UKCA: UL Solutions Expands Scope for Medical Devices

As of February 2024, UL Solutions, through UL International (UK) Ltd., has expanded its Approved Body scope for United Kingdom Conformity Assessment (UKCA) for Medical Devices, offering manufacturers a new route to market and product marking, the UKCA marking. UL International (UK) Ltd. Is now fully equipped to conduct conformity assessments for the UKCA marking for Medical Devices under Part II of the Medical Devices Regulation (MDR) as they apply in Great Britain   (SI 2002 NO 618, as amended; UK MDR 2002). The full scope of this designation is available on the Medicine and Healthcare Products Regulatory Agency (MHRA) website.

The future core regulation is expected to go into force in 2025 (see Roadmap towards the Future Regulatory Framework for medical devices ). UL International (UK) Ltd. can partner with your current European Union (EU) notified body to support your UKCA application processing.

How UL Solutions can help medical device manufacturers

As a designated Approved Body for Medical Devices, UL International (UK) Ltd. can provide manufacturers with an enhanced pathway to UKCA marking. Customers hoping to get a UKCA certificate before the date of application for future core regulations can apply for conformity assessment evaluation with UL Solutions, leveraging our expertise and capabilities.

Our scope includes many of the codes within the following categories covered by this accreditation:

• MD 0100 - General non-active, non-implantable medical devices
• MD 0200 - Non-active implants
• MD 0300 - Devices for wound care
• MD 0400 - Non-active dental devices and accessories
• MD 1100 - General active medical devices
• MD 1200 - Devices for imaging
• MD 1300 - Monitoring devices
• MD 1400 - Devices for radiation therapy and thermo-therapy

It's important to note that UKCA certificates can be valid for up-to five years, subject to transitional arrangements.

At our UL International (UK) Ltd. facilities, UL Solutions can assist you in achieving your compliance goals for medical devices. Contact us   for more information on the benefits for UL Solutions customers and to register for a UKCA assessment.