UKCA marking for medical devices: Market access in the UK
Demonstrate compliance with UK regulations and maintain continued access to the Great Britain medical device market with DNV’s expert UKCA marking and conformity assessment services.
UKCA marking for medical devices: Market access in the UK
The UK Conformity Assessed (UKCA) marking is the UK’s product marking system, required for medical devices placed on the market in Great Britain (England, Scotland, and Wales). Following Brexit, manufacturers must ensure that their products comply with UK-specific regulatory requirements under the UK Medical Devices Regulations 2002 (as amended).
DNV offers expert guidance and conformity assessment services to help you achieve UKCA marking efficiently and confidently.
Our UKCA Marking Services
Conformity assessment: We assess your devices according to the relevant UK legislation for general medical devices, active implantable devices, and in vitro diagnostic devices (IVDs).
Technical documentation review: Our team provides a comprehensive evaluation of your technical files to ensure alignment with UKCA requirements.
Quality management system (QMS) audits: We audit your QMS to verify compliance with applicable UK standards.
Ongoing compliance support: Receive ongoing surveillance and expert guidance on regulatory updates and post-market obligations.
Transition Timelines
The UK government has extended certain recognition periods for CE marking. However, UKCA marking will become mandatory for most devices in the coming years.
It's critical to begin preparation early to ensure uninterrupted access to the UK market.
Who Should Apply
- Manufacturers selling medical devices in England, Scotland, or Wales.
- Regulatory Affairs Managers seeking to update certification strategies.
- Global market access teams aiming to maintain UK distribution.
Why Choose DNV?
With over 160 years of technical and regulatory expertise, DNV is a trusted global partner in product assurance. Our services combine in-depth regulatory knowledge, robust certification processes, and personalized support – helping you navigate UKCA requirements with confidence.
- Accredited conformity assessment body.
- Strong international presence with local regulatory insight.
- Comprehensive support across device classes and categories.
Resources to support your UKCA journey
Explore guidance, tools, and links to help you navigate the UKCA marking process, prepare documentation, and connect with DNV’s local experts.
6 steps to UKCA marking
Download our step-by-step guide outlining the UKCA certification process for medical devices.
UK Government’s website
Visit the official UK Government page for current UKCA regulations and guidance.
Complaints & Appeals
Learn how to submit complaints or appeals related to your certification process with DNV.
