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

MHRA Promises UK Devices Regulation Will Enter ‘New Era Of Evolution’

ABHI Annual Conference Hears Of MHRA Drive To Get New Regulatory Framework In Place

 
• By Ashley Yeo

No longer a watchdog, the UK MHRA wants to be seen as an enabling regulator, using new methodologies and data sources to bring device innovations safely into use, says agency chief executive June Raine.

union jack flag and iconic Big Ben at the palace of Westminster, London - the UK prepares for new elections - Image

75% of respondents to the Association of British HealthTech Industries’ 2024 survey of UK medtech industry trends and needs say they welcome positively the UK’s plans for international recognition of device approvals. Four comparable regulator countries (CRC), including the US (Food and Drug Administration – FDA), have been selected by MHRA.

So said Peter Ellingworth, the association’s chief executive, as he released key early findings from the survey during the association’s...

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

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

UK MHRA Takes Stock, Seeks CMSO And Reveals Device Innovation Early Access Thinking

 
• By Ashley Yeo

Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.

Siemens Healthineers Mitigates Headwinds With ‘Value-Add Structural Changes’

 
• By Natasha Barrow

Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."

More from Europe

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Why EU Notified Bodies Need To Alter The Way They Work

 
• By Amanda Maxwell

Without change, the implementation of the MDR and IVDR could hit another wall.

UK MHRA Takes Stock, Seeks CMSO And Reveals Device Innovation Early Access Thinking

 
• By Ashley Yeo

Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.