UKCA Update

Following the withdrawal of the United Kingdom (UK), comprising, England, Northern Ireland, Scotland and Wales, from the European Union (EU), referred to as ‘Brexit’, the regulatory requirements for products being placed on the market in Great Britain (GB) (comprising England, Scotland and Wales) is changing.

Non Medical Devices

On 1st of August 2023 the Department for Business and Trade (DBT) announced an indefinite extension to the use of CE marking for businesses. This update applies to the 18 regulations that fall under the DBT which are:

• toys
• pyrotechnics
• recreational craft and personal watercraft
• simple pressure vessels
• electromagnetic compatibility/li>
• 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

This means that for non-medical devices in scope of these 18 regulations, UKCA mark is no longer mandatory, and CE marked non-medical devices will be allowed on the UK market indefinitely.

Medical Devices

In April 2023, the UK government put in place legislation (The Medical Devices (Amendment) (Great Britain) Regulations 2023 (SI 2023 No 627)² which came into force from 30th June 2023 that amended the Medical Device Regulations 2002 (SI 2002 No 618)³ (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain (GB) market.

An infographic summarising the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023 is available from the MHRA here⁴.

After the applicable transition period provided by SI 2023/627, medical devices being placed on the GB market will need to meet the requirements of the applicable UK Medical Devices Regulation and bear the UKCA mark.

As a leader in healthcare and patient safety, we are driving the implementation of policies and procedures to ensure compliance with the new UK requirements by the dates required by the applicable regulations. BD (Becton, Dickinson and Company) is proud to have been supporting our customers and healthcare professionals for more than 120 years, and we are committed to continue doing so by delivering safe and effective medical devices that are advancing the world of health™.

And as such, a global cross-functional team at BD is working on the seamless implementation of the UKCA requirements across our entire company to ensure that our products currently bearing a CE mark under EU legislation can continue to be placed on the market in Great Britain and made available to the healthcare communities.

Further, BD is continuing to monitor the evolving regulatory environment within the UK and will adapt to meet the requirements accordingly.

For more information on the impact of the regulations, please refer to https://www.gov.uk/guidance and use the search term ‘UKCA’.