The Internet of Medical Things (IoMT): Regulatory Pathways & Evidence for NHS Adoption

This new CSL white paper explains the practical steps to achieve market approval and NHS adoption – covering UKCA/CE transitional routes, cybersecurity and interoperability expectations, the NICE Evidence Standards Framework (ESF), and integration with virtual wards. It includes checklists and a step-by-step pathway you can use immediately.

• Medical Device Manufacturers
• Product, Regulatory and Quality leaders at medical device & digital health firms
• NHS digital, clinical safety and virtual ward programme teams
• Investors and partners assessing IoMT compliance and go-to-market readiness

• How UK approval works for connected devices – from classification to conformity assessment, with clear, practical explanations of UKCA/CE transitional arrangements.
• What “good” connectivity looks like in a regulated device – evidence for secure data transfer, interoperability (e.g., FHIR, SNOMED), and cybersecurity (e.g., IEC 81001-5-1).
• How NICE ESF & DTAC influence NHS adoption – and how to map your clinical, usability and real-world evidence accordingly.
• Virtual wards integration – requirements, information governance and workflow fit.
• Ready-to-use tools – manufacturer checklists and a step-by-step approval pathway for a Class IIb IoMT device.

• Executive overview of the UK device framework (GB/NI) and the role of connectivity in safety & performance
• Conformity assessment routes and evidence planning for SaMD/IoMT
• Virtual ward ecosystem considerations (governance, integration and data flow)
• Practical checklists for regulatory readiness, cybersecurity, Information Governance (IG) and post-market surveillance

For over two decades, CSL has delivered resilient, multi-network connectivity for life-critical applications. We work with and help manufacturers de-risk approvals and NHS deployment by aligning device connectivity, security and monitoring with regulatory expectations.