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.
Supporting EU Medical Device Manufacturers to Enter the NHS Supply Chain
At JVR Consultancy, we specialise in supporting EU-based medical device manufacturers looking to supply products to the National Health Service (NHS) in the United Kingdom. With a complex regulatory and compliance landscape to navigate, our expert consultants can guide you through every stage—ensuring your devices meet UK standards and NHS procurement frameworks.
Book your free consultation today to learn how we can support you with NHS Procurement Requirements for EU Medical Device Manufacturers.
This service page outlines the regulatory steps, NHS-specific accreditations, and how JVR Consultancy can support your entry into the UK healthcare market.
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.
JVR Consultancy stepped in to help us bring our management system up to speed and were very professional throughout the process. We passed our audit with no issues raised and our RISQS rating was increased to 5 stars. I would highly recommend using JVR for any company looking to gain RISQS accreditation or for assistance with RISQS compliance and Maintenance.
Speak to us today, call our Head Office:
01628 56 52 56
NHS Data Security and Protection Toolkit (DSPT)
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 NHS Procurement Requirements for EU Medical Device Manufacturers Help and Support?
If you are interested in NHS Procurement Requirements for EU Medical Device Manufacturers, 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.
Foundational Regulatory Requirements
UKCA Marking & MHRA Registration
Since the UK’s departure from the EU, medical devices must carry the UK Conformity Assessed (UKCA) mark to be marketed in Great Britain. Devices already CE-marked under EU MDR or IVDR are accepted until 30 June 2030, but early adoption of UKCA is strongly advised.
In addition:
- All devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA).
- The device classification (Class I to III) determines the required level of conformity assessment and whether a UK Approved Body must be involved.
📎 More on UKCA Medical Device Certification

How JVR Consultancy Supports You
JVR Consultancy is uniquely positioned to help EU-based medical device companies navigate UK market entry and NHS procurement compliance.
We provide:
- End-to-end UKCA and MHRA registration support
- Implementation of DSPT, DTAC, DCB0129, and DCB0160 standards
- Cyber Essentials certification guidance
- Ongoing regulatory consultancy, procurement engagement, and document submission
With years of experience in UK compliance and NHS frameworks, our team—including our Senior Consultant for GDPR & Cyber Security, Tom Hayes—offers tailored consultancy to fast-track your route to market.
📞 Contact JVR Consultancy Today to begin your NHS engagement journey.
NHS Procurement Information
Once your product complies with UK regulatory standards, the NHS imposes additional frameworks to ensure safety, security, and interoperability.
DTAC applies if your product includes software, apps, or digital features used by patients or NHS staff.
Key DTAC pillars:
- Clinical Safety – Compliance with DCB0129
- Data Protection – Including DPIA and UK GDPR compliance
- Technical Security – A valid Cyber Essentials certificate
- Interoperability – Use of NHS-recognised standards like FHIR
- Accessibility – WCAG 2.1 compliance
JVR Consultancy can assist with evidence gathering, risk documentation, and submission support.
📎 Cyber Essentials Support 📎 ISO 27001 Consultancy
DSPT is mandatory for any organisation accessing NHS patient data. It aligns with the National Data Guardian’s 10 data security standards.
Requirements include:
- Annual self-assessment submission by 30 June
- Staff training, incident response, patching protocols
- A Cyber Essentials certificate to align with DSPT expectations
📎 DSPT Consultancy Services
These NHS Digital Clinical Safety Standards are required under the Health and Social Care Act 2012:
- DCB0129: Applies to the manufacture of health IT systems
- DCB0160: Applies to the deployment and use of health IT systems
JVR Consultancy can assist in implementing a clinical risk management framework that ensures full compliance.
While not always mandatory, the following accreditations support NHS engagement and improve credibility:
- Cyber Essentials Plus (CE+) – Higher assurance through independent testing
- ISO 13485 – Quality Management Systems for Medical Devices
- ISO 27001 – Information Security Management Systems
- ORCHA Accreditation – Useful for digital health apps and software
- MHRA Registration
- UKCA Certification
- DSPT Registration & Submission
- DTAC Questionnaire (if digital)
- Cyber Essentials Certification
- ISO 13485 / 27001 (Recommended)
- NHS Buyer Engagement
Whether you manufacture a simple non-digital device or an advanced, connected platform, JVR Consultancy is here to ensure your compliance, safety, and procurement readiness are rock-solid. We demystify regulations and turn them into clear, manageable steps—helping you engage with the NHS efficiently and confidently.
Related Articles
More reasons to choose JVR Consultancy for Compliance & Risk Management