janu­a­ry 2022.

Manu­fac­tu­rers which are not based in the United King­dom must appoint a respon­si­ble per­son for Gre­at Bri­tain which will take respon­si­bi­li­ty for the pro­duct in Gre­at Bri­tain (UK Respon­si­ble Per­son).
If the importer is not the UK Respon­si­ble Per­son, the importer must noti­fy the UK Respon­si­ble Per­son of its inten­ti­on to import a device into Gre­at Bri­tain. In such cases, the UK Respon­si­ble Per­son is requi­red to pro­vi­de the MHRA with a list of device importers. The pre­vious obli­ga­ti­ons regar­ding sto­rage, trans­por­ta­ti­on and che­cking device labels for the CE mar­king or UKCA mar­king will con­ti­nue to app­ly for importers and dis­tri­bu­tors. The importer’s name and address does not need to be pre­sent on the label unless the importer or dis­tri­bu­tor is acting as the UK Respon­si­ble Per­son for the pur­po­ses of the UKCA mark.

UKCA mark and CE mark

The UKCA (UK Con­for­mi­ty Asses­sed) mark is a UK pro­duct mar­king used for cer­tain goods, inclu­ding medi­cal devices, being pla­ced on the mar­ket in Gre­at Bri­tain. The UKCA mark is not reco­gni­zed in the EU, EEA or Nort­hern Ire­land mar­kets, so rele­vant pro­ducts requi­re a CE mark for sale in the­se markets.

Manu­fac­tu­rers can use the UKCA mark on a vol­un­ta­ry basis until 30 June 2023. From 1 July 2023, a UKCA mark will be requi­red in order to place a device on the Gre­at Bri­tain market.

CE-marked devices will con­ti­nue to be accep­ted on the Bri­tish mar­ket through 30 June 2023 pro­vi­ded they con­form to the EU Direc­ti­ves still in effect, or the Regu­la­ti­ons which will take effect in the future, the MDR or the IVDR. CE cer­ti­fi­ca­tes which con­form to the­se rules will con­ti­nue to be reco­gni­zed through 30 June 2023.

In other words, devices which alrea­dy have a valid CE mar­king do not have to be re-labelled with a UKCA mark in order to be pla­ced on the Bri­tish mar­ket through 1 July 2023. Devices can have both marks pre­sent on the label­ling pri­or to 1 July 2023, and dual mar­king will con­ti­nue to be accep­ted on the Bri­tish mar­ket after 1 July 2023. Howe­ver, the name and address of the UK Respon­si­ble Per­son, whe­re app­li­ca­ble, needs to be inclu­ded on pro­duct label­ling whe­re the UKCA mark has been affi­xed (inclu­ding when devices have been dual marked).

Noti­fied bodies

Whe­re third-party con­for­mi­ty assess­ment is requi­red, a UK Appro­ved Body is nee­ded. Howe­ver, Class I device and gene­ral IVD manu­fac­tu­rers can self-certify with the UKCA mark.

The MHRA can desi­gna­te UK Appro­ved Bodies. Exis­ting UK Noti­fied Bodies with desi­gna­ti­ons under the EU MDD, EU IVDD or EU AIMDD have had their desi­gna­ti­ons rol­led over auto­ma­ti­cal­ly without having to under­go a new desi­gna­ti­on process.

For the pur­po­ses of the Gre­at Bri­tain mar­ket, UK Appro­ved Bodies can con­duct con­for­mi­ty assess­ments in rela­ti­on to the UKCA mark for medi­cal devices, acti­ve implan­ta­ble medi­cal devices and in vitro dia­gnostic medi­cal devices under Parts II, III, and IV of the UK MDR 2002 (as amen­ded). But UK Appro­ved Bodies are not able to con­duct con­for­mi­ty assess­ments in rela­ti­on to the CE mar­king other than for the pur­po­ses of the “CE UKNI” mar­king, which is valid in Nort­hern Ireland.

Regu­la­ti­ons for Nort­hern Ireland

The fol­lowing rules app­ly for medi­cal device manu­fac­tu­rers see­king to place their devices on the mar­ket in Nort­hern Ireland:

  • Devices must con­form to the requi­re­ments of the MDR and IVDR as of 26 May 2021 and 26 May 2022 respectively.
  • CE mar­king is required.
  • UKNI mar­king is also requi­red if a UK Noti­fied Body is invol­ved in the con­for­mi­ty assess­ment process.

Manu­fac­tu­rers are requi­red to affix UKNI mar­king to their devices in addi­ti­on to CE mar­king if they deci­de to use a UK Noti­fied Body for the pre­scri­bed con­for­mi­ty assess­ment pro­ce­du­re. Device manu­fac­tu­rers must never app­ly the UKNI mar­king on their own – it must always accom­pa­ny a CE mar­king. Howe­ver, goods bea­ring the “CE & UKNI” mar­king will not be accep­ted on the EU market.


The abo­ve aspects are only the most important of the new regu­la­ti­ons which will app­ly for the pla­ce­ment of medi­cal devices on the mar­ket in Gre­at Bri­tain and Nort­hern Ire­land. The afo­re­men­tio­ned rules are sup­ple­men­ted by a wide ran­ge of indi­vi­du­al and detail­ed rules for many dif­fe­rent pro­duct clas­ses, the descrip­ti­on of which would exceed the bounds of a news­let­ter arti­cle. Befo­re pla­cing devices on the mar­ket, manu­fac­tu­rers should exami­ne the rules which app­ly to them and to their spe­ci­fic device in order to ensu­re that their devices meet the requi­re­ments for sub­stan­ti­ve con­for­mi­ty as well as the spe­ci­fic labe­ling and pro­duct regis­tra­ti­on requi­re­ments in Gre­at Bri­tain and Nort­hern Ireland.


Stay up-to-date

We use your e-mail address exclusively for sending our newsletter. You have the right to revoke your consent at any time with effect for the future. For further information, please refer to our privacy policy.