As of 23.00 on 31st December 2020 the United Kingdom officially (and finally) withdrew as a member of the European Union (EU).

Firstly, a geography lesson: the sovereign nation commonly known as the United Kingdom consists of the island of Great Britain (England, Scotland and Wales) and the north east part of the island of Ireland (Northern Ireland).

The separation of the UK (GB + NI) from the EU has not only severed alignment with Europe but has also led to the partitioning of the application of legislation for medical and invitro diagnostic device registration, approval and marketing between Great Britain and Northern Ireland, per terms of the Northern Ireland Protocol.

Legislation Requirements

  • Products destined for the EU market must be MDR compliant as of 26 May 2021
  • Products destined for the NI market must be MDR compliant as of 26 May 2021
  • Products destined for the GB market will continue compliance with Medical Device Regulation 2002

Notified Bodies

  • UK approved body certification for NI is only valid for Northern Ireland (UKNI)
    • Note NI based manufacturers can continue to place CE and CE UKNI marked devices on the Great Britain market after 30 June 2023
  • UK approved body certification for GB is only valid for Great Britain (UKCA)
  • EU notified body certification for EU is valid for Northern Ireland (CE)

Authorised Representatives

  • UK Responsible Person is required for registration for non-UK based manufacturers to market in Great Britain
  • GB based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative to market in Europe

CE Marking

  • EU will no longer accept CE certification from UK notified bodies from 01 January 2021
  • GB will accept EU CE marking until 30 June 2023 – however certification changes/updates during this period will necessitate a UKCA assessment

Labelling

  • UK CA mark mandatory on labelling for GB market from 01 July 2023
  • EU market will accept both CE and UK CA on labelling
  • CE + UKNI must appear on labelling for Northern Ireland market when certified by UK approved body
  • CE + UKNI labelling is not valid for EU

Registrations

  • MHRA will not have access to the EUDAMED database
  • All device products for GB market must be registered with the MHRA according to classification schedule (30 April, 31 August, 31 December 2021)
  • Where the manufacturer is in the UK or the Authorised Representative is in Northern Ireland, the following devices should be registered with the MHRA (no grace period)
    • Class I devices
    • Custom-made devices
    • General IVDs

These bullet points are just the highlights.

Please read the MHRA guidances and then read them again. When you think you may have thoroughly digested the information, discuss with your colleagues. Determination of how to maintain the lifecycle of your products for the EU, GB, and NI markets requires not only comprehensive knowledge of the regulations but also an intimate relationship with your entire portfolio. Implementation of a reliable electronic regulatory database is the essential tool to support compliance in this new environment, dependence on manual spreadsheets with their limitations, is significantly outmatched.

Comments respectfully requested

K Young

KimYoung@instem.com

References:

https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#contents

https://geology.com/world/british-isles.shtml

Photo by Rocco Dipoppa on Unsplash