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UK’s Ambitious Plan For Medtech Regulation Merits Attention

MHRA aims for balance in future system consultation

 
• By Ashley Yeo

The MHRA’s efforts to give the UK a nimble, responsive, innovation-facing medtech regulatory system earnt high marks from Bristows’ Alex Denoon, who assessed the opportunity at hand during the MedTech Summit.

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The Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the role and shape of the UK’s post-Brexit medical devices regulatory landscape is exactly halfway through the 10 weeks given. In a perfect world, the responses would be graded, analyzed and factored into legislation that is scheduled for release as a draft instrument in April 2022.

That would give 15 months for the legislation to get through parliament, be put in place and working at full...

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A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By Ashley Yeo

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

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A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
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HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 
• By Natasha Barrow

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

More from Europe

European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.

Medtech Will Benefit From Boost To EU’s Quantum Technology Initiative

 
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The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
• By Amanda Maxwell

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.