White Paper:
The Internet of Medical Things (IoMT) - Part 3
IoMT in the UK: Regulatory IoMT Pathways and Evidence Standards for Market Approvals
A CSL white paper for device makers, digital health teams and NHS partners. Clear steps to navigate UKCA/CE transitional routes, NICE ESF/DTAC, cybersecurity and virtual wards integration.
Introduction
Introducing and deploying connected medical devices demands more than clever or innovative technology. You need compliant connectivity, the right clinical & real-world evidence, and a confident route through UK regulation. This concise guide from CSL explains how to plan your approvals and NHS adoption, and what evidence is expected, how to position connectivity and cybersecurity, and the checklists teams can use immediately to help navigate the processes involved.
What you’ll learn:
- How UK approval works for IoMT/SaMD (with UKCA/CE transitional clarity)
- Evidence expectations across NICE ESF and NHS DTAC
- What “good” secure connectivity looks like in a medical device
- How virtual wards change integration and information governance
- Ready-to-use checklists and a step-by-step approval pathway
Who it’s for:
Regulatory, Quality and Product leaders; Clinical Safety & Digital teams; NHS programme leads; investors and partners assessing IoMT readiness.
Why CSL
CSL delivers secure and resilient connectivity for life- and mission-critical applications across the UK and EU. We help teams align device connectivity, security and monitoring with regulatory expectations – helping to accelerate safe, compliant deployment.