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.

Recom­men­da­ti­on 

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.

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