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MedTech Forum 2023: Europe’s Regulatory Maze Must Be Simplified, But How?

 
• By Eliza Slawther

Navigating Europe’s increasingly complex maze of regulations was the topic du jour at this year’s MedTech Forum conference. Despite growing concerns that the EU is losing its historic attractiveness for companies, a spirit of resilience characterized the busy three-day meeting.

Oliver Bisazza, CEO of MedTech Europe, Dublin, 2023
Oliver Bisazza, CEO of MedTech Europe, speaking at the MedTech Forum 2023 in Dublin, Ireland

Hundreds of medtech innovators, policymakers and thought leaders convened in Dublin on 30 May – 1 June for the MedTech Forum 2023, hosted by trade body MedTech Europe, to discuss and debate how best to tackle ever-increasing regulatory pressures faced by EU medical device and diagnostic companies.

Opening the conference, MedTech Europe’s new CEO Oliver Bisazza did not shy away from acknowledging that Europe faces “slowly losing...

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European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

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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

 
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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 Geography

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

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.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.