What the latest Brexit U-turn means for CE Marking of medical devices in Great Britain

Dr Hanna Gul
An EU and UK flag

The UK Department for Business and Trade (DBT) announced on 1st August 2023 that CE safety marking of products for businesses is to continue indefinitely in the UK, beyond the 2024 deadline.

Following the departure of the UK from the European Union in 2016, UKCA marking was to replace the CE mark, along with changes to the process of medical device regulation. Several extensions to the transitional arrangements have already been made, with the latest deadline for mandatory use of the UKCA mark being the 30th June 2024.

Due to issues surrounding the burden of these changes on businesses and impact on economic growth, the DBT has consulted with industry professionals and will now allow the continued use of the CE mark alongside the UKCA. For the time being, this update refers to 18 regulations it will apply to (that fall under the DBT), of which medical devices has not been included.

The regulations stated are as follows:

  • toys
  • pyrotechnics
  • recreational craft and personal watercraft
  • simple pressure vessels
  • electromagnetic compatibility
  • non-automatic weighing instruments
  • measuring instruments
  • measuring container bottles
  • lifts
  • equipment for potentially explosive atmospheres (ATEX)
  • radio equipment
  • pressure equipment
  • personal protective equipment (PPE)
  • gas appliances
  • machinery
  • equipment for use outdoors
  • aerosols
  • low voltage electrical equipment

Whether medical device regulation will be impacted is yet to be confirmed, although given the current trend in extensions made to the transition deadline, it would not be a surprise if it were to follow suit. To date, no update has been provided by the MHRA regarding this matter.

Keep an eye out for an article regarding an update on this topic.

Please contact us if you have any questions about this article or would like to discuss how we can help you with your CE & UKCA certification in more detail.

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