# In Vitro Diagnostic roadmap

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/95553d7f-5995-4c53-aa69-d2165e2f7da6
Type: Guidance
Published: December 15, 2025

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a strategic roadmap for In Vitro Diagnostics (IVD) as part of a broader MedTech Regulatory Reform initiative. This plan aligns with the government's 10 Year Health Plan and Life Sciences Sector Plan, aiming to transition diagnostics into community settings while accelerating access to innovative medical tools. Although the document does not stem from specific inspections or address regulatory violations, it outlines a structured approach to evolving the regulatory landscape. The framework focuses on three primary themes: providing regulatory support for innovative technologies, advancing regulatory science through research and standards, and strengthening pandemic preparedness. Key priorities include developing guidance for Next Generation Sequencing (NGS) in cancer diagnostics and establishing best practices for genetic testing. The roadmap sets out specific deliverables and timelines spanning 2026 and 2027. Required actions for the agency include promoting scientific research, creating reference materials for emerging diagnostics, and fostering international collaboration to build resilience against future health emergencies. By modernizing these processes, the MHRA aims to support high standards in assay development and ensure that timely, effective diagnostic solutions are available to improve patient outcomes.

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## Content

The MHRA committed to publishing an In Vitro Diagnostics (IVD) roadmap as part of the MedTech Regulatory Reform roadmap . There are commitments in the 10 Year Health Plan and the Life Sciences Sector Plan to expand diagnostics into community settings and speed up access to innovative diagnostics. The roadmap supports the development and access of innovative IVD devices which play a critical role in improving patient outcomes through timely diagnosis and effective treatment. We are continuing to focus on strong research and high standards to support rapid assay development, such as Next Generation Sequencing (NGS)-based cancer diagnostics, while providing best practice guidance for complex technologies like genetic testing, and strengthened pandemic preparedness. The roadmap sets out broad timelines and deliverables across 2026 and 2027 across three themes: Regulatory support for innovative IVD technologies - Guidance for new technologies and companion diagnostics. Regulatory science and research - Promoting scientific research, standards, and reference materials for emerging diagnostics. Pandemic preparedness and resilience - Strengthening regulatory frameworks and international collaboration for future health emergencies.

## Attachments

- [In Vitro Diagnostic Roadmap](https://assets.publishing.service.gov.uk/media/693c1382adb5707d9f33d6ba/MHRA_IVD_Roadmap.pdf)