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

 
• By Eliza Slawther

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.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) aims to be recognized globally as a “home of responsible innovation” when it comes to regulating software and artificial intelligence (AI) when used as medical devices.

This is according to its new software and AI as a medical device change program, the details of which...

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More from Europe

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

More from Geography

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

Medtech Experts Debate EU Recertification Gridlock

 
• By Amanda Maxwell

Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.