New regulations for clinical trials – Join our Route B substantial modifications pilot

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September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …

Decentralised Manufacturing: emerging considerations

Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …

MHRA MedTech Regs blog: working together to advance safety, access and innovation

In our September MedTech regulations blog, MHRA Head of Diagnostics and General Medical Devices Joseph Burt seeks stakeholder feedback to two surveys and looks ahead to Autumn updates about the Pre-market statutory instrument, an IVD roadmap and the next IMDRF …