Joseph Burt

Innovative approaches to Med Tech regulatory reform

Posted by: , Posted on: - Categories: AI Airlock, designated standards, Health Institution Exemption, Med Tech Regulations, Medical Devices

Well, hello again.  Hasn’t time passed by so quickly since my last blog in September. At the MHRA, we have many exciting and pioneering initiatives underway. I was listening to a medical device podcast recently and the podcast host proclaimed …

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 …