Tracking the UK’s medical devices reforms - the IVDs Roadmap

The MHRA has published an In Vitro Diagnostics Medical Devices Roadmap (IVDs Roadmap) as part of its wider Medical Devices Regulatory Reform Roadmap to implementation. The IVDs Roadmap is intended to support the NHS’s 10 Year Health Plan (discussed here) and the Government’s Life Sciences Sector Plan on expanding diagnostics into community settings and accelerating access to innovative diagnostics.

The IVDs Roadmap is intended to be a ‘living’ document and is expected to change to keep track of developments. It sets out broad timelines and deliverables in 2026 and 2027 across three themes:

• Regulatory support for innovative IVD technologies: This will include guidance addressing new technologies like software IVDs and pharmacogenomics. It will also establish a new integrated pathway for performance studies of companion diagnostics and clinical trials of medicines;
• Regulatory science and research – This workstream is intended to promote links with institutions supporting research in areas like dementia, cancer genomics and antimicrobial resistance, as well as expanding the portfolio of biological standards and reference materials for emerging diagnostics; 
• Pandemic preparedness and resilience – This will include greater international collaboration for future health emergencies, and adoption of the International Medical Device Regulators Forum clinical evidence framework for IVDs intended for pandemic pathogens.

The MHRA has stated that it continues to focus on strong research and high standards to support rapid assay development, for example Next Generation Sequencing-based cancer diagnostics, while providing best practice guidance for complex technologies like genetic testing, and strengthened pandemic preparedness.

Looking forward, we are expecting the pre-market regulatory reform package for medical devices to be notified to the World Trade Organisation shortly.

Learn more about our Life Sciences practice.

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