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

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