Why is UKCA Marking Important?
Legal background
From 1 July 2024, all medical devices, IVDs, and custom-made devices must bear the UKCA mark to be sold in Great Britain. Properly affixing the UKCA mark demonstrates that your product meets the essential requirements of the UK MDR 2002, can be legally placed on the Great Britain market and demonstrates it has undergone third-party conformity assessment. Choosing the right compliance partner ensures you meet every deadline and avoid these costly setbacks.
Failure to comply with UKCA requirements can result in:
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- Rejection at borders or customs.
- Regulatory enforcement action or financial penalties.
- Delayed time-to-market or product withdrawals.
- Reputational damage and loss of market access.
Our services
Expert Guidance to Achieve UKCA Certification
Obelis offers full-service support to obtain UKCA marking for your medical devices. We assist in preparing the Declaration of Conformity, identify whether self-declaration or UK Approved Body certification is needed. We advise on classification and coordinate with the appropriate UK Approved Body when necessary. Our team guides you through technical documentation requirements, labelling reviews (including mandatory placement of the UK RP address), and device registration with the MHRA. With Obelis, you ensure your product is ready for the Great Britain market with no regulatory delays.
FAQ
Frequently Asked Questions
UKCA (UK Conformity Assessed) marking is a certification logo that demonstrates a medical device’s compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002). It is legally required to place medical devices on the market in Great Britain (England, Scotland, and Wales).
UKCA marking is required for most medical devices, in vitro diagnostic devices (IVDs), and custom-made devices placed on the Great Britain market. This includes both newly developed products and legacy devices previously sold under the CE marking in the EU.
UKCA marking becomes mandatory for medical devices sold in Great Britain starting 1 July 2024, following the UK government’s transition period. After this date, CE marking will no longer be accepted in Great Britain for most devices.
While similar in intent, the UKCA marking process follows UK-specific regulations (UK MDR 2002) and requires involvement with a UK UK-approved body instead of an EU Notified Body. Additionally, the UKCA mark is not recognised in the EU or Northern Ireland, where CE or CE UKNI marks are still required.
