Why is UKCA Marking Important?
Legal background
The UKCA mark is required for most medical devices, IVDs, and custom-made devices placed on the Great Britain market. It demonstrates compliance with the UK MDR 2002, confirms successful conformity assessment, and allows products to be legally marketed in England, Scotland, and Wales.
The consequences of non-compliance
What happens without UKCA marking
Market access blocked
Products without a valid UKCA mark may be refused entry at customs or prevented from being sold in Great Britain.
Regulatory enforcement
Failure to comply with the UK MDR 2002 may result in regulatory action or financial penalties.
Commercial delays
Missing or delayed UKCA certification can postpone product launches or lead to product withdrawals.
Reputational damage
Non-compliance can disrupt market access and reduce confidence among customers and business partners.
Our services
UKCA Compliance Support from Obelis
Obelis provides quality assistance throughout the UKCA marking process for medical devices. Our specialists help prepare the Declaration of Conformity, determine whether self-declaration or UK Approved Body certification is required, advise on device classification, and coordinate with the appropriate UK Approved Body where necessary. We also review technical documentation, verify labelling requirements including the UK Responsible Person details, and support MHRA device registration, helping manufacturers achieve UK compliance efficiently.
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Step 1
Determine Your Compliance Path
We classify your medical device, assess the applicable UK MDR 2002 requirements, and determine whether self-declaration or UK Approved Body certification is required.
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Step 2
Prepare Your Documentation
We review your technical documentation, verify labelling, and prepare your Declaration of Conformity in line with the UK MDR 2002.
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Step 3
Complete the Conformity Assessment
Where required, we coordinate with the appropriate UK Approved Body and support the successful completion of the UKCA certification process.
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Step 4
Register & Place Your Device on the Market
We support MHRA device registration, confirm all UKCA marking requirements have been met, and help you place your medical device on the Great Britain market with confidence.
Related Services
Compliance for Medical Devices in the United Kingdom
Frequently Asked Questions
UKCA marking is the conformity marking required for most medical devices, IVDs, and custom-made devices placed on the Great Britain market. It demonstrates that a product complies with the UK Medical Devices Regulations 2002 (UK MDR 2002) and has successfully completed the applicable conformity assessment, allowing it to be legally marketed in England, Scotland, and Wales.
Most medical devices, IVDs, and custom-made devices require UKCA marking before they can be placed on the Great Britain market. Depending on the device classification, manufacturers may be able to self-declare conformity or may need certification from a UK Approved Body before affixing the UKCA mark.
To obtain UKCA marking, manufacturers must determine their device classification, prepare compliant technical documentation, complete the required conformity assessment, issue a Declaration of Conformity, appoint a UK Responsible Person where required, and complete MHRA device registration before placing the product on the Great Britain market.
Obelis UK provides end-to-end UKCA marking support by helping manufacturers classify their medical devices, prepare technical documentation, determine whether self-declaration or UK Approved Body certification is required, coordinate with UK Approved Bodies, review labelling, appoint a UK Responsible Person, and complete MHRA device registration to achieve compliance with the UK MDR 2002.