1. Medtech Insight
  2. >>Geography
  3. >>Europe
  4. >>United Kingdom

UK MHRA Full Steam Ahead On Transformation Plan But Medtech Regulation Still Held Up

UK regulatory agency’s One Agency approach on cusp of going live

 
• By Ashley Yeo

Teething troubles including staffing issues and a hold-up in the progress of the post-Brexit medical devices statutory instruments have beset the UK MHRA as it transforms to a new lifecycle-based regulatory agency that puts primacy on patient safety. But there is much to celebrate, says chief executive June Raine.

Shutterstock

The “people” aspects of the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) transformation remain a key priority, the agency’s 21 June board meeting held in public heard. Recruitment to new agency roles has taken longer than anticipated, but with over 90% of them now filled, the new MHRA structure officially came into operation on the designation date of 1 June, the agency’s chief executive, June Raine, said.

“We are in business,” she said, adding that the live launch of the new “One Agency” will take place in a week’s time. Among its many advances in the past...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United Kingdom

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.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.

More from Europe

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.