MHRA publishes new IVD Roadmap
MHRA publishes new IVD Roadmap
Regulatory Affairs In Vitro Diagnostics
Wednesday, 17 December 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 15 December 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a new IVD Roadmap, setting out the planned priorities and deliverables for its IVD regulatory programme through mid-2027.
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MHRA publishes new IVD Roadmap | QbD Group Regulatory Update
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The roadmap sets out broad timelines and planned activities across three key themes:
- Regulatory support for innovative IVD technologies, including 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.
This roadmap complements the existing Medical Devices Regulatory Reform Roadmap and provides insight into MHRA’s priorities for the coming years.
What does this mean for you?
The roadmap provides insight into MHRA’s priorities for the next two years. Manufacturers of IVDs can expect continued focus on guidance for innovative technologies and companion diagnostics, support for regulatory science and emerging standards, and strengthened preparedness for future health emergencies. While the roadmap itself is not regulatory guidance, it signals the areas where MHRA is likely to focus resources and attention, helping manufacturers anticipate developments in UK IVD regulation.
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