Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


‘Project Glass Box’ - UK Reveals Roadmap For AI Medtech Regulation

Executive Summary

The MHRA recently announced plans to review and reform how medical devices with AI or software components are to be regulated in the UK. Its new roadmap sheds light on how, exactly, it will deliver on these ambitions.

You may also be interested in...

What Regulators Want To See From AI And Software-Based Devices

Experts in software and AI medtech regulation from the UK’s MHRA have outlined the questions that device developers should seek to answer when preparing for the regulatory process.

News We’re Watching: UK Software Guidance, FDA Approvals, Halyard Mask Warning

Abbott landed a surprise US FDA approval for the FreeStyle Libre 3 glucose monitoring system. Also this week: updated guidance documents on software (UK) and angioplasty catheters (US), FDA clearances for Candesant and Moximed, new regulatory requirements for spinal spheres, and a warning on Halyard masks. 

What The UK’s “Non-Statutory” AI Regulatory Framework Means For Medtech

The UK government has proposed a “pro-innovation” AI regulation strategy, which will utilize the expertise of existing regulators and avoid new legislation. But what does this mean for the medtech sector, and how does the UK approach differ from the EU’s AI Act?

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts