MHRA publishes roadmap for reform of IVD in UK

The MHRA has released its first roadmap of regulatory reforms to improve development and access of innovative In Vitro Diagnostic (IVD) devices. It sets out plans for 2026 and 2027 designed to support the 10 Year Health Plan and Life Sciences Sector Plan, with IVDs seen as a critical part of delivering on commitments for early diagnosis and treatment. 

The roadmap is part of the UK’s wider medical device regulatory reform programme and follows consultations on planned changes to IVDs, including aligning the classification of IVDs with International Medical Device Regulators Forum (IMDRF) principles – see our earlier blog post for details.

The roadmap is a living document that sets out the MHRA’s plans for IVD reforms. It is built around three themes with the following deliverables:

1. Regulatory Support for Innovative IVD Technologies
   • Guidance for innovative IVDs on genetic testing, pharmacogenomics and Software as an IVD
   • Integrated pathway for performance studies of companion diagnostics (“CDx”) and clinical trials for medicines
   • Best practice guidance on a risk‑based approach to clinical evidence requirements for different CDx
2. Regulatory Science and Research
   • Links with institutions that support research into novel biomarkers for dementia, cancer genomics and novel IVDs for antimicrobial resistance
   • Expansion of portfolio of biological standards and reference materials, including in silico, based on emerging trends in IVDs and need
3. Pandemic Preparedness and Resilience
   • Statement addressing the gaps in diagnostic regulation identified by the International Pandemic Preparedness Secretariat
   • Adoption of the IMDRF’s clinical evidence framework for IVD devices intended for pandemic pathogens
   • Increased national and international collaboration for future health emergencies

The MHRA’s IVD roadmap shows the above being delivered over Q1 2026 to Q2 2027. Further updates with more precise timings are expected as work streams develop. 

If you would like to discuss any of the above, please contact a member of our Life Sciences team. This article was written by Rory Trust and Katie Matthews.