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 24th of January 2024 the Department for Business and Trade extended an indefinite extension to the use of CE marking for businesses to three more Regulations. This means that for non-medical devices in scope of 21 Regulations listed below UKCA mark is no longer mandatory and CE marked non-medical devices will be allowed on the UK market indefinitely.

The non-medical device Regulations in scope^l of the indefinite CE mark recognition are:

• Equipment for use in potentially explosive atmospheres Regulations 2016/1107
• Electromagnetic compatibility Regulations 2016/1091
• Lifts Regulations 2016/1093
• Electrical Equipment (Safety) Regulations 2016/1101
• Pressure Equipment (Safety) Regulations 2016/1105
• Pyrotechnic Articles (Safety) Regulations 2015/1553
• Recreational Craft Regulations 2017/737
• Radio Equipment Regulations 2017/1206
• Simple Pressure Vessels (Safety) Regulations 2016/1092
• Toys (Safety) Regulations 2011/1881
• Aerosol Dispensers Regulations 2009/ 2824
• Gas Appliances (EU Regulation) 2016/426
• Supply of Machinery (Safety) Regulations 2008/1597
• Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001/1701
• Personal Protective Equipment (EU Regulation) 2016/425
• Measuring Instruments Regulations 2016/1153
• Non-automatic weighing instruments Regulations 2016/1152
• Measuring Container Bottles (EEC Requirements) Regulations 1977
• Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘The RoHS Regulations’)
• Ecodesign for Energy-Related Products Regulations 2010
• Explosives Regulations 2014

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 comes into force from 30th June 2023 that amends 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 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’.