BREXIT: Market access to Great Britain and Northern Ireland

Access to the European and UK markets for health products has changed dramatically since the UK left the European Union on 31 January 2020 and became a third country.

Background

On 1 January 2021, the UK became a third country (no longer a Member State of the European Union). A Trade and Cooperation Agreement was signed with the UK on 30 December 2020. Since 1 January 2021, this agreement has set out the rules applicable to the relationship between the United Kingdom and the European Union in a number of areas, including the marketing of health products in Great Britain (England, Wales and Scotland) and Northern Ireland. Although an agreement was signed, Brexit has resulted in significant changes to which manufacturers of medical devices (MDs) and in-vitro diagnostic devices (IVDs) must adapt.

What are the impacts for EU manufacturers ?

Since 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) has been responsible for regulating the UK market for MDs and IVDs. Recognition of the CE mark in the UK remains valid until 30 June 2023, with CE certificates issued by EU-recognised notified bodies remaining valid. The main changes introduced with regard to access to the UK market are as follows:

• UK Conformity Assessed (UKCA) marking required for MDs and IVDs will require that products comply with the essential safety and performance requirements of the UK MDR 2002¹, which will be modelled on the existing EU directives. This marking is mandatory; however, a transition period is granted for CE marked devices, ending on 30 June 2023. This transition period will allow manufacturers to comply with the UK regulations.

• Mandatory registration with the MHRA of all MDs, IVDs, custom-made MDs and systems and procedure packs, irrespective of their risk class, before they are placed on the UK market. A transition period is granted to manufacturers:
  • Registration from 1 May 2021 for active implantable MDs, Class III MDs, Class IIb implantable MDs, and IVD List A products.
  • Registration from 1 September 2021 for Class IIb non-implantable MDs, Class IIa MDs, IVD List B products, and self-test IVDs.
  • Registration from 1 January 2022 for Class I MDs, general IVDMDs and system and procedure packs if the manufacturer is based outside the UK. If the manufacturer is based in the UK, it must register these devices.

It should be noted that the MHRA offers manufacturers the opportunity to register all of these medical devices at the same time, regardless of the class.
Manufacturers based outside the UK will need to appoint a UK Responsible Person (UKRP) who will take responsibility for the product in the UK, including with the MHRA. The UKRP is the regulatory contact point in the UK and must comply with the registration requirements. Similarly, a UK manufacturer will need to have an authorised representative in Europe.

It should be noted that for Northern Ireland, different rules apply to those in the UK, in particular with the application of MDR 2017/745 and IVDR 2017/746 from 26 May 2021 and 26 May 2022 respectively. However, if the device is registered in the UK, no further steps are required for registration in Northern Ireland. Nevertheless, if the manufacturer wishes to market the device in Northern Ireland only, it will need to register with the competent authority and affix a specific CE UKNI marking.

Why should you turn to the Efor group for assistance ?

Our quality and regulatory affairs experts will be pleased to offer you high-quality support with regard to all of the following topics (non-exhaustive list):

• Support for market access to the UK (England, Wales and Scotland) and Northern Ireland
• Assistance with CE and UKCA/CE UKNI marking
• Support in finding your UK representative (UKRP)
• Support in registering your products on the UK market (England, Wales and Scotland) and in Northern Ireland
• Support in updating product information

To contact us: onedt@efor-group.fr

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¹ NB This Regulation is under review; a new regulation should be published in the coming years.