JVR Compliance Consultants & Auditors
Email: info@jvrconsultancy.com Need Help? Call: 01628 56 52 56With the UK’s exit from the European Union, the UKCA (UK Conformity Assessed) mark has become the new standard for placing medical devices on the market in Great Britain (England, Wales, and Scotland). For any medical device manufacturer—particularly those based in the EU or outside the UK—understanding and complying with the UKCA and MHRA requirements is essential for market access and NHS procurement.
At JVR Consultancy, we offer dedicated regulatory support to help manufacturers achieve full compliance with UKCA marking and MHRA registration, opening the door to business opportunities within the NHS and wider UK healthcare market.
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The UKCA mark is the UK’s replacement for the CE mark, and it demonstrates that a product conforms to the applicable UK legislation and standards. For medical devices, this is governed by the UK Medical Devices Regulations 2002, which are based on the earlier EU Directives.
The UKCA marking applies to:
It is mandatory for all new medical devices placed on the market in Great Britain, though CE-marked devices under EU MDR or IVDR may still be accepted until 30 June 2030, under transitional arrangements.
📎 See full guidance on UKCA for medical devices (gov.uk)
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s competent authority overseeing medical devices. All manufacturers must register their devices with the MHRA before they can be placed on the UK market—even those relying temporarily on CE marking.
Key points:
📎 MHRA Registration Services – Learn More
Devices are categorised based on risk and function:
The higher the classification, the more rigorous the conformity assessment process. Most medium- to high-risk devices require involvement from a UK Approved Body (similar to a notified body in the EU).
JVR Consultancy will guide you in identifying your classification and the appropriate conformity path.
While the UKCA and CE marks are based on similar principles, there are important distinctions:
If you’re planning to supply your device to the NHS, UKCA marking and MHRA registration are prerequisites for procurement eligibility. NHS buyers will also expect:
📎 NHS DSPT Consultancy
📎 DTAC Support Services
If you are a non-UK manufacturer (including EU-based), you must appoint a UK Responsible Person (UKRP) to:
JVR Consultancy can act as your UKRP or help you appoint one, ensuring seamless compliance and communication with the MHRA.
We provide end-to-end regulatory support for manufacturers navigating the UKCA and MHRA landscape.
Our Services Include:
We make UKCA and MHRA compliance understandable, achievable, and efficient.
Step-by-Step Guide:
JVR will walk you through each step, ensuring your device is ready for UK launch and NHS supply.
Whether you’re a startup or a global manufacturer, gaining UKCA and MHRA approval is a key milestone—and JVR Consultancy is here to make that process faster, clearer, and more compliant.
📞 Contact us now to book a consultation and take the first step towards UK market access.
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