Foreword


Diagnostics at a turning point Mark Reed – European General Manager, Pro-Lab Diagnostics


The next few years will be decisive for the UK diagnostics sector. Regulatory reform is front and centre. The MHRA’s transition to a UK-native medical-device and IVD regime introduces new conformity routes, post- market obligations and evidence expectations. Organisations should map product portfolios to the emerging framework and update technical documentation now, and plan for more intensive post-market surveillance. Parallel to regulatory change, data


governance is being rebalanced. The Data (Use and Access) Act and related measures will broaden opportunities for secondary use of health data and AI development while imposing new safeguards around automated decision making and cross-border flows. For diagnostics developers this means investing in robust data-governance frameworks, updating data protection processes and designing AI systems with transparency and explainability built in. Public-health priorities are shifting


resource and procurement. UKHSA’s priority pathogen families and renewed emphasis on surveillance highlight demand for rapid, multiplex assays, genomic compatibility and wastewater and sentinel systems. The NHS’s move to expand community diagnostics and decentralised care means that devices must be operationally flexible, interoperable with NHS systems and deliver measurable pathway improvements. Technology promises enormous benefits but brings fresh obligations. AI-enabled diagnostics and digital triage tools must be supported by rigorous


THE BIOMEDICAL SCIENCE INDUSTRY HANDBOOK 2026 l 9


clinical validation, ongoing real-world performance monitoring and demonstrable risk management. Cybersecurity and supply- chain resilience are now procurement criteria. What should industry do today? Prioritise


regulatory readiness, update governance for data and AI, align R&D with surveillance needs, and reframe value propositions around pathway impact for the NHS. Build rapid validation playbooks for emerging variants, strengthen partnerships with sequencing hubs and be transparent with patients and clinicians about data use and algorithmic decision making. By setting clear standards for technical


evidence, data stewardship, AI governance and resilience, our industry will promote safer innovation and stronger public trust. The companies that step up by investing in compliance, interoperability and rapid responsiveness will not only meet regulatory expectation but will deliver diagnostics that protect patients and strengthen the nation’s preparedness.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86