Social adVentures are a Social Enterprise that provides NHS and Local Authority Adult and Children’s Services. We worked with JVR Consultancy to obtain our Cyber Essentials accreditation. JVR Consultancy were a great organisation to work with and they had a clear approach to help ensure that we met the requirements of the accreditation. Their team are highly professional and have a deep understanding of cyber security and information governance.
UKCA Marking & MHRA Registration – A Guide for Medical Device Manufacturers
With 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.
Book your free consultation today to learn how we can support you with UKCA Marking & MHRA Registration.
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.
I contacted JVR Consultancy for last-minute support with Achilles certification. They were more than happy to assist, providing their expertise to help fill any gaps we had before our audit submission. Their invaluable support ensured we had best practices in place moving forward.
Director
From our first conversation with JVR Consultancy, we knew that they were the perfect company for JAPP Transmissions to work alongside. Their consultant was extraordinarily knowable and completed the work ahead of schedule. JAPP Transmissions would recommend JVR Consultancy to any company who requires multiple accreditations.
Director
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01628 56 52 56
NHS Data Security and Protection Toolkit (DSPT) accreditation and compliance
Do you need help to achieve NHS Data Security and Protection Toolkit (DSPT) compliance for your organisation? Look no further than JVR Consultancy for the ultimate solution to your problem.
Medical Devices and Cybersecurity: What You Need to Know
Medical equipment is unquestionably required – they can mean the difference between life and death, yet are they safe from hackers?
Ae you looking for UKCA Marking & MHRA Registration Help and Support?
If you are interested in UKCA Marking & MHRA Registration, or would like to talk to one of our expert consultants simply click the following button to arrange a call back request. In a hurry, call head office today on 01628 56 52 56 and don’t forget to mention our fast track support service.
What is UKCA Marking?
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:
- Medical devices
- In vitro diagnostic medical devices (IVDs)
- Active implantable medical devices
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)
MHRA Registration – What is it and Who Needs to Register?
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:
- All classes of devices (Class I, IIa, IIb, III) must be registered
- Distributors and importers may also need to register
- Overseas manufacturers (including EU-based) must appoint a UK Responsible Person
📎 MHRA Registration Services – Learn More
UKCA Marking & MHRA Information
Devices are categorised based on risk and function:
- Class I Low risk – (e.g. non-sterile, non-measuring devices)
- Class Is/Im/Ir – Class I sterile / measuring / reusable devices
- Class IIa & IIb – Medium to high risk
- Class III – Highest risk (e.g. implantable or life-sustaining devices)
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:
- UKCA is valid only in Great Britain (not recognised in the EU)
- Devices must conform to UK Medical Devices Regulations
- UK Approved Bodies must be used instead of EU Notified Bodies
- A UK Responsible Person is required if the manufacturer is not based in the UK
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:
- Cyber Essentials certification
- Data Security and Protection Toolkit (DSPT) compliance
- Digital Technology Assessment Criteria (DTAC), if digital components are involved
📎 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:
- Act on your behalf in the UK
- Register your devices with the MHRA
- Ensure compliance with UK legislation
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:
- Device classification guidance and conformity assessment advice
- UKCA technical file preparation and documentation reviews
- MHRA registration support and portal navigation
- Appointment or coordination of a UK Responsible Person (UKRP)
- Ongoing regulatory monitoring and updates
- Integration with broader NHS requirements such as DTAC, DSPT, and ISO certifications
- Expert knowledge of UK and EU medical device regulations
- Specialists in helping EU-based manufacturers enter the UK market
- Deep understanding of NHS procurement processes
- Hands-on assistance with technical documentation, registration, and audits
- A holistic compliance partner, not just a checklist provider
We make UKCA and MHRA compliance understandable, achievable, and efficient.
Step-by-Step Guide:
- Classify your device – Based on risk and intended use
- Determine conformity route – Self-certification or via UK Approved Body
- Prepare UKCA documentation – Technical files, clinical evaluation, labelling
- Register with MHRA – Using your UKRP if applicable
- Gain UKCA marking – Label your product and begin distribution
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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