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.
About the Author
MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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