Pre-market statutory instrument

2025 in MedTech: a year of innovation, global leadership and regulatory milestones

Posted by: , Posted on: - Categories: AI Airlock, Diagnostics, Health Institution Exemption, IMDRF, IVD, Med Tech Regulations, Medical Devices, Post-Market Surveillance, Pre-market statutory instrument, Uncategorized

Rob Reid, MHRA deputy director of innovation devices, at AI Airlock Connect, October 2025 As the end of 2025 rapidly approaches, I find myself searching out those articles and lists that reflect on key moments across the year. Whether it …

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

Posted by: , Posted on: - Categories: designated standards, Health Institution Exemption (HIE), IMDRF, IVD, Med Tech Regulations, Post-Market Surveillance, Pre-market statutory instrument

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 …