Innovation and medical devices

Regulatory advisory, health economics and stakeholder acceptability

Two people using a digital tablet to discuss clinical information

We help you build the evidence that regulators, commissioners and patients actually need – not just the evidence that is convenient to collect.

MHRA regulatory process advisory

Anglia Ruskin Clinical Trials Unit (ARCTU) provides in-house advisory support for the MHRA regulatory pathway for medical devices, SaMD, AI as a Medical Device (AIaMD) and in vitro diagnostics.

We help you understand your regulatory obligations and design studies that will satisfy the MHRA without unnecessary over-engineering.

  • UKCA pathway assessment for medical devices (Class I, IIa, IIb, III)
  • MHRA clinical investigation notification and Investigational Device Exemption requirements
  • AI as a Medical Device (AIaMD) regulatory guidance interpretation
  • Software as a Medical Device (SaMD) classification and clinical evaluation requirements
  • IVD regulatory framework and UKIVDR transition advice
  • Pre-submission meeting preparation and MHRA Scientific Advice support
  • Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) drafting
  • Post-Market Surveillance and PMCF planning
  • Regulatory documentation review for clinical investigation applications

Health economics advisory

Clinical evidence alone rarely secures NHS adoption. Commissioners, NICE and NHS England increasingly require economic evidence alongside clinical data.

Our in-house health economists advise on the economic evidence required at each stage of the development and commissioning pathway, and integrate economic data collection into clinical study design from the start.

  • Economic evidence requirements for NICE technology appraisals and medical technologies guidance
  • NHS commissioning evidence requirements for ICBs and NHS England specialised commissioning
  • Budget impact analysis for hospital procurement and formulary decisions
  • Cost-effectiveness model design and development
  • Resource use data collection integrated into trial eCRFs from the outset
  • EQ-5D and PROM selection for economic analysis
  • Value of information analysis
  • Evidence dossier preparation for NICE, NHS Supply Chain and HealthTech procurement
  • NHS AI Lab framework, Accelerated Access Collaborative (AAC) and HealthTech Navigator evidence requirements

Stakeholder acceptability and human factors

The most rigorously designed clinical study is worthless if the technology it evaluates is not acceptable to the clinicians, patients or organisations that would need to adopt it. This is particularly important for digital health tools, AI-based technologies, novel devices and interventions that change established clinical workflows.

  • Early stakeholder mapping – who needs to accept your technology, and what will persuade them?
  • Clinical champion identification and engagement strategy
  • NHS operational and workflow impact assessment
  • Human factors and usability study design (formative and summative)
  • Qualitative acceptability studies with patients and clinicians
  • Public acceptability and PPIE advisory for novel technologies
  • Organisational change and implementation readiness assessment
  • Commissioner and ICS engagement strategy for NHS adoption
  • Early multi-stakeholder workshops to pressure-test your technology concept before significant investment is committed