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.
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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.
In an interesting development for the life sciences sector, and which could therefore also have significance for the health and education sectors, the government announced in late November 2025 that it was laying a statutory instrument to include Life Sciences infrastructure as key national infrastructure for the purposes of the Public Order Act 2023.
The government is moving to classify life sciences infrastructure as key national infrastructure under the Public Order Act 2023, a change that may also impact the health and education sectors.
The MHRA has launched its call for evidence on regulation of AI in healthcare. This particular call for evidence relates to AI used in medical devices (including standalone AI as a medical device).
Virtual wards and remote healthcare are reshaping the delivery of medical services. With the global telehealth market expected to reach $175.5 billion by 2026, both the UK and the EU are working to adapt their regulatory frameworks.
The recently announced US/UK trade deal on pharmaceuticals and medtech has been warmly welcomed by industry representatives, research institutes and medical research charities.
UK medicines regulator, the MHRA, has carried out an extensive, two-day raid on an illicit weight loss medicines facility.
Legislation passed in 2023 opened the door to greater flexibility for precision genetic technology. From November 2025, new rules will streamline the approval process (in England only) for precision bred plant varieties—those developed using advanced gene editing tools like CRISPR, but without introducing foreign DNA.
PISCES is a new type of platform where shares in private companies can be traded. As companies choose to stay private for longer, PISCES should give investors the opportunity to trade private company shares easily and efficiently in an organised marketplace.
The UK’s clinical trials framework is undergoing a major transformation. Both the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have published updated guidance to support sponsors and other stakeholders through the transition.
The European Commission announced on 30 September that it has carried out unannounced inspections (otherwise known as ‘dawn raids’) at the premises of a company active in the vaccines sector. The dawn raids constitute a preliminary step in the Commission’s investigation into whether the inspected company has undertaken practices which may amount to anticompetitive disparagement.
The UK is positioning itself as a leading choice for clinical research. Alongside streamlining its legislative framework to offer greater efficiency, accessibility and innovation, the UK government is pushing for improvements to contracting and review processes.